Scilife Blog

A few years ago I sat in on a customer onboarding call where the Head of Quality opened with a sentence I still remember. “We’ve validated this computerised system three times in five years,” she said, “and we still got a Form 483 observation on it l...

Quick answer The EU AI Act is the European Union's risk-based regulation for artificial intelligence. It applies to organizations that develop, provide or use AI systems, including pharmaceutical, biotechnology and medical device companies. Complianc...

Quick answer Draft Annex 22 is the EU's proposed GMP guidance for data-trained AI and machine learning (AI/ML) models used in critical pharmaceutical manufacturing applications. It introduces AI-specific expectations for governance, validation, risk ...

ALCOA was born on a crowded slide in the early 1990s. An FDA officer called Stan Woollen ran out of room while preparing a presentation, so he typed five letters as a memory prompt: Attributable, Legible, Contemporaneous, Original, Accurate. The acro...

Data integrity is one of those topics that sounds simple until you are sitting in an audit room and someone asks: can you prove where this data came from?

Medical device companies operate in one of the most highly regulated industries in the world. To consistently deliver safe and effective products while meeting regulatory requirements, organizations need a structured approach to quality management.

If you work in medical devices, chances are you’ve heard at least one version of this question over the past year: “Wait… does the device history record still exist under QMSR?”

If you’ve worked in medical devices for a while, the term Device Master Record or DMR probably feels like muscle memory. It’s been part of the regulatory vocabulary for decades, especially if you’ve worked with U.S. Food and Drug Administration (FDA)...

In 2026, the life sciences sector operates in a state of high-precision oversight, where even the most established partnerships require constant, data-driven verification. I recall a situation involving a critical component manufacturer who had maint...

Most people know the name of a medicine, but not the part that actually makes it work. That part is the active pharmaceutical ingredient (API), and in pharmaceutical manufacturing, its quality is everything.

If you work in medical devices in the EU, the question is no longer what EUDAMED is, but whether your data and ownership model will survive mandatory use.

Any QA professional in life sciences who has ever prepared an annual product quality review knows how demanding it can be. What should be a structured quality exercise often turns into weeks of pulling information from everywhere—spreadsheets, emails...