Scilife Blog

Quality professionals in the life sciences industry are dedicated to achieving the highest standards of quality, safety, and efficacy in all products, while also improving manufacturability. Medicines must meet the intended use. To accomplish this, t...

GMP stands for “Good Manufacturing Practices.” In the realm of manufacturing, a buzzword you'll often hear is "Good Manufacturing Practices," commonly known as GMP. What exactly does it entail? This piece will outline the five main components of GMP ...

In the fast-paced and highly regulated world of pharmaceuticals, ensuring the highest standards of quality is paramount. Pharmaceutical Quality Assurance (QA) leaders face a myriad of challenges in maintaining compliance, minimizing risks, and delive...

Regulatory agencies demand life science companies to produce high-quality, affordable medicines without compromising quality in manufacturing. For this reason, well-defined quality assurance goals are key for making life science businesses successful...

In Life Sciences, quality management systems are essential for ensuring the safety and efficacy of products. However, having a robust quality management system is only one part of the equation. To promote a culture of quality far beyond mere complian...

Corrective and Preventive Action (CAPA) is an essential component of quality management in the pharmaceutical and medical device industry. However, problems with the CAPA process can lead to regulatory action, product recalls, and, most importantly, ...

Quality Assurance (QA) is an essential process in life sciences organizations, regardless of their size. It involves ensuring that products, services, and processes meet specific standards and regulations, and meet the needs and expectations of custo...

Data Quality… it's not a Goal, it’s a Mindset! Despite investing huge amounts of money in setting up data collection and storage infrastructure, many companies are insight-starved, experience data leaks and are unable to formulate a Data Quality plan...

Natural Language Processing (NLP) is on a significant growth trajectory—and the Life Sciences are increasingly relying on this groundbreaking technology. A subfield of linguistics, computer science, and artificial intelligence (AI), NLP involves the ...

Why GAMP 5 Needed a 2nd Edition GAMP 5 (Good Automated Manufacturing Practice) is a risk-based approach for the implementation, operation, and validation of GxP Computer Systems in regulated industries – including the Life Sciences. Recent technologi...

The requirements of Life Sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to learn mor...

What Is a Non-Conformance Report? A non-conformance report is a document that explains a deviation from the anticipated outcome of a process or product. Some examples of events in the Life Sciences that may call for a non-conformance report are: