Cartoon women standing with FDA icon and check mark
 
 

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 realize 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 necessary access to change records.
  • Each user should have their own, as opposed to shared, log-in 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 re-occurring: 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 the 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 pre-requisites 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 on 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.

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.

GlobalVision software on Phone, Tablet and laptop

A name on a dotted line may technically hold just as much legal weight as ever, but in the era of electronic signatures a contract can be enforced without a pen ever touching paper.

What Are Electronic Signatures?

Indeed, electronic signatures, where an “electronic sound, symbol, or process” is used to sign and show intent to sign a record, are becoming increasingly common and for good reason. You may have run into examples of electronic signatures already, maybe without realizing it. Here are a few:

  • Physical, electronic signatures created with a stylus
  • Options to sign that have been selected in e-signature software
  • Usernames entered in (upon a request for consent), accompanied by their passwords
  • Various forms of biometric data

They’re each arguably more convenient than their physical counterparts (based on the ability to sign documents remotely), while the environmental benefits are obvious. Reducing the reliance on paper records to the point that they may become obsolete obviously reduces the carbon footprint of companies making the switch.

Overhead costs drop as a result too, making electronic signatures cost-effective in addition to simply being the next stop at which an increasing number of businesses are getting off. It may be time to join in or risk watching the world pass you by from out the passenger window.

Digital vs. Electronic Signatures

There can be some confusion over the difference between digital and electronic signatures. To be clear, they aren’t the same thing. Electronic signatures are electronic versions of what one would consider a hard-copy signature used to confirm consent.

Digital signatures are similar, but take the extra step of verifying the identity of the person doing the signing. In that sense, one could argue all digital signatures are electronic signatures, but not vice versa, kind of like how a thumb is a digit on the hand, but not all fingers are thumbs.

So, why are electronic signatures all the rage and digital ones aren’t? Based on the Uniform Electronic Transactions Act and Electronic Signatures in Global and National Commerce Act the two are equal in terms of legal significance. Remember, individual businesses can always go the extra mile and require digital signatures and they’d still be considered electronic as well. They don’t have to, though. In other words, why run a marathon when everyone just cares about the 100m dash?

Are E-Signatures Legal?

Rest assured, electronic signatures, even if they’re not digital, are legally bindingWith partial exception to in California, electronic signatures are enforceable throughout the country just as if they were handwritten signatures. After all, there’s little reason to doubt the security of an electronic signature. They’re actually more secure than a physical signature.

Look at it this way: What makes a physical copy of a contract so secure? “Secure” in that context usually implies it’s safely under lock and key in a file cabinet somewhere. That doesn’t make documents invincible by any stretch. Pieces of paper can easily fall victim to random acts of God or crime… or a simple accidental rip.

In fact, it just seems second nature to back up a contract by scanning it in and keeping a digital copy. And how far removed is that from embracing e-signatures, really? Pretty far, in the sense that a document with a digital signature becomes effectively tamper-proof. In terms of record-keeping, administrators are given greater control through the use of electronic signatures, which also lead to enhanced traceability via an audit trail, for example.

If the authenticity of a physical signature ever comes into question, there is only so much you can do to prove it’s real. You can go much deeper with digital signatures, which can provide a data trail directly inside.

In a data-driven society, electronic signatures aren’t just a fad, but instead, represent a single example of an ongoing societal trend of improving on set standards. They’re also setting new ones.

Cartoon characters working with pills bottles packages

Despite political hurdles and an economic recession, Brazil is forecasted to move up in the pharmaceutical world. The Latin American behemoth was ranked as the world’s 10th largest pharmaceutical market in 2011 and is predicted to take the fifth spot by 2021. In addition, Brazil’s pharmaceutical market is estimated to grow to $29.9 billion by 2021. How can Brazil achieve this? There are a few key factors at work here.

A Growing Demand for Healthcare

A change in demographics seems to be a key element in this financial turnaround. Brazil has an aging population, increasing the need for healthcare. There are cities that have expanded their population to the point where they would now be able to contribute more to the growth of the economy. These citizens are making more money, increasing their purchasing power and demand for better healthcare services. As it turns out, the public is willing to pay for it.

According to McKinsey & Company, “midsized cities (20,000 to 500,000 people) will be responsible for more than 50 percent of total consumption growth in Brazil.” About fifty percent of citizens living in these cities say they are willing to spend more on healthcare. This will increase the demand for a pharmaceutical market… and one that will last.

Storage and Transportation Efficiency

In the past, Brazil’s infrastructure was poorly designed and was infested with bureaucratic control. It has since made improvements, especially to Rio de Janeiro International Airport, which has tripled its cold-storage capacity, making it easier for the country to store pharmaceutical products with proper insulation.

In addition, it has been recognized by the International Air Transport Association and was awarded their Center of Excellence for Independent Validators (CEIV) Pharma certificate. It has proven to be a good investment for Brazil, as temperature-controlled pharmaceuticals make up about a quarter of the cargo’s revenue.

FedEx, DHL, and UPS have also expanded their services in Brazil and now have the capability to transport temperature-controlled drugs and medicines. According to Pharma Logistics IQ, Brazil has acquired about 300 trucks that will cover the Rio de Janeiro region as well as the state of Goias and its surrounding areas.

A Wealth of Opportunities

Another reason Brazil is predicted to move up in the pharmaceutical world is the growth of opportunities. Many pharmaceutical companies see the expansion of the market because of the availabilities of active ingredients that have been brought into the nation. Brazil has been relying on imports from other countries, like the United States, who provide them with raw materials. This is because of a partnership with the World Health Organization and the United States Department of Health.

The Butantan Institute in Brazil partnered with these organizations to produce the Zika vaccine. In 2015, the virus-carried by mosquitos-ravaged Brazil, causing birth defects in newborns. The institute was granted this opportunity in 2016 because of the production of new biopharmaceuticals. This is a huge accomplishment for Brazil, as it will be able to protect its citizens as well as any visitors from the potentially fatal disease. According to Jorge Kalil, director of Butantan, this break will allow the institute to “contribut[e] to the advancement of scientific research in the country.” However, the after-effects of the economic crisis are still an issue to not only Brazil but to its pharmaceutical market as well.

Rise Just to Fall… Again?

With big responsibilities can come big problems and Brazil is no exception. Every year the Agência Nacional de Vigilância Sanitária (ANVISA) sets a maximum price increase that drug makers must follow. According to Pharma Logistics IQ, 90% of active ingredients are imported to Brazil, and the country’s tax code is very restrictive. Thanks to these two factors combined, drugs become very expensive to manufacture in Brazil.

Edwin Dominguez, a GlobalVision sales representative who does business in Brazil, shares the same sentiment. He says that imports have become increasingly expensive.

“It is a very protective market for goods coming from anywhere outside of the Mercosur trade bloc [whose members include Argentina, Brazil, Paraguay, and Uruguay], which makes raw material an expensive part of the final product for the consumer, “ he says.

This, in turn, slows down the production of its drug-making process. Although the government has implemented initiatives to promote local drug production in Brazil, it remains to be seen if the country will be able to overcome this financial hurdle.

Politically-Charged Economy

“Political climate on Brazil is very unstable right now,” says Dominguez. He feels that the damage has already been done and “corruption cases are overwhelming in Brazil.”

The scandalous and corrupt government led by President Michel Temer, who was charged in June 2017 with accepting bribes, has made it difficult for the pharmaceutical industry to make headway in Brazil. This, combined with already tough economic times, has proven to be a challenge for Brazil.

Brazilians will go to the polls in October 2018 and it is unknown how this will affect the pharmaceutical industry. There are so many opportunities for Brazil, but the past might hold the market back.

Conclusion

Predictions surrounding Brazil’s pharmaceutical market are logically optimistic, pending certain factors of course. However, these are numbers that can change at any time because of the notoriously unstable environment in question.

The country has come far regarding biopharmaceutical advancement and infrastructure, something that most Brazilians would have never thought was possible. They have been given a chance to help their aging population and those who have been affected by deadly diseases. Now that small to mid-sized cities are contributing to consumer growth, there is an increase in demand for healthcare. It appears that the South American giant has a lot of potential, but can it move forward beyond the past that haunts it?

With the constant increase in manufacturing prices for drug makers combined with the political pitfalls, there is no telling what the future of Brazil’s pharmaceutical market will look like. If it can overcome the financial and political adversity, nothing stands in the nation’s way of becoming the next capital of the pharmaceutical market.

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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Globalvision brand with ISO certification

How can you define product quality? This term can be interpreted in different ways depending on the country or region you live in, but perhaps the most crucial variable that determines what quality represents is the unique set of quality objectives integrated by a company.

In a nutshell, quality refers to all actions taken to meet consumers’ expectations; therefore, a quality management system (QMS) refers to the compilation of processes that such companies use to maintain customer satisfaction by implementing quality objectives and quality policies. When a company establishes a matured QMS, an intricate network of resources, procedures, and policies is set to guide them towards one simple goal: deliver the very best version of their product.

Quality management systems have such an essential role in today’s marketplace that no modern company is likely to survive without one. They integrate several internal policies that eventually provide the company with a process approach to project execution. Simply put, it enables businesses to identify, control, measure, and improve what they do to boost their performance.

What the ISO 9001:2008 Standard Represents

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 the ISO 9001 exposes the requirements that companies wishing to fulfill the standard must meet.

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 have to 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 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:

  1. Delivers results consistently
  2. Possess great problem-solving abilities
  3. 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 their 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.

Conclusion

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 in which we develop all of our systems. Because our main line of business is to provide quality control services for others, we take our own product’s quality very seriously, that’s why our final goal is to assure our clients we keep their specified requirements in mind at all times.


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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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Pill bottle label under inspection

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

Proofreading Images and Labels

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.


GlobalVision Solution

DocuProof – Text Inspection Solution
(available as a workstation or web-based app: Proofware)

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

ArtProof – Artwork Inspection Solution
(available as a workstation or web-based app: Proofware)

  • 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.


GlobalVision Solution

Documents under text inspection using GlobalVision tool

DocuProof – Text Inspection Solution
(available as a workstation or web-based app: Proofware)

  • Validates that the correct font and font size is 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.

ArtProof – Artwork Inspection Solution
(available as a workstation or web-based app: Proofware)

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

ScanProof – Print Inspection Solution
(available as a workstation)

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

BarProof – 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 to require Braille on outside packaging of all medication – including name, dosage of medication.


GlobalVision Solution

BraillePoint – Braille Dot Height Measurement Tool
(available as a workstation)

  • 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.


GlobalVision Solution

DocuProof – Text Inspection Solution
(available as a workstation or web-based app: Proofware)

  • 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

ArtProof – Artwork Inspection Solution
(available as a workstation or web-based app: Proofware)

  • 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

Email: info@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, everytime.