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    Validating software process

    Validation Plans are different than Validation Master Plans.

    Validation Plans are usually project specific; Validation Master Plans govern validation activities for an entire organization or site.

    Each of these tools will be summarized and their application in validation described.An FMEA involves listing out the potential problems or failure modes and evaluating their risk in terms of their severity, likelihood of occurring and ease of detection.Where potential risks exists, the FMEA can be used to document which failure modes have been addressed and which still need to be addressed.Change Control systems are a favorite target of regulatory auditors because they vividly demonstrate an organization’s capacity to control its systems.Organizations need to explicitly define their processes for evaluating changes to validated systems.

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