Mar

2011

Revised EU GMP Computerized Systems Annex 11

The EU Medicinal Products GMP contains an Annex (11) on use of computerized systems. This annex identifies requirements for validation, electronic records, and use of third party software. In some instances it is more specific than FDA requirements. The new version at the link provided obsoletes the Dec 1998 version when it becomes effective June 30, 2011.

This version requires risk management throughout the lifecycle taking into account patient safety, data integrity and product quality. It also has a section on the operational phase similar topics related 21 CFR 11 for electronic records and signatures among other requirements.

View the annex at this link: annex11_01-2011_en

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

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Americas: 11-13 February 2025
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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

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Medical Device Cybersecurity (Public or Private)

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2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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Revised EU GMP Computerized Systems Annex 11

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