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  • Chris Vasquez replied to the topic Maintenance & validation in the forum Process Validation and Process Risk 8 years, 1 month ago

    Hi Fady,

    when we say severe failure, are there critical components within the equipment that broke down or is the product itself being produced or being check incorrectly? I would say that we should treat this as a preventative maintenance to restore the equipment to a satisfactory operating condition and we could run a verification to ensure that it meets standards for production or for testing. Revalidating the equipment will not be necessary unless you move it.

    Chris