Quality Management, man in checking pharma production machine

Quality Management: A Tool for Business Acceleration

With strict regulatory codes and a responsibility for the wellbeing of patients, ensuring adequate quality management has often meant slower adaption of new technology in life sciences. However, rising maturity in the tools for quality assurance means that companies can now utilize quality management to accelerate their processes and pursue alternative business opportunities in an agile fashion.

Pharma 4.0, quality management, filling test tube in lab

Quality Management. A term, life sciences businesses have long associated with a slow, costly process to keep up with regulations.

But why not use the resources spent on validating IT systems to propel your business forward instead of just documenting, that your current efforts are “within the lines”?

According to Michael Clausen, Associate Vice President in charge of NNIT’s Digital Assurance department, combining proper quality management doesn’t have to end with “just a tick in the compliance report”.

– Quality assurance of IT systems has often been perceived as a kind of nuisance, something you had to deal with. But it’s time to change that perception. With technologies such as scriptless automation, proper quality management and assurance can even be used as an accelerator for your business, he emphasizes.

Taking the leap

The shift towards a higher degree of technology supported quality management is, according to Michael Clausen, steadily gaining traction in the life sciences sector, which both Gartner (Life Science Companies’ Digital Platform Implementation) and World Quality Report from 2018 mentions.

– The C-level management are continuously looking for ways to strengthen the business, reduce cost and reap benefits – and many have noticed the potential in quality management. They recognize that competitors, who manage to streamline QA, are raking in new revenue streams, Michael Clausen states.

In years past, the leading life sciences companies were the ones who managed to make the best treatments. But today, user experience (UX) plays a much bigger role for the end users. The best treatment must also be the best experience. And if you’re the last one to incorporate new technology, the competition will surpass you.

From script to scriptless

Michael Clausen explains, that life sciences companies have traditionally regarded QM as a means to secure that IT systems followed protocol – rather than supporting what IT potentially could do.

– We need to look at the tools available and how they can support the customers’ journey. Technology involving automation is moving from scripted to scriptless tools. As a result, you no longer need hours of coding to build automation, which is both useable and within the guidelines of QA, Michael Clausen says.

According to him, regulatory demands set by authorities don’t outlaw any kind of technology up front. The question is how you validate and document your processes, your software and/or your technology which doesn’t change with scriptless automation

Unlike case-to-case scripted code, scriptless tools closes the gap between the understanding of the business process and the automation itself through visually bringing the two together. All in all, it enables better understanding between the automation and the business as well as acceleration on test automation, while at the same time dramatically lowering the entry cost.

– We are now able to do a Proof of Concept (PoC) in a few days with a crystal clear and visual understating of the business process in scope. This reduces costs but also saves precious time, while enhancing the end user experience by continuously ensuring fast paced testing of your app or software, Michael Clausen states and continues:

– If you’re used to using a smart device, you know that people don’t want to wait months, weeks or even days for an update to be implemented. With automation you can sharply reduce the time these processes take since you can accelerate the testing or validation. Combining this with paperless validation supporting your documentation and specification processes we can now start the dialogue on continuous validation accelerating both the “left and the right leg” of the v-model – hence addressing the end user experience through providing full acceleration and faster time to market.

As for the future, Michael Clausen is brimming with confidence, when it comes to helping customers take the leap towards more effective quality management.

– If a customer called me today and wanted to talk automation of quality management, we already have a scriptless tool matching their needs, so we would be able to do a PoC in a matter of days to clarify if it works or not. Before, using scriptless tools, it wasn’t unheard of, that companies invested at least the better half of a thousand hours in just writing the code and doing the PoC. That isn’t the case with today’s technology.