Pharmaceuticals, Life Sciences & Biotechnology

Increasing challenges in quality management

Nowadays, quality management professionals in the Pharmaceuticals, Life Sciences and Biotechnology sectors are facing growing regulatory and internal challenges, driven by FDA and EMA constantly refining their regulations & guidance. Over the last years, this led to a 15% increase in warning letters issued by the FDA. 40% of those warning letters relate to cGMP (current Good Manufacturing Practices).

Meanwhile, companies active in Pharmaceuticals, Life Sciences and Biotechnology are also increasingly outsourcing processes to CRO’s, CMOs and logistic partners. However, more than 50% of them still manage their Good Manufacturing Practices on paper, which is a risk and doesn’t make things easier from a compiance perspective.

More flexibility, more changes

The pressure on QA professionals poses considerable challenges: it shifts the focus from strategic thinking and risk mitigation towards short-time projects, like new production lines. Because more flexibility is required, the error margin also becomes bigger and more resources are needed. As a result, compliancy and production continuity – both crucial for the company’s future – are hanging in the balance.

A 360° solution for smoother change control processes

As an answer to these growing complexities, Neomatics offers a payable, 360° solution for smoother control of all QA processes.

Forget the nuisances of a paper environment or manual processes. Forget all those lost or delayed signatures, all those hours overtime maintaining traceability. We’ll help you keep everything under control flawlessly. You’ll deal with your challenges in the easiest, fastest and most efficient manner.

Discover our solutions now

Eager to find out more? Discover all of our products here.
Want to learn how it works? Ask for a demo or contact us.
We’ll gladly listen to your needs, in order to propose the right solutions.