Analytical Instrument Validation
Commissioning & Qualification
Computer System Validation
Electronic Logbook ManagementUnlike some other platforms that focus only on data-centric, form-driven validation — such as Veeva Vault and ValGenesis VLMS — Kneat Gx offered flexibility and configurability.
The challenge
Paper-based validation slowed approvals and made retrieval hard. With 180+ FDA data-integrity observations across industry, Recipharm Advanced Bio needed a compliant, flexible platform meeting 21 CFR Part 11 and EU Annex 11 across multiple disciplines.
The solution
Recipharm Advanced Bio deployed Kneat Gx for AIQ, CQV, CSV, eForms, and QA eLogbooks. A Word-like UI eased adoption; paper templates became digital workflows. Scalable structures, access controls, search, and version-compare enabled fast, consistent execution.
The results
Review cycles cut from days to hours. Strong alignment with 21 CFR Part 11, EU Annex 11, and ALCOA++. QA eLogbooks replaced paper, streamlining issuance and archival. Shared, global folders improved collaboration while preserving site-level specificity.
See how Recipharm Advanced Bio transformed validation with Kneat Gx
Understand the business challenge, solution, and results in this case study
Download case study