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

ComplianceSolutions designed to facilitate compliance with all industry standards and regulations

VConnectData captured from equipment is plugged into all documentation and evidence

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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Retirement and Decommissioning Process

ValGenesis helps organizations plan and execute retirement and decommissions through the required approval process. A retirement schedule will be created and approved in ValGenesis and can be created with both record retention periods as well as scheduled alerts to associated user groups for any planned and/or required retirement schedule activities.

The retirement and decommissioning process is the final stage in the lifecycle management of any application or product. Many different factors can trigger this event—technological advancement, business needs, and acquisitions/mergers—while the underlying business process can become obsolete, unnecessary, etc.

In regulated life science organizations, the retirement and decommissioning process must be planned and documented. Associated records will have to be retained as per the approved validation plan and relevant procedures. Retirement of GxP assets and computer systems need to be planned and documented so that they are smoothly migrated to a new system in such a way that there is no data integrity concern or deviation from the approved plan and procedure.

Benefits of implementing ValGenesis:

Users can create retirement schedules for GxP assets, templates, validation documents, and associated records

Different schedules can be created based on the type of asset and related records

Records can have separate retention periods

Retirement schedule can be reviewed and approved

Once GxP assets or documents are retired, associated records are retained in the system until the scheduled retention period expires

Data and documents related to retirement and decommissioning activities are always available for audits in real-time

ValGenesis Validation Lifecycle Management System Modules

Retirement and Decommissioning Process 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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Webinar

How to Manage Logbooks Electronically

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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.