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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Empowering Life Sciences

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.

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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.

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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.

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Mabel Santana

Compliance Manage

ValGenesis provides an exceptionally detailed level of configuration for user roles, which we found to be incredibly powerful and effective.

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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.

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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.

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Raghav Mathur

Senior Validation Engineer

Impact Metrics

100 %

Audit readiness with traceable, secure digital workflows 

90 %

Reduction in validation related observations 

90 %

Reduction in time to complete testing activities 

80 %

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

White Paper

ValGenesis VLMS Compliance Assessment - FDA 21 CFR Part II

ValGenesis VLMS Compliance Assessment - FDA ...

Based on the increased use of computer systems in the pharmaceutical ...

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White Paper

ValGenesis VLMS Compliance Assessment - Annex 11

ValGenesis VLMS Compliance Assessment - ...

This white paper describes how ValGenesis VLMS meets EU Annex 11 ...

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White Paper

ValGenesis VLMS Compliance Assessment - PIC/S Data Integrity Guidance

ValGenesis VLMS Compliance Assessment - ...

This white paper describes how ValGenesis VLMS is designed to comply wirth ...

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White Paper

ValGenesis VLMS Compliance Assessment - USFDA Data Integrity Guidance

ValGenesis VLMS Compliance Assessment - ...

This white paper is a compliance assessment of ValGenesis VLMS with US ...

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E-Book

Top 10 Fastest Benefits of Paperless Validation

Top 10 Fastest Benefits of Paperless ...

Validation processes in many life sciences organizations remains a ...

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Webinar

How to (Really) Calculate the ROI of Digitized Validation

How to (Really) Calculate the ROI of ...

The webinar covers the following: The frightening true cost of paper and ...

Watch

Webinar

Understanding Digital Validation: How Does It Work?

Understanding Digital Validation: How Does ...

The webinar covers the following: Why digitizing validation cuts your ...

Watch

Case Study

Theragent

To drive growth and become a premier CDMO, Theragent needed to get their ...

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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.