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Labcompliance News, April 2000

April 12, 2000

PIC Computer System Draft guidelines

The Pharmaceutical Inspection Convention (PIC) has developed a draft guidance on "Best Practices for Computerized Systems in Regulated GxP Environments". The guidance document is intended to provide a logical explanation of the basic requirements for the implementation, validation and operation of computerized systems. The document is 45 pages long. It is currently distributed for inputs.