GMP or 21 CFR-Pa rt 820, Process Validation, and Control

MOS is a medical device component manufacturer and assembler that understands the responsibilities of contract manufacturing including interpretation of the Quality System Regulation 21 CFR-Part 820 or what was formerly known as Good Manufacturing Practices. MOS assimilates measures into its quality systems to insure that code is met and that all components conform to spec.

We employ Process Validation which identifies variables that significantly impact the process including identifying equipment, materials, inspection systems, and procedures that are the basis for process control ensuring both compliance with code and consistent high quality parts and assemblies.

We utilize Prospective Validation where changes made to a component or process is validated prior to delivery of the affected part or assembly. DOE or Design of Experiments is used to identify causes of performance variations and eliminate or reduce those variations by controlling process parameters which in-turn raises product quality.