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.

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...

Most pharma and medical device companies are increasingly adopting electronic Quality Management Systems (eQMS) to streamline their quality management processes. A well-designed quality management system helps you to meet customer satisfaction and re...

In today's world, environmental sustainability has become increasingly urgent. The planet, and by extension its people, is under pressure, and all evidence points towards increasingly critical consequences if we do not act. Industries around the glob...

Audits and inspections are a part of the quality management lifecycle, they are simply a fact of life in the medical device and pharmaceutical industry. The purpose of an inspection of Quality Management Systems is to ensure your company has establis...

In the era of Quality 4.0, cloud cybersecurity has become a crucial concern for businesses. Many companies are exploring the impact of switching from on-premise Quality Management Systems (QMS) to cloud-based QMS. It is important to understand the di...

According to the U.S. Food and Drug Administration (FDA), data integrity is the completeness, consistency, and accuracy of data. The agency places a significant emphasis on data integrity in regulated industries such as pharmaceuticals, biotechnology...