It is critical during the inspection process that FDA inspectors can determine the veracity of the data that is presented to them. The draft Guidance “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments” dated August 10, 2016, provides inspectors detailed instructions on how to verify the integrity of the data during inspection by ensuring the data is “…complete, consistent and accurate”. The focus of the document is the Data Governance System where the expectation is that the firm has arrangements for data governance which is documented within their Quality Management System. Such Data Integrity (DI) controls should be risk-based, utilizing the ICH Q9 guidance where any residual DI risk is documented and regularly re-assessed by senior management.

The draft document provides inspectorate guidance on the assessment of Data Criticality and Data Risk when reviewing a firm’s DI Risk Assessment. A significant proportion of the document discusses Organizational Influences on DI which includes: Code of Ethics; Quality Culture; Quality Metrics and expectations when addressing identified DI issues. In addition, the document discusses principles of DI including the Quality Elements of Data via the ALCOA+ acronym and the specific DI considerations for both paper and computer based systems. Interestingly, there is a section dedicated to third party vendors where it states that the “contract giver” as part of vendor qualification needs to verify the third party’s data governance measures.

This draft Guidance provides insight for how a firm should prepare themselves for an agency inspection in relation to DI where they need to ensure there are risk base DI controls over the lifecycle of data and how collectively they are contained within the Data Governance System. Lachman Consultants will post additional comments on specific areas of this new draft guidance of particular interest to the pharmaceutical industry.

For further information and training on the topic of data integrity in the pharmaceutical industry and the importance of taking a proactive approach, please contact Paul Mason, Ph.D. at or James Davidson, Ph.D. at