Scilife Blog

As quality professionals, we know that a vital part of keeping patients safe is making sure that drug products are manufactured consistently and that the end products are of high quality. This is pretty much taken for granted by the public today, but...

As one of the most regulated industries on the planet, the challenges in the pharma industry are countless, especially when it comes to managing a pharmaceutical Quality Management System.

Let's be honest, quality management in life sciences can be a real headache. The amount of paperwork, the complexity of the regulations, and the constant pressure of audits is tremendous. It's enough to make anyone's head spin.

Standard Operating Procedures (SOPs) are the backbone of quality management systems in the life sciences industry. Whether you're working in pharmaceuticals, medical devices, or biotechnology, SOPs ensure consistency, compliance, and safety in proces...

In the life sciences industry, a robust Quality Management System (QMS) is all-important for achieving compliance, sustaining operational efficiency, and safeguarding public trust. A QMS underpins every aspect of quality control, from adhering to str...

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.

Regardless of your position, whether you are a CEO, or a C-suite executive in the life sciences industry, here at Scilife we understand - every second counts, every dollar counts. Accelerating time-to-market is essential to be competitive.

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.

The In Vitro Diagnostic Regulation (IVDR) has ushered in a new era of stringent requirements for manufacturers of in vitro diagnostic (IVD) medical devices. Compliance with the regulation is imperative to ensure the safety and efficacy of IVD product...