In April 2016, the FDA released a draft guidance titled: “Data Integrity and Compliance with cGMP Guidance for Industry”. In this draft guidance, the FDA clarified much of the confusion and misunderstanding around 21 CFR Part 11 and how Data should be addressed, maintained, included/excluded from critical path decisions, and several other key elements to the regulation that have perplexed many of my contemporaries in regulated industry.
Of the many topics discussed in the guidance document, one particular item of note that readers seemed to focus on is the topic of Metadata. While seemingly minor and only referenced at a high level, it changed what many consider to be the key components of a data record and in some cases the way in which they were maintaining data backup and other IT related practices. The mention of Metadata was intentional and divisive by the FDA as it has been a longstanding point of pain for their organization and one that on the surface would appear to be low-hanging fruit to manage but has proven to be a challenge many organizations.