AI-Powered Validation.
From Planning to Execution.

ValGenesis Validation Lifecycle Suite connects iVal, iClean, and iOps in a single digital platform—standardizing validation, accelerating time to market, and ensuring audit readiness across the enterprise.

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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

Applications

iVal

Supercharge validation with ValGenesis iVal™. AI-powered authoring, automated execution, live anomaly flags, and bulletproof traceability slash cycles by up to 80% and cut observations by 90%. From CQV to CSA, you’ll be audit-ready and market-ready faster than ever. iVal takes digital validation to the next level.

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iClean

Halve cleaning validation timelines and wipe out manual math with ValGenesis iClean™. Automated MACO calculations, ADE-aligned limits, 2D/3D equipment maps, and rule-driven workflows deliver digital, inspection-ready files across all sites. Standardize globally, flex locally, and gain real-time oversight - discover iClean today.

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iOps

Leave paper logbooks behind with ValGenesis iOps™. Mobile, QR-enabled forms capture every use, cleaning, and calibration event in real time; automated reviews, deviations, and alerts seal compliance gaps. Achieve 100% traceability, trim documentation labor by 70%, and connect ops to quality with iOps today.

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Overview

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Unified, End-to-End Validation

Manage the entire CQV, CSV, and CSA lifecycle in one centralized, standardized platform.

Continuous Compliance and Traceability

Ensure audit readiness with secure, real-time validation records, impact assessments, and change management oversight.

Smarter, Paperless Workflows

Replace manual tasks and siloed tools with intelligent, automated processes that ensure teams are always ready to execute.

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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 ...

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Webinar

Understanding Digital Validation: How Does It Work?

Understanding Digital Validation: How Does ...

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

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Case Study

Theragent

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

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Frequently Asked Questions

The platform is CSA ready and supports risk-based assessment to automatically identify and enforce appropriate testing types, including scripted and unscripted testing. This unique feature provides technical controls to support a CSA approach, simplifying validation processes and improving resource use and product quality.

The solution is highly configurable. Workflows, fields, and rules can be tailored to specific business needs, with customers empowered to configure templates, forms, workflows, and entities themselves. The system supports the creation and modification of workflows based on SOPs, roles, phases, and steps without customization, and allows for enforceable business rules. Access levels and system settings can be independently configured for each client, and workflows can be copied, reused, and adapted as needed. Standardized templates and customizable reports further enhance flexibility and alignment with regulatory requirements.

ValGenesis offers a comprehensive training program where users involved in the implementation delve deep into the system and receive administrator/super user training covering full system functionality. Technical and business user training is provided with ValGenesis training material and through the ValGenesis University. The ValGenesis University eLearning program delivers interactive, role-based courses with hands-on, simulation-driven lessons, practical assessments, and certification. The blended approach allows for self-paced, live, or virtual sessions, supporting all phases from implementation to go-live, and is designed to maximize engagement and knowledge retention.

The solution effectively manages all types of validation activities, including equipment, instruments, computer systems, cleaning, and method validation. The system is modular and can be implemented in phases.

ValGenesis VLS features advanced impact assessment functionality, specifically designed to streamline change management throughout the lifecycle of a system, equipment, or process. When a change is required, users initiate the impact assessment process by selecting the necessary updates, after which the system automatically identifies the directly and indirectly impacted specifications and tests using the dynamic requirements trace matrix.

Beyond impact determination, VLS enables modifications exclusively to affected requirements, specifications, and tests, eliminating the need for individual document revisions. Additionally, the system possesses a unique capability to generate a consolidated document from impacted components, significantly reducing the time required to manage changes of any scale.