Akatalyst Validation Tool

The SaaS platform that moves beyond digital CSV to intelligent validation automation. Built by GxP experts, it digitizes and automates the entire lifecycle — making compliance faster, simpler, and always audit-ready.

A professional analyzing complex data on a computer screen, representing IT system validation and compliance.

Key Capabilities

  • End-to-end digital CSV workflows (URS → FS → DS → IQ/OQ/PQ)
  • Automated, zero-gap traceability matrix generation
  • Tamper-proof electronic records & signatures (21 CFR Part 11 compliant)
  • AI-Powered protocol and test script generation

Value to You

  • Cut validation timelines by 40–60%
  • Eliminate document gaps and reduce human errors
  • Maintain a state of continuous, inspection-ready compliance

The AI & Agentic Validation Layer

For forward-thinking organizations, our optional AI layer integrates with the Validation Tool to assist, accelerate, and automate critical validation tasks—transforming validation from a manual exercise to an intelligent, data-driven process.

AI-Powered Protocol Generation (IQ/OQ/PQ)
Intelligent Test Script & SOP Authoring
AI-Assisted Evidence Review
AI-Assisted Risk & Deviation Analysis

Ready to Enhance Your Compliance Framework?

Let's build a resilient, efficient, and inspection-ready future for your organization. Schedule a complimentary, no-obligation consultation with our experts to discuss your specific challenges and discover how Akatalyst can be your catalyst for success.

Our Product Suite

Our pre-validated, GxP-compliant software simplifies quality management, with an optional AI layer to unlock next-gen efficiency.

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