JVT

The Elements of Process Validation: A Preview of Medical Device Validation Handbook

The elements of process validation ideally follow a chronological order, as presented in this chapter.  Exceptions to this order of operations include, but are not limited to, remediation of legacy processes, and partially leveraged existing process validations. Determine Risk Process validation begins with determining risk, not only in the manufacturing process but also in the design and use of the device.  Risk assessment and management is the logical foundation of engineering, especially in the medical device industry, and it is required by regulatory bodies.  Risk determination...

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