Faster Validation.
Smarter Execution.
Always Audit-Ready.

ValGenesis iVal™ accelerates end-to-end validation by automating authoring, execution, and traceability for faster cycles, reduced effort, and greater confidence in every deliverable.

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Global Adoption. Powerful Results.

Join the industry leaders who are replacing disconnected documents and silos with a unified validation lifecycle approach.

bayer

milipore sigma

roche

alexion

strides

philips

stryker

biocon

transcat

dr reddys

ilumina

alkermes

noven

catalent

Customer Testimonials

milipore sigma

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

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catalent

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

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Impact Metrics

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Audit readiness with traceable, secure digital workflows 

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Reduction in validation related observations 

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Reduction in time to complete testing activities 

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Reduction in validation cycle time through AI-powered content creation and execution 

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Discover How iVal Works as Part of Our Validation Lifecycle Suite

iVal is the AI-enabled backbone of your digital, automated validation tool—centralizing planning, test authoring, execution, and oversight in one intelligent system. AI-powered tools generate validation content, automate test execution, flag anomalies in real time, and analyze content to detect gaps or GDP issues based on approved SOPs. Integrated risk assessments, automated traceability matrices, and change impact tracking ensure every decision is data-driven and audit-ready.

iVal supports CSA, CQV, and CSV with offline execution, automated deviation handling, and full lifecycle traceability—accelerating time to market and reducing time to production volume, all while maintaining confident, audit-ready compliance. 

Overview

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Accelerate validation with less effort

Shorten cycles by up to 80% through paperless validation and AI-powered execution.

Stay compliant, anywhere 

Offline execution with full traceability ensures continuous readiness.

Scale globally with control

Standardize across sites with seamless integration and flexible workflows.

Resources

Industry Insight

Best Practices in Commissioning and Qualification

Best Practices in Commissioning and Qualification

Use this C&Q best-practices guide to reduce rework and speed release ...

Industry Insight

The Impact of Artificial Intelligence on CQV

The Impact of Artificial Intelligence on CQV

Speed CQV documentation, execution, and quality decisions with AI while ...

Frequently Asked Questions

Yes, multiple users can collaboratively author and review documents. ValGenesis iVal supports real-time collaboration, allowing more than one user to make changes and add comments during the authoring and review process. Reviewers can see each other's changes in real time, and the system supports parallel workflows for concurrent review and approval. Authors can accept or reject changes and respond to comments, ensuring an effective and efficient collaborative process.

Yes, the system can auto-generate validation documents using existing data. ValGenesis iVal leverages AI and decision tree logic to automatically generate documents, including test scripts and validation reports, by evaluating user responses and utilizing existing templates and data. The AI Assistant (VAL) can also auto-generate documents from existing ones in the customer's database, significantly accelerating document generation and improving efficiency.

Yes, the system can perform detailed change-impact assessments. When a change is made to a requirement, specification, or test script included in a traceability matrix, the system automatically identifies and highlights the impacts to related deliverables, including specific requirements, specifications, and tests. It also supports upstream and downstream impact analysis and enables bundling of all deliverables related to the same change for efficient management.

Yes, ValGenesis enables automatic capture of raw data and metadata from analytical instruments and manufacturing equipment, directly integrating this data into validation protocols, batch records, and equipment logs. It supports RS232, TCP/IP, and PC-based instruments, ensuring secure archival with version control and compliance with 21 CFR Part 11 and Annex 11 requirements.

Go Paperless. Go Faster.

Book a demo and watch iVal put digital validation on fast‑forward.