testo Saveris 21 CFR Part 11 Edition Software - Multi-user licence

Order-Nr.  0572 0182

  • 21 CFR Part 11 compliant (validatable)

  • Electronic signatures

  • Allocation of access rights on 3 user levels

CFR software, incl. Ethernet connection cable base to PC

Product Description

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

What's included

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.

 

Delivery Scope

  • - testo Saveris CFR Software basic package with testo Saveris Web Access on CD-Rom and instruction manual
    - Ethernet connection cable (from the testo Saveris base to the PC)
    - 21 CFR Part 11 certificate
    - Documents to assist with validation

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