With digital transformation accelerating across the industry, companies are increasingly aware that their most valuable asset may not be a molecule or drug brand – but their data.
Yet, companies often face the same challenge – that their data is produced, formatted, and stored in ways that leave it ill-suited for accessibility and use. Most data generated (around 80%) is unstructured and poorly utilized, and only 1% of unstructured data is used or analyzed.
A major reason for this problem is the lack of data governance. This issue will only be exacerbated as volumes are increasingly driven by industry 4.0 connectivity of IT and operational technology (OT) systems. Many companies now have so much data they do not know what to do with it.
One of the crucial questions for many organizations is, “Where do we start”?
Our new paper, Data governance needs in biomanufacturing: a position paper, sheds light on this area and contains simple and easy-to-digest information to help you take those first steps in data governance on your digital transformation journey.
Making it FAIR
Recognizing that any solution needs flexibility to allow innovation, we propose using the FAIR Guiding Principles. Standing for Findable, Accessible, Interoperable, and Reusable, they are a functional approach to structuring large and diverse datasets, including CMC data.
Using the FAIR Principles, our paper walks you through the first steps of building a structural framework so you can answer questions such as, can you find your data? When you find it, can you access it? Can it work with other systems?
Adopting these principles is a transformational opportunity for industry that could shift it away from its status quo of scattered, siloed, single-use datasets and toward a future of high-performance, data-driven drug development. The principles should be used holistically across your legacy and new data.
“Data integrity is critical to organizations, but they won’t achieve this if they don’t build a solid data governance platform behind it,” said Yash Sabharwal, President & CEO of QbDVision and lead author on the paper. “Data governance ultimately impacts patients by supporting high product quality, so there is a crucial need for organizations to properly manage and utilize their data.”
The paper is aimed at Chief Digital Officers and other senior IT management – and those trying to influence them – who are thinking about their organization’s approach to data on the clinical and manufacturing sides of their business.
Alongside the paper, we created ten typical biomanufacturing personas, such as an Analytical Development Scientist or a Quality Assurance Specialist. These helped us to consider the value of data, how people interact with it, and where these personas sit on the data creator/consumer spectrum. These personas will be published in a separate document.
If companies do not approach data governance in a structured way, supported by a strong data culture embedded within their business processes, they can start expensive projects that do not achieve their objectives because they don’t consider the entire journey to high data quality.
Do you know where to start?
For more information, download the paper here.
If you want to share your experience of data governance and collaborate with other leaders in this field, then please get involved by contacting Julian Goy, Global Change Facilitator, at firstname.lastname@example.org