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Efficient Audit Trail Review for PIC/S GMP Annex 11 Compliance

April 30, 2025

Audit trails play a crucial role in ensuring data integrity, traceability and compliance with Good Manufacturing Practice (GMP) regulations. Under the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-16), Annex 11 outlines specific requirements for computerised systems, emphasising the need for audit trail reviews....

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