Validation in accordance with GAMP 5

Our software solutions for the pharmaceutical industry supply data for decisions which may embody risks for the health of patients. This is not the only reason why a high level of quality and correctness is required.

In order to meet the strict requirements of the international regulating authorities as well, above all the American FDA (Food and Drug Administration), our systems are developed, validated and documented conscientiously according to the specifications of GAMP 5.

GAMP (Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture) is the standard technical guideline for the validation of computer-assisted systems in the pharmaceutical industry.

http://www.ispe.org/cs/gamp_publications_section/gamp_publications_overview

For the validation, a detailed risk analysis is worked out for all functionalities of a system which considers different aspects. Departing from the risk classification, type and scope of the required tests is determined.

The security of the final product is in contrast to the costs for development and testing. To keep these in an affordable range, an effective test strategy is used which supplies the highest possible expressiveness with the least effort required.

 

The five basic concepts of GAMP

  • product and process understanding
  • life cycle approach within a QMS
  • scalable life cycle activities
  • science based quality risk management
  • leveraging supplier involvement