Scilife Blog
Here you will find interesting articles and news related to your industry.
Before a drug is suitable for patients, it must pass rigorous testing and cost-benefit analyses. In this post, we will discuss the journey a new medicinal product must take from the lab to final authorization in the EU. Continue reading thi...
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Managing your documents doesn’t have to feel like a never-ending nightmare. Good document practices, also known as GDocP, are essential to streamlining your document workflow, enhancing employee efficiency, and ensuring compliance with regulatory sta...
Ensuring compliance with 21 CFR Part 11 and EU GMP Annex 11 is crucial for any Life Sciences company using computerized systems in this highly regulated landscape. Both 21 CFR Part 11 and EU GMP Annex 11 act as safeguards for the Quality, integrity, ...
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...
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, ...
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 ...
On October 20, 2022, I had the unique opportunity to attend Evgeniya Makarova‘s virtual talk at Scilife’s Smart Quality Summit. I must admit: I was very excited to listen to her speech. I even bought brand-new white AirPods for the occasion! As a pas...
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...
