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.

Discover AI Validation

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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

Read the Case Study

Used By Life Sciences Leaders Worldwide

Validation
Lifecycle Suite

AI-Powered Validation.
From Planning to Execution.

Download Product Sheet

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

Unified, End-to-End Validation

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

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

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 ...

Industry Insight

The Future of Cleaning Validation

The Future of Cleaning Validation

Modernize cleaning validation with digital CPV, better documentation, and ...

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 Shift from CSV to CSA

The Shift from CSV to CSA

Explains why life sciences companies should move from CSV to CSA, with FDA ...

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.

Ready to Accelerate Your Validation Lifecycle?

Book a demo today and unify your validation lifecycle in one AI-powered platform. Standardize workflows, ensure continuous compliance, and accelerate time to market.