SoftwareCPR Part 11 Consulting
Web based and On-site Training
Regulatory Risk Analysis
Assessments
Vendor Software Evaluation
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Selected FDA Part 11 Related Documents and Links
21 CFR Part 11 Feb 2003 Federal Register Notice Announcing Major Redirection for Part 11
21 CFR Part 11 Final Scope and Application Guidance
Sept 2004 Draft FDA Guidance Computerized Systems Used in Clinical Trials
21 CFR Part 11 Electronic Records;Electronic Signatures Rule
FDA ORA IOM Electronic Copies Investigator Guidance
FDA Guidance Computerized Systems Used in Clinical Trials
QS Regulation Record Keeping Requirements CDRH Report
Click Warning Letters to search for Part 11 excerpts
NuGenesis Web Page of Part 11 Software and Service Providers
SoftwareCPR Part 11 Related Training Aides
21 CFR Part 11 SoftwareCPR Memory Jogger
Part 11 Regulation and Preamble Side by Side
Part 11 Regulation Only - No preamble
The items listed below are only available to subscribers of SoftwareCPR.com:
SoftwareCPR 21 CFR Part 11 Reference Manual (also for sale separately)
SoftwareCPR Part 11 Audit Checklist
SoftwareCPR Clinical Trials Software Audit Checklist
21 CFR 11 Book Chapter Reprint
Additional information is in the Part 11 Roadmap in the site Library and the Reference Manual is also listed in the Catalog.
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