PIC/S PI 023-2 Aide-Memoire: Inspection of Pharmaceutical Quality Control Laboratories, 9/07

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This 2007 Pharmaceutical Inspection Convention provides guidance to inspectors of pharmaceutical quality control laboratories.

This inspector’s guide indicates the following areas of focus for systems:

• Section 9.1 instructs inspectors to check the validation, change control, personnel training, access authorization, and security of Laboratory Information Management Systems (LIMS)
• Section 3.4 refers inspectors to use PI 011 Good Practices for Computerised Systems for specific inspection questions for computer systems