A Day in the Life of A Compliance & Validation Manager

A Day in the Life of A Compliance & Validation Manager

Working hand-in-hand with our customers and partners to improve our product means we at Panaya get to meet some forward-thinking, insightful ERP professionals. We’ve set out on a mission to bring you the voices and stories of those people. Today, we’re going to meet Panaya customer Pieter Tombeur.

Pieter Tombeur
Pieter Tombeur

Pieter Tombeur,
IT Manager Compliance & Validation, Terumo Europe

Pieter Tombeur is an ECA Certified Computer Validation Manager and an ISEB/ISTQB Certified PRINCE2® Practitioner. He’s been with Terumo Europe for nearly eight years, and for the past two has been a Manager of Compliance and Validation, based in Leuven, which is just outside of Brussels, Belgium. Before joining the Terumo team, Pieter worked for four years in compliance and validation in Janssen Pharmaceutica, also in Belgium.

With some 25,000 employees worldwide, Terumo Corporation is a core player in the EMEA healthcare market – providing best-in-class medical products and services that meet customer and regulatory requirements.

Currently on His Plate

As Manager of Compliance and Validation in IT, Pieter’s main responsibility is to ensure that Terumo’s primary IT applications run in a compliant manner. This mandate is actually quite broad. Being a medical device company, Terumo has to adhere to a wide range of specific medical regulations, along with the financial and privacy regulations that apply to all multinational enterprises – and many of these touch directly on Pieter’s domain. 

Ongoing Testing Projects

Terumo’s SAP release cadence is robust – involving three fixed and major releases each year, that demand large-scale user acceptance and other types of testing. Each major release involves around six weeks of intensive testing. In between these major releases, Pieter’s group juggles multiple projects that vary in scale and urgency with company activity – and require testing periods of 1-2 weeks to 6-8 weeks.

Favorite Part of His Role

Pieter loves the fact that no day is the same in his job. Since his role involves being in constant touch with auditors, he’s constantly pivoting and adapting on-the-fly to choose the best compliance and validation tools from his toolbox. 

Beyond this, Pieter is a central player in a large organization, who is tasked with supporting a process that is considered cumbersome and difficult. This makes finding the correct balance across all departments (especially the Quality department) in the organization a challenge he enjoys.

”Ramping up towards a release, we try to ensure maximum compliance up front. This means gathering user requirements, making sure the proper documentation is in place, and that all the testing is happening. Since we have a decentralized testing team, that includes many business users, making sure tooling is available is one of my main concerns.”

Tips for Other Validation and Compliance Managers:

  • Tip #1 –Get The Right People — Pieter strongly believes that the right team is crucial for any compliance and validation effort. He seeks out and engages people who both know their processes and are technically savvy. For this reason, his team is better positioned to appreciate tools like Panaya. It’s a key success factor to executing good test runs, in Pieter’s view.
  • Tip #2 – Breaking Things is Good – Pieter holds that smart testing doesn’t just try to prove a solution works. Rather, it’s worthwhile to try to break it. Breaking, in Pieter’s eyes, means finding non-mainstream processes to test, and also sometimes straying from test protocols. 

“Sometimes, it can be valuable to just go into a system and see what you can break. For example, if the test script says write ‘ABC’, why not write ‘123’ and see what happens?”

Life Before Panaya 

“Before Panaya, I would spend a lot of time supporting testing efforts. This often meant supporting people that need to do something with a certain tool. I often would get around to doing much more than just explaining for the 27th time which button to click…”

Life After Panaya

For Pieter, the one word that describes life after Panaya is “easier.”  Panaya is so intuitive that the task of onboarding new users has just disappeared. 

Pieter feels that Panaya makes things easier because testers and staff alike no longer complain about the tool they have to use for testing. “They may complain about the testing itself,” he jokes, “but never about the tool.” Moreover, Pieter and his team truly value what he lovingly calls Panaya’s “in-your-face reporting, which is automatically there and you don’t have to think about.”

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