Who is our biggest enemy within GCP?
In this article, Katarina Thor, former GCP inspector, shares lessons from the real world.
Today, she uses mock inspections to help organizations see their processes end to end, break down silos, and start working as one team — long before inspectors walk through the door.
QA is more than compliance — it’s a catalyst for reducing risk, building trust, and keeping the patient at the center.
So how do you package QA services in a way that reflects that breadth?
Maybe the answer is simple: we don’t sell tasks — we tell the story of the value.
Today the team gathered to welcome Katarina Thor to the team — one of those moments that reminds me why I love doing this.
Just everyone around the table, sharing stories, laughing, and talking about the year ahead… it just felt right. And watching Katarina slip into the group so effortlessly made it even better.
Yes, she brings a wealth of experience and heart with her, but today was simpler: the ease of the conversations, the curiosity, the sense that we’re all moving together. That’s the kind of energy that gives — and the kind of collaboration our clients feel when they work with us.
We’re incredibly happy to have Katarina on board!
Here’s to a strong start to 2026, and to building something meaningful together.
We’re excited to welcome Katarina to our team.
In clinical trials, speed saves time—but quality saves the trial. Can we afford to compromise one?
Tina Lidén Mascher describes briefly how sponsors we work with keep both, by tightening oversight without drowning the team in paperwork.
By Raf Lemmens
Every start-up faces the same dilemma: the push for speed and market traction versus the pull for structure and quality. In the beginning, the business imperative usually wins—after all, every hour spent on documentation feels like an hour lost to innovation. A management system? It seems like overkill.
But here’s the turning point: once you cross a certain threshold, NOT having scalable processes becomes the real brake on growth. What felt like freedom early on starts to feel like friction. Deals slow down, compliance becomes a scramble, and teams rely on extensive effort instead of systematic excellence.
This is why quality from the start changes everything. A well-designed management system, fit-for-purpose, isn’t bureaucracy—it’s rather a foundation for growth. It transforms quality from a cost centre into a business accelerator:
Early adoption of scalable processes means we don’t have to choose between speed and structure—you get both.
And here’s the part we can make use of: standards aren’t there to slow us down—they’re there to make us reliable at every scale. Frameworks like ISO 9001’s process approach and risk-based thinking, or ICH Q9’s guidance on managing subjectivity and driving data-based decisions through integrated risk management, are powerful when implemented smart. They help prevent firefighting, reducing rework, and help teams make decisions with confidence.
Far from being a burden, we could see these standards as a blueprint for sustainable growth.
So quality and business don’t need to be opposing forces. They can be partners. When we invest early in scalable processes, we create a business that’s not just fast, but sustainable. This helps to build trust, reduce risk, and unlock the ability to grow without chaos.
So, the next time we’re struggling with the dynamics between speed and structure, we can think of quality not being a a brake, but an engine for growth.
An effective way to create the necessary structure for order and traceability in the company’s documentation and processes is to adopt the ISO principles of management systems. By following the principles of the t.ex. ISO 9001 standard, the company establishes clear processes, procedures and documentation requirements for all parts of the business. This creates a structure that allows the company to grow and scale in an organized and sustainable way. A standardized methodology for quality management ensures consistency and stability in products and services, which in turn can lead to increased customer satisfaction and loyalty. By regularly evaluating and improving its processes, the company can increase its efficiency, reduce costs, and increase its competitiveness in the market.
In conclusion, order and traceability in the company’s documentation are essential to ensure efficiency, compliance with laws and regulations, and the smooth running of operations. Investing time and resources in establishing and maintaining the documentation is an investment in the company’s future and competitiveness.
We are celebrating our first six months as a consulting company with the good news that another GMP/GDP expert will soon join our team.
Anders has a pragmatic approach to quality management, and will bring his experience in building upp quality organisations to the team. He has extensive experience as GMP/GDP pharmaceutical inspector and in performing supplier audits for all types of (bio)pharmaceuticals. Anders has had roles as Qualified Person as well as Responsible Person.
Welcome Anders Bonnert!
Welcome to QAlliance – where quality is not just a goal; it’s an integral part of the journey. In a world where businesses constantly strive for innovation, creativity, and effectiveness, we believe that quality should never be sacrificed.
Our approach is simple yet profound – we call it ’Working Quality.’ It’s about nurturing an environment where excellence becomes second nature, where quality is not a constraint but a catalyst for growth and success. Quality must permeate every aspect of your operation, from product development to customer service.
Want to learn more? Stay tuned as this site is under construction.
Welcome to QAlliance – where quality is not just a goal; it’s an integral part of the journey. In a world where businesses constantly strive for innovation, creativity, and effectiveness, we believe that quality should never be sacrificed.
Our approach is simple yet profound – we call it ’Working Quality.’ It’s about nurturing an environment where excellence becomes second nature, where quality is not a constraint but a catalyst for growth and success. Quality must permeate every aspect of your operation, from product development to customer service.
Want to learn more? Stay tuned as this site is under construction.
