Validation Master Plan for Medical device

A master validation plan (MVP) is without a doubt a plan on your system and system validation activities. all of the gadget, procedures, and software program requiring validation have to be covered within the MVP. The plan need to reference the relevant protocol and document for every item in the plan. If there are revalidation requirements, the plan ought to imply when the ultimate validation was executed and what the frequency of revalidation need to be. preferably, comparable equipment will use the identical validation protocols that are managed files and pre-accredited. through the years the variety of news referenced will increase, however the plan have to best reference the most recent authorized protocol(s).
some businesses include the cause or triggers for a revalidation in the plan–just as you’ll for a document retention desk. but, other corporations will encompass this element inside the validation protocol and/or inside the manner validation process. The reason for revalidation best needs to be in one among 3 locations, and duplication of the records just encourages errors and audit nonconformities.

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