Most of the NIS2 Germany coverage I have read in the last six months came from law firms or IT consultancies. Much of it treats NIS2 as a standalone cybersecurity programme.
In highly regulated industries like pharma and biotech, organizations are typically well-versed in compliance and regulations. Yet as they scale, some quality systems begin to show cracks in ways that aren’t immediately obvious.
In the medical devices industry, “design transfer” refers to the process of transitioning a medical device from development to large-scale manufacturing. For manufacturers, particularly personnel in the quality, R&D, and manufacturing functions, ...
In my experience as a quality professional, I have found that a CAPA medical device system is the most revealing part of a company's internal structure. I once worked with a team that had nearly 40 open files, some dating back eighteen months, becaus...
Switching from paper to eQMS creates the perfect opportunity for QA teams to build on what already works and streamline what doesn’t.
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…
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