Scilife Blog

Medical device teams often spend months perfecting a breakthrough design. But the moment ISO 13485 certification and compliance enter the picture, momentum often grinds to a halt. The quality team has been brought in too late. Documents are scattered...

I’m willing to bet you’re here because of a specific incident. Maybe it was during a batch record review, you saw a signature next to a step that you know, for a fact, was not performed correctly.

Are you spending countless hours sifting through disorganized spreadsheets and SharePoint documents, or worried sick about your next audit due to the sheer volume of documentation that you have to prepare?

In my years working in quality, I’ve learned a few things that cause more anxiety than an upcoming audit of a newly qualified piece of equipment. That's why having a solid grasp of IQ OQ PQ: Installation Qualification (IQ), Operational Qualification ...

There’s no easier way to illustrate compliance vs quality than through a real-life example…

In our past training session, “Making AI work for you: everyday wins in QARA”, life sciences expert Martin King taught us how to use AI in quality management to enhance quality processes.

In today’s fast-paced and tightly regulated medical device industry, a Quality Management System (QMS) is far more than a mere compliance exercise, especially for medical device manufacturers. In this article, we will tell you the ins and outs of QMS...

GxP regulated sectors – pharma, biotech and medical devices – manage large volumes of documentation. Securely and efficiently managing it, always in compliance with industry regulations, is essential for quality, R&D, supply chain, human resource...

As quality professionals, we know that a vital part of keeping patients safe is making sure that drug products are manufactured consistently and that the end products are of high quality. This is pretty much taken for granted by the public today, but...

As one of the most regulated industries on the planet, the challenges in the pharma industry are countless, especially when it comes to managing a pharmaceutical Quality Management System.

Let's be honest, quality management in life sciences can be a real headache. The amount of paperwork, the complexity of the regulations, and the constant pressure of audits is tremendous. It's enough to make anyone's head spin.

Standard Operating Procedures (SOPs) are the backbone of quality management systems in the life sciences industry. Whether you're working in pharmaceuticals, medical devices, or biotechnology, SOPs ensure consistency, compliance, and safety in proces...