22
Nov
2007

FDA Computer System Inspection for BIMO-Part 11

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0

As part of the Compliance Guide (issued 21-Feb-01) for inspections as part of Bioresearch Monitoring (BIMO) Good Laboratory Practice Section 7348.808 has specific guidance to inspectors for computer systems use in research/studies. This CPG is at . Section 3 address inspections in particular.

Although computer related items are spread throughout this section, Attachment A of is an attempt by ORA to provide all computer related guidance for inspection under BIMO for Good Laboratory Practices (21 CFR Part 58 – GLP) with particular emphasis on 21 CFR Part 11. A reprint of Attachment A is at the link provided and may be useful from a Part 11 and validation perspective beyond just those interested in BIMO inspections.

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