Dismantling Validation
Before a meaningful digital transformation can occur within your organization, a full dismantling and rebuild of the traditional ‘validation’ framework is required. As the next generation of employees join our industry, they will likely be dumbfounded by the lack of digitalization and common-sense approaches to quality, and may resort to parallel solutions (and unanticipated risks) if we do not adapt. We must go further than a simple mindset shift – such as “we now take a CSA approach”, which is often a half-hearted effort that will likely result in confusion rather than solution. We need to go all in.
Steps for success:
Breakdown ‘validation’ into its individual components (hardware, software, personnel, documentation)
New definitions (e.g., ‘qualification’) and work streams (e.g., Quality Intelligence) are needed
New risk-management tools are [definitely] required (e.g., qualitative) - no quantitative tools allowed, without compromise
Run a pilot, followed by presentation of the business and GXP perspectives to senior leadership
In my experience, you will find that if your organization is equipped with the mindset and appropriate toolbox, cost and quality have a more nuanced relationship than was historically thought to be true…. Does higher quality require bigger budgets? Maybe not.
To realize that opportunity, however, your origination must approach this issue more like a re-build than a re-model, for those of you who have ever been a home owner…
A simple visual representation with three product streams is outlined below, and for a deep dive, join us in Austin for a week long re-building journey:
