Safe, agnostic, fast, and end-to-end β Valkit is built for regulated digital validation: human-controlled AI, open architecture, rapid drafting, and one continuous lifecycle from requirements to sign-off.
Every AI output requires mandatory human review and e-signature before it enters the record.
AI drafts. Qualified people decide. Compliant by design.
Open LLM architecture β not locked to any single AI provider. As the AI landscape evolves, Valkit evolves with it.
No vendor dependency. No forced migrations.
AI creates requirements, risk assessments, and test steps from system descriptions, uploaded docs, or unstructured legacy sources.
Months of drafting become hours.
One platform from requirements through risk assessment, test execution, and sign-off.
Automated traceability maintained continuously β inspection-ready by design, not by effort.
Mandatory review and e-signature before AI-assisted content becomes part of the record
Swap and evolve models as the landscape changes without rewriting your validation program
Requirements, risks, and test steps from narratives, files, and legacy unstructured inputs
Requirements, risk, execution, and approval in one system with continuous traceability
Evidence and lineage structured for audits and inspections from the ground up
Complete critical workflows without AI where policy or preference requires it
Valkit positions itself as the SAFE GxP DVT: compliance is not bolted on after the fact β safety, openness, speed, and lifecycle completeness are how the product is designed.