Scilife Blog

Medical device teams often spend months perfecting a breakthrough design. But the moment ISO 13485 certification and compliance enter the picture, momentum often grinds to a halt. The quality team has been brought in too late. Documents are scattered...

I’m willing to bet you’re here because of a specific incident. Maybe it was during a batch record review, you saw a signature next to a step that you know, for a fact, was not performed correctly.

Our webinar ‘How to win buy-in for quality investments with a soft skills approach’ is addressed to QA professionals who deal with resistance from those who really have the power over the QA budget in their company. Our speaker, Lesley Worthington, C...

In today’s fast-paced and tightly regulated medical device industry, a Quality Management System (QMS) is far more than a mere compliance exercise, especially for medical device manufacturers. In this article, we will tell you the ins and outs of QMS...

When working with medical device companies, one thing becomes very clear: the difference between a team that’s audit-ready and one that’s constantly chasing documentation often comes down to a single factor—training. If quality and compliance trainin...

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...

If you’ve ever been through an audit in the life sciences industry, you know how important Corrective and Preventive Actions (CAPAs) are. Regulatory bodies expect you to have a strong CAPA process in place to uphold product quality and patient safety...

Every Quality Assurance (QA) professional knows that a Quality Management System (QMS) is the foundation of product safety and effectiveness in the pharmaceutical industry.

In the pharmaceutical industry, ensuring the safety and quality of medicines is a big responsibility. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the two most influential regulatory agencies overseeing drug...

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...

In the fast-paced and highly regulated life sciences sector, maintaining an effective Quality Management System (QMS) is critical to ensuring product quality, compliance, and continuous improvement.

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. ...