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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...

Medical devices on the market are under strict surveillance by governing bodies such as the FDA. As with all tech nowadays, the Medical Device industry is evolving at hyperspeed, and regulations need to constantly keep up to date in order to continue...

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...

Scilife adds a powerful Risk Assessment module to their digital Life Sciences platform. The latest in their broad repertoire of functional modules, Scilife adds Risk Assessment to the Scilife spectrum. This hotly awaited module, specifically designed...

What is GAMP 5 GAMP®5 stands for Good Automated Manufacturing Practices issue 5. The GAMP 5 Guide is meant to assist pharmaceutical manufacturing companies in managing GxP Regulated systems. The GAMP guideline is purely advisory and has no legal obli...

We have a very systematic approach to onboarding new clients. We hold weekly meetings on the progress of the project to completion. The goal is to get trained, validated and to go live with your data in production in the least amount of time. In the ...

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...