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27

Sites deployed

2023

Kneat customer since

Case study

Harmonization that works

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Customer

Fresenius Kabi

Industry

Pharmaceutical

use cases

  • Equipment Validation Equipment Validation
  • Process Validation Process Validation

Customer

Fresenius Kabi

Industry

Pharmaceutical

use cases

  • Equipment Validation Equipment Validation
  • Process Validation Process Validation
27

Sites deployed

2023

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.

Deanna Vona, Supervisor, Tech Transfer, Fresenius Kabi

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

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