Description
In an increasingly complex IT landscape, CSV is a challenge for many companies. Whether you lack in-house resources to implement the validation strategy with your QA (Quality Assurance) in your IT project or the costs for validation are too high - with us, CSV and quality management become a cost-efficient routine through the right validation strategy and the custom-fit implementation plan.
We provide long-term support for the complete validation process or short-term support for an upcoming rollout date. You benefit from our know-how from many successful validation projects and our best practices. You can rely on the timely completion of projects with the highest quality standards and on our way of working, which always complies with regulatory requirements (21 CFR Part 11, Annex11) and standards (GAMP5).
These are the services we offer:
- Preparation, execution and finalization of all validation documents (validation plan, URS, FS, etc.)
- Prepare, moderate and finalize the functional risk analysis.
- Creation of test plan and test cases for IQ, OQ, PQ
- Test and validation report
- SOPs for system management and users
