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GUIDANCE Final

Computerized Systems Used in Clinical Investigations

FDA · 2007 U.S. Food & Drug Administration
ABSTRACT — EDITORS' SUMMARY

Pre-cloud-era guidance on validation, audit trails, and access controls. Still cited for predicate-rule expectations.

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METADATA
TypeGUIDANCE
Year2007
VersionFinal
StatusCurrent
FormatPDF
Pages18
Size420 KB
Last reviewedMAY 2007
SOURCE
PDF · CANONICAL LINK https://downloads.regulations.gov/FDA-2004-D-0039-0007/attachment_1.pdf ↗
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