Description
In an increasinglycomplex IT landscape, CSV poses a challenge for many companies. Whether you lack the in-house resources to implement the validation strategy with your QA (Quality Assurance) team in your IT project, or whether the costs of validation are too high—with us, CSV and quality management become acost-effective routine through theright validation strategyand atailored implementation plan.
We can providelong-termsupport throughout the entire validation process orshort-term assistancefor an upcomingrollout.You’ll benefit from our expertise gained through numerous successful validation projects and our best practices. You can rely ontimelyprojectcompletionto the highest quality standards and on our approach, which consistently complies withregulatory requirements(21 CFR Part 11, Annex 11) and standards (GAMP5).
We offer the following services:
- Preparation, execution, and finalization of all validation documents (validation plan, URS, FS, etc.)
- Preparing, facilitating, and finalizing the functional risk analysis
- Creating test plans and test cases for IQ, OQ, and PQ
- Test and Validation Report
- SOPs for System Management and Users
