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Overcome Your Content Challenges in Cosmetic Labeling to Meet FDA Requirements

Blog - Overcome Your Content Challenges in Cosmetic Labeling to Meet FDA Requirements

Date: December, 2022 | Category: Proofreading | Author: Hana Trokic

When most of us go out searching for our next “new favorite product,” we rely heavily on the claims written on the packaging. “All natural ingredients,” “results after only one use,” and “98% effective” are only some claims we see scattered across cosmetic aisles globally. 

But just how effective are these labels? For perspective, ask yourself, would you buy a cosmetic product that didn’t have a label? What about a product that had errors and typos on its labeling? It’s safe to say that most of us would skip that product and move on to one with more enticing branding and trustworthy labeling and packaging. 

In other words, packaging and labels are consumers’ first impressions of your product, so you want to get it right. As a form of advertising, cosmetic labels often include a long list of promises as manufacturers try to sell you on their claims. Yet, not only do they have to convince you of their guarantees of beauty and benefits, but they also need to sell you on its efficacy. 

Moreover, cosmetic manufacturers operate in a highly regulated industry, further complicating the labeling process. Not only do they have to consider branding and marketing guidelines, but they also have to focus on FDA cosmetic labeling requirements, as there are strict rules and regulations behind every cosmetic label.

The Challenges of Cosmetic Labeling

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All cosmetics marketed globally must comply with provisions set by the governing body of that specific country or region. In the United States, the FDA is responsible for regulating cosmetic labeling with the main goal of ensuring consumer safety and avoiding fraudulent and deceptive statements.

What are Cosmetics?

The FDA defines cosmetics as “articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions.“

Some products that fall under this category include creams, lotions, perfumes, make-up, shampoos, toothpaste, and deodorants.

While it may seem clear what cosmetics are, manufacturers need to be careful when creating, labeling and marketing their cosmetic products to ensure they fit under the FDA’s definition and regulations. If not appropriately labeled, some claims may cause a product to fall under the category of a drug, in which case it has to undergo a set of regulations that differ significantly from cosmetics. 

Though sometimes lines can be blurred, manufacturers must understand the difference between cosmetics and drugs and label their products properly to avoid potential complications, fines, and recalls.

Cosmetic Labeling

Cosmetic products distributed in the United States must comply with all label regulations established by the FDA. Labels are otherwise considered all written, printed, or graphic matter on or accompanying a product.  

The FDA requires that all label statements appear on the inside and outside of the packaging and wrapping. 

It is also important to note that false and misleading claims and wrongly labeled products that do not follow FDA cosmetic labeling requirements and regulations may be subject to regulatory action.

How to Correctly Label Cosmetics

To ensure the proper placement of cosmetics on the market and that consumers use them appropriately, manufacturers need to take note of adequate labeling requirements and adhere to them as strictly as possible. 

A cosmetic label must contain the following: 

  • Product identity
  • Net contents 
  • Declaration of Ingredients
  • Label warnings

Product Identity 

Product identity is the most crucial aspect of FDA cosmetics labeling requirements as it tells consumers what your product is and its intended use. Many cosmetic products and packaging look the same, i.e., lotions, shampoos, creams, etc. 

The label and statement of identity are what help consumers tell them apart. Because of this, product identity has to be displayed on the front of the package, so the general public is immediately aware of its intended use. 

Net Contents

Net contents tell consumers the quantity of your product, i.e., how much product is in the package. 

Products that are solids display their net content in terms of weight, while liquid products display their contents in terms of volume. The accuracy of the net contents is also highly regulated by the FDA as it ensures that it accurately reveals the quantity of cosmetics in the container in terms of weight, volume, measure, numerical count, or combinations of count and weight, volume, or measure.

Declaration of Ingredients

All cosmetics under the FDA are required to bear an ingredient declaration. 

The declaration of ingredients must be clearly visible so that it can be found and read at the time of purchase. The placement of the ingredients is not strictly standardized like the product name or net contents. It can be displayed on any information panel on the package. 

The ingredients must also be listed in order of predominance. In other words, the ingredient with the highest percentage is listed first, while other ingredients are listed according to their percentage in descending order. Ingredients at 1% or less can be listed in no particular order at the end of the ingredient declaration.

Label Warnings

Cosmetics that may cause adverse reactions or be hazardous to consumers if improperly used must be addressed through FDA cosmetic labeling requirements. Appropriate warnings and directions of use need to be clearly labeled and prominently displayed.

Some cosmetics that fall into this category include:

  • Aerosol products
  • Deodorant sprays
  • Children’s bubble bath 

Overcoming the Cosmetic Labeling Challenges

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Just as it’s crucial to follow FDA regulations for labels, it’s equally as important that those labels are entirely error-free. Typos and artwork errors can make cosmetic products seem untrustworthy and unreliable. After all, why would consumers trust the contents of a product that was so hastily packaged and labeled?

Once you have ensured your labels meet all FDA cosmetic labeling requirements, the next step is to ensure that your content and artwork are error-free. 

Text comparison software is a tool that allows cosmetic manufacturers to run an automated side-by-side comparison of two files to identify discrepancies and errors with complete ease. 

Eliminating the need for laborious and error-prone manual proofreading checks, this advancement in automated quality control simplifies, optimizes, and upgrades workflows to ensure that your cosmetic labels are always top quality and free from mistakes. 

Through the simple addition of this software, manufacturers can proofread and run checks for every aspect of their labels and packaging. With accuracy and precision, the software finds errors and discrepancies in text, colour, graphics, barcodes, and print, to name a few. 

To ensure that you keep your product’s quality, reliability, and status on the market, implement processes that keep your labels and packaging safe from unwanted errors.

Automated quality control streamlines revision and proofreading processes and brings endless benefits for businesses and manufacturers – especially those dealing with sensitive copy, documentation, and content, such as pharmaceuticals and cosmetic manufacturers. 

Cosmetic Labels that Meet all FDA Requirements

A miracle in a bottle – a claim most cosmetic manufacturers love to make. Yet without proper labeling and packaging, it’s hard for them to make such a statement and sell consumers their product.

To ensure market success and picture-perfect labels that stand out, you must get your cosmetic labels right. Implement a text comparison tool that helps you create flawless labels, speeds up the content creation process and revision times, and gets your product to market in record time.   

The benefits a file comparison tool will bring cosmetic manufacturers are countless and, in most cases, are a crucial company resource. The only way manufacturers can be completely confident that their content and products are error-free is through fast, accurate, and trusted software. 

Ready to step into the world of automated proofreading? Request a demo of our innovative text comparison software and see how this technology can revolutionize your everyday business practices. Transform your quality control processes with GlobalVision.

Also, to learn more about how technology can help manage regulatory compliance, check out GlobalVision’s guide Digital Transformation for Pharmaceutical Packaging Quality.

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How to Ease the Labeling Proofreading Process for Medical Devices

How to Ease the Labeling Proofreading Process for Medical Devices

Date: November, 2022 | Category: Proofreading | Author: Hana Trokic

A medical device can range from the simplest household item found in everyone’s pantry, like a band-aid, to more complex technology like an x-ray machine. Regardless of its complexity, there is a constant amongst them all. They all need to be tested and approved to meet FDA requirements and compliance. 

While there is a long list of requirements to meet to even be classified as a medical device by the FDA, once labeled, there are strict rules and regulations put in place to ensure its proper use along with patient and consumer safety. These rules surround all documentation associated with the device, including labels, packaging, and technical documentation.  

A long and tedious process, FDA labeling requirements for medical devices is rigorous for good reason. The detrimental consequences that can come with the improper use of devices are extremely high risk and companies make sure to take every precaution possible to avoid irreversible and potentially permanent problems. 

One way medical companies ensure the safety and quality of their products is through precise checks, reviews, and thorough proofreading. Every aspect of the device is inspected and reviewed to ensure no mistakes have slipped through and that the final product is error-free.

Yet, when companies rely on manual methods as their primary approach to proofreading and quality control, they are increasing their chances of producing faulty products, labels, and packaging, due to the heightened likelihood of human error. 

Luckily, pharmaceutical companies and medical device manufacturers don’t have to rely on manual methods anymore to ensure their label and content accuracy. They can now turn to automated quality control as their secret to flawless labels, artwork, and products. 

Types of Medical Devices and Their Regulations

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Medical devices can range from simple to complex. Regulatory authorities globally have put into place risk classifications that group devices into categories based on their potential harm if misused, the complexity of the device, and certain use characteristics. 

These classifications are essential to ensure safety and ease the marketing and placement of devices. It also sets a standard for testing where officials know, according to classification, how much testing a device needs to undergo to be deemed safe and ready for patient use.

Medical Device Classification

In the United States, the FDA has classified medical devices into three categories based on the level of control needed to ensure the safety of use. The classifications are: 

  • Class I – Low risks: Includes devices such as bandages, toothbrushes, floss, and hospital beds. Only requires general controls.
  • Class II – Medium Risk: Includes contact lenses, pregnancy tests, and catheters. Requires general controls as well as pre-market notifications 
  • Class III – High Risk: Includes respirators, prosthetics, and pacemakers. Requires all general controls along with special controls and pre-market approval.

Regulations and Standardizations

Regardless of their classification, it’s important that all medical devices adhere to a certain set of regulations and standardizations. Much like pharmaceuticals, medical devices are treated with similar rigor and are highly regulated. 

The FDA offers a detailed overview of all the regulations devices need to follow in order to be deemed fit for use by the general public. The International Organization for Standardization (ISO) sets the standards and convenes them for ease of implementation in the industry.

Some regulations that are put in place for medical devices include: 

  • Establishment registration 
  • Medical device listing 
  • Pre-Market notification 
  • Pre-Market approval 
  • Quality system regulation 
  • Labeling 
  • Medical device reporting

Labels and Labeling

The FDA defines a label as a “display of written, printed, or graphic matter upon the immediate container of any article” or “all labels and other written, printed, or graphic matter.”  

As such, labels are the first point of contact for information for many medical practitioners, patients, and consumers, and need to be accurate to avoid confusion or life-threatening consequences.  

The FDA breaks down label regulations and clearly defines them by the following: 

  • General device labeling 
  • Use of symbols 
  • Unique device identification 
  • Good manufacturing practices 
  • General electronic products 

These regulations are in place to primarily ensure that the products and devices in question are being used as they are intended and that the safety of those using them is guaranteed. 

Keeping up with these regulations is already an extremely complicated process, but simplifying workflows and streamlining processes to increase efficiency is very much possible. 

Once you ensure that your medical device labelings are following all regulations and standardizations how can you ensure that the written, printed, and graphic matter of your products are error-free? 

A document comparison tool is the natural next step in your regulation and standardization process that enhances your labels and artwork and makes keeping up with regulations easy. In a fraction of the time, you will be able to check and inspect entire files and documents and increase the accuracy of labels while easing the FDA labeling requirements put in place for medical devices.    

Making FDA Labeling Requirements a Breeze

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While traditionally manual checks were the method by which medical device labels, packaging, and graphics, were inspected, in today’s modern, globalized markets, demand is too large to rely on outdated methodologies. 

Devices and accompanying content are being produced at such rates and numbers that companies need to turn to technology to help ensure the accuracy of their products along with all technical documentation. 

In other words, a text comparison tool is the ideal solution they are looking for. 

A text comparison tool proofreads documents and files in seconds. The software works by overlaying two files to find discrepancies between the two. No matter how small the errors or differences may be, the software will detect them and pinpoint their exact location on the file.

The software can detect errors in copy and artwork that is nearly impossible to see with the naked eye. Using a document comparison tool, errors and differences can be easily found in text, graphics, barcodes, braille, print, and color.  

The result is proofread and error-free labels and packaging in record time – every time. 

To avoid unnecessary and hasty product mistakes that can be easily corrected and avoided, introduce text comparison technology to your workflows to ensure your medical device labelings reach the hands of consumers in pristine condition – down to the last period. 

Ready to Simplify Your Processes?

In an already complicated and highly regulated industry, keeping up with regulations can be complicated and hard to follow. 

Pharmaceutical companies and medical device manufacturers should search for solutions to help ease the FDA labeling requirements for medical devices while simultaneously increasing the accuracy of their labels and the efficiency of creating and printing them. 

Through the use of the right technology, such as text comparison technology, companies and manufacturers can see increased benefits in their workflows that result in better and more accurate products.  

Using trusted automated proofreading technology like GlobalVision, companies in regulated industries can automate their quality control and get products to market faster, with complete confidence.

To learn more about file comparison technology and how it can benefit your company, request a demo of GlobalVision today!

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Ensure Your Labels Meet all FDA Drug Labeling Requirements with Automated Quality Control

Ensure Your Labels Meet all FDA Drug Labeling Requirements with Automated Quality Control

Date: November, 2022 | Category: Quality | Author: Hana Trokic

For highly regulated industries like pharmaceuticals, following FDA drug labeling requirements is one of the most crucial aspects of the product lifecycle. With so many laws, rules, and regulations to follow, the task of creating documentation, labels, and content surrounding a single drug or product quickly becomes stressful and tedious.  

Yet, drug label requirements are in place for a reason – and a good one at that. The accuracy of drug labels ensures that patients and consumers are being given proper instructions and dosages of a prescribed drug. Label accuracy also ensures that pharmaceutical companies avoid life-threatening side effects for their consumers, large recalls, and colossal financial downfalls.

With so much on the line, pharmaceutical companies cannot risk label errors slipping through.    

Thankfully, software shortcuts such as automated quality control is a one-stop shop for your compliance needs that makes sure your labels meet any and all FDA drug labeling requirements. 

Automated quality control is an easy solution that allows you to proofread labels and content in record time. Not only does it decrease proofreading and review times, but it also decreases errors while increasing the efficiency of your workflows. 

With this comprehensive software solution, you can ensure that all of your labels follow FDA requirements while being accurate and completely error-free.    

The Highly Regulated Pharmaceutical Industry 

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When it comes to drug labeling, the FDA’s primary purpose and concern are to ensure patient safety and provide healthcare professionals with information about the drug and how it should be prescribed. Some of the FDA’s drug label requirements include: 

  • Highlights (a concise summary of label information)
  • Full prescribing information
  • Recent Major Changes 
  • Indications and Usage 
  • Dosage & Administration 
  • Dosage Forms & Strengths 
  • Contraindications 
  • Warnings & Precautions 
  • Adverse Reactions (listing of most common adverse reactions) 
  • Drug Interactions 

With so many regulations to follow, it’s no surprise that such heavy importance is placed on label accuracy. Even so, it is estimated that over 50% of medication use errors are associated with poor drug labeling. Though this includes patient misunderstandings, it is generally believed that implementing standardizations such as text, language, typography, and other display standards will drastically reduce errors in drug labels. 

Along with patient safety, it is also important to note that labeling errors lead to significant recalls and financial losses, which are more frequent than you would think. Clinically important drug recalls occur approximately once per month in the United States. For perspective on just how significant these financial impacts can be, Johnson and Johnson lost roughly $600 million in sales after closing a distribution site due to a recall.

To avoid the detrimental consequences that label errors bring, pharmaceutical companies need to implement a functioning proofreading and reviewing process. They must inspect labels, artwork, and content at every step of production, ensuring the accuracy of the complete file. 

Innovations in automation, such as GlobalVision’s file comparison software, allow pharmaceutical companies to implement an all-in-one quality control platform that inspects complete files, including text, spelling, artwork, graphics, braille, and barcodes, at every stage of production. It allows for label standardization as it detects discrepancies no matter how small, making it easier for companies to ensure their labels are following the standards set in place.

Through automated quality control, companies can be sure that their labels are consistently accurate, and meet all standards and compliance guidelines, while meeting FDA drug labeling requirements with increased ease and efficiency. 

The Benefits of Automated Quality Control 

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Many large global pharmaceutical companies have yet to implement new technologies that increase workflow efficiency. 

In some cases, many still rely on manual and labor-intensive proofreading and reviewing processes prone to mistakes, leaving huge potential for operations to be optimized and streamlined for maximum efficiency. 

The solution, thankfully, is simple. Automated quality control inspects content and artwork with complete ease, lightning speed, and increased accuracy.  

To keep up with increasing global consumer demands, pharmaceutical companies are creating almost immeasurable amounts of products, each with its own packaging, labeling, and documentation. This content must be meticulously reviewed and proofread to ensure that the final product is error-free. 

Manually proofreading this amount of content is not an efficient solution for companies that need to keep up with growing demands. Automated proofreading software offers a foolproof solution to ensure all this generated content is checked and proofread perfectly. 

This advancement in proofreading processes eliminates the need for manual document inspections and leaves it up to technology. The software conducts digital checks for discrepancies in text, spelling, graphics, color, and more. The software conducts thorough inspections in a fraction of the time and ensures that labels and content are 100% accurate before going out to the hands of patients and consumers. 

This technological advancement ultimately increases productivity and workflow efficiency and offers endless benefits unmatched by manual inspections. Not only does automated proofreading software help ease the proofreading process, it simply makes proofreading better. 

Keep Up with FDA Drug Labeling Requirements 

Spell Check imageIf you want to keep up with FDA drug labeling requirements with complete ease, switch to automated quality control. A trusted technology, GlobalVision’s innovative automated solutions have been solving problems for pharmaceutical companies globally for over thirty years.  

By using GlobalVision to eliminate time-consuming and inaccurate manual checks, the largest pharma companies worldwide cut review times by 89%. Just by making the simple switch to automated quality control, top companies got critical healthcare products into the hands of consumers faster and with complete confidence that their labels and content are 100% accurate and FDA compliant.

To name only a few, GlobalVision has helped:

Ensuring that you meet all FDA drug labeling requirements is far from easy. Yet, through the simple introduction of automated quality control, companies can rest assured that they are drastically eliminating the risk of human error, getting their product to market faster with fewer revision cycles, and reducing the risk of costly recalls and misprints. 

Ensure Consistent Quality 

With endless benefits and countless advantages to your company’s revision processes, automated quality control is the leading solution for pharmaceutical companies that wish to ensure the quality of their labels and content. All the while ensuring they meet all FDA labeling requirements. 

Enhance your proofreading practices and make the switch today. See how automated quality control can streamline your business’s workflows by allowing you to proofread critical content at scale while maintaining the complete accuracy of your labels and content.   

Discover firsthand the benefits of automated quality control. Request a demo of GlobalVision, and get started today! 

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6 Ways Businesses Can Overcome Data Integrity Issues

6 Ways Businesses Can Overcome Data Integrity Issues
 
 

Date: September 14, 2021 | Category: Compliance | Author: Kayla Caticchio

In today’s digital age, a new threat presents itself to businesses that are heavily reliant on data. Many data-driven organizations rely on data integrity to be able to conduct their business operations without issues.

These businesses must take great care to ensure the consistency, accuracy, validity, and safety of data. Failure to do so can result in the corruption of information that can negatively affect all aspects of a business. To avoid being put in a vulnerable position, there are many steps that can be taken to help overcome data integrity issues.

What is Data Integrity?illustration of a lock

Data integrity refers to the reliability and trustworthiness of data over the course of its lifecycle. Data can be either valid, invalid or in the process of becoming valid. Error-checking and validation processes are methods often used to ensure data integrity.

 

Why is Data Integrity Important?

illustration of security windows

Data is perpetually vulnerable to corruption of any kind. The degree of its vulnerability depends on the efforts taken to preserve its original state over time. These efforts exist to preserve the reliability and trustworthiness of data to ensure proper decision-making within an organization. Any impactful decision within a business requires data to be accurate and consistently valid in order for any progress to occur.

 

What Are the Threats to Data Integrity?Illustration of a person facing data integrity issues

Threats to data integrity can appear in many different forms. Threats can be accidental or voluntary, taking the form of cyber attacks with the intent to alter or destroy data. Some of the most common threats, however, are often internal. Examples include:

  • Human error
  • Unintended actions
  • Security errors
  • Malware
  • Compromised hardware

 

How Can Businesses Overcome Data Integrity Issues?

  1. Validate Input: Documented evidence of validation is a crucial way to ensure that input data is accurate. Once a data set is received, it should always be systematically verified.
  2. Validate Data: Ensuring data meets pre-determined specifications and key attributes is crucial to ensuring its validity and the system through which it passes.
  3. Remove Unnecessary Data: Duplicate files and unidentified data can potentially open doors to unwanted intruders set on exploiting or corrupting information.illustration of security process and checklist
  4. Data Back-Ups: Permanent data loss is a real threat to businesses. Staying on top of routine backup checks is crucial to avoid losing critical information. Businesses should be proactive in creating a recovery strategy in the event of an unexpected data loss or application error. This will help to restore any losses that could potentially occur.
  5. Manage Access Control: Setting limits and controls on who can access certain information within an organization is crucial in protecting data from unauthorized users, including intruders and impersonators. Actions must be taken to ensure that the unwanted spread of sensitive information is limited. Furthermore, the importance of physical access controls must not be neglected. Businesses should take care to protect places like server rooms that can be especially vulnerable to corruption.
  6. Traceability: Data integrity relies heavily on the ability to track down the source of a breach at any point within operations. Ensuring that audit trails are consistently in place helps to provide security in the event of a breach and allows organizations to identify the source.

 

Overcoming Data Integrity IssuesIllustration of someone using GlobalVision to address data integrity issues

Data is useless without the underlying assumption that it is reliable and accurate. Management is dependent on the accuracy and integrity of data to be able to make decisions. In addition to the methods mentioned above, automation technology can help businesses secure their data and other information. GlobalVision’s inspection technology features audit trails and other controls developed to meet compliance and data integrity requirements for regulated industries. To learn more, visit globalvision.co.

 

 

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Why Regulatory Affairs Needs Automated Proofreading Software

Globalvision on laptop, tablet and other devices helping quality control

Date: July 28, 2020 | Category: Quality | Author: Kayla Caticchio

Now more than ever, the demand for safe and effective medical drugs is increasing on a global scale.

This means that regulatory affairs teams are working overtime to interpret, apply, and communicate the guidelines received from governing bodies like the FDA and EMA when it comes to developing new drugs. 

However, when medical drugs are approved, they must then be made available for use on a global scale. As a result, all content must be adapted to meet the legal and cultural requirements of markets beyond the country in which they were produced.

As market sizes expand, pharma companies must localize products for new markets, which involves more than just translations, but also adjusting elements like color, date formats, units of measurement, and artwork.

All content like leaflets, cartons, inserts, and legal documentation must also be fully adapted, creating challenges for regulatory teams when combined with the speed at which products must be released.

An easy way to overcome the challenges of placing medical products on shelves worldwide, is to implement effective solutions that ensure the accuracy of products, for all markets and consumers. One technological solution that can help quality assurance teams achieve this, is automated proofreading software. 

What is Automated Proofreading? 

illustration showing laptop with process of folders

A key way to effectively manage the increasing workloads as a result of globalization is to harness technology that allows regulatory affairs teams to operate at scale. When it comes to proofreading, manual processes are no longer efficient given the speed and complexity in which products must be delivered.

With automated proofreading technology, proofreaders and RA teams can verify content accuracy on digital files and printed packaging components, eliminating inefficiencies at every stage of the pharmaceutical workflow. 

To begin, product requirements are submitted to regulatory bodies who then compile the information into briefing documents. At this stage, automated proofreading software would ensure that all copy documents are error-free and accurate for internal revisions.

At the artwork creation stage, artwork files can be automatically inspected to make sure that no errors are introduced during the file creation process. Examples of errors that could be created during this stage include logo errors, incorrect product information, and barcode defects. 

At the final stage, automated proofreading software can automatically compare approved files to supplier proofs before going to print, ensuring that products make it to market with packaging that is entirely error-free.

Why Automated Proofreading Technology? 

Regulatory industries are abundant with complex documents, extensive regulations, and critical content. Any mistake, no matter how small, can have far-reaching consequences, from costly delays to serious compliance issues. 

That’s why automated proofreading software has become indispensable in this highly regulated domain. Here are only some ways this software can help quality assurance teams in highly regulated industries:  

Ensuring Compliance

Regulatory affairs professionals are responsible for ensuring all documents, content, and submissions meet the stringent requirements set by government agencies, such as the FDA or EMA. Failure to comply with these regulations can result in severe consequences, including product recalls and legal actions. 

Automated proofreading software helps catch errors, inconsistencies, and content issues that may lead to non-compliance. They act as a safety net, reducing the risk of costly regulatory violations.

Reducing Human Error

Even the most experienced regulatory professionals can make mistakes when reviewing extensive documents. Manual proofreading is not foolproof, and the risk of human error always exists. Automated proofreading software eliminates this risk by inspecting documents for errors and inconsistencies, thus improving the overall quality of regulatory submissions.

Time Efficiency

Regulatory submissions often involve voluminous documents with tight deadlines. Manual proofreading can be time-consuming, slowing down the review process and potentially delaying product approvals. 

Automated proofreading software allows you to compare documents at rates as high as 1000 characters per second while also ensuring the integrity of your work. This means documentation that would take hours, or even days, to proofread can be completed within mere minutes through this lightning-fast technology. 

Consistency in Terminology

Consistency in terminology is critical in regulatory affairs. Using different terms or phrases to describe the same concept can lead to confusion or misinterpretation. Automated proofreading software can help maintain consistency in terminology throughout documents, ensuring clarity and preventing any misunderstandings.

Improved Document Formatting

Regulatory submissions often come with strict formatting requirements. Ensuring that documents adhere to these guidelines is crucial. Automated proofreading software can detect formatting errors, such as incorrect font usage, inconsistent spacing, or improper margins, ensuring that documents meet the prescribed formatting standards.

Scalability

As regulatory affairs professionals are tasked with managing a growing volume of documentation, scalability is a critical concern. Proofreading software can not only inspect individual documents and pages, but it can also inspect large, multi-page documents along with large volumes of content in a fraction of the time. 

Expect automated proofreading software to easily adapt to increasing workloads, making it an ideal solution for a field where the demand for accuracy and efficiency continues to grow.

Document Version Control

Keeping track of multiple versions of documents is a common challenge in regulatory affairs. Automated proofreading tools can help manage document version control by highlighting the changes and differences between versions, ensuring that the most up-to-date and accurate information is included in submissions.

Handling Multilingual Documents

In the globalized world of regulatory affairs, documents are often required in multiple languages. Translating complex regulatory content can be challenging and prone to errors. Automated proofreading software equipped with multilingual capabilities can identify issues in translated documents, ensuring that the content remains accurate and compliant in all languages your organization requires.

Foreign Languages & Data ComplianceAn illustration of a stairway between 2 structures

Managing content in foreign languages is a specific challenge for regulatory teams in the pharmaceutical industry. As medical products make their way into foreign markets, all materials and content must be properly translated into multiple languages which creates significant room for error. 

Along with accurate foreign translations, following compliance and data integrity, guidelines are essential in the pharmaceutical industry. Automated proofreading software utilizes audit trails and reporting features to track all activities, ensuring compliance with bodies like ISO certifications, 21 CFR Part 11, and Annex 11. 

These tools help protect data integrity by providing full traceability on who ran an inspection, the inspection results, and what changes need to be made.

The Ultimate Solution: Automated Proofreading 

As the nature of regulatory standards continues to evolve, so does the need to effectively implement technology solutions such as automated quality control. These technology solutions not only improve processes between teams but also increase cross-functional collaboration and give pharmaceutical companies the tools they need to operate on a global scale.

To learn more about how technology can help manage regulatory compliance, head over to our demo center to learn more about our innovative proofreading software and see how this technology can revolutionize your everyday business practices, at your own pace.

If you are looking for a cloud-based solution, transform your quality control processes with GlobalVision’s cloud-based quality inspection tool, Verify.

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How FDA Regulatory Compliance Affects All Aspects of Manufacturing

Illustration of the FDA regulatory compliance process

Date: April, 2019 | Category: Compliance | Author: Ryan Szporer

 
 

There’s a saying: “Winning isn’t everything; It’s the only thing.” In business, however, before you can win, you have to first comply with regulations.

Sure there are get-rich-quick schemes that have earned many a matchstick man a pretty penny. Lasting success, though? That’s earned on the basis of hard work and a solid reputation.

This concept makes regulations the building blocks of any kind of fruitful venture. The rungs in a ladder or the linchpin in a wheel, if you will. The metaphors are especially apt because, when it comes to manufacturing consumable goods, regulations become the guiding force to all aspects of production.

The Key to FDA 21 CFR Part 11 Compliance

If success is built on a solid reputation, then reputation is almost like currency. Waste enough goodwill by taking customers for granted, or worse, for a ride, and you run the risk of having nothing left. That’s why abiding by guidelines is crucial for both your customers and business prospects. The Food and Drug Administration’s (FDA) 21 Code of Federal Regulations (CFR) Part 11 serves as a prime example of the lengths to which one must go to ensure compliance.

The set of guidelines applies to food and beverage companies, drug makers, and medical-device manufacturers among others, all of which are overseen by the FDA. The standards call for the implementation of various controls with regard to the processing of electronic data.

Requirements for the following controls are included:

  • Audits
  • Audit trails
  • System validations

Furthermore, and perhaps most notably, the subject of electronic signatures is covered in great detail. As electronic signatures become more prevalent, their legal weight has grown. They are now recognized throughout most of the United States as being just as binding as handwritten ones, possessing even greater security.

Following FDA Regulatory Compliance

FDA 21 CFR Part 11 effectively smoothed any company’s transition to digital records and electronic signatures at the time of its introduction in the 1990s by establishing international standards for each. Today, compliance keeps operational costs down and speeds up time to market, all by minimizing the risk of human error. Following set FDA standards is in the best interest of all parties involved, including the companies themselves who only stand to benefit.

The kinds of companies in question face a bevy of additional regulations. There are countless FDA guidances aimed at current Good Manufacturing Practices so pharmaceutical companies aren’t limited to respecting FDA 21 CFR Part 11.

For further proof, consider labeling and packaging, covered in 21 CFR Part 211. After all, even the smallest typos can have significant repercussions if dosage information is misprinted.

It all goes back to human error and how it must be mitigated, even if only to avoid costly recalls, with the well-being of consumers logically being an even higher priority. What should CEOs be more worried about? How much does a recall cost or how much damage a lawsuit can do? The first leads to significant short-term losses. The second leads to irreparable harm to a company’s brand equity and integrity to the point that there may not even be a long term.

The Real Building Blocks of Success

Systems do exist that both help eliminate the risk of human error and enable FDA 21 CFR Part 11 compliance. For example, the GlobalVision quality control platform, which digitally and efficiently proofs packaging components, has the required technical controls built into the software.

These include:

  • The ability to sign electronically, as mentioned earlier
  • A hierarchy of access levels, including managers and administrators
  • Inspection profiles only admins or managers can create or edit
  • A Login Management module, requiring unique User ID and password combinations
  • A comprehensive Audit Trail, which logs events, tracing them back to specific users

It’s critical to note software doesn’t ensure compliance. That is and always will be the responsibility of the manufacturer, but the right tools to make it simpler to get there. Just consider them building blocks in their own right, towards keeping compliant.

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Following FDA Data Integrity Guidelines Is Easier than You Think

Cartoon women standing with FDA icon and check mark

Date: March, 2019 | Category: Compliance | Author: Ryan Szporer

 
 

Of note, the Food and Drug Administration (FDA) has official data integrity guidelines, out in full force as we speak. However, firms who are already following current Good Manufacturing Practices (cGMP) have nothing to worry about.

Of course, the title of the document in question, “Data Integrity and Compliance With Drug CGMP”, serves as clear confirmation to that effect. It also somewhat formalizes cGMP as its own set of guidelines, but it’s best to consider what that acronym stands for before overreacting and realizing good manufacturing practices as a concept just makes sense.

Meanwhile, data integrity in this instance is simply a byproduct of cGMP, but achieving it is just as critical if not more so in this day and age.

Data Integrity and Security

Take for instance how compliance with the General Data Protection Regulation, or GDPR, is an ever-present item on the task lists of firms in the European Union these days. The security of customer data has become more critical in the internet age and data security and integrity simply go hand in hand.

For the uninitiated, data integrity, as defined in the FDA document, is “the completeness, consistency, and accuracy of data.” To achieve integrity, data should follow the ALCOA mnemonic device by being Attributable, Legible, Contemporaneously recorded, Original, and Accurate. Based on the official set of guidelines, abiding by many if not all of these should be downright logical.

For example:

  • Personnel should be trained to prevent and detect data integrity issues.
  • Each detected quality issue must be handled formally.
  • Only authorized personnel must have the necessary access to change records.
  • Each user should have their own, as opposed to shared, login credentials.
  • Electronic signatures over handwritten ones are permitted.

The Benefits of Good Manufacturing Practices

So, if these guidelines should already be in place, in conjunction with the proper operating procedures of any self-respecting company, why have them at all?

Well, it’s always better to make standards and regulations official. In an industry like pharma where skirting rules can have severe consequences for consumers, the need is even more prevalent.

In fact, the whole concept of cGMP originated from an inability to get fatal, contaminated tablets off the market in time, before they caused hundreds of injuries/ deaths in 1940. The FDA has multiple tools at its disposal these days to prevent such a disaster from reoccurring: random inspections, official warnings, and drug seizures. Arguably the most effective tool at all though is having the data integrity guidelines in place to start, because they’re preventative instead of reactive.

Keeping Up with FDA Regulations

Complying with cGMP admittedly means devoting a lot of resources to one’s operations. For example, appropriate quality management systems and procedures must be maintained, only qualified and fully trained employees must be kept on board, and reliable testing facilities and calibrated equipment must be used. What all those prerequisites have in common is they have come to characterize businesses serious about maintaining some semblance of long-term success.

While the abstract concept of data integrity is far removed from the drugs themselves, there is a direct relationship between it and product quality. Meanwhile, not only is there an indirect relationship between data integrity and product defects, but data integrity and product costs too.

So, in the end, the FDA isn’t asking firms to do anything other than to make life easier for themselves. After all, the “current” in cGMP simply seeks to remind companies that their systems must stay up to date with today’s latest technologies. Any company stuck in the past generally and justifiably gets passed by anyway. The overall goal may be to ensure customers don’t get hurt, but, if companies take the guidelines in stride, neither will they.

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Get your complete guide to meeting FDA labeling requirements here

Take the first step towards error-free packaging and labels by starting your free trial of GlobalVision

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Why Automated Quality Control is Needed in Regulatory Affairs

Compliance documents under digital proofing for EU regulatory affairs

Date: January, 2019 | Category: Compliance | Author: Ryan Szporer

Regulatory affairs were created to meet a pressing need, regardless of the industry in question.

For example, in pharma, the Biologics Control Act of 1902 was the first legislation to regulate drug quality in the U.S., while American apothecaries date back to colonial times. Of course, medicine as a sheer concept dates back just a couple more years before that, illustrating how much regulatory affairs departments have had to catch up in what can only be considered a short period of time in comparison.

In any case, whether that aforementioned need is in the pharmaceutical (Food and Drug Administration; FDA), energy (Department of Energy; DOE), or financial industry (Securities and Exchange Commission; SEC), the overriding role remains the same.

Regulatory affairs officers liaise with those governing bodies and different departments within the company to ensure the rules in every region in which a company’s products and services are distributed are met.

Proofreading meanwhile plays a critical role in different facets of a regulatory affairs manager’s day-to-day duties.

Automated quality control enables those responsibilities to get handled as efficiently as possible.

The Responsibilities of Regulatory Affairs

Regulatory affairs responsibilities take the primary form of oversight of a product’s life cycle. Through each of the product’s development stages, there are strict rules and guidelines to follow to ensure compliance. Proofing figures in several of these steps:

  • Initial rule/ law changes are lobbied at the state and federal levels.
  • Product/ drug applications are submitted to regulatory bodies.
  • Briefing documents are compiled for the appropriate regulatory agency to review.
  • Packaging copy created by marketing is sent for internal and external approval.
  • Packaging and labeling updates are evaluated.
  • Changes are applied across different product lines whenever necessary.
  • Info is revised (like the drug formulation and dosage in pharma) to extend product life cycles.

In each case, the regulatory affairs department enters into or even drives the file-creation process. It is imperative the text and artwork be 100% accurate from a spelling standpoint and based on what had been approved internally. While this can be accomplished through manual proofreading, i.e., with the naked eye, digital systems have been proven to catch more errors early in the process, cut down on revision cycles, and improve overall efficiency.

Automated Quality Control for Customer Safety and Post-Marketing Compliance

As an offshoot of the aforementioned tasks, the responsibility for getting products to market as fast as possible also falls on the shoulders of regulatory affairs associates and offices. Regulatory and compliance managers and coordinators must ensure products meet all requirements and that the tests to that effect have gone smoothly. Automated quality control solutions lend a helping hand in that regard.

Furthermore, regulatory affairs departments are generally in charge of post-marketing compliance. If safety issues arise after a product has gone to market, regulatory affairs coordinate with the appropriate agencies to issue a recall if necessary. Recalls can relate to possible contamination or issues with the manufacturing process or, yes, even the packaging.

From a packaging standpoint, automated quality control serves as a cover-all by ensuring even the smallest issues like missing or misplaced decimal points in dosage figures get printed properly. In an industry like pharma, such an error could prove to be disastrous and, in a worst-case scenario, lead to consumers taking fatal doses.

There’s only a risk of that happening if the packaging makes it to production. The importance of regulatory affairs departments thus becomes clear, as does the need for an automated quality control solution therein.

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FDA Break-Down: What is the FDA, FDA 21 CFR and How Do You Stay Compliant?

Multiple cartoon checklists for FDA

 

What is the FDA?

The Food and Drug Administration is a government agency that operates under the United States Department of Health and Human Services. The FDA is responsible for protecting and ensuring public health in relation to drug and food products. Additionally, they monitor the labeling and advertising of products that are sold in the United States. Whether the products are produced domestically or from foreign countries, the FDA assures that the labels on the products are factual and compliant. Also, The Federal Food, Drug and Cosmetic Act is under the FDA’s authority as well as the Fair Packaging and Labelling Act.

The products that are FDA approved range from human and veterinary drugs, to biological products, to medical devices and the United States’ food supply. The agency monitors bottled water, but not any alcohol products. The Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau deals with all alcohol goods. The FDA is also responsible for regulating, the manufacturing and the marketing of other substances like tobacco. Moving away from the drug and food industry, the FDA also regulates cosmetics and pesticides. They keep up with trends and recalls on the food and pharmaceutical markets to keep the public informed.

The FDA gives their stamp of approval to companies that they have reviewed and conclude that the benefits of these products outweigh the risk of the public’s health. The FDA will deem these goods to be safe for consumers and will not cause bodily harm.

And the CFR? What is that?

Most of us in the packaging and labelling industry are familiar with the FDA and maybe what they do as a government agency, but what exactly is the FDA 21 CFR? Firstly, the Code of Federal Regulations (CFR) is a code that the U.S. Federal Government uses for general and permanent rules. By general, I mean that they edit the volumes periodically. They are created by the Federal Register by the executive departments. The titles of each CFR represent the different types of products that are reviewed by the FDA. The CFR 21 is titled as the Food and Drug Administration. There have been multiple volumes released of the Title 21 over the years, as each volume is revised every calendar year. The current and previous versions of the CFR 21 and other titles can be accessed in the E-CFR.

For anyone that hasn’t accessed the E-CFR before, Title 21 has been broken up into parts that also has links, so they can be viewed individually. In Chapter one, you will find all the information about labeling and packaging for food and drugs. For example, you can read about nutritional quality guidelines and current good practices by FDA approved companies. For any drug or food business that is looking to become FDA approved, this would be a good resource to use for researching.

What about FDA Compliance?

To maintain and ensure the safety of public health, the FDA has policies in place for FDA approved companies to remain compliant. The Compliance Program Guidance Manual (CPGM), gives instructions to those working for the FDA to evaluate businesses that are under the Federal Food, Drug, and Cosmetic Act. According to FDA, this document is available to the public under the Freedom of Information Act. All of the programs in this manual are divided into sections. For example, if you choose to view the Drug Compliance Program, there are subsections that describe how inspections are done and the what to look for during labelling reviews. They even have a subsection that discusses “Drug Repackers and Relabelers.” Any company or person can click on the links in this section to understand how the FDA conducts their compliance evaluations. The Food and Cosmetics Program is similar to the drug program, having different subsections for more specific information about compliance and inspections.

GlobalVision and the FDA

Did you know that GlobalVision works with many products that are FDA approved? Corporations such as Abbott Laboratories, Proctor & Gamble, Pfizer and WestRock all trust GlobalVision to make sure that their labels and packaging are error-free when they hit the market. Whether it’s the software or the hardware, GlobalVision has been able to help many companies in the pharmaceutical and food industries with their proofreading process. GlobalVision can help food, drug and cosmetic companies to remain compliant and hopefully take them on the road to be FDA approved.

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An Overview of ISO 9000 and ISO 9001 and Why They are Vital for Companies

Globalvision brand with ISO certification

Date: November, 2017 | Category: Compliance | Author: Marvin Magasura

One way companies can ensure high-quality standards is by demonstrating to accredited organizations that they can fulfill specific QMS requirements. 

Founded in 1947, the International Organization for Standardization (ISO) is in charge of promoting and setting worldwide guidelines for propriety, commercial, and industrial standards.

Currently working with over 160 countries, ISO has become the world’s largest promoter of international standards and a reference in almost every sector of the manufacturing industry.

Created in 1994, the ISO 9000 family is a series of QMS standards designed to help companies meet both customers’ and stakeholders’ needs while at the same time meeting specific product statutory and regulatory requirements. 

Specifically, ISO 9000 lays down the fundamentals for every QMS, including the seven fundamental quality principles upon which the whole family is based. However, only ISO 9001 exposes the requirements that companies wishing to fulfill the standard must meet.

Looking for Process Change? Think ISO 9000

Every company needs change, but in the midst of implementing it, only a few of them think about ISO 9000. It is mostly perceived as a purely technical standard that only specific industries have to deal with. But for the experienced business owner, the Geneva-based International Standards Organization (ISO) occupies a prominent place within the company’s strategies and policies, especially when those policies involve process changes.

The strict guidelines provided in the ISO 9000 standards help companies develop a quality management system (QMS) that fits their particular situation. Basically, ISO demands strict adherence to its quality system model coupled with thorough documentation of certain processes. Independent internal audits are also held regularly in order to review the company’s system, and if everything checks out, the certification is issued.

Highlights of ISO 9000

The ISO 9000 family has become one of the world’s largest promoters of quality standards in almost every sector of the industry. 

Here are some of its leading traits:

  • ISO 9000 guidelines focus mainly on quality but can be applied to all types of organizations.
  • They are widely adopted in more than 100 countries.
  • They have global recognition with more than 1 million company certifications worldwide.
  • ISO 9000 helps all types of companies, no matter their size.
  • Since they come from previous standards that have been replaced, they are the true form of evolution in the industry.
  • The first step in becoming certified is to decide to create an effective QMS that complies with ISO criteria.
  • Companies have to set specific objectives based on ISO guidelines and then make the necessary adjustments.
  • Once all ISO requirements are satisfied, the company is held to independent audits for verification.
  • The process is done once the company passes the audit, but certification only lasts three years, and in that time the company must go through additional inspections to ensure compliance.

How to Get Started

Companies wishing to be certified have to deeply examine their quality management system – or even create a new one – to make sure it meets the criteria of the ISO. This mission shows the company’s desire to satisfy its customers, reduce costs, and enter a more competitive market while also adhering to government regulations.

If you’re still not sure whether you want to implement a new system or just improve the one you already have, there are countless benchmarking tools that can help you decide. Most companies will also seek advice from specialized firms that help businesses fulfill ISO 9000 requirements.

One frequently asked question a lot of first-time companies raise is how to determine if a given standard actually complies with ISO criteria. You can consult with the World Standard Services Network, a publicly accessible site for standard organizations, to answer these types of questions.

Most newbie companies are also unclear about the existence of any regional standards that are equivalent to ISO 9000. Although the ISO doesn’t publish this type of information, an ISO member in your country will likely be able to give you this information.

Structure Your Quality Management System

ISO 9000 requires certain documentation regarding all processes that could affect the quality of your product or service. It also demands keeping records of specific activities as evidence of compliance and contrasting the actual results with what was planned. Finally, it requires the integration of a program that deals with any identified inefficiencies in your processes.

At first sight, it can all seem a bit confusing and time-consuming, but with a lot of organization, any company can get ISO 9000 certification. One of the best approaches to structure your QMS is to use the step system:

  • First Step: Develop a Quality Manual, e.g., create and document policies that aim to satisfy all the standard requirements. This manual should describe your entire quality policy, including your mission, organization, specific policies, and responsibilities for each part of your company. Well-written quality manuals can also provide the benefit of acting as an advertisement for the quality of your services or products.
  • Second Step: Document all of your processes. It includes their purpose, what will be done, when, how, where, and by who. Additional descriptions can also include the equipment used.
  • Third Step: In this final step, you have to identify the word instructions, specific forms, procedures, inspections, records, test plans, and quality plans.

With a proper QMS in place, adequate documentation, and an eventual ISO 9000 certification, any company can be confident that all processes will be made following specific requirements and meet the highest quality standards.

The Future of ISO 9000

As industries change, so do the standards that have shaped them. In fact, this is particularly true when it comes to ISO standards, which undergo periodic revisions. Special analysts state that, while it’s true ISO 9000 standards are continually evolving, recent changes are pointing in the same direction: a standardized format. The main reason behind this comes from the need to align all of the QMS together so they can handle many different standards.

On the other hand, recent ISO 9000 changes are moving toward more impartiality, competence, and consistency. The International Standardization Organization is currently trying to come up with standards where businesses and organizations practice those three principles in all their processes. The final goal is to create an industry where all companies across the globe use and recognize the same quality standards. By doing so, they assure everyone is playing on a more level field.

For instance, ISO 9001 is now one of the most prominent quality management standards in the globe that has been continually changed and revised over the years. The 9001 has moved from being a prescriptive, documentation-heavy guideline to embracing more measurement and increasingly subjective terms. Its revisions enable companies in any sector to adopt it, making it a gold standard for other ISO guidelines and an indicator of how they will evolve in the future.

By integrating the so-called ‘process approach’ – a method the ISO community has embraced in which company tasks are measured alongside coordinated goals – organizations can thoroughly evaluate the efficiency of all their processes by identifying the “weak link” in a sequence of activities. Because the ISO 9001 standard shifted toward the process approach, all of the requirements imposed on a company are now going into each and every one of its processes.

What the ISO 9001:2008 Standard Represents

The 2008 update made to the ISO 9001 standard, commonly referred to as ISO 9001:2008, outlines the main modern quality management principles and requirements companies must meet to emphasize customer satisfaction, including business motivation and continual improvement. Using ISO 9001:2008, companies focus on providing high-quality services and products to their customers, and with over 1 million certifications worldwide, it is currently one of the most broadly used QMS tools available.

The first step to becoming ISO 9001:2008 certified involves initial assessments of the company’s quality system, defining the areas that comply and those in which improvements need to be made. Once that’s been resolved, and everything has been set by the standard, a certification body will then conduct a number of audits to ensure conformance with the requirements. 

If approved, the company then has to be subject to a three-year surveillance cycle. As you can see, the certification process can take as long as over a year, yet any company that understands its value knows it is worth enduring this process.

Don’t be Afraid of Internal Audits

Internal audits can be a real nightmare for most companies; however, they’re essential in order to truly examine how quality management systems perform. Because of this, they are also a considerable part of the ISO 9001:2008 certification process. 

While some may be reluctant to them, it’s important to keep in mind not only what they can provide to your business, but what it says about it if you avoid them. A few benefits of internal QMS audits include:

  • Increase in your business’ revenue
  • Valuable feedback that strengthens your QMS
  • Promotion of a positive company culture
  • Greater product quality
  • Better communication and consistency of your company’s processes
  • Boost in workplace morale
  • Increase your reputation as a company
  • Achieve international quality recognition

Why do Businesses Opt for ISO 9001:2008 Certified Companies?

Imagine you’re choosing a new supplier. You will likely look for someone with the following traits:

  • Delivers results consistently
  • Possess great problem-solving abilities
  • Provides a significant return on investment (ROI)

Companies that become ISO 9001:2008 certified already have voluntarily proven all these traits by actively being held accountable for the quality of their processes and operations. The certification also tells future clients they can expect the same high-quality results each and every time. To expand on this, here are the main benefits of working with an ISO 9001:2008 certified company:

Consistency

ISO 9001:2008 certified companies ensure a consistent workflow process every time you choose to work with them. You can even evaluate this by taking a look at the low variation rates these companies offer, which directly translates to product and ordering consistency.

Fast Problem Resolution

Be sure that if any problem arises while collaborating with an ISO 9001: 2008 certified company, the policies, and processes integrated into their QMS will quickly enable a fast resolution of the issue. But the ISO standard doesn’t end with that, it also makes sure the QMS includes a way of collecting and analyzing customer feedback and initiating effective corrective actions. Rather than waiting months for a resolution, an ISO 9001:2008 certified company would already have procedures in place to manage any potential problem that may arise.

Meeting Customers’ Expectations

As we stated before, this is the primary focus of the ISO 9001 standards. Certified companies will know the importance of adopting a QMS that ensures continued quality through the application of preventative measures. When implemented correctly, a good QMS is able to ensure every customer is satisfied while also complying with any regulatory requirements.

Maintaining Certification

An ISO certification is not a lifetime membership. Each ISO 9001:2008 certified company is regularly audited to ensure compliance with the QMS standards. This ongoing process of continued scrutiny actually increases their effectiveness and helps improve final product quality, making these companies an incredible option to work with.

Continual Improvement

By assuring regular audits, the ISO 9001:2008 standard also guarantees that companies evolve and find new ways of addressing different types of issues in order to improve over time. Continual improvement means that all processes must be run efficiently, all policies must be monitored continually, and results must always get better and better.

GlobalVision is an ISO 9001:2008 Certified Company

The ISO 9001:2008 Certification is only given to businesses capable of proving efficient management systems, therefore, companies who work hard on achieving this certification show prospective clients that all of their services and products meet and exceed the highest level of international standards.

To run a business in today’s world not only means that you have to deal with a high degree of competition but also with sky-high customer demands. That’s why complying with ISO 9001 standards has become such a huge advantage right now it can actually make or break the future of your company.

GlobalVision can proudly say it belongs in this group of organizations that offers products specifically built to endure the highest quality standards. We implement and maintain ISO guidelines as a testament to our commitment to our customers and the quality with which we develop all of our systems.  

Our ISO 9001:2008 certification provides worldwide recognition for our products, and it’s a testament to our commitment to providing only the best services to our customers.

Are you ready to implement only the best quality management systems into your workflows? Start by requesting a demo of GlobalVision here or try our web-based proofreading software, Verify, for free!

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