Description
In an increasingly complex IT landscape, CSV is a challenge for many companies. Whether you lack the 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 thanks to the right validation strategy and the right implementation plan.
We provide you with long-term support for the entire 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 working methods, which always comply with regulatory requirements (21 CFR Part 11, Annex 11) and standards (GAMP5).
We offer you these services:
- Preparation, implementation and finalization of all validation documents (validation plan, URS, FS, etc.)
- Preparing, moderating and finalizing 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
