Looking back to my first days 15 years ago, the effort required for validation was, let’s call it, different. Most documents (specifications, tests or similar) were at least in most cases helpful. Often, however, details were missing in the “form” of the documents, or the documents focused on special aspects that were in the eye of the car, algae, etc. All in all, however, mostly manageable.

It was gradually observed that for various reasons and not everywhere, more and more QMS systems such as change management tools and DMS/eDMS systems were introduced. In most cases, however, without fundamentally rethinking or adapting the existing, let’s call it “traditional” approaches. As a result, it “felt” like there was now twice as much to document and approve.

This development often came together with additional demands on the “traditional” documentation and validation strategy. More flexibility was needed, a process-oriented or even an agile set-up was to be created with the help of Word and Excel. Often with the result that the effort and scope involved in creating this documentation also increased.

Just reading it makes you lose track of everything that has changed. Certainly every change, every tool, every approach had its justification, but how often do you not see the forest for the trees…

Let’s be honest, once such a construct has grown, there is a real danger that the processes will be so convoluted and delayed that attempts will be made to circumvent them, shorten them, etc. Or even worse, that they are forgotten. Then the whole thing becomes partially or even completely non-compliant.

Actually a perfect playground for a consulting team, which is now starting to turn even more screws and control mechanisms to make the whole thing compliant again… that means the whole thing continues to grow…

You can see what we are getting at! Finding a way through the undergrowth without cutting down the whole forest. Let’s consider step by step how your validation process can be streamlined/improved/optimized, how you can regain compliance, resiliency and agility, and how you can save costs very quickly in the process.