Computer System Validation (CSV)

Subscribing for AMACENA as “Software as a Service” SaaS allows access to a software which is fully validated according all legal regulations. This is possible because AMACENA is a standard software which is tested fully according GAMP 5 by Hicof and we operate it. The image shows in general which steps will be conducted by whom according the V model for computer systems validation. Thereby, the majority of specifying and testing is constantly conducted by Hicof. The Hicof customer gets a certificate of compliance for these tests which can be used to show auditing parties that the software is compliant with:

  • GAMP 5 validation framework
  • 21 CFR Part 11 specifically sections 11.10, 11.30, 11.50, 11.70, 11.100, 11.200, 11.300

Finally, the customer only needs final high-level tests, which show the overall functionality of the system e.g. including the line integration. Hicof can support the customer with test scripts that can be used to design these tests.