News

Doing Business in the Pharma Industry: Quality is not just a Name, it is the Game.

News

Doing Business in the Pharma Industry: Quality is not just a Name, it is the Game.

Inside Modum

February 20, 2020

At Modum we aim to be the measure of all things when it comes to transforming global supply chains into transparent, trusted and efficient digital ecosystems for sensitive goods. With pharma being one of our focus industries, this also means being the measure of all things when it comes to quality control and management. So, what does this mean for a young company like us?

Quality at Modum has two dimensions – product and process, both being equally important.

From a product perspective, we need to ensure that we adhere to the latest national and international engineering and safety standards, such as EN 12830:2018 or Welmec 7.2, go through rigorous testing and ensure products are released for the market only if they match the defined quality requirements. As widely used in the industry, the quality release process of our products is based on sample inspections according to ISO 2859, conducted by independent and accredited external laboratories.

From a process perspective, it is key to have a quality management system (QMS) in place that is ingrained within the organization and part of everything we do. Early on we have invested in setting up a professional, but lean QMS according to ISO 9001, that is not just a control system, but supports our work from a quality perspective. As according to the standard every organization is free to define exactly how they do this, this means implementing a continuous cycle of defining, evaluating, updating, discarding and improving processes.

Obviously we are not the only company that takes quality seriously – but for us as a young company founded in summer 2016 in some cramped room at the University of Zurich and having a fully pharma qualified monitoring solution as well as being ISO 9001:2015 certified by SGS just two and a half years later is quite an achievement and shows our ability to get things done fast and reliably.

So, what is our secret, you may be asking? It’s relatively simple actually:

  • Define processes you actually live daily and improve from there
  • Keep it simple, don’t try to overengineer things or over-qualify your products – quality means meeting requirements, not exceeding them
  • Ensure your people are trained in a way that they understand the benefits of a quality management system for their daily work
  • Repeat all the above regularly

Not to pat ourselves on the back, but the SGS auditor sums up our efforts quite nicely: “Modum’s QMS is the second best I’ve ever seen – the best being the one I myself set up!” Well – there’s still room for improvement.