The DGS Experience
It’s a beautiful day here in Southern Colorado, and I spent the morning in front of the fire reading chapter 6 of one of my favorite books on data governance: “Data Leadership for Everyone” – Anthony J. Algmin. If you haven’t had a chance to read it – I highly recommend bumping it up on your 2026 queue!
Chapter 6 [and really the book in general] speaks to the fact that data governance without leadership and a clear goal to establish ROI assures failure. This takes vision and planning. The most important ingredient in a data governance system (DGS) is not actually the data… Data is needed [obviously], but the most important factor is establishing ‘data value’ and ROI through people’s participation in the DGS. If no beneficial actions come from the DGS (other than some “compliance satisfaction”) and passing an internal audit, then the whole thing was a massive capital sink and will forgotten by 2027. The term DGS will be viewed as negatively as the ALCOA project, which began in 2015 and piled layers of additional work on our operations staff with little ROI from the quality or business perspective.
Success in our next endeavor (the DGS) will require a mix of senior leaders, middle managers and front-line operations staff all establishing a common aim other than “compliance”. In the GXP world, a DGS is not optional, as it is explicitly expected per the EU GMP Chapter 4 [revision] – but what is a DGS?
A DGS is a theory… a way of thinking and acting that goes way beyond SOPs and compliance training. It requires top management to establish a common aim throughout the organization: continuous improvement, which is then executed throughout the organization through the GXP framework: establish the meaning/value of our data (ICH Q9) and then act on that data (CAPA) to make a better product at a lower cost… this also happens also to align perfectly with patient safety – hence in theory this should be an easy adjustment for us in the GXP universe. But I am 100% convinced that this will depend on your senior leadership. As I have mentioned previously in this blog, if you want to enjoy meaning in labor and a great place to work, make sure your leadership is aligned with this goal – otherwise get your resume out there. It is not your job to convince management that a DGS is a worthwhile endeavor. Who wants to swim through the swamp of patchwork CAPAs, never ending deviations, and metrics that are designed to place blame on employees instead of leaders?
There are various levels of a functioning DGS, from basic to advanced. Any organization can establish a fake DGS for regulatory inspection, where beautiful SOPs written by consultants shine brightly from the screen in the conference room, perhaps even a fancy PPT is presented with AI generated images and buzz words… The inspector is initially impressed, but then disappointed once they realize data remains siloed and individual departments struggle to understand what to do with all these audit trails and how they are at all connected to the product/patient. Some days, if they don’t have time – they just skip the review… I fully understand. Don’t ask me to perform a task without understanding the meaning – that is dehumanizing.
The goal of a DGS as outlined in the GMP regulation was never intended to be a “compliance activity” – like old school 1970’s regulations… This is a new era of regulation, where requirements are aligned with good practices from other industries who make excellent products at low costs and have high levels of worker satisfaction in labor.
To get started here are three simple bullets that summarize the journey as outlined in our GXP guidance and regulation:
Data/Process Mapping
Data/Process Risk Assessment
This exercise establishes “data value”
What to review, how often, and its importance
Continuous Improvement via CAPA
This demonstrates ROI from the DGS and engages employees… without continuous improvement as the final step: expected and measured [metrics] by senior leaders, the DGS will wilt faster than a flower in the desert
Once your senior leaders have established the end goal of the DGS, and have provided usable tools and clear metrics – the project can get started and will accelerate quickly; with success [almost] guaranteed.
Pete
