Calibration Software Risk Assessment, Qualification, and Validation
Testing of Critical Software Activities
- Area: Greater Durham Area
- Project Type: CSV
About this Project
OBJECTIVE
Calibration Software Risk Assessment, Qualification Protocols, and Validation Plan Development.
SERVICES
PSC Biotech® performed a Risk Assessment of critical calibration software functionalities and developed a Validation Plan. Our consultant developed configuration specifications, performance qualification protocols, and test scripts for specification of testing of critical calibration software activities. They completed gap assessments or vendor installation qualification, operational qualification, user requirements, and traceability matrix documentation forms. PSC® generated risk-based testing of the calibration software system and generated a final validation report which included a summary of protocol tests.
Project Success
Related Projects
20 Years & Counting of CQV Services
Cleaning Validation & Decommissioning Project
PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.
Sterile Fill/Finish Laboratory Facilities CQV Project
The operations performed included: Filling, Parts Preparation, Formulation, Filling, Process Support Systems and Cleaning.
How Can We Help You?