What does 21 CFR Part 11 mean?
21CFR Part 11 is a regulation issued in 1997 by the US government agency FDA (“Food & Drug Administration”) that describes the requirements and standards for the handling of electronic data.
This regulation shows how online electronic records and electronic signatures must be implemented when data is processed electronically or transmitted to the FDA in electronic form.
Since FDA inspectors are strictly implementing these rules, it is becoming necessary for laboratory data processing to conform to these standards.
- Closed System
- Digital signature
- Electronic records
- Multi-instruments applications
- Multi-user level.
- Electronic signatures
- Report accessible from excel, etc.
- Easy & intuitive supervision software.