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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 e-Logbook

Web-based electronic logbook software built for pharmaceutical, 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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Periodic Review Management

ValGenesis users are able to create periodic review schedules that automatically alert users/groups of any upcoming or delayed periodic review tasks.

Products Periodic Review Management

This reliance on human interaction translates into an increased possibility for errors as well as heightened levels of risk. ValGenesis VLMS users can create periodic review schedules that automatically alert users/groups of any upcoming or delayed periodic review tasks.

Conducting periodic reviews on previously validated GxP systems, assets, and/or processes is a critical regulatory requirement in any validated environment. Systems and/or processes must be reviewed for changes — both physical and procedural — to verify that all is operating as expected, as well as review maintenance and calibration schedules.

In a traditional environment, the management of periodic reviews has been achieved through the use of spreadsheets and other such paper-driven tools. In turn, this often leads to an overreliance upon a single user (or group of users) tasked with ensuring periodic reviews are being performed on time and documented accordingly.

The chances of human errors are entirely removed from the process, and users are always aware (in real-time) of the status of any periodic review. Alert notifications are automatically sent to impacted users/groups via corporate email.
Periodic Review Management

ValGenesis Validation Lifecycle Management System Modules

Periodic Review Management is a fully integrated module for ValGenesis VLMS, the most complete digital validation system.

Validation Plan and FrameworkMaintain a consistent approach across all validation processes and sites
Content Lifecycle ManagementTrack documentation from design to change management and validation
Risk-Based ValidationEvaluate and control risk at functional and/or system levels
Electronic Test Case ExecutionExecute test cases quickly and securely, anywhere at any time
GxP Asset ManagementManage the lifecycle of GxP assets with a documented audit trail
Validation ProjectsManage complex validation projects with required quality gate checks
Periodic Review ManagementIdentify and manage the review schedules of validated GxP systems
Robotic Test Case ExecutionReduce execution time by up to 90% by removing human errors
Change Control and ManagementTrack and efficiently manage any type of change request
Dynamic Trace MatrixIdentify and fix defects related to important requirements
Requirements ManagementManage change requirements as a closed loop validation process
Retirement and Decommissioning ProcessPlan and execute the entire process with required quality gate checks
Equipment Log ManagementRecord, verify, and review logs as per approved SOPs/standards
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Event Presentation

Ensure Data Integrity by Design (DIbD) - The Right Data, Right from the Start

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White Paper

ValGenesis VLMS Compliance Assessment - Annex 11

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