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....
A major pharmaceutical distribution organisation engaged the services of SeerPharma (Singapore) Pte Ltd to provide a review on the compliance of its core SAP-Centric solution to the GxP Computer Systems Validation (CSV) requirements of both FDA 21 CFR Part 11 and PIC/S Guide to GMP Annex 11. There were 2 phases to this project.
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