SoftwareCPR® can assist with achieving and maintaining compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures requirements. Many manufacturers are utilizing electronics records in greater numbers. Certainly the use of electronic records can help achieve greater process efficiencies. However, the manufacturer should consider how the integrity of the electronic records will be managed and maintained throughout the required records retention period. We can help with:
- On-site Training
- Regulatory Risk Analysis
- Assessments
- Vendor Software Evaluation
- Validation Assistance
- Realistic Advice Consistent With Evolving FDA Interpretation
Selected FDA Part 11 Related Documents and Links:
Part11-cd0314-Early Draft of Rule in 2003 21 CFR Part 11 Feb 2003 Federal Register Notice Announcing Major Redirection for Part 11
Part11FinalGuidanceFromFDA-Aug2003 21 CFR Part 11 Final Scope and Application Guidance
FDAClinicalTrialsComputerSystemGuidance-051007-04d-0440-gdl0002-May2007 May 2007 Revised FDA Guidance Computerized Systems Used in Clinical Trials
Part11FinalRule-March2007 21 CFR Part 11 Electronic Records;Electronic Signatures Rule
FDA-InvestigationsOMerecordssection2007 FDA ORA IOM Electronic Copies Investigator Guidance
CDRHInfo-collection-reqmtsExcerpts-July2001 QS Regulation Record Keeping Requirements CDRH Report
Also, search for “Warning Letters” and “Part 11” for warning letters related to Part 11 compliance.
