ValGenesis VLMS
The complete Validated Lifecycle Management System from ValGenesis is the industry-leading solution for digitizing the entire validation lifecycle.
ValGenesis VLMS Express
Simplified, cloud-based digital validation. Designed for small and mid-sized life sciences companies.
ValGenesis e-Logbook
Web-based electronic logbook software built for pharma, 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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ValGenesis BlogExplore key industry insights in validation, life sciences and more.
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Paperless Validation for GxP Laboratories
With ValGenesis VLMS’ data tracking and automated audit trails, your data is secure, organized, and readily available.
ValGenesis completely replaces inefficient paper-based validation processes with an electronic system that helps to implement and enforce validation standards and procedures that are typically buried in validation master plans, SOPs, and policy documents.
GxP Laboratories play a crucial role in the development and testing of new and existing drug substances and drugs, ensuring accuracy of results while meeting regulatory requirements adhering to Good Laboratory Practice (GLP). Laboratories must implement and maintain robust and validated quality management systems (QMS).
GLP section 58.63, requires laboratories to conduct periodic review and calibration of equipment used for GLP studies; maintenance and calibration of equipment must be conducted according to a set schedule. Section 58.63(a) states, “Equipment shall be adequately validated, cleaned, and maintained.” Equipment used for the generation, measurement, or assessment of data must be adequately validated, calibrated and/or standardized.” As a result, an increasing number of clinical, quality control, and medical laboratory organizations seek solutions that can both sustain compliance and standardize the quality process. All instruments/equipment must be validated and periodically reviewed to meet these requirements.
Manual or paper-based systems require extensive effort to validate and maintain throughout the lifecycle of the systems. ValGenesis completely replaces inefficient paper-based validation processes with an electronic system to provide a robust regulatorily compliant solution. Our unique technology helps to implement and enforce validation standards and procedures that are typically buried in validation master plans, SOPs, and policy documents.
ValGenesis is the de facto standard adopted by life science companies worldwide for 100% electronic management of validation execution and approval. Any organization developing blood and tissue products can benefit from our solutions.
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Ensure Data Integrity by Design (DIbD) - The Right Data, Right from the Start
WatchHow to (Really) Calculate the ROI of Digitized Validation
WatchWant to learn more about paperless validation?
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.
