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The Gen 2 Digital Validation Platform

Transform Your Validation Process with

CQV
CSV
CSA

AI-Augmented Assurance

Trusted by Leading Life Sciences Organizations

Valkit.ai supports digital validation for pharmaceutical, biotech, and medical device innovators worldwide.

80%

Cost Reduction

Smart Automations, Packages Cloning, Master Data Management and optional AI Augmentation combine to reduce life cycle validation costs by up to 80%

85%

Time Reduction

What used to take weeks now takes hours. Valkit.ai's Gen 2 design and smart automation make validation fast and frustration-free.

70%

Resource Efficiency

Empower your team to do more with less. Valkit.ai's simple, AI-enhanced workflows let everyone contribute—no steep learning curve required.

Intuitive by design

If you know how to validate, you know how to Valkit.

Clear structure, predictable flows, less ramp-up—built for how validation teams actually work under GxP.

  • Thoughtful information hierarchy
  • Friction-free authoring and review
S.A.F.E. Framework

SAFE GxP DVT — human-in-the-loop AI for regulated validation

Safe, agnostic, fast, and end-to-end: controlled AI, open LLM architecture, rapid authoring, and one lifecycle from requirements to sign-off.

Explore SAFE GxP DVT
“What's the catch, the team is telling me this is night and day better than the other validation tools they have used”
“I love how nippy it is, it's super fast. We're excited with how easy it is to use and how productive we are already.”
“Love it, we had our trace matrix built for us in realtime. That's a gamechanger for us, we saved weeks of work with just that.”
“It's so intuitive. We were able to start being productive in no time. The team has been all buzzing about how much easier it is than anything else they have used.”
“Your customer support has been amazing so far, really impressed with how on it the entire team has been. We really appreciate it.”
“We were up and running so quickly, I kept thinking we must have missed a step. Turns out, it's just that easy.”
“The onboarding was so smooth. Our team actually enjoyed the process for once!”
“I can't believe how much time we're saving. The automation is next level.”
“We finally have a validation tool that feels modern. The UI is clean and everything just works.”
“The summary report got built automatically for us. It's saving us so much time.”

The Complete Digital Validation Solution

A comprehensive platform that combines AI, automation, and compliance in one powerful solution.

Build Once, Use Many

Org to Org and in-project cloning, Smart Tagging, Data Capture and Image libraries

Documents

Automated version control, e-signatures, and smart templates.

Trace

Instant mapping of requirements, risks, and tests for full traceability.

Projects

Live dashboards, instant status updates, and real-time test tracking.

AI

Context-aware content generation and predictive risk insights.

Security

Uncompromising data protection and regulatory compliance.

Seamless Integrations for Modern Validation

Import your requirements and tickets from Jira and Azure DevOps directly into Valkit.ai for seamless validation and compliance management.

Jira
Connected

Sample backlog (illustrative)

  • Story

    VAL-2841Electronic signatures aligned with 21 CFR Part 11

  • Task

    VAL-2836IQ/OQ scripts: purification skid CIP cycle

  • Bug

    VAL-2822Trace review: URS-011 risk treatment coverage

Azure DevOps
Connected

Sample board (illustrative)

  • User Story

    #4108Map Azure Boards work items to Valkit requirements

  • Feature

    #4102Bioreactor qualification package — trace baseline

  • Bug

    #4091Pipeline evidence attachment on OQ execution steps

API integration
In ValkitSynced
  • 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.