SoftwareCPR® Part 11 Consulting

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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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