Scilife Blog

If you work QARA in medical devices or pharma, you know that CAPAs aren’t just paperwork - they’re at the heart of compliance and audits. That said, writing CAPA reports that hold up under inspection can be tricky.

If you work in medical devices in the EU, the question is no longer what EUDAMED is, but whether your data and ownership model will survive mandatory use.

Corrective and Preventive action (CAPA) sits at the core of every quality system in the life sciences. When a deviation appears, a complaint escalates, or an auditor asks an uncomfortable question, your CAPA process ultimately decides the outcome.

Any QA professional in life sciences who has ever prepared an annual product quality review knows how demanding it can be. What should be a structured quality exercise often turns into weeks of pulling information from everywhere—spreadsheets, emails...

Switching from paper to eQMS creates the perfect opportunity for QA teams to build on what already works and streamline what doesn’t.

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...