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Cut CSV process steps 40%, validation cycle time down 25% via integrated processes — (URL not separately confirmed; referenced in ValGenesis blog/resource content

OtsukaShipValGenesis

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, referenced in ValGenesis’s own case-study library without a standalone URL.

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  1. 01Launched ValGenesis iVal in 97 days; moved off paper; saved 20-25 hrs/week; recouped 50% of investment in 20 weeksMilliporeSigmaValGenesisShip
  2. 02Transformed continuous process verification (CPV) approach via ValGenesis iCPVTeutoValGenesisShip
  3. 03Aligned ValGenesis with a new computer system validation (CSV) program; identified process improvementsCatalentValGenesisShip
  4. 04Transitioned from paper-based to digital validation during an ERP upgradeNovenValGenesisShip
  5. 05Eliminated legibility/data-accuracy concerns by adopting digital validation documentationTransCatValGenesisShip
  6. 06Implemented standardized validation management; impressed FDA inspectorsTheraGentValGenesisShip