The PDA published Technical Report 84, Introducing Data Integrity Requirements into Manufacturing and Packaging Operations (here), which reaffirms that Data Integrity is not only a concern for the laboratory but for any aspect of the pharmaceutical industry where data/records are generated and handled.  There are excellent tools within the document as it applies to the use of Quality Risk Management at the time of the implementation or as part of system change management.  TR 84 introduces the Data Integrity Risk Management model, which considers the criticality of the data that is generated by the system/process and the current level of system controls (data management, GMP processes, and human factors) that together determine the level of data vulnerability.  This data vulnerability matrix is intended to be a tool in developing the risk-control strategy for that system.  The guidance document also provides suggestions on those Data Integrity controls where it is considered appropriate that the level of control can be differentiated based upon the criticality of the data that is generated by the system (such as audit trail review).

Even though TR 84 is written for manufacturing and packaging operations, it is recognized that the concepts that are discussed within it apply throughout the company where it is expected that a firm is aware of the data integrity risks that exist within all systems and the criticality of the associated data.

If you have any questions in relation to Data Integrity risk assessments or would like one done for your organization, please contact Paul Mason, Ph.D. at