The CFR software version fulfils the requirements of the FDA’s 21 CFR Part 11 and is thus validatable. This is confirmed by a certificate from the independent Fraunhofer Institute for Experimental Software Engineering. Testing took place in accordance with the evaluation guidelines of the GAMP Special Interest Group: Complying with 21 CFR Part 11, Electronic Records and Electronic Signatures. The software is therefore ideal for use in regulated sectors of the pharmaceutical industry.
The software can be installed on multiple PCs (multi-user licence). The software offers interesting additional functions beyond the attractive basic functions of the Professional version, e.g.:
- 21 CFR Part 11 compliant (validatable)
- Electronic signatures
- Allocation of access rights on three user levels
- Audit trail for the traceability of user activities
Along with the software, you also get documents to support you with the validation based on GAMP5. These consist of:
1. Customisable templates for risk analysis
2. Individually applicable templates for:
- validation master plan
- validation specifications
testo Saveris 21 CFR Part 11 software, including Ethernet connecting cable base - PC and instruction manual, including 21 CFR Part 11 certificate and documents to assist with validation.