EU GMP Annex 11
Also: Annex 11
The European GMP guideline governing computerised systems used in regulated activities, covering the system lifecycle, data integrity, security and suppliers.
Annex 11 is broader than Part 11: it is explicit about the validation lifecycle, risk management, and agreements with suppliers and service providers, in addition to audit trails and access control.
Operations that span the US and EU generally satisfy the stricter of Annex 11 and Part 11 on each control.
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