Scilife Blog

The FDA's Quality Management System Regulation (QMSR) no longer uses the term Design History File (DHF). Instead, ISO 13485:2016 Clause 7.3.10 requires manufacturers subject to design and development requirements to maintain a design and development ...

Quick answer: What is ISO/IEC 42001? ISO/IEC 42001 is the first international standard for establishing and continually improving an AI management system. For life sciences organizations, it provides a structured way to govern AI risks, responsibilit...

Quick answer: The validated state is the condition in which a computerized system consistently performs as intended and continues to meet documented GMP requirements. Validation establishes this state before go-live, while change control, incident ma...

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 computerized 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...