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...

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...

While sometimes deprioritized, regulatory compliance is critical for medical device manufacturers. And among the global regulatory frameworks, the Medical Device Single Audit Program (MDSAP) has gained prominence over the past decade. MDSAP is a comp...

While the pharmaceutical industry continues to grow and evolve, GMP (Good Manufacturing Practice) compliance remains a top priority to ensure the safety and quality of products. Therefore, GMP is essential to every pharma manufacturing process to mai...

Internal audits can strengthen the quality management system (QMS) of your organization by improving sub-processes by identifying open issues and opportunities. In addition, internal audits can be more informal than external audits so that your organ...

Introduction to Audits An audit is the verification, inspection, or examination of a process, product, or system to guarantee compliance with regulatory or organizational requirements. The scope of an audit can apply to an entire organization or be l...