Master Validation Plan – Process Types and Description
Paramit’s validation program follows FDA Process Validation Guidance: General Principles and Practices. We perform validations (IQ, OQ, PQ) as part of our qualifications plan for PCBAs, finished devices and instruments. We create a comprehensive Master Validation Plan (MVP) for every manufacturing process including manufacturing equipment, customer tooling, test fixtures, and software validations. Every key manufacturing process has a Quality and Process Control Plan where the control methods, records, and metrics are identified as well as a reaction plan when a non-conformance occurs.