In April 2016, the FDA issued its draft “Data Integrity and Compliance with cGMP Guidance for Industry.” This document comes quickly on the heels of similar documents issued by governing bodies including MHRA (final in 2015) and WHO (draft in 2015). These documents are in response to the increase in data integrity violations observed during inspections. As stated in the FDA’s draft guidance, “This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health.”
The regulatory expectation that data must be reliable and accurate is certainly not new (as we will point out in the predicate rules), but these documents serve to clarify and standardize current thinking. The focus of this training is to review, compare, and contrast currently available draft and final guidance documents in order to understand the various agencies’ current thinking on data integrity and how it impacts the GxP-regulated industry. The outcome will be the delivery of data governance strategies that position organizations for compliance.
- Compare and contrast FDA, MHRA, and WHO data integrity guidance content
- Understand the relationship of guidance documents to predicate rules
- Application of the predicate rules to paper and electronic data integrity
- Identify the most common issues observed with electronic data integrity compliance, including example warning letters
- Understand the role of robust data governance in achieving compliance
- Develop strategies that increase data integrity compliance