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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Types of Validation Processes in the Life Science Industry
Validation is a global regulatory requirement for the life science industry. Validation is defined by the FDA as a process that is required to establish documented evidence which provides a high degree of assurance that a specific, system, equipment, computer system or process will consistently meet the requirements and its intended use. In the life science industry all systems, computers, equipment and processes that have GxP impact require validation.
In the life science industry, the following processes and systems are subject to validation requirements
- Computer Systems
- Laboratory Instruments
- Analytical Methods
- Manufacturing Processes
- Manufacturing Equipment
- Shipping
- Cleaning and Sterilization (CIP/SIP)
- Packaging
- Fill and Finish Manufacturing Processes
- Traditionally validation is managed as a paper-based process.
Paper-based validation is very inefficient and requires a significant amount of resources to print, scan, archive, review and approve validation documents. Paperless validation systems eliminate the inefficiencies that plagued paper-based validation processes.
Summary
Validation is defined by the FDA as a process that is required to establish documented evidence which provides a high degree of assurance that a specific, system, equipment, computer system or process will consistently meet the requirements and its intended use.