Scilife Blog

If you're in pharmaceutical development, Quality by Design (QbD) is a term you know well. It represents an advancement in how we develop and manufacture medicines, and at its heart is the ICH Q8 guideline.

In my experience working with quality teams, GxP compliance in pharma is often perceived as a burden. However, it's a framework that protects what matters most to our industry: patients, product quality, and regulators' trust.

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.