Designing a Global Labeling Strategy, Given the Volatility of the Regulatory Climate

By Tim Fischer

What is hot in the medical device industry?

Regulation around labeling for the medical devices industry has evolved significantly in the last 40 years. From the challenge being the creation of exact definitions for labeling in the 1970s, to the release of the Health Industry Barcode Supplier Labeling Standard in the 80s, and issues such as multi-language labeling, symbology and e-labeling in the 90s & early 2000s, today’s hot topic is UDI. Moreover, with the EU Council and Parliamentary Committees having signed off new Medical Device & In Vitro Diagnostic (IVD) regulations in June 2016, UDI is set to remain a hot topic years from now.

However, with the UDI implementation deadline for class II medical devices impending in September 2016, 23% of the companies surveyed by PRISYM ID at the beginning of the year admitted that implementing a labeling system in preparation was the biggest issue they have incurred. * While the FDA estimated that companies have invested only 3 to 4% of revenue to ensure operational compliance.

UDI Survey

*See the UDI infographic for more survey results

Regulatory Requirements vs Organizational Demands?

In the best case scenarios the label produced says is what the product is; what the customer asked for, they got; and what the patient needed was delivered. However in the worst case scenarios the executive management didn’t see ROI; regulatory overlooked a critical labeling attribute; operations ran a wrong, but similar label; and quality failed to catch the error. So now what?

The key to optimizing organizational efficiency and meeting the increasingly complex regulatory requirements is to build a strong foundation for devising a global regulatory labeling strategy, built upon the GAMP V Standard for the Validation of Automated Systems and the Code of Federal Regulations (CFR) Title 21, Part 820 Quality System Regulation for current good manufacturing practice (CGMP) requirements.

Creating a User Requirement Specification (URS)

Ownership of requirements lies with the regulated company. Without user ownership, the business operational needs and any associated issues can never be fully understood and captured.

Documented Requirements form the basis for acceptance of the system by users. See more about the GAMP V URS here.

The URS must address these key points:

  • Total Enterprise End Goals
  • End to End Capability
  • Import / Export Data Connectors/Source of Data
  • Validation and Change Management
  • Workflow Approval
  • Languages
  • Print Inspection

Start Your Engines: Leverage the Regulatory Rules Engine to Obviate Compliance Pitfalls and Challenges

The Final Analysis – Who can deliver?

Global label lifecycle management solutions such as PRISYM 360, supported by Lifecycle documentation based on the GAMP V Model to gain CGMP compliance, are key to mitigating risk and meeting today’s increasingly complex labeling challenges.

Learn from one of the world’s largest medical device manufacturers, who was looking to standardize on a single labeling system. This project initially arose when a worldwide branding exercise highlighted the huge variances in label formats and styles on secondary packaging.


About the author:

tim-fischerTim has spent over 25 years in and around Life Science compliance. Having launched his career at Abbott Labs in the Hospital Products Division in North Chicago, he spent most of his early days within Biological QA/QC as well as Small Volume Parenteral operations management. He then did additional technical work.

Following his Abbott days, he worked as Director of Compliance for 3 CMOs and in 2007 decided to strike out and perform 21 CFR 820 quality system consulting. It was during this period that he developed an appreciation for compliance software of which he has been heavily involved in over the course of 6 years including with PRISYM ID.