21CFR Part 11 is a regulation issued in 1997 by the American FDA (Food and Drug Administration) to define the requirements for submitting documentation in electronic format and the criteria for the use of legally binding electronic signatures. The 21 CFR Part 11 regulation is of importance to all U.S. pharmaceutical and healthcare companies and international companies wishing to export to the USA. Many other countries also use this regulation rather than developing their own.
Labman has developed the Camelot toolkit software which provides features and tools to assist a company to achieve compliance with the 21CFR Part 11 regulation. The toolkit can be easily integrated with applications developed using Microsoft .NET technologies.
GxP & 21 CFR Part 11 Compliance
- FDA 21CFR Part 11 Compliance
- European Union Annex 11 Compliance
- Data Validation
- Report Generation
- Protection of Records
- Limiting System Access
- Audit trails
- Record Traceability
- Electronic Signatures