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Selected FDA Part 11 Related Documents and
Links
Over 70 others available by clicking Library and selecting the pull down document type for Part
11
21 CFR Part 11 Feb 2003 Federal Register Notice Announcing Major Redirection for Part 11
21 CFR Part 11 Final Scope and Application Guidance
May 2007 Revised FDA Guidance Computerized Systems Used in Clinical Trials
21 CFR Part 11 Electronic Records;Electronic Signatures Rule
FDA ORA IOM Electronic Copies Investigator Guidance
QS Regulation Record Keeping Requirements CDRH Report
Click Warning Letters to search for Part 11 excerpts
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