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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Standard operating procedures (SOPs) describe, well, the standard operating procedures of a company. They provide step-by-step instructions on how to perform the most common tasks at a company. When SOPs are efficient, they decrease miscommunication ...
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 ...
The FDA is transitioning from Computer System Validation (CSV) to Computer Software Assurance (CSA) for computers and automated data processing systems used as part of medical device production or medical device quality systems. So, what is the diffe...
Medical devices have one purpose: to improve the life of patients. They are developed with this purpose in mind, and the entirety of regulatory compliance is designed to ensure that medical devices remain safe and perform as intended throughout their...
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...
Quality risk management is a non-negotiable requirement to comply with ISO13485 and 21 CFR 820. Yet, every year, Life Sciences companies face warnings from regulatory bodies, such as the FDA in the U.S., the EMA in Europe and MHRA in the U.K. Warning...
In May 2017, Life Science organizations were hit by one of the biggest cybersecurity incidents - the WannaCry ransomware attack. WannaCry spread rapidly across networks, encrypting files and demanding ransom payments in Bitcoin to decrypt them. The U...
Any medical device manufacturer developing new products comes across design verification and validation. They are essential stages during the design control of a new medical device. Design controls are a series of steps and processes during the devel...
The pharmaceutical industry has a responsibility to prioritize sustainability, but unfortunately, it has not always done so in the past. At present, sustainability is often viewed as a trendy buzzword, used by companies to improve their public image ...
The pharmaceutical industry is one of the most rapidly evolving industries in the world, with new advancements and breakthroughs being made every day. Keeping up with the latest pharmaceutical industry news can be challenging, but fortunately, there ...
With the European Medical Device Regulation (EU MDR, 2017/745), the Unique Device Identifier (UDI) became mandatory for medical device manufacturers in the European Union. The MDR aligned the EU with the US market, where the UDI system had already be...
