From the Experts Blog - Montrium

Articles from Montrium's Expert Professional Services team!

Regulations Standards

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.

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Where do Annex 11 and Part 11 intersect?