Computer systems controlling or documenting GMP-relevant processes have to be validated
Valicare supports you to fulfill the requirements of GAMP 5.
Valicare GmbH extensively offers validation support for computer software and systems. Our expertise and long-term experience with GMP/CSV projects makes us the perfect partner to implement a concept for computer system validation and to validate comprehensively existing systems. Therefore, the whole product lifecycle is taken into account including planning up to decommissioning. We provide comprehensive validation of your systems starting with the generation of a validation masterplan and basis documents for planning, continuing with commissioning and decommissioning of hard- and software, development of validation concepts, “hands-on” validation implementation, finalizing it with the preparation of the validation report.
We support you with the implementation of software validation, the validation of Excel spreadsheets and the validation of computerized laboratory systems. Due to systematical application of industry standard GAMP5 at validation implementation, a high quality level is ensured. Furthermore, validation procedure including validation of hard- and software also comprises operating environment, networks and databases.