CPS will develop a testing plan that meets your requirements – from GMP pharma protocols to simple 1 page outlines all with the goal of proving your system works as expected.
For pharmaceutical and biotech projects, CPS can provide validation for GMP and GLP systems. We can provide full or partial validation services including protocols, methods, documentation and execution support to suit your project needs.
- Work with you to create URS (User Requirement Specifications), FRS (Functional Requirement Specifications, HDS (Hardware Design Specifications, SDS (Software Design Specifications
- FAT (Factory Acceptance Test), SAT (Site Acceptance Test) that can be leveraged in the IOQ
- IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification)
- GAMP Compliant
- 21 CFR Part 11
- Traceability Matrix
- Validation Reports
- Sterilization and Clean In Place
For other projects that do not require pharmaceutical level testing, CPS can help to prepare just the right level of testing and project documentation to verify your system is working properly.