Scilife Blog

Navigating the complexities of FDA inspections is crucial for QA professionals in the pharmaceutical and medical device industries. The stakes are high, with regulatory compliance directly impacting your organization's ability to operate smoothly, av...

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...

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...

A quality audit is an inseparable part of the life sciences business. This is because healthcare products can have desired as well as undesired effects on patients. Therefore, it is important to manufacture them by following the best practices in the...

As of February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) is officially in force. The FDA’s new Quality Management System Regulation (QMSR) represents the most significant overhaul of U.S. medical device quality requirements in mo...

What is EU GMP Annex 11? EU GMP rules, also known as the ‘EudraLex rules’ govern the medicinal products in the European Union. The EU GMP rules are split into three different parts plus about 20 annexes. ‘The EU GMP Annex 11’ is one of the supplement...

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...

An eQMS is a digitalized Quality Management System where you can create, store, retrieve, and archive all of your company’s quality-related documents. In the context of a life sciences company, an eQMS also automates compliance requirements under 21 ...

If you’ve been on the lookout for a go-to resource offering valuable tips for technical writing, your search is finally over. We’re here to simplify complexity.

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.

Life science industries have their language and it consists of many concepts, terms, and abbreviations that are commonly mixed up. When you see them together it is even harder to grasp the nuances between concepts. Today we’ll give you a long list of...