Validation Information

Computer Validation Information

Guidance Documentation

Organization	Item	Description
Apic	Computer Validation Guide, December 2002	Outline of the scope and legal requirements for the validation of computerised systems.
ISPE	Risk-Based Approach to 21 CFR Part 11	A brief interpretation of the requirements stipulated in the 21 CFR Part 11 regulation.
Picsheme (PIC/s)	Good Practices for Computerised Systems in Regulated "GxP" Environments	Recommendations and background information concerning the use of computerised systems in regulated environments.

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