We have experience with qualifying systems that may not have been initially designed for qualification. Perhaps some equipment that was carried over from R&D, or a control system which is outdated, or an HVAC system that is already in place.
Based on an initial review of the existing systems, we can help you determine what upgrades may be required and provide you with ongoing system support if appropriate. This may result in a solution that will work for your situation.
We have experience with the bringing legacy systems into cGMP compliance:
- Retrospective validation
- Identifying cGMP gaps
- Review systems for 21CFRPT11 Compliance
- Upgrading systems where necessary
- Generate testing and documentation to demonstrate GMP compliance