Process Validation and Process Controls
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 which have proven the highest quality level can be achieved consistently in the production phase. 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.