In April 2016, the FDA released a draft guidance titled: “Data Integrity and Compliance with cGMP Guidance for Industry.” In this draft guidance, the FDA clarified much of the confusion and misunderstanding around 21 CFR Part 11 and how data should be addressed, maintained, included/excluded from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 for many organizations.
What Is Metadata?
Metadata is the data about the data; it is akin to a legend on a map and explains what data elements are and speaks to their meaning.
Why Is Metadata Important?
The importance of metadata is very easy to explain, without the details associated with a data element, the data just becomes data. The best way to explain it to folks who are not technical is the example of two books on the auto industry in Germany:
- Book 1 has no cover sleeve, no title displayed, and no detail of its subject
- Book 2 has a highly embellished cover sleeve depicting a scene from a German countryside with a stretch of the Autobahn, there is also a title of “Homeland, an adventure through the German automobile industry”
If one were to see both books on a table, there is no doubt that it would be very simple to understand what Book 2 contained. Book 1 would require further investigation, opening the book, and eventually, after skimming through the table of contents, you would gain an understanding of its content.
Metadata is like Book 2 in this example, it clearly defines and explains what a data element means.
Am I Required to Consider Metadata in My Overall Data Strategy?
Per the 2016 draft guidance, “Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.” While the FDA has ruled on the “Complete” data record that is required to be maintained through standard retention periods (both subjective), the definition of Metadata and its importance has never been clarified.
The litmus test in my opinion regarding Metadata’s importance is simple: If one were to review their current data records could you interpret the data in a standalone manner, or do they require additional explanation?
Metadata is not a new concept but rather a new inclusion to the recipe for what constitutes a “Complete” data record.
Simple advice for the masses would be to use common sense. If you question what is documented, have a third party unrelated to the process review it. If they can understand what is there then you have passed the metadata test.
(Source: IPS – Integrated Project Services, LLC)