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Valkit at a glance

Valkit is a Gen 2 paperless Digital Validation Tool (DVT) for life sciences: GxP authoring, execution, traceability and e-signatures in one place, with optional human-in-the-loop AI.

Headquarters
Indianapolis, Indiana, United States (born in scotland)
Leadership
Hugh Devine, Chief Executive Officer; Stephen Ferrell, Chief Product Officer and co-founder; Chris Ferrell, Chief Technology Officer
Disciplines
Commissioning and qualification (C&Q / CQV), Computer system validation (CSV), Computer software assurance (CSA), Lab instrument qualification, Tech transfer, MSAT and CDMO collaboration
Products
Valkit, Valkit MSAT, Valkit GREENFIELD
Compliance and security
  • Electronic signatures aligned with 21 CFR Part 11 and EU Annex 11
  • ISO 27001:2022 certified
  • Listed in the Cloud Security Alliance STAR registry
  • ISPE GAMP 5 Infrastructure tool (Category 1), with a Validation Package for each validated release
AI
  • AI is optional: full, partial or no AI augmentation
  • Human-in-the-loop inside governed validation records
  • Customer validation data is not used to train models
  • LLM-agnostic: Valkit-managed models or the customer’s own
Licensing
Licensed per project, with no seat limits.

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