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.

Laptop, hard drive, monitor and other devices

Date: December, 2016 | CategoryQuality 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

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

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Software Development & Data Integrity

Pharmaceutical Companies Manufacturing

Date: July, 2016 | CategoryCompliance 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.


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

Pill bottle label under inspection

Date: April, 2016 | CategoryCompliance 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:


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 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.


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


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.