June 2020/2 – Data Integrity Risk Assessments

From the information published by health authorities (i.e. FDA’s Warning Letters, MHRA deficiency database and IgJ inspection reports - in Dutch), it can be concluded that Data Integrity (DI) is a continuing challenge in the regulated environment. There are still facilities that fail to comply with the ALCOA/ALCOA+ requirements for the GxP systems they are using, be it paper-based, computerized or a combination of both. An explanation for this may be found in the fact that Data Integrity Risk Assessments (DIRA) tend to be system focused, and relevant information on the data itself (e.g. process flow, type of data, data content, data intended use, etc.) is insufficiently accounted for.

This flaw has been recognized and addressed by APIC/CEFIC with the publication of their “Practical risk-based guide for managing data integrity” (link) that was issued in March 2019. In this document, a workflow is described for the execution of DIRA’s for GMP processes in API manufacture. The workflow is based on;

  1. Mapping of the GxP process subject to the DIRA e.g. a manufacturing process or a laboratory control process,
  2. Definition of the data format, data elements and system(s) used in the above GxP process,
  3. Definition of the data severity and categorization of the system(s),
  4. Execution of a DI gap assessment against a predefined set of questions / requirements, on the defined data and system category,
  5. Execution of a FMEA risk assessment on the identified gaps, including definition of mitigation measures.

At Lucas GxP consultancy we have created a tool that will support in the execution and documentation of the above DIRA process - from the beginning to the end - in ONE document. In addition, we added text fields to include references to existing documents and controls (i.e. procedural controls, organizational controls, functional controls) to maximize the knowledge captured. Finally, we have adapted the pre-defined set of questions / requirements for the gap assessment with additional DI requirements, to make this practical approach also applicable to other GxP areas.

If you are interested in this tool and would like to have more detailed information, please contact Lucas GxP Consultancy on +31 6 36258806 or submit an email to hans.lucas@gxpconsultancy.com

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