Quality and compliance in pharmaceutical companies: meet the expert.

All pharmaceutical or biotechnology companies struggle with the balance between compliance and innovation. The Ordina life sciences sector team offers help in both areas. But they are not alone in taking up this task. When a company calls for a compliance solution, the team calls in the help of Tom Voet and his colleagues from the Ordina Quality & Compliance (Q&C) team. Tom has worked on computer validation for the pharmaceutical sector for more than 20 years.

The catalogue of rules and legislation with which life science companies have to comply is growing in scope and complexity. There are technical product requirements, rules on market access and data usage along with good laboratory, clinical, manufacturing and distribution practices. The computer systems that life science companies use also have to be validated, although that isn’t anything new. The rules governing computer system validation (CSV) date back to 1997.

When CSV was still in its infancy

Tom Voet still remembers when CSV first saw the light of day. “With a master’s degree in applied linguistics, I started working at Real Software in 1997, where I translated software and user manuals for the medical sector,” he explains. “In March 1997, the FDA, the American food and drug administration, launched what was called the ‘rule 21, part 11’ that determines how life science companies should handle electronic data. The directive landed like a bomb. For decades, developers of medicines, medical devices, etc. had kept all their data up to date manually. But with the advance of the computer, more and more data was being processed automatically. This was no longer possible without the necessary regulations.”

For Tom, the FDA directive was the trigger for a change in his career. In 1998 he started working at Johnson & Johnson as a CSV consultant. A few years later he was given the same role at Pfizer Global Manufacturing. He was then named Quality & Compliance Manager at Tibotec and at Sogeti. In May 2015, he joined Ordina to add his expertise to the Q&C team.

Open culture with attention to self-development

Why Ordina? Tom: “I’d heard many positive things, knew Sven Mus, the head of the business unit, and the idea to work on a project basis for different pharmaceutical customers really appealed to me. I am still very happy with my decision. Ordina is a great company that’s genuinely concerned with its people. There’s an open corporate culture, everyone is encouraged to take initiative and we are given lots of room to grow.”

There’s an open corporate culture, everyone is encouraged to take the initiative and we are given lots of room to grow.

Computer validation at Ablynx

Today Tom works on a large CSV project at Ablynx, a young Ghent company that develops Nanobodies®, a type of biological drug. “Ablynx came to us for IT quality assurance expertise,” says Tom. “Their own IT team is small. They don’t have the space or the expertise to have in-depth knowledge of all the validation processes and to apply them smoothly. Moreover, the IT and business sections didn’t always agree on how the CSV directive should be interpreted. We were instructed to steer everything in the right direction working in close cooperation with their own team. A number of important audits were also coming up, including a first FDA Pre-Approval Inspection Audit.”

Tom reviewed existing IT quality assurance processes, updated existing procedures, gave training courses, made clear agreements on documenting computer systems and worked out a ‘configuration management database’. It contains all the information about the hardware and software components that Ablynx uses.

Change management

“As in any CSV project, change management was crucial,” Tom emphasises. “Processes and tools are essential of course, and if the project is to be successful everyone involved has to respect all the different steps. By engaging all the Ablynx stakeholders – both IT and business – in our decisions, we managed to get everyone on side. Today, there is tremendous cooperation between the various internal teams. There are clear processes and everyone complies with them without any problems.” The approach is bearing fruit. In 2018, Ablynx successfully completed the audit and Tom gained the confidence to continue supporting the company with computer validation.

Change management is crucial in any CSV project. Processes and tools are essential of course, but if the project is to be successful everyone involved has to respect all the different steps.

Mission: to help people

“Compliance and, more particularly, computer validation are long-term projects. Or rather: continuous projects. And they’re not always met with cheers,” Tom admits. “CSV is invariably a delaying factor and the added value is not immediately visible. But there is no way of avoiding it. Failing an audit can have serious consequences: from fines and shutting down production to closure and the risk of criminal proceedings. Which makes sense to me. Ultimately, life sciences is about public health and drug safety. That’s why I like this job so much: the pharmaceutical sector is there to help people. And I can contribute a little bit to that.”

Multidisciplinary team

Today, the Quality & Compliance business unit that Tom belongs to, has 87 experts: from IT people to industrial and bio-engineers, masters in biomedical sciences, etc. Thanks to this mix of competences, the team combines thorough knowledge of the regulatory framework and legislation (cGxP, CFR21 Part 11, ISO, etc.) for the pharmaceutical sector with knowledge of IT and business. They also work together with colleagues from the life sciences sector team or with other Ordina teams. “This helps us to keep abreast of all developments that could have an impact on our jobs. Ordina also offers unique combinations such as validated software robotics, validated development etc.”

Competitive edge

“Pharmaceutical companies are not trailblazers in the digitisation race. There is a certain reticence because safety is so important and legislation so strict. But they must change. For example, the increasing amount of medical data available can provide important insights that can give pharmaceutical companies a competitive edge. By working together with us, they gain these insights without any risk as we take handle the compliance.”

An increasing amount of medical data is available. Life Science companies can gain important insights from this that can give them a competitive edge.

Are you struggling with compliance? Do you want to know Ordina can help you? Get in touch with Tom.