AI-Powered Validation for Faster Launches and Improved Compliance
First-in-Class, 70% Faster—Purpose-Built for Global Life Sciences
Where Classic Validation Fails
Duplicated Effort. Teams rebuild protocols site-by-site because they can’t see what already exists.
Manual Processes. Drafting protocols, copying screenshots, and collecting files still happen by hand, burning 10–15 minutes per test step.
Inconsistent Documentation. Grammar slips, missing structure, and presentation gaps invite regulatory findings.
Slow Execution and Review Cycles. Data entry errors and line-by-line approvals stall releases and inflate costs.
Beyond Spreadsheets: Reinventing Validation With AI
Manual validation was built for a paper world, then crudely ported to spreadsheets and shared drives. Even digital tools still rely on humans to think, copy-paste, and chase approvals.
AI, on the other hand, opens many possibilities:
- Auto-capture and auto-link. Grabbing files the moment a step is completed, hashing them for integrity, and attaching them to the exact step—no hunting, no doubt.
- Protocol reuse by design. AI can surface match previously approved protocols and adapt them in seconds, eliminating duplication and standardizing formats enterprise-wide.
- Real-time anomaly detection. An LLM can cross-check data against expected values and flag inconsistencies the instant they appear—before a reviewer ever sees them.
- Embedded regulatory brain. AI can compare every protocol line-by-line with current FDA, EMA, and company SOP requirements, alerting you to any gap instantly.
With AI doing the fieldwork, teams can stay focused on what really accelerates time to market.
VAL™ The AI Validation Assistant: Cut Costs, Speed Validation, Reduce Errors
| VALTM agent | What it does | Benefits |
| Smart Validation Document Generator |
Automates the creation of compliant validation protocols in as little as 90 seconds |
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| Smart Gap Assessor | Analyzes validation documentation to identify gaps to meet regulatory requirements and standards |
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| Smart Validation Executor | Automates the execution of validation protocols, evidence collection, and pass/fail tagging |
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| Smart Anomaly Detector | Instantly cross-checks executed results, verifies evidence, and flags inconsistencies or errors |
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Using our Application
We chose ValGenesis because they were a known and trusted vendor. We had limited time and resources, and we knew the quicker we could implement the solution, the sooner we’d start realizing value from it.
Joshua Pelina
Validation Engineer
Working with ValGenesis was great. They helped us align the system with our new CSV program and uncover opportunities for process improvements and efficiency gains to maximize value.
Jeff Onis
Global IT Data Integrity Manager
Our ERP upgrade would touch every department in the company. This was the ideal opportunity to transition from paper-based to digital validation, and now we’re reaping the benefits: signoff documents organized in one place, simplified review and approval, no more issues deciphering handwriting, one-click access to deviation reports, reduced printing costs—all totaling up to a successful outcome.
Mabel Santana
Compliance Manage
ValGenesis provides an exceptionally detailed level of configuration for user roles, which we found to be incredibly powerful and effective.
Laurie Lipper
IT Computer System Validation Manager
Legibility concerns were a common problem when delivering hard-copy qualifications that were documented using pen and paper. And simple, common mistakes like accidentally writing 2024 instead of 2025 after the year change are a big deal in a regulated industry. With ValGenesis, date attributions will always be correct, and legibility problems are solved.
Jonathan Revere
Director of Validation
We used ValGenesis’ vendor testing documentation because it was thorough, and it saved us a lot of time. We estimate saving 100 hours of work, which we reallocated to other parts of the project like training.