Gen 2 digital validation for life sciences
Author, execute and sign CQV, CSV and CSA work in one place, built for GxP teams.
Clear structure, predictable flows, less ramp-up—built for how validation teams actually work under GxP.
A comprehensive platform that combines AI, automation, and compliance in one powerful solution.
Human-in-the-loop AI, provider-agnostic models, and an end-to-end validation lifecycle.
Paste a change, review AI proposals, and let SMEs accept or dismiss — never auto-apply.
Author, version, and e-approve validation documents in one Contents surface.
Live requirements-to-test matrices plus reusable libraries, bundles, and linked sources.
IQ/OQ/PQ execution, evidence capture, data capture tables, and environmental imports.
Scoped drafts for requirements, risks, and tests — human review required, AI optional.
Import your requirements and tickets from Jira and Azure DevOps directly into Valkit.ai for seamless validation and compliance management.
Sample backlog (illustrative)
VAL-2841Electronic signatures aligned with 21 CFR Part 11
VAL-2836IQ/OQ scripts: purification skid CIP cycle
VAL-2822Trace review: URS-011 risk treatment coverage
Sample board (illustrative)
#4108Map Azure Boards work items to Valkit requirements
#4102Bioreactor qualification package — trace baseline
#4091Pipeline evidence attachment on OQ execution steps
URS-014 · Electronic record integrity
Requirements ↔ tests · 12 linked artifacts
RSK-031 · Data integrity controls
Risk assessment · reviewed · in baseline
Import from Jira or Azure DevOps and link requirements, tests, risks, and documents in Valkit.
Valkit.ai makes it easy to import and synchronize your validation data from Jira and Azure DevOps, so you can automate traceability, accelerate compliance, and leverage the power of AI—all in one platform.
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