Scilife Blog

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...

Validation is the process of establishing documented evidence that a process or system is reliable and suitable to fulfill its intended purpose.

Navigating the complexities of FDA inspections is crucial for QA professionals in the pharmaceutical and medical device industries. The stakes are high, with regulatory compliance directly impacting your organization's ability to operate smoothly, av...

In the highly regulated pharmaceutical and medical device industries an electronic Quality Management System plays a pivotal role where you can create, store, retrieve, and archive all of your company’s quality-related documents. Those activities ens...

Medicinal products and medical devices should be manufactured at a high level of quality to ensure they are fit for purpose. Manufacturers must also ensure patients are not at risk due to inadequate product quality.