Date: May, 2024 | CategoryProofreading Author: Amanda De Luca


In the highly regulated and complex world of pharmaceuticals, accuracy and precision are paramount. Even minor oversights or errors in labeling, packaging, or documentation can lead to significant consequences from regulatory non-compliance issues such as sanctions and recalls, to potentially compromising consumer and patient safety. 

To navigate these challenges, leading pharmaceutical companies are increasingly leveraging advanced technologies like GlobalVision’s Verify to automate the proofreading and quality inspections of their critical content and labeling files. 

In this blog post, we will explore 10 reasons why leading pharma companies are opting for automation with Verify and putting their trust in this market-leading software.

1. Ensures Regulatory Compliance

It’s no secret that health authorities such as the FDA in the United-States and the EMA in Europe  impose stringent regulations and  guidelines on pharmaceutical companies, making compliance a non-negotiable. 

These companies operate within an environment of strict regulatory guidelines and any deviation from these standards throughout the drug development and packaging process, can lead to regulatory sanctions  or even hefty fines—noting that this also applies to medical device companies.

Verify’s cloud-based automated proofreading tools  are designed to detect any potential deviations or errors in documentation from text, graphics, barcode and even braille, thus ensuring that documentation and all critical content align with regulatory requirements, minimizing the risk of non-compliance and associated penalties. Key features built into the platform such as medical and custom dictionaries are there to streamline the workflows of regulatory professionals, and ultimately providing peace of mind when it comes to compliance.

2. Eliminates Human Error

Manual proofreading and quality inspections are prone to human error, especially when dealing with large volumes  of documents which only increase with the size of the organization. Those tasked with this tedious process are often prone to fatigue due to long hours of reviewing text-heavy documents such as Instructions for Use (IFUs). This is where automated proofreading comes to play, setting out to eliminate the risk of human error in such processes. 

Verify’s cloud-based automated proofreading tools  significantly reduce the chances of oversights, ensuring that critical information is accurately reviewed and approved. As a result, the efficacy and accuracy of the proofreading process are drastically enhanced, offering a reliable solution for meticulous document scrutiny across pharmaceutical companies.

3. Accelerates Time-to-Market

Experts suggest that delaying the commercialization or launch of a $150 million pharmaceutical product by just one month could lead to a sales shortfall exceeding $12 million. This is why life sciences enterprises cannot depend solely on existing full-time employees engaged in other duties to facilitate a product launch.

Verify’s automated proofreading software streamlines the proofreading process, reducing the time required for quality control and enabling companies to bring products to market faster without compromising on quality or accuracy. 

By automating the proofreading process, Verify’s automated solution frees up valuable human resources within pharmaceutical companies allowing teams to focus on more strategic tasks, such as research and development, while the software aids in the meticulous task of quality control. 

Thanks to this automation, the regulatory, labeling, and commercial processes within pharma are significantly optimized, resulting in a swifter time-to-market, which is key for capturing market share and maintaining a competitive edge in the market. 

For perspective see what a top pharmaceutical company had to say about GlobalVision’s automated solutions, “Manually proofreading one document would take one hour to complete. Considering workloads of over 2 dozen document inspections weekly, manual checks would result in 24 hours of proofreading in a week. With GlobalVision, this task is completed within minutes.”

4. Helps with Brand Equity 

Precision is crucial in pharmaceutical documentation, however this does not only apply to text but to all components of a document as well. 

Pharmaceutical documentation often includes graphics such as logos, diagrams, and more. Automated proofreading, with its robust and comprehensive capabilities, is capable of inspecting these graphics for any discrepancies with pixel-to-pixel accuracy, ensuring that they meet quality standards and are correctly placed within the document without any errors. 

What’s more, this precise graphics compare capability enables companies to better ensure brand equity by checking graphical components such as logos and images. By checking these graphics, companies can ensure that all brand guidelines are being followed and met and that products are reaching consumers at the highest quality, ensuring brand reputation and subsequently, brand loyalty

With such precise and accurate graphics comparisons, pharmaceutical teams can be sure that not only is their text and spelling correct, but their artwork and complete product is accurate as well. 

5. Eases Global Scalability 

Pharma companies often operate globally and need to cater to diverse markets with different language requirements. 

Automated proofreading tools such as Verify supports multilingual proofreading and checks spelling in 37 global languages which includes Medical and Custom dictionaries to cater to the unique terms and needs of individual companies. What’s more, Verify is able to find discrepancies in different scripts and alphabets such as Asian characters, Cyrillic, Greek, etc. and can also accurately inspect right-to-left languages such as Arabic and Hebrew. 

This advanced capability not only aids in the enhanced accuracy of pharmaceutical products, it also makes scaling globally much easier for global enterprises with customers all over the world. In one quick inspection, companies can leverage the advanced language capabilities available to them in Verify and check for text and spelling differences, all within a seconds to minutes. 

This allows companies to maintain consistency and accuracy across various languages and regions and enables them to scale more easily, meeting the needs of their customers worldwide. 

6. Enhances Collaboration

Verify’s automated proofreading software facilitates collaboration among teams by providing a centralized platform for proofreading and quality inspections. This ensures that all stakeholders, from regulatory affairs to labeling and commercial teams, can review documents and share reports with relevant stakeholders, fostering better communication and alignment amongst teams and cross-functionally.

Also, the capacity to monitor modifications and uphold version control guarantees that every stakeholder has access to the latest information. This leads to better-informed choices and enhances the quality of documentation and subsequently, products. 

7. Minimizes Product Recalls

Product recalls can be detrimental to a pharmaceutical company’s reputation and finances. 

For perspective, clinically important drug recalls occur approximately once per month in the United States while one of the top recall causes in pharmaceuticals is incorrect labeling. 

Automated proofreading helps identify these potential issues early in the production process by pinpointing inconsistencies and deviations in critical documentation, allowing teams to catch errors on time and make the necessary adjustments before it’s too late. This enhances the accuracy and consistency of information, minimizing the risk of recalls due to documentation or labeling errors and safeguards both consumer safety and the company’s reputation.

8. Improves Cost Efficiency

Manual proofreading is not just time-consuming—it can also be expensive! 

Hiring external proofreaders, especially when dealing with languages where native speakers are needed for the task, or simply allocating internal resources for this task incurs costs that add up over time. While implementing automated proofreading solutions may require an initial investment, the long-term cost savings and return on investment are substantial. 

By reducing the need for manual proofreading and minimizing errors, Verify enhances cost efficiency in the pharmaceutical production process and is ultimately a solution that pays for itself through increased efficiency and error prevention.

9. Offers Comprehensive Reporting

For pharmaceutical companies, documentation is not just about producing critical documentation such as labels and inserts — it’s also about maintaining a detailed record of changes and approvals. 

Verify, with its automated proofreading features, provides comprehensive reporting tools that track every step of the proofreading process, offering transparency and audit trails for regulatory purposes. This not only helps in inspection and revision workflows it also is a key competent in ensuring data integrity. 

In fact, automated proofreading software is not just a form of error-detection software, GlobalVision’s Verify features an audit trail for compliance with FDA 21 CFR Part 11. The platform doesn’t just go over the document pixel-by-pixel or character-by-character to detect graphics and text differences, it also tracks parameter changes and log-ins, so data becomes “attributable,” one of the five principles of data integrity.

10. Adapts to Evolving Technologies

Verify prioritizes innovation and is constantly evolving through feature enhancements and regular updates. 

As technology continues to advance, pharmaceutical companies must stay ahead of the curve. Verify, as GlobalVision’s newest and most innovative cloud-based, automated proofreading tool, is a future-ready solution that adapts to evolving technologies, ensuring that pharma companies can meet the challenges of an ever-changing industry.

The software is updated every quarter and also leverages the newest technologies such as machine learning and artificial intelligence. By embracing these technologies, Verify equips pharmaceutical companies with the latest and most cutting-edge proofreading tools, constantly setting the bar higher with each new software release.

Automate Your Proofreading Today

For the pharmaceutical industry, the benefits of automating proofreading processes with GlobalVision’s Verify are evident for top pharma companies striving for excellence in quality control. 

From ensuring regulatory compliance to accelerating time-to-market, top pharma companies are choosing automation as a strategic investment in precision, efficiency, and overall operational excellence. 

As the pharmaceutical world continues to evolve, automation through proofreading software becomes not just a choice, but a necessity for success in a highly competitive and regulated environment.

Learn more about Verify’s automated proofreading solutions by booking a demo today.

Date: April, 2024 | CategoryProofreading Author: Hana Trokic


Automated Proofreading—A Sustainable Approach to Proofreading That Reduces Carbon Footprint in the European Union and Beyond 

The current global climate urges sustainability not just in individual aspects of our lives, but also in the ways we conduct business – from European Union (EU) markets and beyond.  

As individuals and businesses alike strive to reduce their carbon footprint, innovative solutions emerge to address this growing concern, one solution lies in automated proofreading—a tool that not only enhances the overall efficiency of workflows across various industries but also contributes to the sustainability efforts of global organizations.

The Environmental Impact of Traditional Proofreading Methods

Traditional manual proofreading methods involve printing documents on paper, manually reviewing them, and making corrections by hand. This approach is not only time-consuming but it is also resource intensive as vast amounts of paper are required to proofread documents while significant energy for printing and transportation is also needed.

Additionally, manual reviews are unreliable methods that are prone to human error, especially when dealing with complex documentation that includes small text, graphics, barcodes, and braille. This increases the risk of misprints and leads to resources being wasted for a single set of documents or packaging assets.  

Now, consider the cumulative effect of this process across industries and sectors worldwide, and the effect these manual methods have on the environment becomes evident. From forest depletion for paper production to emissions generated by transportation and disposal, traditional proofreading practices can significantly contribute to ecological degradation.

According to studies from Gartner, 50 percent of business waste is composed of paper products, with the average office worker going through 10,000 sheets of paper per year. These numbers alone are staggering and don’t even account for other print products such as boxes, labeling, and packaging. In the EU alone for example, from 2010 to 2021, paper and cardboard was the main packaging waste material (34.0 million tonnes in 2021), 

Looking further at the environmental implications, 40 percent of the world’s timber is being cut down for paper production, making the need for sustainability in business practices in the EU and globally even more apparent as brands and consumers alike should look for ways to limit this waste in resources. 

Automated Proofreading for Sustainability

Automated proofreading offers a sustainable alternative that aligns with modern technological advancements. By leveraging innovative technologies, automated proofreading software meticulously inspects documents for errors in text, graphics, barcode and braille, eliminating the need for manual reviews.

This digitalization not only leads to less physical resources, like paper, being used, it also increases accuracy in proofreading, lowering the risk of errors slipping through to print, resulting in less reprints and less waste in production. 

Specifically, automated proofreading technology plays a significant role in promoting sustainability across various industries in the EU through the following sustainability efforts.

Paper Reduction

Automated proofreading eliminates the need for printing documents for proofreading purposes. By inspecting digital files directly, it drastically reduces paper consumption. This reduction in paper usage not only conserves valuable natural resources but also minimizes the environmental impact associated with paper production, transportation, and disposal.

Energy Conservation

Additionally, traditional proofreading methods involving printing and manual reviews consume substantial amounts of energy. By automating the proofreading process, automated proofreading software reduces the energy consumption associated with printing equipment and related machinery. This conservation of energy contributes to lower carbon emissions and supports EU business efforts in creating more sustainable and environmentally friendly processes

Waste Reduction

Manual proofreading often results in discarded or outdated printed materials, contributing to waste generation. With automated proofreading software, errors are identified and corrected digitally, eliminating the need for physical copies and reducing waste. 

It is also important to note that the software finds errors in the early stages of asset development, mitigating the risk of errors slipping through in the final phases of production and print. This helps prevent misprints from occurring and significantly reduces waste production, increasing the sustainability of EU business practices and processes.  

Enhanced Accuracy

Automated proofreading software offers unparalleled accuracy in error detection and correction. By leveraging the latest and most advanced technologies such as artificial intelligence, this software identifies even the smallest errors that are likely to be overlooked manually. This high level of accuracy reduces the need for reprints and revisions, further minimizing resource consumption and waste generation.

Streamlined Workflows

Automated proofreading software streamlines workflows by automating repetitive tasks and accelerating the identification of errors. This efficiency improvement not only saves time and resources but also enhances overall productivity. By optimizing workflows, the technology enables organizations in the EU to accomplish more with fewer resources, ultimately promoting sustainability through resource efficiency.

Remote Collaboration

Automated proofreading facilitates remote collaboration by enabling users to proofread documents digitally from any location. This capability reduces the need for physical meetings and transportation, thereby lowering carbon emissions associated with travel. By promoting remote work and collaboration, the technology supports sustainable practices by minimizing environmental impact.

Increased Sustainability with GlobalVision’s Suite of Automated Proofreading & Quality Inspection Tools

As we continue to strive to reduce our carbon footprint and increase sustainability, adopting automated proofreading technology represents a meaningful step in the right direction. 

More specifically, GlobalVision’s suite of automated proofreading and quality inspection tools are the ideal solution for promoting sustainability within various regulated industries as it is not only tailored to meet the stringent standards of regulated industries, it also streamlines revision workflows to reduce the unnecessary use of resources and energy. 

GlobalVision’s Verify 

For pharmaceuticals, CPG, and agencies in the EU, GlobalVision’s Verify is a cloud-based automated proofreading solution that can help increase sustainability within regulatory compliance, labeling quality control, and promotional materials quality control. 

By digitizing the document and packaging asset review process, the platform minimizes paper and energy consumption throughout the asset development life cycle. Organizations in the EU will be able to use less paper and energy throughout the regulatory, labeling, and promotional stages.  

GlobalVision Desktop 

For print and packaging companies in the EU, as well as incoming quality assurance within brands, GlobalVision Desktop helps sustainability in processes pertaining to press quality control and production quality control 

Built for use in production and incoming quality environments, GlobalVision Desktop combines powerful inspection tools into one robust application and ensures files are accurate as they move along the quality workflow. Due to its precision and accuracy, the platform minimizes errors that lead to production waste. It also minimizes document versions and decreases revision times leading to a significant reduction of paper and energy use across the production lifecycle and increases sustainability of workflows.  

Conclusion

Striving to become more sustainable in your everyday processes whether big or small—matters. 

Automated proofreading represents a tangible and impactful way for organizations in the EU and beyond to reduce their carbon footprint and increase sustainability while optimizing productivity and accuracy. 

Not only will it enhance operational efficiency but it will also significantly reduce resource consumption and waste generation. By leveraging advanced technologies, such as Verify, businesses can streamline revision workflows, minimize paper and energy use, and ensure the accuracy of critical documents from the very beginning of the production lifecycle.

Overall, automated proofreading not only contributes to individual businesses’ sustainability goals but also advances collective efforts towards a greener, more sustainable future for all.Request a demo of Verify’s automated proofreading software today and see how this technology can revolutionize your every day, sustainable business practices.

Date: April, 2024 | CategoryCompliance Author: Hana Trokic


Understanding the complex regulatory compliance landscape of the European Union’s (EU) pharmaceutical industry poses a significant challenge for companies aiming to remain compliant while ensuring the highest standards of product quality and safety. 

The stringent regulatory framework for EU pharma, designed to safeguard public health, mandates adherence to rigorous regulatory compliance with the European Medicines Agency (EMA)Heads of Medicines Agencies (HMAs), the European Commission, and guidelines such as the Good Manufacturing Practice (GMP), and the Good Clinical Practice (GCP), among other requirements. 

By exploring the pivotal role of technology in enhancing compliance, and highlighting the importance of quality control systems like automated proofreading technology, this guide serves as a roadmap for pharmaceutical companies striving to navigate the demanding regulatory environment of the EU. 

Understanding EU Pharmaceutical Regulatory Compliance

The foundation of staying compliant begins with a thorough understanding of the relevant regulations in the European Union. 

The EU has established a comprehensive regulatory compliance framework that includes directives and regulations from the above-mentioned health authorities, along with specific national regulations of member states.

All of these guidelines are in place to ensure the safety, efficacy, and quality of pharmaceutical products, subsequently ensuring their proper use and the well-being of consumers and patients. These guidelines cover a broad spectrum, from clinical trials to marketing authorizations, pharmacovigilance, and manufacturing practices. 

Key EU Pharmaceutical Guidelines

Key pharmaceutical guidelines for the EU are enforced by the European Medicines Agency (EMA) and national regulatory agencies within member states, aiming to harmonize regulatory compliance standards across the EU and ensure the highest level of protection for public health.

Some key guidelines include: 

  • Good Manufacturing Practice (GMP): Any manufacturer of medicine intended for the EU market, regardless of its global location, must adhere to GMP standards, ensuring that the medicines are of consistently high quality, appropriate for their intended use, and meet the requirements of the marketing authorisation or clinical trial authorisation.
  • Good Clinical Practice (GCP): Represents an ethical and scientific quality benchmark for the design, recording, and reporting of trials involving human subjects, ensuring public confidence by protecting the rights, safety, and wellbeing of participants and guaranteeing the credibility of clinical trial data.
  • Good Laboratory Practice (GLP): Defines a set of rules and criteria for a quality system focused on the organizational process and conditions under which non-clinical health and environmental safety studies are systematically planned, executed, monitored, documented, reported, and archived.
  • Good Distribution Practice (GDP): Ensures that medicines are legally authorized, correctly stored and transported, free from contamination, properly rotated in storage, and delivered on time to the right recipient. It also mandates a tracing system for identifying and recalling faulty products. Additionally, GDP covers the proper handling of active ingredients and other materials used in making medicines.
  • Clinical Trials Regulation (EU) 536/2014: Aims to unify clinical trial rules across the EU by introducing a single submission and authorization process through an EU portal, a uniform assessment leading to one decision, and clear rules on participant protection, informed consent, and transparency.
  • Pharmacovigilance Legislation: Enacted in July 2012, this legislation mandates reporting and monitoring of adverse effects from medical products to ensure patient safety. It also establishes regulatory frameworks for assessing risks, managing safety information, and communicating it to healthcare professionals and the public.
  • Advanced Therapy Medicinal Products (ATMPs): ATMPs are divided into three main categories:
    • Gene therapy medicines: includes genes that cause therapeutic, preventive, or diagnostic effects by introducing lab-created DNA into the body to treat diseases like genetic disorders, cancer, or chronic illnesses.
    • Somatic-cell therapy medicines: consist of cells or tissues that have been altered in their biological characteristics or are used in different ways from their original functions in the body, aiming to treat, diagnose, or prevent diseases.
    • Tissue-engineered medicines: involve cells or tissues modified to repair, regenerate, or replace human tissue.

Leveraging Technology for Regulatory Compliance

Having gone through key pharmaceutical regulations in the European Union, let’s explore how technology helps organizations adhere to them to ensure the regulatory compliance of their products. To do this, technology plays a critical role in achieving and maintaining compliance, especially in regulated industries such as pharmaceuticals. 

Automated systems and advanced technologies such as Artificial Intelligence (AI) and Machine Learning (ML) are being leveraged to streamline regulatory compliance processes throughout the pharmaceutical and drug development lifecycle. These algorithms analyze vast amounts of data to identify patterns, deviations, and potential risks in manufacturing processes, enabling proactive intervention to prevent compliance breaches. 

For perspective, GlobalVision’s independent market research has recently shown that AI-powered technologies help pharmaceutical companies get their products to market faster. Our survey results revealed that 89% of regulatory survey respondents said that using AI-powered solutions significantly reduced their compliance review process, allowing them to deliver products to market faster.

This goes hand in hand with recent plans being put into place with regards to the use of AI in EU pharma. As it is predicted to be so substantial in the near future, the EMA and the HMA have published an artificial intelligence work plan to 2028, setting out a collaborative and coordinated strategy to maximize the benefits of AI to stakeholders while managing the risks.

Along with AI technologies, other solutions to consider are quality control systems that help organizations stay compliant by easing the regulatory compliance process, and improving processes, and also cloud-based solutions that enable data sharing among stakeholders to maintain data integrity and confidentiality. 

It is also important to take into consideration solutions that have gone through a validation process. Validation involves a series of activities that take place over the lifecycle of any product and process to ensure that it has the required quality and is satisfying all requirements before being used. 

By integrating these technologies into regulatory compliance frameworks, and taking into consideration certain features, EU pharmaceutical companies can enhance regulatory compliance, minimize risks, and ultimately improve the quality of their products.

The Right Solution for Regulatory Compliance – Automated Proofreading Software

Choosing the right technological solution is essential for ensuring compliance with EU regulations. But one that incorporates many solutions and leverages many technologies may be the best way to go. This is where automated proofreading software comes into play. 

Automated proofreading is an innovative quality control solution for pharmaceuticals that helps  maintain the accuracy and quality of documents and subsequent products by inspecting all types of regulatory content present in pharmaceuticals. 

These documents include, packaging inserts and leaflets, product labels and packaging, regulatory submissions, clinical trial protocols and reports, Standard Operating Procedures (SOPs), and marketing materials such as brochures, websites, and promotional videos.

Regardless of the type of file or document, the advanced system helps pharmaceutical companies in the EU uphold quality standards with greater ease and efficiency, ensuring regulatory compliance within the EU.

This technological innovation provides better proofreading results and empowers teams to produce compliant and error-free documents as it acts as an added layer of insurance in quality control processes. Some benefits of automated proofreading include:

  • Proofreads critical content at scale: Automates proofreading of large volumes of documents at lightning speed, saves valuable time and resources and accelerates company growth while maintaining quality assurance.
  • Mitigates risk of financial losses: Automatically identifies critical errors such as incorrect drug names, dosages, and safety warnings and minimizes the risk of costly errors like product recalls, legal disputes, regulatory fines, reputational damage.
  • Expedite time-to-market: Increases speed of review and approval cycles for regulatory submissions, labeling, packaging, marketing materials and more and allows organizations to gain a competitive market advantage.

In essence, automated proofreading works by comprehensively inspecting documents to find discrepancies in the file. The innovative software conducts detailed inspections and proofreads all packaging assets from text, color, graphics, barcodes, braille, and more. 

Through automated proofreading, inspections of packaging components are completed exponentially faster than traditional proofreading, and a task that once took hours or days to complete is now reduced to only a few minutes.

“The biggest benefit [of GlobalVision] to our facility is the reduction in the amount of processing and testing time (by at least a factor of 3) and the ability to receive competent and timely support when needed….Overall, the greatest benefit is being able to rely on a high-quality product that allows us to be more efficient.”

  • Veronica Guilliams, Senior Manager – Visual Inspection, Pfizer 

Why Automated Proofreading is Essential for EU Regulatory Compliance 

Automated proofreading software plays a crucial role in enhancing the quality and regulatory compliance of pharmaceutical products in the EU. Some reasons why automated proofreading is an essential tool and software to leverage are:

  • Error Detection: Swiftly identify potential errors on pharmaceutical files, guaranteeing both accuracy and quality. This is vital not only for regulatory adherence but also for safeguarding patient safety. Accurate content ensures vital product information such as ingredients, dosages, and expiry dates are correctly portrayed, mitigating potential risks and upholding user well-being.
  • Consistency: Verify consistency in terminology, dosage information, and instructions throughout pharmaceutical documentation. Consistent information reduces confusion among healthcare professionals and users, enhancing clarity and usability.
  • Regulatory Compliance: Adhering to stringent regulatory requirements is critical in the pharmaceutical industry. Automated proofreading ensures all content aligns with regulatory standards, minimizing the risk of non-compliance issues such as fines, recalls, or legal repercussions.
  • Efficiency and Speed: Streamlines the proofreading process compared to manual reviews and methods, offering significant efficiency gains. This speed offers a particular advantage in the dynamic and fast-paced pharmaceutical industry, where timely and accurate product releases are crucial to get oftentimes life-saving pharmaceuticals to market and to capture significant market share. 
  • Version Control: Facilitate effective version control, ensuring that all documents reflect the most current and accurate information. This mitigates risks associated with outdated content, maintaining precision and relevance.
  • Consistent Branding: For pharmaceutical companies with diverse product portfolios, maintaining consistent branding across all products and content is essential for brand recognition and trust. Automated proofreading aids in upholding this consistency, reinforcing brand integrity.

By leveraging automated proofreading, EU pharmaceutical companies can elevate the accuracy, quality, and regulatory compliance of their products. This ultimately not only enhances patient safety but also preserves the integrity of medical products, aligning with corporations commitment to excellence and safety in healthcare.

GlobalVision’s Verify For Complete EU Regulatory Compliance

Verify, is GlobalVision’s cloud-based proofreading platform that is tailored specifically for the needs of regulated industries in the European Union such as pharma. 

The software has been meticulously evaluated and its functionality, performance, security, and compliance with relevant standards and regulations in the EU is guaranteed as the software fits the needs of end-users and helps adhere to industry-specific regulatory compliance requirements.

As a solution created for regulatory professionals, teams, and corporations, Verify seamlessly integrates with existing workflows and acts as an added layer of insurance that mitigates the risk of errors slipping through in highly-regulated documentation. 

The software allows for comprehensive inspections with robust capabilities including text and graphics comparisons, spell check, braille, and barcode inspections, all critical components of EU pharmaceutical documentation. What’s more, these comprehensive inspections are done in record-time and eliminate the need for tedious, manual reviews.  

This speed and precision in document inspections allow for faster review and approval cycles, enabling EU-compliant products to reach the market quickly, subsequently capturing market share from competitors due to their expedited workflows and allowing for a competitive advantage. 

Conclusion

For the pharmaceutical industry, navigating the complex regulatory landscape of the European Union is no easy task and demands commitment to compliance. 

The strict regulations set forth by governing health authorities in the EU are in place to help ensure the safety and efficacy of medicinal products while subsequently ensuring the safety of the end user. 

Once a tedious and time-consuming task, adhering to regulations becomes easier when corporations turn to technology to help them adhere to regulatory compliance 

Leveraging technology not only increases the speed at which quality control processes can be undergone, but also increases the accuracy and efficiency. Automated proofreading in particular, stands out as an ideal technological solution for EU pharmaceutical companies, offering advantages to document reviews such as error detection, speed, consistency, and version control, to name a few.

By integrating this technology, companies can not only meet EU regulatory compliance requirements but also uphold the highest standards of product quality and safety, thereby reinforcing their commitment to excellence in healthcare and ensuring the well-being of consumers and patients alike.

If you want to begin ensuring the regulatory compliance of your EU pharma documentation, book a demo of Verify and see firsthand the transformative impact it will have on your pharmaceutical proofreading and quality control processes.

Also, read our Pharmaceutical Industry Report to get exclusive insights into the growing role of technology in regulatory affairs and see how other top industry leaders are leveraging this technology to help them achieve their business goals. 

Date: April, 2024 | CategoryCompliance Author: Hana Trokic


GlobalVision’s Braille Height is breaking new ground by offering unmatched precision and speed never before seen for regulatory Braille inspections. With the new GVD Braille Height, inspections on pharmaceutical packaging can be completed in record time and with complete accuracy, getting products out to market faster than ever before.

This fully automated scanner-based solution is the first detailed Braille height measurement solution that measures the exact height of each individual Braille dot. Previously, teams had to rely on manual inspection methods or had to suffice with automated solutions giving an average measurement value across Braille regions instead of exact measurements, resulting in compromised compliance in the EU market.

GVD Braille Height not only eliminates the need for these error-prone and time-consuming manual Braille inspections, it also sets a new standard for speed of automated Braille inspections for professionals in regulated industries including pharmaceuticals and print and packaging. 

The GVD Braille Height inspection software is a one-of-a-kind solution on the market allowing teams in quality assurance and prepress to confidently meet regulatory standards and ensure accurate Braille assets leading to safer and more accessible products, marking a significant step forward in technology-driven quality assurance.

The Importance of Braille Accuracy 

In regulated industries, where adherence to standards and accessibility is crucial, Braille is a vital component of a product’s packaging or labeling to foster compliance and inclusivity.  

Braille, a universally accepted system of writing designed for individuals with visual impairments, is critical in ensuring that information, particularly in industries subject to strict regulations such as pharmaceuticals, is universally accessible.

The importance of Braille accuracy on pharmaceutical packaging and labeling cannot be overstated as it directly impacts the health and safety of consumers and patients with visual impairments. Taking into consideration that there are currently 295 million people worldwide with moderate to severe visual impairment, the need for Braille only becomes more pronounced.

 

 

In pharmaceuticals, where a single mistake can lead to serious health complications or even life-threatening consequences, the accuracy of Braille is a vital component of patient safety. Accurate Braille, including height, spacing, and translations, ensures that patients can independently access critical information regarding dosages, ingredients, and usage instructions, significantly reducing the risk of misuse. 

Yet, ensuring the accuracy of Braille assets is not just a matter of health safety, it is also a question of legal compliance and ethical responsibility. 

From a quality assurance and production perspective, Braille accuracy is vital as it is a mandatory component on pharmaceutical packaging all across Europe, governed by the European Medicines Agency (EMA) and is strongly recommended by the U.S. Food and Drug Administration (FDA) in Western markets, while other regions such as the ASEAN markets are working to heighten inclusivity by implementing Braille requirements on packaging soon.

Get To Market Faster Than Before 

By harnessing automated technology, the GVD Braille Height is 10X faster than competitor solutions and cuts down inspection times dramatically, from what would previously take several hours, down to just a few minutes. This drastic reduction in inspections enables teams to handle larger volumes of inspections with the same (or less) labor resources, boosting productivity and streamlining operations.

In the competitive EU medicines environment, time to market is a critical factor for success. The Braille Height inspection software streamlines inspection processes for Braille assets, allowing products to move more quickly from production to market. This speed can provide a competitive advantage, enabling companies to capture market share more effectively. It also aids teams specifically in pharma packaging to produce fast and accurate products allowing for life saving medicines and drugs to reach consumers more quickly.

In under 3 minutes, the software can accurately inspect Braille height for each individual dot, and all other aspects of Braille across various materials and formats, including foil cartons and full press sheets. It can also inspect and translate Braille in 43 languages – the highest amount of supported languages available for Braille translations – allowing for easier global scalability. 

These metrics once again set GVD Braille Height apart from other solutions as its automated technology is more robust and comprehensive than any other solutions on the market.   

For perspective, competitor software on average takes 50 mins to complete a full Press sheet Braille inspection, while GVD completes the same inspection in less than 3 minutes. What’s more, inspections can be done in 43 global languages, on different materials, across multiple Braille regions, and can be conducted simultaneously, with other GVD capabilities such as graphics, text, color, and barcode inspections. 

All of these capabilities allow teams to accelerate their inspection times and get vital pharmaceutical products to markets all across Europe at never before seen speeds. 

Experience Unmatched Braille Accuracy Through Precise Inspections

Traditionally, Braille inspections have been conducted manually to ensure the accuracy of Braille on packaging, labeling, and other regulatory documentation. This method involved trained personnel visually inspecting for obvious defects such as missing dots, misalignment, or inconsistencies in the Braille pattern. It also involved tactile inspections where Braille would be manually felt to ensure that the dots are raised to the correct height, are distinguishable to the touch, and are translated properly.

Due to the high risks that come with manual inspections, these methods have proven to be unreliable verification processes that are highly susceptible to human error, including oversight and fatigue. The GVD Braille Height mitigates these risks by automating the inspection process, thus significantly lowering the chances of mistakes that can compromise the quality and compliance of Braille outputs.

The Braille Height inspection software enables teams to check for Braille accuracy through automated inspections that check for Braille height, spacing, translations, missing dots, and more in one comprehensive scan. For Braille height specifically, the software inspects the exact height of each individual Braille dot ensuring the accuracy of Braille assets with extreme precision. 

In a matter of minutes, the inspection will yield a detailed report of all non-compliant Braille dots on packaging assets, allowing teams to make adjustments accordingly and ensure the complete accuracy of their regulatory documentation. 

Currently, GVD Braille Height is the most accurate on the market, yielding inspections that are 2 X more accurate than competitor solutions. 

Have Complete Confidence in Your Compliance 

For pharmaceutical and packaging industries, the accuracy of Braille on packaging and labeling is critical. This is due to the fact that errors in Braille can lead to devastating non-compliance issues.

When it comes to inspecting Braille accuracy on regulatory content such as packaging and labeling files, the process is done to ensure, amongst many things, the compliance with the Marburg Medium Font Standard as well as ISO 17351:2013 requirements for Braille on pharmaceutical products. 

Braille inspections in particular have posed challenges to the pharmaceutical and print and packaging industries as stringent regulations such as the Marburg Medium Font Standard requires a height of 0.20mm, with many companies producing at a height of 0.10mm. This makes Braille’s height incredibly difficult to measure through manual inspections and heightens the risk of errors slipping through that can lead to non-compliance issues.

GVD Braille Height addresses these unreliable and inefficient manual verification processes, reducing risks of incorrect Braille translations, tactile issues, spacing errors, and spelling mistakes, all of which cause compliance issues such as financial penalties, recalls, risk to consumer and patient safety and damage to a company’s reputation. 

This automated solution detects even minor discrepancies in Braille assets by inspecting each individual Braille dot, thereby increasing the accuracy and reliability of Braille asset verification. Not only does it render manual inspections obsolete, it outpaces other automated solutions that only give average measurement values across Braille regions.   

This advanced technology allows teams and organizations to avoid the consequences of non-compliance as they can now meet regulatory standards with greater precision, accuracy, and speed.

A New Standard for Braille Inspections

Due to its never-before seen accuracy, precision, and speed, the GVD Braille Height is a market-leading solution that sets a new standard for Braille inspections. 

Incoming quality assurance and production teams in the pharmaceutical and print and packaging industries can now leverage the latest and most innovative Braille inspection technology to eliminate bottlenecks and get critical products out to market all across the European Union faster than any other competitor.

By replacing slow, inefficient, error-prone manual inspections with fast, accurate, and automated technology, the Braille Height inspection software eliminates risks associated with human errors in Braille verification which include incorrect translations, tactile issues, spacing errors, and spelling mistakes all which can all lead to compliance issues, financial penalties, recalls, risks to consumer and patient safety, and damage to a company’s reputation.

If you want to discover the full capabilities of our innovative GVD Braille Height, book a demo today and see firsthand the transformative impact it will have on the accuracy, speed, and compliance of your regulated Braille assets.

Date: April, 2024 | CategoryProofreading Author: Hana Trokic


With AI, pharmaceutical companies can now streamline the process of analyzing vast amounts of data and documentation, ensuring compliance with regulatory standards and minimizing errors. ChatGPT, for example, with its natural language processing capabilities, empowers regulatory and quality assurance teams in pharma to leverage AI in simple ways that greatly enhance the overall quality of their content revisions. 

It can serve as a valuable tool for reviewing and refining regulatory documents by providing real-time feedback and suggestions,enabling efficient analysis of complex regulatory requirements, and ensuring compliance with stringent standards. 

By leveraging AI solutions such as ChatGPT, pharmaceutical companies can streamline the documentation revision process, identify potential errors or inconsistencies, and refine language to convey information more clearly and accurately. This not only improves the quality of their documentation but also enhances overall efficiency, ultimately contributing to safer and more reliable healthcare products.

Below, we delve into various ChatGPT prompts that revision teams in the pharmaceutical industry can use to streamline their proofreading efforts, improve accuracy, and ultimately accelerate time to market for vital drugs and medications.

The Difference Between ChatGPT and GPT Pro for Pharmaceutical Proofreading 

Before using ChatGPT to help enhance your pharmaceutical proofreading, it is important to understand the differences between ChatGPT, the free version, and GPT Pro, a paid version of the AI tool.  

ChatGPT is proficient in understanding and generating human-like text, offering a solid foundation for proofreading tasks, identifying grammatical errors and suggesting stylistic improvements in documents. However, its use case in pharmaceuticals is somewhat limited due to its generality. 

GPT Pro builds on ChatGPT’s conversational features with enhanced precision, offers a deeper understanding of pharmaceutical terminology, and the ability to adhere to the stringent regulatory standards of the industry. GPT Pro’s advanced algorithms can navigate the complex language of pharmaceutical documentation such as clinical research papers, drug development reports, and regulatory submissions with a high level of accuracy. This not only improves the efficiency and reliability of proofreading processes but also significantly reduces the risk of costly errors. 

What’s more, with the pro version of ChatGPT, users will be able to upload images and documents, a feature that can really aid teams that work with long form documentation and ultimately offer better quality results to specific prompts. 

Finally, ChatGPTs knowledge base is more up-to-date, resulting in more accurate answers and results to prompts. ChatGPT was last updated in January 2022, while ChatGPT Pro was updated in April 2023. 

While the pharmaceutical proofreading needs of individual teams can vary, it is important to research and choose the best software for your needs to yield the best proofreading results of your critical content.

1. Simplifying Complex Information

Prompt: “Summarize the following document* for a non-specialist audience, highlighting key points and any areas that may require further clarification. Extract specific quotes.”

This prompt helps teams break down complex pharmaceutical documents into simpler summaries, making it easier to identify areas that may be prone to misinterpretation or errors. By focusing on clarity and comprehension, teams can ensure that essential information is accessible to all stakeholders, including regulatory bodies and patients, and also ensure their pharmaceutical proofreading has been heightened. 

*Note: You will need access to GPT Pro to upload documents 

2. Identify Regulatory Guidelines

Prompt: “Review this file and identify the regulatory guidelines that apply to the document, highlighting the sections.”

With regulations constantly changing and evolving, keeping up with all updates can be difficult and time-consuming. This prompt directs ChatGPT to scan documents for compliance by indicating which specific regulatory guidelines are present in the file. By identifying the guidelines, it will be easier to conduct manual checks of said guidelines to confirm if they are up-to-date, ultimately safeguarding from potential issues that may require attention. It’s a proactive step in mitigating risks associated with regulatory submissions and ultimately improving your pharmaceutical proofreading.

*Note: You will need access to GPT Pro to upload documents 

3. Enhancing Document Consistency

Prompt: “Check this document for consistency in terminology, and referencing against the provided style guide.”

Consistency in pharmaceutical documentation ensures clarity and professionalism, reducing the risk of consumer and medical staff misinterpretation. This prompt assists teams in maintaining uniformity throughout a given document such as labeling files or instructions for use  improving the overall pharmaceutical proofreading process and subsequently the quality of pharmaceutical products. 

4. Detailing of Storage and Handling Instructions

Prompt: “Review storage and handling instructions for detail and clarity, ensuring they are practical and can be easily followed by end-users.”

This prompt helps ensure that instructions for storing and handling medications are clear and easy to follow, which is key to preventing mistakes and ensuring the medicine works as it should. From doctors to patients, it ensures that everyone understands how a pharmaceutical product should be stored and used safely and effectively.

5. Verifying Scientific Data and References

Prompt: “Verify the accuracy of the scientific data and references in this document, flagging any discrepancies or outdated information.”

Accuracy in data and references is non-negotiable in the pharmaceutical industry and regulated industries in general. For pharmaceutical proofreading, this prompt can help teams ensure that all cited studies and data points are current, relevant, and correctly interpreted, increasing the document’s credibility.

6. Ensuring Clear Communication of Risks and Side Effects

Prompt: “Highlight any sections related to drug risks and side effects that may need clearer explanation or more prominent disclosure.”

Effective communication of risks and side effects is crucial in pharmaceuticals for patient safety. This prompt for pharmaceutical proofreading aims to ensure that information on documentation such as drug packaging inserts, patient information leaflets (PILs), and medication guides is presented clearly and prominently, facilitating informed decision-making by healthcare providers and patients alike.

7. Cross-Checking Dosage Instructions

Prompt: “Review the dosage instructions in this document for accuracy and clarity, ensuring they are concise and easily understandable by healthcare professionals.”

This prompt focuses on the critical aspect of medication dosage, aiming to ensure that instructions on documents such as prescribing information, summary of product characteristics (SPC), patient information leaflets (PILs), and emergency use authorizations (EUA) are both accurate and clearly understandable to those administering the drugs.

8. Identifying Potential Ethical Concerns

Prompt: “Scan this document for any potential ethical concerns related to patient privacy, informed consent, or the presentation of clinical trial results.”

Ethical considerations are paramount in pharmaceutical documentation. This prompt helps in pharmaceutical proofreading by proactively identifying sections that might raise ethical issues, ensuring respect for patient rights and integrity in reporting.

9. Enhancing Document Accessibility

Prompt: “Suggest changes to improve the accessibility of this document, including the use of non-technical language, visual aids, and structure for readers with varied abilities.”

Accessibility ensures that information is available to everyone, regardless of their technical background or physical abilities. This prompt for pharmaceutical proofreading encourages the creation of documents that are more inclusive and user-friendly.

10. Optimize for Searchability

Prompt: “Review the document’s layout to improve searchability, including the use of headings, bullet points, and keywords related to the drug’s use and effects.”

Being able to find critical information about a pharmaceutical product quickly is of high importance. This prompt for pharmaceutical proofreading improves document organization, making important drug information like dosages and side effects easier to find and understand quickly. It helps consumers quickly locate the information they need, ensuring safety and efficiency in drug use.

Simple ChatGPT Prompts for Pharmaceutical Proofreading 

Simple ChatGPT prompts also offer immense value to revision teams in the pharmaceutical and other regulated industries. They are quick ways to ensure certain aspects of documentation are accurate, compliant, and are overall error-free, consistent and ready for market. 

The following short and simple ChatGPT prompts can help heighten pharmaceutical proofreading:

  • Is there any misleading information in this document?
  • Review this section of our regulatory submission and provide suggestions for improving clarity and compliance.
  • Help us identify any potential inconsistencies or errors in this document.
  • Is there any inconsistent language in this document? 
  • Summarize the key regulatory requirements for this product and provide a concise overview. 
  • Generate a comprehensive list of references to support the efficacy and safety claims in our submission.
  • We need to optimize the labeling information for this drug. Can you assist with drafting clear and compliant language?
  • Review our clinical trial data and ensure that it aligns with regulatory guidelines and standards.
  • Interpret the latest regulatory updates and incorporate them into our submission. 
  • Suggest ways to strengthen the risk management section of our regulatory documentation.

By leveraging AI, even in simple ways like using these simple ChatGPT prompts above, pharmaceutical companies can expect to see vast improvements in their proofreading processes while having an added layer of assurance that their documentation is free from errors and aligns with all regulatory and compliance requirements. 

Automated Proofreading for Pharma – A Leading Technological Solution 

While ChatGPT is a great tool to use to ensure certain aspects of your documentation is accurate, automated proofreading software is a comprehensive solution that leverages AI technologies to ensure the complete and holistic integrity of critical pharmaceutical and regulatory documentation and is an ideal solution for pharmaceutical proofreading. 

Any revision team in pharmaceuticals that deals with extremely sensitive documentation and products where even a minor content error can have detrimental or irreversible consequences can benefit from automated proofreading software.

Much in the same way ChatGPT identifies issues quickly, Verify, conducts comprehensive inspections of regulatory documents in a matter of minutes and produces an annotated report of all differences found, allowing for teams to make appropriate adjustments in record time and ensuring the accuracy, compliance and quality of documents and critical assets. 

The software’s diverse capabilities enable teams to effortlessly run a holistic inspection of documents to detect errors, from text, spelling, graphics, barcode, and braille.

This provides teams in the pharmaceutical industry with an added layer of insurance and a sense of confidence, knowing that all errors are being identified, and amended and that only high-quality products are going out to market.  

Conclusion

The integration of AI-powered tools like ChatGPT into the regulatory documentation process and for pharmaceutical proofreading represents a significant shift in the way revision teams tackle their proofreading and revision tasks in pharmaceuticals and other regulated industries

From simplifying complex information, ensuring regulatory compliance, enhancing document consistency, and improving overall clarity and accuracy, these AI solutions are paving the way for new benchmarks in accuracy, efficiency and reliability in healthcare product development and beyond. 

As these AI technologies continue to develop and AI applications continue to be refined, proofreading tasks will become increasingly easier and faster leading to safer, more accessible healthcare products. 

If you’re ready to take the first steps towards leveraging AI technologies to produce error-free regulatory content, get started with Verify’s automated proofreading software specifically tailored to regulated industries, and begin experiencing the advantages of using cutting-edge technology to proofread your critical content. 

Date: March, 2024 | CategoryProofreading Author: Hana Trokic


The Verify x Esko WebCenter Integration represents a digital shift in the packaging artwork review process.

Verify x Esko WebCenter – An Integration to Unify Your Artwork Management Processes  

The integration brings together Esko’s WebCenter, a web-based platform specifically tailored for CPG and pharmaceutical corporations to manage all aspects of the packaging management workflow from creation to approval and distribution—with GlobalVision’s industry-leading automated proofreading platform, Verify. The result is a unified and user-friendly workflow that streamlines document quality inspections and ensures 100% accuracy, compliance, and print readiness.

This integration harmonizes previously siloed systems that did not communicate with each other, which forced artwork, labeling, and prepress managers to constantly move back and forth between systems throughout disjointed packaging artwork processes. As teams need to meet strict deadlines, these disjointed processes resulted in major delays that ultimately hindered go-to-market timelines, team productivity, and even information security.

With the Verify x Esko WebCenter Integration, users can now perform various checks, including text and graphics comparisons, spell check, braille, and barcode inspections, and then seamlessly integrate these inspection reports including annotations back into their workflow with single-click file transfers.

Guarantees Content Security

The Verify x Esko WebCenter Integration changes the way artwork, labeling, and prepress teams operate by putting data security at the forefront of this automation. 

The integration not only automates the proofreading process and removes the need for manual file transfers and reviews, it also ensures that all files and their data is being protected. This is due to the closed-loop integration that ensures that all files leaving Esko WebCenter are securely transferred to Verify, prioritizing data security and protecting sensitive information. Through this integration, teams can now have complete confidence that all files are safe, accurate, and up-to-date. 

This secure and seamless interaction between systems allows for a smoother, more efficient process from start to finish, providing the right foundations for producing high-quality products while simultaneously giving teams confidence that their sensitive information remains within the protected confines of the integration. 

IT and Technology leaders can be assured that their teams are leveraging the latest innovations in automated proofreading while safeguarding files and data against potential threats.

Ensures File Compliance 

By operating within the secure framework provided by this integration, teams can now automatically identify errors in labeling and packaging materials. This capability is critical in minimizing the risk of compliance issues, especially for CPG, pharmaceutical, and other regulated industries, where it helps ensure patient and consumer safety. 

Through this integration, teams can position themselves as having the highest quality standards on the market, while keeping compliance at the forefront of their operations. With the ability to consistently produce error-free labeling and packaging assets, artwork, labeling and prepress teams can uphold and maintain compliance with the industry’s most stringent regulations. This focus on quality and compliance translates into greater trust and confidence from consumers and regulatory bodies alike. 

The Verify x Esko WebCenter Integration empowers teams to not just meet but exceed regulatory requirements, reinforcing their commitment to excellence and safeguarding their organization’s reputation for producing high-quality, compliant products.

Drives Productivity and Collaboration 

Artwork, labeling and packaging, as well as prepress teams can experience enhanced productivity through the integration of Verify’s automated proofreading capabilities within Esko’s WebCenter. 

With a single-click, Esko WebCenter users can identify potential errors on packaging files in real-time, and address them with the appropriate stakeholders for a swift resolution The ability to catch these errors early in the workflow not only alleviates stress among artwork,graphics, and prepress team members, it also reinforces  a higher level of collaboration throughout the process.

As a result of this seamless integration, artwork teams will see major improvements in productivity and efficiency. Through the reduction of time lost to disjointed processes and the enhancement of data integrity, this integration creates a smoother proofreading experience, leading to faster project completion times and heightened productivity

This advancement in packaging artwork management results in effective collaboration and communication within the team. 

Gets Products to Market Faster

Speed to market is a success metric that virtually all brands must strive for in our increasingly competitive global economic landscape. Often, being first to market represents a significant monetary and market share advantage for pharmaceutical and CPG companies alike.

With this in mind, labeling and packaging, as well as artwork and prepress teams are constantly working to reach increasingly strict deadlines and while navigating between siloed systems and disjointed processes before this integration, delays to market are almost inevitable. 

With the new Verify x Esko WebCenter Integration, automated proofreading tools are just one click away, allowing teams to significantly reduce process bottlenecks and move the needle when it comes to speed to market, thus allowing them to capture more market share and grow their competitive advantage. 

The New Standard for Packaging Artwork Reviews and Quality Control

The Verify x Esko WebCenter Integration sets a new standard where technological integration, automation, and collaboration are not just recommended but expected in the world of artwork management, labeling, and prepress. Organizations can now easily embrace and leverage technology to create efficient, secure, and innovative workflows that drive long term success.

Some key features teams can leverage with this new integration include:

  • Automated Proofreading: The automated proofreading capabilities of the integration ensures that potential errors are caught in real-time. This not only enhances accuracy but also saves time and resources that would otherwise be spent on manual proofreading and corrections.
  • Real-time Collaboration: Teams can collaborate in real time where annotations, comments, and feedback flow effortlessly between Verify and Esko WebCenter, eliminating communication gaps and ensuring that everyone involved is on the same page throughout the artwork development lifecycle.
  • Enhanced Security: The integration ensures that security concerns are alleviated through the secured closed-loop system. The new norm prioritizes data security, giving confidence to teams that sensitive information remains within the protected confines of Esko WebCenter.
  • Efficient Version Control: Version control is streamlined and efficient within the integrated system. Teams will no longer struggle with tracking different versions of artwork, reducing the risk of using outdated files and improving overall project management.
  • Focus on Innovation: With the streamlined processes, teams will now have more time and energy to focus on innovation and creativity. This encourages a proactive approach to quality assurance, compliance, and the development of packaging materials that go beyond industry standards.

How the Verify x Esko WebCenter Integration Works 

This integration is impactful yet remarkably simple to use, allowing you to leverage the power of Verify’s automated proofreading and quality control capabilities with just one click from your Esko WebCenter account. 

Simply create a new project in Esko WebCenter, choose the desired files to be inspected, and upload them to your  project. 

From there, just click on the ‘GlobalVision Verify’ button, and your files will be securely transferred to the Verify platform within seconds. In Verify, you can then compare text and graphics to instantly catch all differences between the two files. Once your inspection is complete, you’ll be able to review results and leave comments as you see fit.  

Finally, generate an inspection report, which is of course time and date-stamped for ultimate compliance and data integrity. The report will automatically be sent directly to Esko WebCenter and saved, where you will be redirected to carry on with your day-to-day tasks. Back in Esko WebCenter, you’ll also have the option to download the report and look through all annotations, allowing you to make the necessary corrections to your files or simply communicate the changes that are needed with your team. 

The Verify x Esko WebCenter Integration: The Future of Packaging Artwork Management 

With the Verify x Esko WebCenter Integration, artwork, labeling and prepress teams can expect to experience new highs in their packaging artwork workflows. 

The frictionless, automated proofreading processes this integration brings through the ability to check files as they move through the Esko WebCenter workflow, will enable teams to maintain accuracy and compliance by catching potential errors in real-time, alleviating the stress associated with misprints, recalls, and compliance issues while simultaneously boosting productivity and increasing efficiency.

The Verify x Esko WebCenter Integration brings together speed, precision and security into one cohesive solution to address the unique challenges faced by artwork, labeling and prepress teams and empowers them to save time and maintain compliance by automating proofreading throughout their packaging artwork management process.

See how top companies globally are already leveraging GlobalVision’s proofreading and inspection tools from Esko and book your free personalized demo today.

Date: March, 2024 | CategoryProofreading Author: Hana Trokic


Why does pharma need document comparison software for their regulatory proofreading?

For pharmaceutical companies, keeping documentation compliant with regulations is a top priority. From regulatory submissions to drug labels, promotional materials, and more, every piece of critical content must be meticulously proofread to ensure it adheres to strict regulations and is free from all errors. 

To ensure this level of accuracy and compliance, proofreading teams in pharma turn to technology, more specifically document comparison software, to help with their regulatory content revisions.

Keep reading to discover the top reasons why pharma needs document comparison software for regulatory proofreading and see why pharmaceutical companies are already turning to the software to proofread their regulatory documentation and to ensure the accuracy and compliance of their critical content.

1. Mitigates Risk Through Accuracy

Above all, ensuring the accuracy of pharmaceutical documentation is a top priority due to the severe consequences that errors can lead to, including regulatory fines, product recalls, and risks to consumers.

Document comparison software plays a vital role in enhancing pharma documentation accuracy by inspecting and detecting deviations in critical content such as regulatory submissions, labels, packaging files, batch records, standard operating procedures, marketing materials, and more. 

By automating revision tasks, the software eliminates the need for error-prone manual checks, which often result in inaccuracies and oversights. Document comparison software provides a detailed overview of differences in files, easing proofreading processes by enabling teams to catch discrepancies early in the process and minimizing the risk of error.  

This proactive approach not only ensures the accuracy of documentation, it also helps mitigate the risk of potential regulatory issues, product recalls, or legal actions stemming from documentation errors. This ultimately ensures compliance with government agencies and health authorities and proves why pharma needs document comparison software for their regulatory proofreading. 

“Accurate, precise, and efficient for label inspections. […] The software is a critical part of our inspection process. It provides what is expected upon using it by minimizing human inspection errors, improved efficiency, and customizable inspection reports that fits the situation.”

  • Corey Burgauer, Regulatory Technician, International Labels 

2. Increases Confidence in Compliance

Pharmaceutical companies need to navigate the complexities of ever-evolving compliance standards, regulations, and guidelines. Because of this, proofreading teams in the pharmaceutical industry are tasked with reviewing critical content that must adhere to stringent regulations.

Document comparison software plays a vital role in ensuring pharmaceutical companies’ confidence in regulatory compliance by thoroughly comparing document versions to an approved file and highlighting all differences to ensure that only the intended changes were made while no unintended changes were introduced. This can be especially helpful to automate for critical documents such as Drug Master Files (DMFs), fostering confidence that it remains compliant throughout the drug development lifecycle.

The software helps identify discrepancies allowing teams to make corrections and adjustments with ease, and ensures adherence to regulatory standards set by authorities like the FDA, EMA, MHRA, and beyond. 

“Even if you have a comma missing [the Regulatory Authority] ask us to repackage the product. [GlobalVision] saves us a lot of headaches and we avoid the costs of recalls.

  • Slava Krauklis, Deputy General Manager (Quality), Generium Pharmaceuticals

3. Speeds Up Product Time-to-Market

Without the use of technology, pharmaceutical companies are forced to conduct manual checks of their lengthy and extremely technical regulatory documents. This is not only error-prone but it is also filled with bottlenecks that slow down proofreading processes and ultimately slow down time-to-market. Document comparison software allows for the complete automation of these processes, significantly reducing the time and effort required for proofreading

By significantly reducing the time required to proofread critical documentation, the entire product lifecycle is sped-up allowing pharmaceutical companies to bring often life-saving drugs and medical devices to market faster without compromising on their quality.

“GlobalVision has been vital in artwork development as it helps pick up the tiniest of errors and differences both within text and graphics. It also saves so much time by not having to do manual proofreading.”

  • Praenisha Ramnath, Pharmacovigilance & Compliance Manager, iNova Pharmaceuticals

4. Enables Global Scalability

As pharmaceutical companies expand their product portfolios and global reach, scalability becomes a critical factor. Document comparison software is created to scale with growing business needs, ensuring that proofreading processes remain efficient and effective as companies expand on the global market.

The software, for example, offers a text comparison feature which has automatic language detection and works on all global languages, including right-to-left languages, and can also inspect different scripts, including Arabic, Hebrew, Asian characters, and more. This is crucial for any global pharmaceutical company that deals with critical documentation in several languages and needs to ensure the accuracy of their translations and files. 

The software can also be leveraged by global corporations who want to work in their native tongues by having the ability to change the UI in any available language of their choice. Users have the freedom to change the login and main page in languages they feel most comfortable working in for an ever more comfortable and seamless proofreading experience.  

“[GlobalVision] makes the entire process more streamlined and allows us to deal with foreign languages and very small font changes”

  • Imran Masood, Quality Specialist and Labs Head at Unilever – Dubai Personal Care Factory

5. Enhances Team Collaboration

Document comparison software significantly enhances team collaboration in pharmaceutical companies by streamlining the process of reviewing critical documents. 

With the software, team members can easily identify any changes made to documents, facilitating seamless collaboration on shared files. By providing a clear visual representation of differences between document versions, it minimizes misunderstandings and miscommunications, ensuring that every team is aware of the corrections made to a document and that they are working on a single version. 

Moreover, the ability to track changes and maintain version control ensures that all stakeholders have access to the most up-to-date information, leading to more informed decision-making and higher-quality outputs. 

“GlobalVision has allowed our group to be more efficient […] It is extremely beneficial to be able to put your documents into the software and within a very short amount of time be able to run a report on any differences found.”

  • Jan Meyers, Global Labeling Sr. Specialist, Regulatory Affairs, Bristol Myers-Squibb

6. Increases Resource and Cost Savings

Automating the process of proofreading critical documentation reduces the need for manual reviews, saving valuable time and labor resources. 

Manual proofreading is labor-intensive, often requiring a team of skilled professional proofreaders to meticulously review documents. The added cost of employing skilled labor for proofreading tasks can quickly add up, especially for large or ongoing projects. Manual processes are also extremely time-consuming often taking hours or even days, depending on the length and complexity of a piece of content. 

This delay in revision times can also lead to delays in product launches resulting in companies losing competitive market positioning and losing profits to faster competitors.

Document comparison software, however, enables the automation of proofreading tasks as the software comprehensively inspects and identifies errors in a fraction of the time by a single individual or small team, significantly speeding up proofreading times and reducing labor and resource costs involved.

Additionally, the software’s intuitive interface makes it easy to use, reducing the need for extensive training and support resources. As a result, pharmaceutical companies can optimize their workflows, allocate resources more effectively, and ultimately reduce operational costs associated with proofreading. 

7. Offers Continuous Technological Innovation

Document comparison software such as GlobalVision is at the forefront of technological innovation, continuously striving to enhance its capabilities and stay ahead of evolving industry needs. 

Through regular updates and feature enhancements, the software incorporates the latest advancements in document comparison technology for pharmaceuticals and regulated industries, ensuring that users have access to cutting-edge tools for their proofreading needs. 

Most recently, GlobalVision’s cloud-based proofreading software, Verify, has started leveraging machine learning algorithms and artificial intelligence with their OCR feature, providing the newest features and capabilities for pharmaceutical companies looking to automate their proofreading, even on rasterized or flattened documents. 

The constant innovation that is being put into Verify allows it to offer increasingly accurate results, minimizing false positives, and overall enhancing the productivity of proofreading teams in regulated industries. 

Moreover, for pharmaceutical companies, innovation and adopting the latest technologies serves as a critical competitive advantage on today’s fast-paced markets. Companies that leverage modern solutions, like document comparison software, can significantly outpace competitors who continue to use outdated methods that do not solve the bottlenecks in their processes. 

By prioritizing innovation, GlobalVision empowers pharmaceutical companies to stay competitive in a rapidly changing regulatory landscape, offering a reliable solution that evolves alongside technological advancements and industry standards and further proves why pharma needs document comparison software for their regulatory proofreading. 

“We’ve caught numerous mistakes, which has saved the company thousands of dollars over the years that we’ve been using GlobalVision. It’s a tool that I don’t know how we did without it. It’s become a tool that we use every day now.”

  • Vince Costanza, Phoenix Lithographing Corporation President 

Why Pharma Needs Document Comparison Software for Regulatory Proofreading

By continuously innovating and integrating cutting-edge technology, document comparison software allows pharmaceutical companies to stay ahead of industry needs, providing them with a reliable solution that evolves with the ever-changing regulatory landscape. 

It not only sets a new benchmark for proofreading in pharmaceuticals, bringing with it unmatched speed and accuracy, it also contributes to the industry’s main goal of delivering safe and compliant medical products to consumers worldwide. 

To begin exploring and leveraging this cutting-edge technology, book a demo of Verify and see firsthand the transformative impact it will have on your pharmaceutical proofreading and quality control processes.

Also, read our Pharmaceutical Industry Report to get exclusive insight into the growing role of technology in regulatory affairs and see how other top industry leaders are leveraging this technology to help them achieve their business goals. 

Date: February, 2024 | CategoryCompany Author: Hana Trokic


Verify’s New AI-Powered OCR Feature is Here!

Verify, GlobalVision’s newest and most innovative cloud-based proofreading software, has just raised the bar for proofreading in regulated industries with the official launch of its groundbreaking AI-powered OCR (optical character recognition) feature. 

This launch is set to transform the compliance and proofreading landscape, bringing with it many benefits that cater to the diverse needs of regulated industries ranging from regulatory, commercial pharma, to agencies, labeling and more.  

The addition of OCR to the Verify platform marks a strategic launch into Artificial Intelligence, aligning with GlobalVision’s commitment to empowering regulated industries with cutting-edge solutions that facilitate their workflows and accelerate time-to-market.

Watch our OCR feature in action! 

The OCR Technology Gap 

Previously, without OCR proofreading technology, regulatory, commercial, and labeling professionals in regulated industries, as well as the agencies that serve them, struggled with manual processes, facing challenges in handling flattened documents containing rasterized text. They were forced to perform visual text extractions, manual proofreading, and manual data entries.

While receiving flattened documents is often out of their control due to the many stakeholders often involved in working on a single document, in the absence of OCR technology, having to perform manual proofreading hinders efficiency, exposes them to potential errors and compliance risks, compromises consumer and patient safety, and causes bottlenecks in the asset development process. 

These critical problems only worsen with the added challenge of localization and translation tasks necessary for scalable, multinational operations.

Verify’s AI-Powered optical character recognition technology is designed to solve these problems and revolutionize how regulatory, commercial, agencies, and labeling teams handle text within their document review processes, bringing automation and accuracy to the forefront. 

OCR for Compliance With Regulatory Requirements

For industries governed by strict regulations, compliance is non-negotiable. 

Regulatory teams are often faced with the difficulty of dealing with rasterized documents, leading to manual inspections, increased risk of errors, and workflow inefficiencies. Similarly, commercial teams and agencies encounter difficulties in handling vast amounts of promotional content which is held to the highest standard in compliance, hindering creativity and time spent on more meaningful work. In parallel, labeling teams also deal with proofreading tasks within strict deadlines and regulations. 

With the launch of Verify’s newest AI-powered OCR feature, compliance and review processes are simplified through the automation of text extractions, and the verification of critical text data in documents. This not only eliminates the need for error-prone manual checks, it ensures greater accuracy and significantly reduces the risk of human error, ultimately streamlining compliance processes and ensuring compliance with global health authorities. 

Regulated companies can now navigate the complex regulatory landscape with greater confidence, knowing that Verify’s OCR feature acts as an added layer of insurance, guaranteeing the quality of their documentation. 

Increased Patient and Consumer Safety Assurance

Verify’s OCR feature will help ensure the accuracy of critical content that is directly associated with patient and consumer safety. This spans a wide range of content types that could potentially hinder safety such as instructions for use, allergen statements, dosages, warning statements and more. 

If documents or digital packaging assets do not contain live text, the absence of OCR technology would force content revision tasks to be done manually. With files or labels that include small text, graphics of text, and multilingual files in different languages and scripts, this could prove to be a time-consuming and almost impossible task. 

By automating the extraction of rasterized text, OCR not only accelerates the proofreading process it also provides a level of accuracy for document and label inspections that was not previously possible, as it allows for a character-for-character precision level

Thanks to this technology, pharmaceuticals, medical device, and CPG companies can ensure that their customers remain safe thanks to the mitigation of potential errors slipping by. 

Accelerated Scaling of Global Operations

Scaling globally often comes with the challenge of dealing with multiple languages, different scripts and the obligation of adhering to global regulatory standards—noting that the complexity is compounded when those tasked with proofreading are not native to the languages they are faced with. 

Verify’s OCR feature facilitates the extraction of text for translation purposes which supports the localization of documents. This reduces the risk of errors in translated content, whether it be regulatory, promotional documents, or labels. 

This allows brands to scale globally at a quicker rate by efficiently and safely distributing error-free products and content across their target markets.

With Verify’s new AI-powered OCR feature, the software has the ability to proofread and validate content in various languages and scripts even if they are in a flattened format, enhancing efficiency and promoting consistency in communication, facilitating smoother global expansion strategies.

Faster Product Time-to-Market

For regulated industries, being first to market offers a huge competitive advantage with often limited market share to capture before it’s too late. Thankfully,  Verify’s new OCR feature leverages AI technology to expedite the proofreading process, reducing the overall time it takes to bring products to market. 

For teams who deal with proofreading regulatory submissions, batch records, promotional and marketing materials, as well as labels or packaging assets, optical character recognition will prove to be particularly beneficial.  

By automating text extractions and reducing the need for manual content revisions and manual data entries, content revisions are now sped up throughout the product development lifecycle, allowing companies to respond more swiftly to market demands and gain a competitive edge.

This feature will also specifically benefit label labeling teams as the content they review includes both physical label scans as well as e-labels. In these cases, labeling teams are often forced to manually review and proofread within strict deadlines—increasing the risk of errors, and often delaying product time to market for sometimes life-saving drugs and medical devices.

With Verify’s new OCR feature, these teams will not only accelerate their speed to market, they will also have complete confidence that their documents and labels are accurate when they hit the market. 

Protect Your Brand’s Reputation

Verify’s OCR feature acts as a safeguard against damaging content errors, which can lead to catastrophic consequences on a brand’s image. 

By maintaining the integrity and accuracy of content, the software protects brand reputation and instills confidence among customers, stakeholders, and the wider public. It reduces the risk of typographical errors that could impact brand perception and contributes to a cohesive and reputable brand image. 

OCR allows regulatory, commercial, labeling professionals in regulated industries, and agencies to achieve streamlined workflows, and elevated brand excellence. With this feature, they can deliver accurate, compliant, and impactful content and packaging assets to market, contributing to the overall consistency and success of their brand. 

Begin Your AI Journey with New AI-Powered OCR! 

The official launch of Verify’s AI-Powered OCR feature signifies a transformative moment for proofreading in regulated industries. 

This feature brings innovation to the technology gap that was previously stunted by manual processes, providing a solution that significantly reduces the risk of errors and ensures compliance in industries that need to adhere to strict regulations. 

Verify’s new OCR launch also goes beyond the needs of regulated industries and actively contributes to increased patient and consumer safety assurance, accelerated global operations, faster time-to-market, and the protection of brand reputation. 

This innovative feature leverages the latest AI technology to reinforce Verify as a market-leading proofreading solution for regulated industries, empowering professionals with cutting-edge solutions and setting a new standard for excellence in compliance and proofreading workflows.

If you want to experience these benefits and more, begin your AI journey and try Verify’s OCR feature for free today. 

If you want to discover the full capabilities of our innovative cloud-based proofreading software, book a demo of Verify and see firsthand the transformative impact it will have on your proofreading and quality control processes.

Date: February, 2024 | CategoryProofreading Author: Hana Trokic


Why do regulatory affairs teams need document comparison software in 2024?

For Regulatory Affairs, where adherence to strict compliance standards and efficient quality control processes are critical, the use of technology to help ease daily workflows has become particularly apparent in the past decade—2024 is expected to be no different.  

While Regulatory Affairs teams are faced with growing complexities due to large content workflows, ever-changing regulations, and faster-than-ever product-to-market times, they continuously turn to technology to address bottlenecks in their proofreading and compliance review processes.  

One tool that has been proven vital for the content reviews of Regulatory Affairs professionals is document comparison software which helps proofread critical content at scale, mitigate risks of financial losses, and expedite product time to market.

What is Document Comparison Software 

Document comparison software allows users to compare two and identify their differences within seconds. 

The software is designed to help users detect changes made to files as they move through revision and submission cycles, correcting errors, ensuring consistency, and overall simplifying proofreading processes while increasing accuracy and efficiency. 

Document comparison software inspects digital files, including labels and packaging materials, to find any discrepancies between the two. A simple inspection will reveal and pinpoint differences allowing adjustments and corrections to be made in record time. 

This technology plays a crucial role in regulated industries such as pharmaceuticals, and consumer packaged goods where precise and accurate documentation is essential from reviewing initial drafts to final submission documentation. 

Automated Quality Control 

Document comparison software simultaneously serves as an automated quality control tool that expedites the proofreading process and enhances the accuracy of your work.

This type of software automates the revision process through digital inspections that can detect errors across files and documents at all stages of the content lifecycle – even in the early stages. By catching errors early on, it helps to avoid the need for multiple inspections, saving time and resources for Regulatory Affairs teams. 

Additionally, the software also contributes to the overall efficiency and saves resources for cross-functional teams. The streamlined process ensures that all teams involved can allocate their time and resources more effectively, creating a more coordinated and time-efficient work environment.

With document comparison software you can find discrepancies in text, spelling, images, graphics, barcode, color, and braille, making it ideal for Regulatory Affairs teams that deal with documentation that needs to adhere to strict regulations in all of these areas. 

It also allows for the automatic inspections of digital files commonly reviewed by regulatory teams. This includes regulatory submissions, instructions for use, drug development documents, legal agreements, and much more. 

With document comparison software, you can increase your confidence in regulatory submissions and subsequent product launches by ensuring that all documentation, labeling, and packaging go out to market without any errors.

Why is Document Comparison Software Important for Regulatory Affairs Teams in 2024

Document comparison software plays a critical role in Regulatory Affairs for several reasons, addressing this field’s unique challenges and requirements. 

The software allows teams to increase the efficiency of their workflows by speeding up compliance review and proofreading processes, identifying errors, and ensuring the overall integrity and quality of their regulated documents. 

The main reasons why document comparison software is important for Regulatory Affairs include: 

  • Ensures Regulatory Compliance: Regulatory affairs navigate a complex landscape of evolving standards, regulations, and guidelines. They are tasked with reviewing critical content such as regulatory submissions, labeling & packaging files, clinical study protocols, marketing and promotional materials, and more. Document comparison software plays a vital role in ensuring the regulatory compliance of these files by thoroughly comparing document versions and highlighting all differences to ensure that only the intended changes were made while no unintended changes were introduced.
  • Saves Time and Enhances Productivity: Manual comparisons of lengthy regulatory documents is a time-consuming task. Document comparison software automates this process, significantly reducing the time and effort required for proofreading. This efficiency not only saves time but also enhances overall team productivity, allowing regulatory affairs professionals to focus on more strategic aspects of their work.
  • Reduces Risk of Errors and Oversights: Inaccuracies or oversights in regulatory documentation can have severe consequences. This risk is only heightened when conducting manual checks. Document comparison software minimizes the risk of errors by providing a detailed and accurate overview of differences and deviations on a file. This helps teams catch discrepancies early in the process, mitigating the potential for regulatory issues, product recalls, or legal actions due to documentation errors, and ultimately facilitates and ensures compliance with health authorities. 
  • Ensures Patient and Consumer Safety: Document comparison software helps Regulatory Affairs teams keep track of changes in regulations, ensuring accurate and up-to-date information. It fosters better collaboration among diverse regulatory teams, simplifying the revision process. This ultimately leads to the software playing a key role in protecting consumers and patient safety by ensuring the accuracy of crucial information in documents such as instructions for use (IFUs), labels, allergen statements, dosages, and warning statements, to name a few. 

How to Implement Document Comparison Software

Yes, regulatory affairs teams need document comparison software in 2024, but how easy it is to implement? 

The ability to efficiently review critical documentation in Regulatory Affairs is essential for maintaining the accuracy of documentation and compliance. That is why document comparison software has become a valuable tool for organizations looking to enhance their document management processes in 2024 and beyond. 

Here are simple steps you can follow to implement this innovative technology into your content revision workflows in 2024: 

  • Define Your Requirements: Before searching for the perfect document comparison software for your team, clearly outline your organization’s requirements. Consider the types of documents you frequently work with, the level of detail needed in inspections, and the frequency of your document revisions. Understanding these aspects will guide you in choosing the most suitable software for your needs.
  • Select the Right Software: Next, it’s time to search the market and sift through potential solutions. When making a final decision, consider the features, ease of use, data security, support, and compatibility with your existing systems to make an informed decision. All of this will help you choose the document comparison software solution that aligns best with your identified requirements.
  • Integrate with Your Workflow: Once you’ve selected a software solution, ensure seamless integration with your existing workflow. Collaborate with your IT and implementation teams to address potential compatibility issues and ensure a smooth transition. Consider how the software will interact with your document management system to optimize efficiency.
  • Schedule User Training: Once the software has been implemented, provide comprehensive training for teams to familiarize them with the software’s features and functionalities. This step is crucial to ensure that your team can effectively navigate and utilize the full potential of the document comparison software.
  • Don’t Forget About Regular Software Updates: Document comparison software evolves over time with updates and improvements. Regularly check for updates and implement them promptly to access new features, enhance performance, and ensure compatibility with the latest document standards and compliance regulations. Alternatively, opt for a solution that offers automatic updates every quarter and prioritizes innovation, ensuring you consistently benefit from the latest advancements in technology.
  • Establish Guidelines and Best Practices: To maintain the efficiency and accuracy of your content revision workflows, establish clear guidelines and best practices for the use of the software. Define standard procedures and regularly review and refine these guidelines based on user feedback and evolving document requirements. For pharmaceutical and CPG companies, it’s crucial to go beyond general guidelines and establish specific Standard Operating Procedures (SOPs) for using document comparison software. This ensures a more organized and compliant approach that meets the unique regulatory requirements of these industries.
  • Conduct Ongoing Review and Optimization: Implementing document comparison software is not a one-time task. Conduct regular audits of your content revision and proofreading processes and see where teams need support or added training. See what technological gaps you may have and amend them to keep your workflows optimized. Update training materials, and refine guidelines to continuously enhance the efficiency and effectiveness of your proofreading practices.

Automated Proofreading – A Leading Technological Solution 

GlobalVision is the market-leading document comparison software and automated proofreading tool for Regulated Industries, specifically built with their requirements in mind. 

For over three decades, this technology has proven to be beneficial for Regulatory Affairs teams. This successful track record with some of the world’s largest companies in the regulated industry is only expected to grow in the future, making 2024 the perfect year to start incorporating this transformative technology into your content revision workflows. 

Any regulatory affairs team that deals with extremely sensitive documentation and products where even a minor content error can have detrimental or irreversible consequences can benefit from document comparison software.

The software’s diverse capabilities enable regulatory affairs teams to effortlessly maintain compliance of documentation across the asset lifecycle. Holistic inspections of documents enable the software to detect all errors, allowing for teams to make appropriate adjustments, ensuring the accuracy and quality of documents and critical assets. 

This provides companies with an added layer of insurance and a sense of confidence, knowing that all errors are being identified, and amended and that only high-quality products are going out to market.  

Conclusion – Why Regulatory Affairs Teams Need Document Comparison Software in 2024?

Regulatory Affairs need to make the best of technology available to them to ensure that they implement and use best practices in their workflows. This way, they will be able to optimize processes and stay profitable while thriving in the very competitive and fast-paced globalized markets in 2024. 

As Regulatory Affairs teams continue to learn how to navigate the difficulties of ever-changing compliance regulations and look for ways to ease their proofreading processes, the adoption of document comparison software stands out as the ideal technological solution of the year.

If you’re ready to take the first steps towards error-free content in 2024, get started with GlobalVision’s document comparison software and begin experiencing the advantages of our cutting-edge technology today while seeing firsthand why regulatory affairs teams need document comparison software in 2024!

Date: January, 2024 | CategoryCompliance Author: Hana Trokic


In the UK healthcare industry, medicine packaging plays a crucial role in ensuring the efficacy and security of not only medical products but of consumers as well. 

Over the years, requirements of UK medicine packaging have undergone significant changes, driven by advancements in technology, changes in consumer expectations and needs, and, most importantly, the ever-evolving stringent regulations imposed by regulatory agencies such as the MHRA.

Understanding and navigating these regulations is essential for medical companies to bring their products to market quickly and securely, and for healthcare professionals to ensure patient safety when prescribing medicine. 

The Early Days of UK Medicine Packaging 

Throughout history, the main role of UK medicine packaging has been to safeguard and conserve the contents of medical products. Glass bottles and vials were commonly used and were typically sealed with cork stoppers. 

These bottles were usually accompanied by simple labels containing essential information. The labels were essentially handwritten instructions and information on paper that would be wrapped around the bottle. Overall, packaging was basic, serving the primary purpose of protecting the medication from external contaminants.

However, as the medical industry advanced, so did the need for standardized and regulated packaging to ensure patient safety and facilitate the administration of medications.

Blister Packs and Pill Bottles

As medicine research advanced, so did the need for more sophisticated packaging. In the mid-20th century, blister packs, the ones we so often see today, emerged as a popular choice. This sealed, foil-based packaging, offered enhanced protection against moisture and air and helped in extending the shelf life of medications. 

Glass bottles were becoming less common as plastic pill bottles became a more popular substitute. They provided a more user-friendly and portable alternative to the old, heavy, and fragile glass bottle.  

The Rise of Regulation in UK Medicine Packaging

While advancements in UK medicine packaging were present throughout the 20th century, the greatest turning point came with the strict implementation of medicine regulations aimed at standardizing the industry. This was due to the fact that traditional UK medicine packaging and the lack of proper guidance and regulation were proving to be greatly limited in ensuring the safety of products and consumers.

Regulatory agencies have been present globally since the beginning of the 20th century, but in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has been at the forefront of setting guidelines to ensure the quality, safety, and efficacy of medical products since 2003. 

Their main responsibilities include:

  • Ensure safe and effective medicines, medical devices, and blood components
  • Establish a secure supply chain for healthcare products
  • Promote global standardization for the safety and effectiveness of biological medicines
  • Educate the public and healthcare professionals on the risks and benefits of healthcare products for safer use
  • Support innovation and research for public health benefits
  • Collaborate with UK and international partners for early access to safe healthcare products and to safeguard public health

Since its implementation, the United Kingdom has played a pivotal role in shaping the evolution of UK medicine packaging through its stringent regulatory framework. The MHRA consistently sets forth updated guidelines that govern the packaging of medicine, ensuring safety, efficacy, and adherence to quality standards. 

Labeling Requirements of UK Medicine Packaging 

UK medicine packaging is made up of many different components that are all strictly regulated and controlled to ensure its accuracy and safety for use and consumption. 

One of the most critical aspects of UK medicine packaging is the labeling, or the information provided on labels. Regulations mandate that packaging must include essential details such as the name of the medicine, dosage instructions, expiry date, batch number, and manufacturer information, to name a few. 

Additionally, UK medicine packaging labels often feature critical safety information, such as potential side effects and storage guidelines. The main goal of a label is to ensure that individuals administering or consuming the medication are well-informed about its proper use and potential risks. 

Compliance with labeling regulations not only supports the safe and effective use of medicines but also plays a pivotal role in promoting transparency and accountability within the medical industry. Strict adherence to labeling requirements contributes to the overall goal of ensuring public health by providing users with all the necessary information and knowledge needed to make informed decisions about their healthcare.

Tamper-Evident Measures

Tamper-evident packaging is described as “having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.” 

These measures in UK medicine packaging play a crucial role in ensuring the safety and integrity of medical products. The measures are implemented to provide visible signs of interference, making it evident if a package has been tampered with or compromised. 

Common tamper-evident features include seals or bands that are broken or altered when the packaging has been opened. By incorporating these features and measures, UK medicine packaging manufacturers aim to protect consumers from potential tampering, contamination, or unauthorized access to medications. 

Tamper-evident packaging not only serves as an added layer of protection and security but it also builds trust among patients and healthcare professionals, assuring them of the authenticity and safety of the medicine inside a package. This added security measure contributes significantly to maintaining the quality and reliability of medicine products throughout the supply chain, ultimately safeguarding public health. 

Child-Resistant Packaging

Another important addition to UK medicine packaging regulations came in the later half of the 20th century. Child-resistant packaging became a requirement, addressing concerns about accidental ingestions and poisoning of young children. This type of packaging is designed to be difficult for children under the age of five to open, thus reducing the likelihood of unintentional ingestion.

Child-resistant UK medicine packaging was first introduced into the United Kingdom in the mid 1970s but only became standardized in 2001. Since then, a number of different regulations have been put in place, including European and International standards, as well as the Human Medicines Regulations 2012 and GHS/CLP, which became fully effective in 2015.

Since its introduction, child-resistant packaging has undergone many changes, not only in increasing resistance to potentially being opened by children but also in optimizing usability for adults. There have been continuous efforts to increase the safety of these products and their packaging with constant new developments in packaging improvements. 

Barcoding and Serialization 

Barcoding and serialization are integral components of modern UK medicine packaging, designed to enhance traceability, authenticity, and overall supply chain security. 

Barcoding involves the assignment of unique identifiers, typically in the form of barcodes, to individual medicine packages. This unique identification enables efficient inventory management, reduces errors in product distribution, and facilitates rapid tracking throughout the supply chain. 

Serialization takes this a step further by assigning a distinct serial number to each medicine unit, allowing for precise tracing of products from manufacturing to distribution to the end-user. These measures not only contribute to streamlined logistics but also play a pivotal role in combating counterfeit medicine and in ensuring patient safety. 

GMP (Good Manufacturing Practices) 

Good Manufacturing Practices (GMP) in UK medicine packaging represent a set of strict quality standards and guidelines that medicine manufacturers must adhere to in the production of packaging materials and systems. 

GMP regulations ensure that the entire product lifecycle, from development and production to labeling and storage, follows specific protocols aimed at consistently delivering safe and high-quality UK medicine packaging. 

Compliance with GMP standards is crucial for maintaining the integrity of medicines and preventing contamination or defects in the packaging. These practices encompass various aspects, including personnel training, hygiene, documentation, and equipment calibration. 

By adhering to GMP in UK medicine packaging, manufacturers uphold the highest standards of quality assurance, contributing to the safety and efficacy of medical products and reinforcing the trust of healthcare professionals and consumers in the integrity of the overall medicine supply chain.

Environmental Sustainability

In recent years, there has been a growing emphasis on environmental sustainability in UK medicine packaging. Regulatory agencies are encouraging medical companies to adopt eco-friendly packaging solutions, reducing the environmental impact of the industry. 

Manufacturers increasingly focus on adopting eco-friendly practices and materials to minimize their carbon footprint. This includes exploring recyclable, biodegradable, or compostable packaging options and optimizing packaging designs to reduce material usage. 

Additionally, efforts are being made to enhance energy efficiency in the production processes and choose environmentally responsible printing inks and coatings. The aim is to strike a balance between ensuring the safety and efficacy of medical products while minimizing the environmental impact associated with their packaging. 

By embracing sustainable practices, the medical industry not only aligns itself with global environmental goals but also responds to the growing demand from environmentally conscious consumers.

Smart Packaging and Technological Integration

UK medicine packaging in the 21st century vastly differs from the packaging used over a hundred years ago. In recent years, technological advancements have revolutionized UK medicine packaging, with smart packaging becoming the newest trend in the industry.  

Smart packaging refers to the emerging technologies within the packaging industry that increase consumer and business utility alike, all while simultaneously increasing the simplicity of accessing and tracking the information surrounding products and companies.

This packaging is equipped with features like temperature monitoring, NFC (Near Field Communication) tags, QR codes, and interactive labels. These innovations not only ensure the integrity of the medication but also empower patients with information and enhance overall healthcare management.

Innovation in UK Medicine Packaging – Automated Proofreading 

As the accuracy of all packaging content is of extreme importance, technological solutions that ensure packaging integrity are also increasing in popularity. Automated proofreading is one of those innovative solutions in UK medicine packaging. 

Automated proofreading aids in maintaining packaging accuracy by inspecting all types of regulatory content that would be present on UK medicine packaging. It helps companies uphold packaging and manufacturing standards with greater ease and efficiency, ensuring compliance with UK medicine standards and beyond. This technological innovation provides better proofreading results and enables higher-quality UK medicine packaging as it acts as an added layer of security in quality assurance processes.  

In essence, automated proofreading works by comparing two documents to find discrepancies between the two. The innovative software conducts comprehensive inspections and proofreads all packaging assets from text, color, graphics, barcodes, braille, and more. 

Through automated proofreading, inspections of packaging components are completed exponentially faster than traditional proofreading, and a task that once took hours or days to complete is now reduced to only a few minutes.

Benefits of Automated Proofreading 

Automated proofreading plays a crucial role in enhancing the quality and compliance of UK medicine packaging. Some ways in which automated proofreading helps in UK medicine packaging includes:

  • Error Detection: Automated proofreading quickly detects all potential errors on UK medicine packaging, ensuring the complete accuracy and quality of a product. This is not only important for regulatory compliance, it is also crucial for patient safety, as clear and error-free packaging guarantees critical medicine information such as ingredients, dosages, expiry dates, etc., are being accurately portrayed, preventing potential life-threatening consequences and ensuring patient and user health. 
  • Consistency Checking: Automated proofreading can verify consistency in terms of terminology, dosage information, and instructions across different sections of the packaging. Consistent information helps prevent confusion among healthcare professionals and patients.
  • Regulatory Compliance: UK medicine packaging must adhere to strict regulatory requirements, including specific language and formatting. Automated proofreading helps ensure that the packaging content complies with these regulations, reducing the risk of non-compliance issues, including fines, product recalls, and legal actions.
  • Efficiency and Speed: Automated proofreading significantly speeds up the proofreading process compared to manual methods. This efficiency is particularly beneficial in the fast-paced pharmaceutical industry, where accurate and timely product releases are critical.
  • Version Control: Automated proofreading tools can help manage version control, ensuring that the correct and most up-to-date information is included on UK medicine packaging. This is crucial for avoiding mistakes associated with outdated content.
  • Consistent Branding: For medical companies with multiple products, maintaining consistent branding across packaging materials is essential for brand recognition and trust. Automated proofreading tools contribute to ensuring this consistency.

By leveraging automated proofreading in medicine packaging, companies in the industry can improve the overall accuracy, quality, and compliance of their packaging. This not only increases patient safety but also helps maintain the integrity of medical products. 

Customer Case Study: Automated Proofreading For Error-Free Medicine Packaging 

Prior to implementing GlobalVision, all materials at Bristol-Myers Squibb (BMS) Shanghai were manually reviewed by their Quality Control department. Manually proofreading each packaging component often took too long and was too reliant on the SASS Project Manager. As they only relied on the human eye to catch errors, the risk of faulty inspections was high. 

For a major pharmaceutical company such as BMS, letting a critical packaging error slip by could have damaging effects on its reputation. It may also result in reprints or recalls which can impose huge costs on the business. Worse, it can cause potential consumer harm if these packaging errors made it to market. 

The BMS Quality Control Department uses GlobalVision to inspect incoming packaging materials such as cartons. Batch by batch, the packaging is compared to the approved samples to catch any differences between the two. As a result of the automation, the Quality Control  Department has found that its revisions could be completed faster and more effectively. 

Through the implementation of GlobalVision, BMS Shanghai increased its level of efficiency and accuracy, further aligning its commitment to quality when it comes to both packaging and patients.

The Future of UK Medicine Packaging

The transformation of UK medicine packaging throughout the years has been shaped by dynamic factors such as evolving regulations, changing consumer needs, technological advancements, and a heightened emphasis on safety and responsibility. 

The industry, from basic glass bottles to cutting-edge smart packaging, has consistently adapted to meet contemporary demands, with the MHRA playing a pivotal role in maintaining and enhancing these standards.

Each advancement in the industry shows a commitment to ensuring the highest quality and safety standards. Notably, the integration of technological solutions, including automated proofreading tools, emphasizes this commitment by improving accuracy and safeguarding packaging and, by default, healthcare professionals and consumers alike. 

Automated proofreading serves as a comprehensive solution that not only streamlines quality assurance processes but also facilitates accuracy and compliance for UK medicine packaging manufacturers and beyond.

To experience the transformative power of automated proofreading, request a demo of our innovative software and witness firsthand how this technology can revolutionize your daily business practices.