Scilife Blog

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...

Deviation in pharma is unavoidable, but how you detect, assess, and resolve deviation management in pharma is what protects patients and product quality.

The In Vitro Diagnostic Regulation (IVDR) has been the law in the EU since 26 May 2022. By now, every manufacturer placing IVD devices on the European market should have a compliant quality management system in place. Yet in 2026, our experience show...

Most pharmaceutical and medical device companies adopt an electronic Quality Management System (eQMS) to centralize and control quality processes, improve traceability, and support compliance with applicable regulatory frameworks, including ISO 13485...

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...

In the life sciences industry, the concept of quality transcends mere compliance and enters the domain of strategic business importance. The cost of quality, a pivotal communication tool, was profoundly emphasized by Philip Crosby, a titan in the qua...

Quality can help organizations drive compliance and growth, as well as reduce costs, by shifting from being an operational compliance issue to a strategic business initiative.

Creating a culture of quality is paramount to success, especially in the fiercely competitive pharma and medical device industries. Having a strong quality culture allows you to spark innovation, foster seamless teamwork, and ensure compliance with r...