FAT (Factory Acceptance Test) Audit Support
Our team also provides Factory Acceptance Test (FAT) audit support for pharmaceutical manufacturing equipment before installation at the facility.
Our FAT services include:
- Guidance on how to plan and conduct FAT audits according to regulatory expectations.
- Review of equipment design, functionality, and compliance with user requirement specifications (URS).
- Verification of equipment performance, safety features, and control systems.
- Review of documentation such as test protocols, calibration certificates, and technical manuals.
- Identification of any technical or compliance gaps before equipment shipment to the manufacturing site.
This process helps ensure that equipment meets quality, safety, and regulatory standards before installation and qualification.
