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We are very proud that we provide Scilife's Platform as a pre-validated software. This lifts 95% of the validation burden off the shoulders of our customers. This being said, we often receive a question about the remaining 5% of the part. T...

Tech innovations are driving the rapid evolution of everything humans do, and auditing is no exception. Since 2020, remote or virtual audits have become commonplace, born out of necessity in a time when on-site audits were simply impossible. Due to t...

Stacks of paper, what a hassle!  Staying on top of who printed what, where, and when is a common struggle for many life science companies. Document reconciliation is even more of a challenge. Printing may be unavoidable, but staying compliant and kee...

Most pharma and MedTech companies have had digital transformation on their to-do list for quite some time. Unfortunately, only a few (roughly 20%) have actually pivoted from doing digital to being digital.

Apart from meeting rigorous safety requirements, medical device manufacturers need to comply with strict quality standards. A compliant Quality Management System (QMS) is therefore absolutely fundamental for any medical device company, or any Life Sc...

Scilife has a new module! Finally, risk management is made a whole lot simpler, as well as accessible by everyone. In our webinar on Scilife's new Risk Assessment module, CEO Filip Heitbrink discusses:

In the Life Science industry, the race is on to earn the prestigious ISO 13485 certification as soon as possible, since it prepares companies for the future EU MDR audit. If you're in the life science industry and after the ISO 13485 certification, t...