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Regulations Standards

Understanding Audit Trail Requirements in Electronic GxP Systems

Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions. Therefore, we must ensure the GxP system which maintains the electronic record(s) is capable of meeting these regulatory requirements.

The Microsoft Azure Cloud
Where do Annex 11 and Part 11 intersect?