Today’s world, whether you associate it with “4.0” or “digital transformation” is changing fast, however the modernization of regulatory and quality approaches at the operational level have generally been lagging as compared to the technological changes that are happening all around us. We need to speed up and get out of old mindsets, by focusing on what is important. In the validation world, that is demonstrating control over all aspects that impact patient safety and product quality, and Validation 4.0 means to move to a state of continuous control and validation through digital data.
Aside from the technology focus, there are much deeper changes that must be made both, from documentation centric processes in validation to deeply rooted cultural ‘quality comforts’ that are ultimately non-value added. We will dive into how we need to shift our thinking when it comes to the approaches taken with validation, and discuss that these changes are not just to support an initiative with a finite beginning and end, but rather they should be part of a continuous modernization that supports getting regulated industries closer to the digital capabilities that we already rely on, and benefit from, in our personal and consumer lives.