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Home » The Regulatory Framework for Process Validation
The Regulatory Framework for Process Validation
September 30, 2021
Under the Quality System Regulation (QSR), a product is anything created by a process, including individual components of a device, materials involved in manufacturing
the device — whether or not those materials are a part of the finished device — and even the
in-process device itself. These are products, and all products must be fully verified, generally by
postproduction test or inspection, to ensure that they meet each of their design specifications.