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ValGenesis VLMS

The complete Validated Lifecycle Management System from ValGenesis is the industry-leading solution for digitizing the entire validation lifecycle.

ValGenesis VLMS Express

Simplified, cloud-based digital validation. Designed for small and mid-sized life sciences companies.

ValGenesis e-Logbook

Web-based electronic logbook software built for pharma, biotech and other life sciences for 100% paperless logbook management.
Paperless Validation SoftwareAn overview of ValGenesis Paperless Validation Software Solutions Cleaning ValidationIntegrated, seamless lifecycle process across multiple groups and sites Commissioning Qualification ValidationRisk-based commissioning and qualification process Computer System ValidationError-free, paperless, fully automated lifecycle management process Analytical Method ValidationError-free, paperless, integrated analytical method lifecycle validation Cold Chain ValidationIoT capable validation for temperature controlled supply chains Equipment and Instruments ValidationQuick access to data and validated state of equipment Electronic Logbook ManagementVerification and review (with e-signature) of equipment logs at point-of-need Process ValidationSeamless connectivity across process, data, and knowledge management VConnectData captured from equipment is plugged into all documentation and evidence Hands-Free ValidationAugmented reality validation software for remote, hands-free validation Mobile App for ValidationOnline and offline validation process completion
Pharmaceutical and BiotechnologyAchieve standardization and data integrity via seamless processes Medical Devices and DiagnosticsSeamlessly manage DHFs across all units and sites GxP LaboratoriesEnsure data integrity and get organized with automated audit trails Blood and TissueConsistently meet Blood Establishment Computer Software (BECS) Requirements Regulated Software CompaniesQuickly release new versions/ service packs with our test automation engines Contract Research OrganizationsEnforce approved validation plans to be audit-ready without preparation NutraceuticalsSingle environment requirements management, simplifying proof of compliance
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Product Tour Features Who Uses VLMS Express? Calculate Your Efficiency Gains See a Demo

VLMS Express: The Leanest, Smartest Path to Digitizing CSV

In this webinar, see how to digitize and automate your computer systems validation (CSV) efforts quickly, without the overhead and complexity of an “enterprise” platform. Get a demo of VLMS Express, THE leanest application on the market for converting manual, paper-based processes into fully digital ones – in weeks, not months.

Presented by:

Emmanuel Cansino

Senior Director Industry Solutions

Watch Now

Product Tour

Watch a Product Tour of VLMS Express

Watch an in-depth product demonstration that walks through authoring, traceability matrices, execution, and much more.

Get a Full Demo of VLMS Express
VLMS-Express---Screenshot-Evidence---High-Rez
Capture objective evidence like screenshots with an integrated tool that automatically applies immutable timestamps.

Perfected Execution

Capture evidence with a single click, then easily assemble all data and route for approval with electronic signatures. With timestamps applied at every step, follow ALCOA+ principles while generating a detailed time-motion study to show bottlenecks.

Stress-Free Authoring

Remove validation anxiety by establishing appropriate risk-based rigor and quality, not quantity.

Structured standardization accelerates authoring, and most importantly, establishes critical thinking upfront to ensure the correct amount of validation.
VLMS-Express---Document-Authoring---High-Rez
Rapidly author protocols based on entity.
VLMS-Express---Trace-Matrix---Trace-View---Low-Rez
Dynamic traceability matrices are living documents that show relationships in trace and spread views.

Dynamic Trace Matrices

Traceability matrices in VLMS Express are not static artifacts. They are living documents that link what you say and what you did to demonstrate correct testing, all in real time. No more frustrating Excel marathons at the end of the project.
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Features

Features that matter for validation excellence

  • Integrated screen capture of windows or entire screens (with automatic timestamps) avoids tiresome switching between applications
  • Template and document binding to entities promote consistency
  • Automatic, dynamic traceability matrices create a living document that eliminates the need for Excel and manual tracing
  • Merged cell execution avoids major rework when importing your existing templates and provides unparalleled flexibility in new template creation
  • Ad hoc reporting lets you easily select which fields you want to see in a report
  • Single repository for all documents, both completed and pending approval, for virtual and asynchronous collaboration
  • Integrated electronic signature satisfies 21 CFR Part 11 and Annex 11 requirements (without repeated sign-in)

Go live in fewer than four weeks

VLMS Express Deployment

How fast can you get up and running? Faster than you think. VLMS Express has a deployment timeline of less than one month, and that includes training and onboarding.

Your Data, Your Location

VLMS Express is a cloud application. Instances can be established in US, EU, or India locations to comply with your data sovereignty protocols.

Fully Validated, Of Course

All implementations come with one development environment and one production environment with a certificate of validation. All updates are similarly validated with appropriate certification.
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Who uses VLMS Express?

VLMS Express is designed for small and mid-sized organizations that need fast, simple, and fully digital validation tools with light deployment.

Premarket Biotech

Day-one compliance equals day-one advantage. Ensure your equipment, instruments, facilities, and computer software are validated and compliant while following ALCOA+ data integrity principles.

Mid-Size Medical Device

Eliminate the manufacturing frustrations that impact time-to-patient. Class I, II, and III products require secure, durable validation technology that strengthens compliance, control, and profitability.

Medical Software Startup

Validate software with a modern approach that simplifies inspections, audits, and due diligence. Even better: provide customers with elegant, digital validation packages of your own products.

Capital Project Team

Maximize your commissioning and qualification budget. Activate VLMS Express for your project, then close it upon completion, controlling your expenses and retaining all project data.

Consultants

Validation and engineering consultants: combine your process expertise with market-leading VLMS technology for maximized client value and extended revenue opportunities.

Cannabis Manufacturer

Avoid discarded batches and ensure consistently high product quality and safety with pharmaceutical-grade validation software that modernizes your operations.
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Calculate Your Efficiency Gains

ValGenesis VLMS customers experience significant efficiency gains when transforming away from paper, Excel, and legacy systems into a purpose-built solution. This calculator is based on real-world ROI studies we've conducted with our customers. The ROI of digitizing and transforming validation is experienced as both time and cost savings.

Select the approximate value of your project below.

Validation Budget

Validation costs typically occupy 20% of your total budget.

Validation Cost Savings

Selected Project Budget:

 
Validation task and its portion of validation lifecycle Savings
5% Creating, reviewing and approving validation plans and projects 20% 40% 60%
25% Authoring, reviewing and approving validation protocols 20% 40% 60%
10% Creating and maintaining traceability matrices and requirements 40% 60% 90%
25% Executing, reviewing and approving validation protocols 40% 50% 60%
10% Performing risk assessments, review approval and maintaining the validation status 40% 45% 50%
5% Creating and maintaining periodic review (including risk management) and revalidation schedules 40% 60% 80%
5% Creating, reviewing and approving validation plans and projects 20% 40% 60%
   

The “cost, time, and efficiency saving” calculations provided herein are for demonstration purposes only and do not represent actual or anticipated results of any entity. These calculations represent current estimates based on a limited and controlled data set and average savings multiples. They do not represent guaranteed cost savings and do not bind ValGenesis to any results. To assess potential savings specific to your company, schedule a free ROI assessment with one of our validation experts. They will require further data from you such as the number of employees who may use the system and the validation activities that are most time-consuming for your organization.

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Get started

ValGenesis is the industry-standard provider of digital validation software for life sciences. And ValGenesis VLMS Professional is the fastest and most reliable way to digitize your validation lifecycle.

Fill out the form to get a personal walk-through of the product and get all your questions answered.

Request a demo of ValGenesis VLMS Express