Scilife Blog

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:

As the life sciences are digitalizing at an unprecedented scale and rate, data lifecycle management is becoming increasingly important. The two major factors driving this rapid and close-to-universal digitalization are Industry 4.0 and the COVID-19 p...

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...

Nobody knows the importance of 'Quality Records Management' better than a quality assurance professional! Quality records are invariably scrutinized in every internal or external audit. These documents are treated as living evidence of organizational...

Recently, our Scilife CEO Filip invited Mika Siitonen, Medical Development Manager at Labquality and seasoned expert in medical device regulatory guidelines, to answer anything and everything you wanted to know about performing Risk Management under ...