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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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