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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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Dynamic Trace Matrix

ValGenesis traceability matrices enable you to quickly check requirement coverage, zero in on defects related to requirements, then fix them to maintain project control. A traceability matrix can be dynamically created and updated in real time to reflect changes made to requirements and test functions.

Products Dynamic Trace Matrix
Dynamic Trace Matrix

Building traceability matrices is an essential part of the validation process, providing documented evidence to prove that the intended use of the system has been tested at the requirement or functional level. With ValGenesis, traceability matrices can be dynamically created and updated in real-time to reflect changes made to specifications and test functions. Our VLMS allows users to map multiple documents against each other, automatically linking individual specifications to test step levels. Building traceability matrices has never been more accessible. With just a few clicks of a mouse, our system automatically builds comprehensive trace matrices that provide both forward and backward traceability. Users can also view the traceability between documents for completeness before routing them for review/approval, significantly reducing the overall time needed for authoring.

The trace matrix module in ValGenesis VLMS offers our clients several useful functions and features.

A dynamic traceability matrix generation function helps to expedite the trace matrix generation process and efficiently performs coverage analysis by viewing the relationship between related items

Requirements are linked at the test step level for efficient traceability

Our system supports one to many, many to one, many to many and V model relationships at the requirement level

ValGenesis supports forward, backward and end to end traces

Trace matrices can be approved through a controlled workflow

Any number of items can be included in a single trace matrix. For example, a single trace matrix can have URS, FRS, DS, OQ etc

ValGenesis Validation Lifecycle Management System Modules

Dynamic Trace Matrix 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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White Paper

ValGenesis VLMS Compliance Assessment - USFDA Data Integrity Guidance

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E-Book

Top 10 Fastest Benefits of Paperless Validation

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Reach out to schedule a free, personal demo of the ValGenesis VLMS. We’ll show you our product in-depth and share our experience to identify the perfect solution for your organization.

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