SoftwareCPR Part 11 Consulting

Web based and On-site Training

Regulatory Risk Analysis

Assessments

Vendor Software Evaluation

Validation Assistance

Realistic Advice Consistent With Evolving FDA Interpretation

SoftwareCPR Company and Consulting Information

We help you meet the intent of the rule -- not the hype. 

 

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.

Click subscription service to learn how to access SoftwareCPR training materials.

 

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