Benefits of Digitizing Analytical Method Validation Processes
Complete, compliant system: ValGenesis offers users a lifecycle approach to analytical method validation in compliance with 21 CFR Part 11, EMA Annex 11 and ALCOA data integrity principles.
Holistic validation management: The solution seamlessly integrates with other ValGenesis solutions, including cleaning validation and process validation, for a holistic approach to validation management.
Reduced cycle time: By eliminating non-value-added activities that waste both time and skilled human resources, our VLMS expedites the entire analytical method validation process, resulting in an average 50% reduction in validation costs and overall validation cycle time.
Risk-based approach: Using risk assessment models, our VLMS helps you identify the number of samples to take for analytical method qualification.
Instrument integration: The solution enables you to directly integrate lab instruments (PC-based and non-PC-based) into your validation activities. You can generate sample IDs and labels that can be tracked via instruments with sample results directly captured in the protocol.
Multi-site visibility: Our VLMS offers you a single repository for accessing all your instrument and equipment data, documentation, protocols and batch records. Teams separated by departmental or geographical boundaries can collaborate and communicate more efficiently using a common tool. Better communication improves consistency and increases compliance.
Electronic protocol execution: The solution helps you determine and conduct the design and development of protocols, as well as the execution and approval of protocols, using electronic protocol execution.
Improve Your Method Validation Process with These Unique Features
Many life sciences companies are beginning to realize the cost and time savings of digitizing their validation efforts with ValGenesis’ robust method validation solution. Features include:
- Assessments powered by decision-tree logic
- GxP asset management with real-time validation status
- Parser templates mapped to analytical method protocol specification
- Built-in scientific data management system
- Electronic trend analysis
- Applied critical thinking with procedural risk assessments at a system and function level
- Automatic task notification, schedules, and nudging features with email
- Integrated close-looped method validation lifecycle management
- Paperless test execution with integrated deviations management
- Automated trace matrix generation
- Real-time collaboration with remote and distributed teams
- 21 CFR Part 11-compliant features like time-stamped audit trails, reporting, and electronic signature capabilities
Ready to join the digital validation revolution?
"We reduced cycle time more than 50% and gained data integrity in our validation process."
"Validation-related observations dropped 90% after implementation."
"We can easily manage validation deliverables and change requests across global sites with full data integrity."