The Undeniable Need for Digital Proofing in Regulatory Affairs

Compliance documents under digital proofing for EU regulatory affairs

Still in its relative infancy as a discipline, regulatory affairs was 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. Digital proofreading 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 at 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.

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. Digital proofing 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 coordinates 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, digital proofing 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 a digital proofing 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.

Request a demo.

Sign up for a free live demo to see how GlobalVision can help you optimise your quality control.

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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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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.

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 their 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

Since their first release in the 80s, the ISO 9000 family has become one of the world’s largest promoters for 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.

Globalvision brand with ISO certification

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 to keep records of specific activities as evidence of compliance and to contrast 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.

Girl working in her office

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 to 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 their processes.

GlobalVision is an ISO 9001:2008 Certified Company

Since its foundation, companies like GlobalVision have been strong advocates for quality control in the packaging world, offering products that are specifically designed, built and released complying with the highest quality standards in the industry. Its ISO 9001:2008 certification provides worldwide recognition to their products, and it’s a testament to their commitment to providing only the best services to their customers.

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12 Ways to Reduce Data Integrity Risks for Regulated Industries

Laptop, hard drive, monitor and other devices

Date: December, 2016 | Category: Quality | Author: Mike Malz

What Does Data Integrity Mean?

Data integrity refers to the fact that data must be reliable and accurate over its entire lifecycle. Data integrity and data security go hand in hand, even though they’re separate concepts. Uncorrupted data (integrity) is considered to be whole and then stays unchanged relative to that complete state.

It is important to understand what data integrity really means in order to be compliant.

Maintaining or keeping data consistent throughout its lifecycle is a matter of protecting it (security) so that it’s reliable. And data that’s reliable is simply able to meet certain standards, with which compliance is necessary. For example, the FDA uses the acronym ALCOA to define data integrity standards and to relate to good manufacturing practices.

Data Integrity Best Practices:

Data is expected to be:

  • Attributable – Data should clearly demonstrate who observed and recorded it when it was observed and recorded, and who it is about.
  • Legible – Data should be easy to understand and recorded permanently and original entries should be preserved.
  • Contemporaneous – Data should be recorded as it was observed, and at the time it was executed.
  • Original – Source data should be accessible and preserved in its original form.
  • Accurate – Data should be free from errors, and conform with the protocol.

The Importance of Data Integrity

Why is data integrity important?

Data integrity has become a serious issue over the past few years and therefore is a core focus of many enterprises. The FDA published a Data Integrity Guidance Document outlining compliance with CGMP that addresses the role of data integrity for the industry.

The document is a result of the FDA increasingly observing violations involving data integrity during inspections. These violations have led to FDA warning letters, import alerts, and consent decrees. The guidance document answers integrity questions and strives to clarify what the FDA expects from businesses.

A clip board including a checklist of items

How can Data Integrity Risks be Minimized?

In today’s marketplace, companies need to feel confident that there is no loss of quality when using computer systems. To accomplish this, there are effective strategies that companies may implement to manage their data integrity risks and ensure their data respects the ALCOA principle. By moving from a reactive to a proactive way of thinking, the following key requirements and controls may be put in place to ensure data integrity and minimize risk for your organization.

12 Ways to Reduce Data Integrity Risk:

1. Ensure all computer systems are 21 CFR Part 11 compliant

21 CFR Part 11 is an FDA regulation that applies to electronic records. It is required to ensure that electronic records are trustworthy, reliable, and equivalent to paper records. All computer systems that store data used to make quality decisions must be compliant, making it a perfect place to start with data integrity.

2. Follow a software development lifecycle

A Software Development Lifecycle methodology helps oversee that quality-related tasks are performed to address pertinent lifecycle phases from software development, software testing, integration, and installation to ongoing system maintenance. All computer systems should be appropriately developed, qualified, tested, and assessed on a regular basis.

3. Validate your computer systems

Software validation provides documented evidence to deliver assurance that a specific process consistently produces a product that meets its pre-determined specifications and quality attributes. To ensure your system can be validated, it is key to work with vendors that provide validation.

4. Implement audit trails

A secure, computer-generated, time-stamped audit trail records the identity, date, and time of data entries, changes, and deletions. Audit trails ensure the trustworthiness of the electronic record, demonstrate necessary data ownership, and assure records have not been modified or deleted.

5. Implement error detection software

Automated inspection software can help verify important documents to ensure their accuracy. Manual proofreading or inspections are proven to be inefficient and often cannot assure that files are error-free.

6. Secure your records with limited system access

All systems should require a login with at least two unique pieces of information and provide access only to required individuals to guarantee data integrity.

7. Maintain backup and recovery procedures

A backup and recovery strategy is necessary in the unexpected event of data loss and application errors. This procedure ensures the reconstruction of data is achieved through media recovery and the restoration of both physical and logical data and creates a safeguard to protect the integrity of your database files.

8. Design a Quality Management System with SOPs and logical controls

A Quality Management System with Standard Operating Procedures builds quality into the process by systematically controlling the process. It is essential to write and follow good effective procedures to ensure clear accountability.

9. Protect the physical and logical security of systems

Controls are needed to protect the physical and logical security of your systems, change management, service management, and system continuity. This will assure continuous development for your organization and support of systems.

10. Establish a vendor management qualification program

It is important to evaluate all vendors supplying products to certify that the products are quality products that meet needs (such as validation services). A continuous appraisal is required following the initial evaluation. Often asking what data integrity procedures your vendors have in place will help with your own organization’s data integrity practices.

11. Properly train users and maintain training records

Users should be properly trained so that they have the right education and expertise to perform their job competently. Documented training records provide this proof.

12. Conduct Internal Audits to evaluate controls and procedures

Internal audits ensure that all procedures are followed and that continuous improvement is emphasized.

Data Integrity Success

If you are reading this article, you are most probably aware of how important it is to ensure your data is not compromised. The impact of dangerous data can have resounding consequences on any organization no matter the size. However, if data integrity is thought of as a process, the data infrastructure can become an asset instead of a liability.

GlobalVision is the leading developer of automated quality control technologies for
every stage of the pharmaceutical workflow. Learn how GlobalVision has helped top Pharmaceutical Companies in quality control.

Request a free trial for GlobalVision Automated Proofreading Solution

Related Articles:

What is QMS? Quality Management System?

Software Development & Data Integrity

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CMOs of Increasing Importance to Pharmaceutical Companies

Pharmaceutical Companies Manufacturing

Date: July, 2016 | Category: Compliance | Author: Reuben Malz

The pharmaceutical marketplace has changed dramatically over the last few years as pharmaceutical companies are moving from centralized, internal production to single-source providers or Contract Manufacturing Organizations (CMO).

The principal reason behind this evolution in the landscape is simple, to cut costs, increase capacity and reduce time-to-market. Beyond these obvious criteria, there are numerous other reasons why pharmaceutical companies are relying heavily on the growing CMO market.

Whereas CMOs once produced primary packaging they now offer a multitude of services from design and discovery to final packaging.

Outsourcing to a CMO allows the pharmaceutical company to add technical resources without increasing its overhead costs. The result of this is that the pharmaceutical company does not need to invest in expanding its staff and manufacturing facilities, to add new varieties of medicines into its product lines.

Pharmaceutical companies can now concentrate on core products regarding R&D and production and leave their secondary and tertiary products to the CMO.

CMOs of Increasing Importance to Pharmaceutical Companies 

What is a CMO?

The term CMO can refer to a multitude of different companies including Contract Packaging Organizations, and Contract Pharmaceutical Manufacturers. However, in recent years CMOs have been more or less classified into two types of organizations:

API Contract Manufacturer (Active Pharmaceutical Ingredient)

These are companies that manufacture a substance(s) that are used as a component of a finished drug.

FDF Contract Manufacturer (Finished Dosage Form)

These are companies that provide a drug product for administration to a patient without the need for substantial further manufacturing and often in its final packaged form. The CMO market is currently divided almost equally between API manufacturers and FDF manufacturers.

Within FDF contract manufacturing, solid dose compounds currently dominate the market. However, future growth is likely to be driven by injectables dose manufacturing primarily due to an increased focus on complex disease areas and the growing trend of self-administration.

A Growing CMO Market

Regarding market growth and potential future growth, the CMO channel is a force to reckon with.  

For North America, Europe, and Japan in the last years, the CMO market grew at close to three times the rate of the pharmaceutical market: 8% versus 3%.

(It is important to note that the 3% growth is for the pharmaceutical market as a whole, top Pharmaceutical companies have grown significantly faster at a rate average of over 11%. It is also important to note that most large pharmaceutical companies have divisions operating as CMO)

Over the next decade years, the CMO market is expected to continue to grow at an annual rate of 6% to 9%, with annual revenues currently valued at between 25-30 billion dollars. This growth will be further fueled by new opportunities within the generic drug market.

Challenges for the CMO

Although the CMO seems to be poised to become a major player in the pharmaceutical marketplace several challenges await.

Acquisitions

The trend is already apparent as 2015 saw a glut of companies and manufacturing facilities being bought and sold.

Current Clients

Smaller pharmaceutical companies use the services of CMOs significantly more than large pharmaceutical companies.  The challenge lies in that the growth opportunities are a lot smaller.

Low Capital Costs

With lower capital costs many pharmaceutical companies are rethinking the CMO route for moving back to traditional centralized production.

The Future of CMOs

As with any part of the pharmaceutical landscape, the role of the CMO will follow a predictable route. Larger ones will absorb the smaller CMOs, and the large CMOs will come forward to be the only players to be able to support the large Pharmaceutical and Biopharmaceutical companies.

New channels will open within the generic pharmaceutical marketplace fostering further growth for the large CMO.

GlobalVision is the leading developer of proofreading technologies for the FDF Contract Manufacturer market. All our quality control solutions meet FDA 21 CFR Part 11 / EMA Annex 11 requirements.

For more information on GlobalVision and the Quality Control Platform for CMOs, please visit: globalvision.co or email: info@globalvision.co

Learn More about How to Ensure a Successful Printer-Pharma Relationship

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Having to Rework Label Artwork Again and Again to Stay in Compliance?

Pill bottle label under inspection

Date: April, 2016 | Category: Compliance | Author: Reuben Malz

No matter what industry you are in there are always new regulations that impact the way you create labeling artwork. Staying compliant with regulatory labeling obligations is a complex undertaking that if done wrong may result in undesired errors or reworking.

Regulatory Label Compliance with GlobalVision

GlobalVision provides a Quality Control Platform to proofread artwork, text, print, barcode, and Braille and is designed to help you maintain regulatory compliance.

Major regulations now in place or planned are listed below along with an appropriate GlobalVision solution that can enhance the quality and speed of inspections:

Chemical 

OSHA – Hazard Communication Standard (United States)
In order to ensure chemical safety in the workplace, information about the identities and hazards of the chemicals must be available to workers.

WHMIS 2015 – Workplace Hazardous Materials Information System (Canada)
A regulation to provide health and safety information on hazardous products (labeling, safety data sheets) that is intended for use, handling, or storage in Canadian workplaces.

New Requirements
Chemical manufacturers and importers will be required to provide a label that includes a harmonized signal word, pictogram, and hazard statement for each hazard class and category. Precautionary statements must also be provided.

The GlobalVision Solution

GlobalVision Text Inspection Solution

  • Validates that the correct font and text size are used on the label for artwork.
  • Verifies that the correct font, size, and style are used to differentiate the Signal word

GlobalVision Graphics and Artwork Inspection Solution

  • Verifies artwork including pictograms on a pixel-by-pixel basis.

Food

Food Labeling Modernization Act (Canada)
Update of food packaging labels designed to improve access to information and to increase awareness, to help consumers to make informed decisions about the food they buy.

EU Regulation 1169/2011 (European Union)
Revision of product information on product packaging and online stores pertaining to food and beverages sold in the EU. The objective of which is to standardize food labeling and provide greater clarity to consumers concerning ingredients, nutrition and allergens.

FDA Nutrition Fact Labels Revision (United States)
Update of food labels in the United States to reflect up-to-date serving sizes, as well as percent daily value, designed to better inform consumers.

ACC Country of Origin Labels (Australia)
Revision of food labels to include the addition of a statement and a bar graph indicating the proportion of Australian ingredients by weight.

New Requirements
New food labeling directives all specify lists of mandatory information and details on how the label information should be formatted and displayed – including minimum font requirements, new artwork, and tables on food packaging included in the new formats.

The GlobalVision Solution

Documents under text inspection using GlobalVision tool

GlobalVision Text Inspection Solution

  • Validates that the correct font and font size are used during typesetting. The font type and size have a direct correlation to the X-Height of the final printed package.
  • Verifies that the correct font, size, and style were used to define different elements.

GlobalVision Graphics and Artwork Inspection Solution

  • Compares previous artwork to new version artwork, to ensure stylistic differences are present.

GlobalVision Print Inspection Solution

  • Inspects X-Height in mm on the final printed packaging.
  • Compares the previous package to the new version of the package, to ensure stylistic differences are present.

GlobalVision Barcode inspection

  • Verifies and grades the barcode to ensure accuracy and scanability.

Braille

ISO 17351:2013 (European Union)
Standard outlining the requirements and providing guidance for the application of Braille to the labeling of medicinal products.

Safety and Innovation Act (Pub. L. 112-144, 126 Stat. 993) (United States)
A series of best practices on how to offer guidance to pharmacies and provide accessible prescription drug container labels to patients with visual impairments to enable them to manage their medications independently and privately.

New Requirements
New Braille regulations require Braille on the outside packaging of all medication – including name, and dosage of medication.

The GlobalVision Solution

GlobalVision Braille Inspection Solution 

  • Ensures that Braille Dot Height meets the 0.20 mm requirements ensuring readability by visually impaired persons.
  • Verifies the Braille character spacing
  • Translates Braille into readable text

Pharmaceutical

Old lady reading pill labels with the pharmacist

Directive 2001/83/EC Article 11 (European Union)
Updated packaging and labeling regulations for the EU

FDA Opioid Action Plan (United States)
Revised labeling requirements is to better inform doctors about the risks of opioids and how to prescribe these drugs safely.

FDA NSAID Warning (United States)
Revised warning labels that non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) may cause heart attacks or strokes

New Requirements
Packaging content must match the approved QRD template from the European Medicines Agency (EMA) (for EU).
Multiple modifications and additions to the packaging, labeling, warning labels, and associated literature.

The GlobalVision Solution

GlobalVision Text Inspection Solution

  • Ensures that the approved content contained within the QRD template is consistent with the carton, folding boxes for medicinal products (for EU)
  • Medical spell-check
  • Complex table handling
  • Detect deviations between packaging, labels, leaflets, and the text of the Annexes

GlobalVision Graphics and Artwork Inspection Solution

  • Compares previous label artwork to new version artwork, to ensure stylistic differences are present.

For more information on the GlobalVision Quality Control Platform


and how it can help with your compliance requirements please visit globalvision.co

Journey of the Package Printing Process

Our helpful guide walks you through the major steps of a typical package printing process, and how you can ensure a flawless delivery, every time.

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