Ship · ValGenesis
Eliminated legibility/data-accuracy concerns by adopting digital validation documentation
TransCat eliminated legibility/data-accuracy concerns by adopting digital validation documentation.
ValGenesis is a digital validation-lifecycle platform — one of the two dominant players, alongside Kneat, in producing the validation evidence a GxP system needs before it can go live.
This sits in the Ship stage of the AI use-case lifecycle: Named examples from the vendors pharma teams use to get an AI system live inside a real, regulated production workflow — validation, CRM, safety and clinical systems of record.
Source
Published by ValGenesis on its own site — read the original case study on valgenesis.com ↗
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Related use cases
- 01Launched ValGenesis iVal in 97 days; moved off paper; saved 20-25 hrs/week; recouped 50% of investment in 20 weeks
- 02Transformed continuous process verification (CPV) approach via ValGenesis iCPV
- 03Aligned ValGenesis with a new computer system validation (CSV) program; identified process improvements
- 04Transitioned from paper-based to digital validation during an ERP upgrade
- 05Implemented standardized validation management; impressed FDA inspectors
- 06Cut CSV process steps 40%, validation cycle time down 25% via integrated processes — (URL not separately confirmed; referenced in ValGenesis blog/resource content