Beware: Annex 11 Has Implications for Medical Devices

Beware: Annex 11 Has Implications for Medical Devices

Mark Crawford

In January 2011 the European Medicine Evaluation Agency (EMEA) released an updated version of the European Union’s GMP Annex 11 for computerized systems (Annex 11), as well as an expanded version of Chapter 4 on document management.

These are significant changes for the pharmaceutical industry—the new Annex 11, for example, is about four times larger than the older version

EMEA decided to overhaul Annex 11 to keep up with the increased use of computerized systems in all aspects of good manufacturing practice (GMP), as well as their increased complexity. Annex 11 now addresses the regulatory needs of modern IT systems and imparts extensive requirements for compliance at all levels—for example, it dictates how computer printouts of critical records must indicate if any data has been changed since the original entry. Other key topic areas include business continuity, incident management, electronic signatures, migrating and archiving documents, and more comprehensive security controls.

The impact of these new revisions is extensive—when combined, the new European Union (EU) GMP Annex 11 and Chapter 4 standards are roughly equivalent to the FDA’s Part 11 and pertain to any electronic system used in regulated manufacturing processes.

Although these changes became operational on June 30, many pharmaceutical companies are not fully aware that, in order to comply with these new EU standards, they may be required to update their current management systems.

Overall, the new Annex 11/Chapter 4 is a solid framework for validating computer systems and managing electronic records in increasingly sophisticated manufacturing environments—which will improve quality and reduce risk. Annex 11/Chapter 4 is also important because it is showing us how the EMEA may approach future regulatory changes.

Although Annex 11 technically only applies only to “medicinal” products, there are some key reasons why medical device companies should align themselves with Annex 11, advises Martin Browning, president and co-founder of EduQuest, a provider of regulatory consulting, auditing, and training services to the global pharmaceutical, biologics, and medical device industries.

“Now that the Global Harmonization Task Force is being dissolved, the EU will take a more centralized approach and apply its guidance more broadly to all regulated areas,” says Martin. “Annex 11 represents the clearest thinking yet from the EU on the use of electronic record keeping and electronic signatures in a regulated environment. Complying now with Annex 11 will help you meet Part 11 and go a long way toward meeting future European medical device expectations—especially from a notified body auditor’s viewpoint.”

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