Digital Regulatory Audits

Digital Regulatory Audits – the Fully Compliant, Less Costly, and More Efficient Solution

Like other companies, manufacturers in the life sciences sector faced a number of challenges during the Covid-19 pandemic. One specific and unique challenge was how to conduct a regulatory audit when people couldn’t travel and there were restrictions on who could meet, where, and when. At SL Controls, we developed and successfully implemented a digital audit solution to overcome this challenge.

We worked together with a multinational customer in the life sciences sector to develop our digital audit solution. While the solution made it possible for our client to overcome an immediate challenge, it has retained its benefits beyond the pandemic as well as having wider use cases for medical device and pharmaceutical manufacturers.

Transforming Regulatory Audits in the Life Sciences Sector

Regulatory audits in the life sciences sector are essential for product quality and patient safety. However, they are also resource-heavy, often involving upwards of 60 people. Some of those people may only be needed for a small part of the audit, but they are still needed. Traditionally, that has meant getting everyone together in the same location, from validation staff to subject matter experts to external auditors.

SL Controls co-founder and Chief Digital Architect, Shane Loughlin said: “When we were approached by our client about developing a digital audit solution, we decided to take a step back to look at what an audit process is and what it involves. When we did this, we could see that audits are, at their core, collaboration events.

“So, in developing this digital audit solution, what we were actually creating was a digital collaboration platform. It needed tweaks, adjustments, and specific features to ensure it met the standards and requirements of regulators and our customers. But it was a digital collaboration platform, nonetheless.

“We are excited by this concept as the solution has much wider use cases beyond enabling regulatory audits in pandemic situations. It has the potential to become the standard approach for regulatory audits in the life sciences sector, and it can be tailored as a digital collaboration tool for other applications.”

The Importance of Compliance When Collaborating Digitally

There are lots of digital collaboration platforms available. The difference between standard digital collaboration platforms and the solution we have developed is compliance, i.e., our solution meets the compliance requirements of auditors in Europe, the US, and elsewhere around the world.

SL Controls Compliance Director, Dermot McMorrow, said: “The big difference with our solution is that it is fully compliant on the IT security side of things. As a team, we had been thinking about this for some time before Covid-19 as we knew this was the way things were going. The pandemic acted as a catalyst, so we are now way beyond the proof-of-concept stage.

“The solution has been developed, tested, proven to be effective, and then used in multiple audits of companies in the life sciences sector.

“The results have been impressive, too. Both companies and auditors found the process at least as smooth and seamless as the traditional in-person approach, with most saying it was an improvement. There have also been considerable efficiency and cost savings, primarily through improved communication and control, and the elimination of travel.”

Secure, Compliant, and Effective Digital Collaboration in the Life Sciences Sector

In developing the new digital audit and collaboration solution, we looked for ways to automate and streamline as many of the processes as possible. Systems Engineer Blessing Nwachukwu worked on the project.

“We worked closely with our client on the development of our new digital audit solution. Automating processes was a crucial consideration, as was making the solution as seamless as possible. We also had to ensure the process was integrated into the Microsoft platform to create an effortless experience for the users. The solution can connect people from any location to participate in an audit, making it fully remote-enabled.

“Our initial thought was to host the platform on an external domain, but that created connection and accessibility difficulties. We moved instead to hosting the platform on the customer’s domain using Microsoft Teams and its suite of apps.

“After conducting tests and mock audits, we supported our customer on their first live audit. It was an HPRA audit, so the auditors were in Ireland, but everything was done remotely. The audit went smoothly, and it was successful. This led to more audits and, so far, we have successfully supported our customers in 16 different regulatory audits using our digital solution. Each one resulted in positive feedback.

“This solution and the technologies that make it possible represent an important milestone in the modernization of the compliance processes that are so essential in the life sciences sector. At SL Controls, we are continuing to refine and expand the solution, and we are enthusiastic about its potential.”

If you would like to find out more about our digital audit solution for the life sciences sector, please get in touch with us today.