Scilife Blog

Change is essential for growth, no matter which sector your company or organization excels in. However, change can also be a trying period in any company unless you and your team are well prepared for it. The best way to prepare yourself and your tea...

Every year, the FDA issues hundreds of warning letters along with inspections of manufacturing facilities. You should take the warning letters seriously because they act as a precursor to a worse failure. You should always take proper corrective and ...

A robust laboratory quality management system is essential in medical research laboratories to ensure the integrity and reliability of the tests conducted. Implementing a laboratory quality management system can be an overwhelming task, but organizat...

What is Pharma 4.0? Pharma 4.0 is the trademark of an initiative from the International Society for Pharmaceutical engineering (ISPE). Pharma 4.0 refers to the use of Industry 4.0, also called Smart Factory technologies, to improve quality and effici...

What is GAMP 5? GAMP®5 is an acronym for the guideline Good Automated Manufacturing Practices issue 5. The GAMP 5 guideline provides a risk-based approach to designing, developing, and maintaining computerized systems in a GxP-regulated environment. ...

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...

In June 2022, the European Medicines Agency (EMA) published its first review of the 3-year work plan for the Quality domain (covering January 2021 to December 2023), highlighting interesting strategies and goals applicable to the Life Sciences indust...

Seasoned Pharmaceutical Quality expert Lieve de Wolf (External Quality Manager CAR-T & Advanced Therapies at QbD Group), joined our inaugural annual Scilife Summit to answer everything you wanted to know about novel GTMPs and ATMPs, specifically ...

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 ...

We’re halfway through the year, but there are still plenty of conferences and trade shows coming up. These events are a great way to stay on top of today’s rapid and often overwhelming developments in the industry. This also provides you with a platf...

We’re halfway through the year, but it’s never too late to plan for the conferences and events ahead that will keep you in the loop for the latest and greatest in the pharma and biotech world. Here, we’ll look at some of the biggest events and most i...

Today, the Quality conversation is no longer about making the digital leap from an outdated paper-based Quality Management System (a traditional QMS) to managing your Quality processes with electronic Quality Management software (an eQMS). That trans...