Services

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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Risk-Based Validation

Validation risk assessment is a structured and documented approach for assessing risks in a computerized system, as well as for equipment, instruments, and processes.

Applying risk assessment procedures to validation is a highly effective means of ensuring that all critical requirements are tested – with the appropriate level of documentation – to validate/verify a system or process.

Validation risk assessment is a structured and documented approach for assessing risks in a computerized system, as well as for equipment, instruments, and processes.

Our VLMS comes equipped with convenient Risk Assessment tools that provide clients with several significant benefits:

Supports most commonly adopted risk management processes including FMEA

Supports decision tree driven risk assessment

Users can mirror current risk assessment procedures without customization of the system

Users can conduct risk assessment for the computer systems, equipment, instruments and processes

Supports with built-in best practices for risk management, clients can leverage these prebuilt risk models, templates and decision trees who want to improve the current risk management process

Based on the risk profile, the required level of validation or verification effort needed for the system to be considered validated or verified can be determined

Users can conduct risk assessment at the functional or system level

Functional risk assessment allows users to determine the amount of testing required (based on risk level)

ValGenesis Validation Lifecycle Management System Modules

Risk-Based Validation 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

White Paper

ValGenesis VLMS Compliance Assessment - Annex 11

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E-Book

Top 10 Fastest Benefits of Paperless Validation

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Schedule a demo

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.