The impact of ‘21 CFR, Part 11’
Natasja holds a bachelor’s degree in secondary education, with specialisations in economics, English and IT. But when she had graduated, she thought it was crazy to explain economic principles to a class when she had never worked in a company before. She responded to an advertisement from an IT consultancy company, at which she first worked as a tester and then as a validation engineer at Janssen Farmaceutica. “It was a period of major changes in life sciences,” she says. “Just before that, the American Food and Drug Agency (FDA) had launched ‘21 CFR, Part 11’, which determines how life science companies should handle electronic data. Our customer had to revise a bunch of computer systems, tools and processes.”
From review to coaching
Natasja mapped the extent to which the existing computer systems – whether or not linked to a tool – were compliant with ‘21 CFR Part 11’ and proposed remedial actions. In addition, she also took care of the validation of computer systems across the various departments of that company. She never let go of the subject again. For five years she performed various roles in several pharmaceutical companies: she carried out reviews of QMS processes, validation files, etc., supervised validation projects and provided training and coaching on ‘21 CFR Part 11’ and Computerized System Validation (CSV).
“At the time, the common thread throughout my career was the combination of training and compliance, and it still is,” admits Natasja. For a moment, her social skills gained the upper hand: after five years in life sciences, Natasja made a leap to a small organisation that offers career guidance and training in human and interpersonal skills, among other things. The limited link with quality, regulations and the lack of an international context, however, led her back to the pharmaceutical sector.
The common thread throughout my career is the combination of training and compliance.
Ordina puts people first
In the past, she had mainly been involved in CSV, reviewing and coaching, but she became a project manager and carried out IT audits. For a moment, her ambition took her across the German border, where she tried to set up an IT audit department. Bart Briers, head of Ordina’s sector team in life sciences, brought her back to Belgium. Natasja: “At the time, I was missing a human aspect in my job. Bart, whom I knew from CTG, convinced me to join Ordina. He told me that Ordina is a real ‘people company’ that cares about its employees. That won me over. And it’s a big hit. On day one, I had the feeling that I had been working here for years.”
Support for validation and compliance
Today, Natasja is practice manager software related Quality & Compliance with the Q&C team. “I make sure that my colleagues acquire knowledge and that we safeguard that knowledge,” she explains. “And they’re not just beginners. We also challenge experienced colleagues to continue to deepen and share their knowledge, through a personal growth trajectory.” Natasja also applies her knowledge to Ordina customers. For example, she helps Nelson Labs Europe, market leader in research into ‘extractables’ and ‘leachables’, with validation and compliance. “Our customers conduct research in strictly regulated environments. This means that they have to comply with a number of rules and that their computer systems and software must also be validated. After a cyber-attack, MSD resolutely opted for a more thorough approach, with much more attention to security and compliance. As a Program Manager, I support them in this process.”
We also challenge experienced colleagues to continue to deepen and share their knowledge through a personal growth trajectory.
From assessment to training at Nelson Labs
At Nelson Labs Europe, Natasja, together with her colleagues from the Q&C team, is a fixture. “Nelson Labs Europe asked for our help because they were looking for extra expertise on CSV,” she says. “After a discussion with the internal QA team and management, we launched an assessment process to identify any gaps in existing processes and systems. Based on the results, we made a number of improvement proposals that we prioritised. Now I lead the projects, I coach the internal team and I provide training throughout the different departments.” When Ordina developers produced a solution for Nelson Labs Europe to centralise data, she and her Q&C colleagues ensured a smooth validation.
Multidisciplinary: science + IT
Natasja modestly emphasises that every successful project is a group achievement: “What makes Ordina so strong in Q&C are the multidisciplinary teams. Many of our colleagues are academically trained and speak the language of our customers. Others are experts in regulation and validation. In addition, we work extremely well with other experts. I find it extremely fascinating to think about how to use RPA or blockchain in life sciences, for example, and how to ensure validation, quality and compliance.”
Why would a scientist or IT specialist want to work in the Ordina Q&C team? “Because of the variety: you come into contact with both science and technology. And because of Ordina itself, of course,” concludes Natasja.
What makes Ordina so strong in Q&C are its multidisciplinary teams: scientists work together with experts in regulation and validation.
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