We all agreed that we wanted to come out the gate being GMP compliant, and we wanted to make it a competitive advantage. There was no way this was going to happen if we relied on paper-based validation.
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The two FDA investigators conducting the inspection were familiar with ValGenesis and liked the system. They were pleased we had a standardized tool for validation management. That helped us tremendously.
Our employees don’t want to push paper. They want to change our world and transform medicine. We want to make sure they have the tools they need to do it.
As pharmaceutical outsourcing continues to grow and the competition intensifies, the modern contract development and manufacturing organization (CDMO) has become a vital source of drug development and delivery. Biotechnology companies see CDMOs as extensions of their development and manufacturing departments and a true partner in getting their products to market. To win in an industry where speed defines success, CDMOs must embrace innovative technologies that can save them and their clients valuable time in getting life-changing medicines to market without compromising safety or compliance. Modernizing the collection and management of validation data is a critical step toward that goal.
Key Regulatory Benefits
- FDA 21 CFR Part 11 and cGMP compliance
- Minimize data integrity issues (ALCOA driven)
- Centralized change control
- Risk-based approach to validation
- Definition and protocol development