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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GxP Asset Management

ValGenesis provides regulated companies with management of the entire lifecycle for all GxP assets – such as facility, instruments, equipment, computer systems, and analytical instruments – while maintaining a solid documented audit trail and real-time validation status for every asset.

The GxP asset management capabilities are tightly integrated with functions within the system, thereby improving compliance and traceability, ensuring consistency in corporate validation and quality processes.

Our asset management functionality provides regulated organizations with the security and accountability needed to track, manage, and monitor GxP assets throughout their life cycles while also meeting complex regulatory requirements.

ValGenesis offers a robust electronic system that seamlessly manages GxP assets while eliminating common issues associated with the process:

Maintains a centralized and up-to-date asset inventory of all equipment, instruments, systems, and processes that can be accessed via web browser from any location

An integrated approach ensures that asset inventory is maintained and kept current with real-time validation status information

Provides the ability to conduct a risk assessment for any asset or process, allowing users to determine the level of validation or verification effort required for the system to be considered validated or verified as per the approved Master validation plan and validation procedures

Our GxP system’s electronic logbook allows users to record cleaning, preparation, and usage logs for GxP assets

Real-time cleaning, preparation, and usage logs are readily available, giving users access to integrated asset validation status along with cleaning and usage logs

A built-in change control management function ensures compliance status is maintained

Users can pull calibration data from other systems through web services

Calibration data can be viewed for any GxP asset, along with validation data and cleaning/usage logs

Review and revalidation schedule management functions allow users to define a planned, structured approach to ensure GxP systems and processes are periodically reviewed/revalidated on schedule

Controlled decommissioning/retirement process allows users to enforce the approved retirement process with documented evidence

ValGenesis Validation Lifecycle Management System Modules

GxP Asset 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

White Paper

ValGenesis VLMS Compliance Assessment - PIC/S Data Integrity Guidance

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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.