
Customer
Fresenius Kabi
Industry
Pharmaceutical
use cases
Equipment Validation
Process Validation

Sites deployed
Kneat customer since
It's very important to have flexibility, being in such a large company, to adapt to what we need. We have different regulatory requirements, different procedures at different sites.
The challenge
Fresenius Kabi’s worldwide operations and localized processes became difficult to scale alongside the company’s growth. A standardized approach was wanted to replace site-by-site approaches with a harmonized process to make validation more efficient.
The solution
The company needed an industry-proven, flexible digital validation platform that could harmonize global processes without causing unnecessary barriers for site-specific functions. 21 CFR Part 11/Annex 11 compliance was a must alongside global review and approval capability.
The results
Fresenius Kabi was able to streamline validation at the sites using Kneat and is now expanding to even more locations. Cycle times have decreased and audit readiness has been strengthened across teams.
See how Fresenius Kabi got the best of both worlds
Understand the business challenge, solution, and results in this case study
Download case study
