The primary driver behind life sciences’ urgency to adopt more data-centric approaches to quality and compliance is best understood through the lens of unstructured data, which accounts for more than 80% of data in the life science development, production and commercialization life cycle. Think about locked PDFs, scanned documents, uploaded images and so forth — all elements that can be ‘managed’ within today’s QMS software solutions, but all elements that contain massive amounts of granular data and insights that are currently difficult to extract and hard to correlate and analyze in real time.
There are three critical points to understand about the hazards of unstructured data and its impact in the evolving regulatory landscape:
1. The untapped opportunity in unstrcuted data is tremendous.
2. Data will play an increasingly important role in regulators’ policy enforcement.
3. Unstructured data is a massive blind spot in today’s quality and compliance models.