Data integrity (DI): Universal data integrity system assessment template in the biopharmaceutical industry

The subject matter experts of the BioPhorum IT Compliance Team developed this template in response to the need to ensure compliance with the regulatory guidance for data integrity demanded in the industry. The template has been developed to assess the health of computerized systems and their electronic records from a data integrity perspective. Furthermore, it can be used to evaluate potential risks to a computerized system and its electronic records throughout the system’s lifecycle. An assessment may be conducted during requirements gathering as a part of the initial validation, during assessment of system changes, during periodic reviews and/or at the time of decommissioning. The assessment template should be fully developed in conjunction with a standard operating procedure (SOP) to manage consistent implementation and use. Since this is an example template it is not an exhaustive list of questions and should be augmented to meet each company’s specific needs. The template accompanies the “Data integrity for IT in the biopharmaceutical industry” paper, which was developed in parallel to provide an industry response to regulatory guidelines highlighting risks, controls and best practices.

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