Scilife Blog

Quality in biopharmaceutical manufacturing is non-negotiable. Especially in today's cultural environment, biopharmaceutical quality management plays a crucial role in safeguarding product quality and maintaining the reputation of biopharmaceuticals. ...

In the pharmaceutical industry, maintaining patient safety and product quality is not just a regulatory obligation, it’s an ethical imperative. Any oversight can lead to severe consequences, from product recalls to harm to patients, tarnishing reputa...

Pharmaceuticals are one of the most vital industries keeping the world running. Whether you are involved in the industry or not, the quality control and reliability of top drug companies affect everyone at some point.

When we observe the industry advancements, we see that software validation has become an indispensable yet challenging process. As regulations grow more stringent and technologies advance, the demand for smooth validation strategies is at an all-time...

Quality management software is gaining traction as a dependable adjunct to quality management teams. The benefits are substantial, especially in life sciences, where quality translates to rapport and, subsequently, sales. This growing reliance on qua...

The pharmaceutical industry is highly regulated to ensure the safety, efficacy, and quality of drug products. As part of the FDA’s current good manufacturing practice (cGMP) regulations, 21 CFR Part 211 outlines stringent guidelines for drug manufact...

There’s a common misconception in life sciences that quality “costs” money — that any investment in quality such as an eQMS is just another financial burden. But that couldn’t be further from the truth.

A week of intensive United States Food and Drug Administration (FDA) inspection has just concluded for your team, and while there’s a cautious sense of relief, there’s still that persistent concern.

Regulatory submission can bring both horror and delight to the office: it just depends on which stage you are at. Paperwork can be grueling yet equally rewarding when accepted. In the life sciences industry, regulatory paperwork is what gets your foo...

In the ever-evolving world of healthcare, Laboratory Developed Tests (LDTs) have emerged as critical tools for diagnosing a wide array of medical conditions. These tests, created and used by individual laboratories, are instrumental in everything fro...

In life sciences, one of the most heard terms is non-conformity management or NC management. To utilize and maintain an ideal NC management process, first, you need to understand what it is for and what are the risks and costs if it doesn’t work prop...

It is almost impossible to work in the medical device space without hearing the term ISO 13485. But what is it? And how can you avoid mistakes during scoping and implementation and ensure the continued availability of your products on the market? Tha...