Scilife Blog

Medical devices are a vast category of equipment, treatments, and functional aids, ranging from caries detection software to contact lenses, orthopedic implants, respiratory care, and more. Every person will need a medical device at some point or ano...

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...

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.

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, ...

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 this post to ...

Cultivating a culture built on Quality is paramount to success, especially in the fiercely competitive pharma and medical device industries. Having a strong Quality culture allows you to spark innovation, foster seamless teamwork, and ensure complian...

We all know the EU GMP Annex 1 guideline: Manufacture of Sterile Medicinal Products. Yet manufacturing is evolving, and new technologies have emerged in recent years. It’s important that companies in the Life Sciences stay on top of these changes.

Developing and bringing a medical device to market is a scary process. Not only do you have to come up with a great idea or design improvement and develop a working prototype, but you must also ensure the device is safe and performs as intended in an...

Quality is paramount in the Life Sciences industry. After all, the safety and efficacy of its products can have a direct impact on patient health.

ISO standards are some of the most recognized global harmonized standards currently at work, along with the standards issued by IEC.

In the highly regulated Life Sciences industry, your complaint management system is an integral part of a successful Quality Management System (QMS). Industry leaders with a profound understanding of Quality and a far-sighted approach toward customer...

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...