We all know that in the European Union, Life Science companies that export to the United States must comply with 21 CFR Part 11. The regulation, overseen by the US Food and Drug Administration (FDA), oversees electronic records and electronic signatu...
2023 is almost over. Oh how time flies! As we are entering the last quarter of the year, there are still plenty of conferences and trade shows for you to attend. These events are a great way to stay on top of today’s rapid and sometimes overwhelming ...
Did you know that 80% of Life Sciences companies are lagging behind in digitalizing their core business? For some, paper documentation is still piling up. For others, their new digital solutions are not yet fully utilized.
When searching for an eQMS (Electronic Quality Management System or Enterprise Quality Management System), it is crucial to prioritize platforms that are purpose-built for meeting the Quality Management Systems (QMS) requirements in the life sciences...
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 ...
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...
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...
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...
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