Purpose – The purpose of this (4)-page procedure is to define requirements for process validation to ensure that manufacturing processes and test methods are consistent and capable of meeting regulatory requirements and company specifications where 100% inspection is not feasible.
Scope – This procedure covers process validation of the manufacturing process for finished devices, components and test methods, and is the primary document meeting the applicable regulatory requirements for Process Development as defined in your company’s Quality System Manual (POL-001)…
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