Validation is a crucial portion of regulatory compliance. Panacea utilizes a GAMP 5 risk-based approach to Computer System Validation (CSV). Our Quality System has been successfully audited by many major Pharmaceutical and Biotechnology organizations with no major findings. We can either utilize our own Quality System as part of a project, or adopt and operate within your Quality System for execution and delivery. Our Quality System has been adopted and is currently in use by numerous major Pharmaceutical and Biotechnology companies because of our approach to validation.
In addition to our standard validation services we offer 21 CFR Part 11 Compliance evaluations and test plan creation and execution.