A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all of the data you generate, including analytical data, manufacturing records, and all data submitted to FDA. ![]() A management strategy for your firm that includes the details of your global corrective action and preventive action plan. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity lapses.Ĭ.
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