Scilife Blog

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...

When your manufacturing line is running smoothly and your paperwork looks in order, you might think you’re “doing GMP”.

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.

According to the EMA, Good Distribution Practices (GDP) comprise minimum standards that a wholesale distributor must meet to ensure that the right environment and handling are maintained throughout the supply chain to prevent any alteration of the me...