LABORATORY TESTING IS CRITICAL
Laboratory testing plays a critical role in ensuring the safety of drug products. For this reason, the FDA and international regulators expect a formal qualification program for instrumentation to ensure each machine operates as intended.
CSA offers efficient and affordable solutions for instrument qualification that satisfy the FDA’s requirements for laboratory compliance. We maintain a library of hundreds of protocols built on standard industry practices and scientific principles that can be customized to meet your unique requirements. This creates the optimal blend of quality and affordability that is often lacking in OEM qualification services.
Our services are offered at reasonable fixed prices and can be combined with other services such as integrated software validation.
CSA QUALIFICATION SERVICES ARE FULLY TURNKEY AND INCLUDE:
- All labor for documentation and execution
- Required test equipment and/or standards
- Standard and test equipment calibration certificates
- Customizable protocols developed by instrument SMEs
- Pre-qualification tuning (as applicable)
- Non-conformance investigations (as needed)
- Summary reports
- No travel charges for most major US metros