What Makes Paper-based Computer System Validation So Challenging?
The Benefits of Automating Your CSV Processes
Improved regulatory compliance: The system is fully compliant with FDA 21 CFR part 11 and EU Annex 11.
Increased audit readiness: Manual CSV processes require an excessive amount of time for searching, retrieving, routing, and approving documents. During an audit, it's critical to have immediate access to standard operating procedures (SOPs) and other vital records. Our powerful search tools ensure you're always audit-ready and reduce audit duration time—from days to hours.
Reduced cycle time: By eliminating non-value-added activities that waste both time and skilled human resources, our VLMS expedites the entire CSV process, resulting in an average 50% reduction in validation costs and overall validation cycle time.
Streamlined cross-functional collaboration: Our comprehensive, fully automated solution offers you a single repository for accessing all your CSV data and documentation. Validation and quality teams separated by departmental or geographical boundaries can collaborate and communicate more efficiently using a common tool.
Enhanced traceability: Large enterprise computer systems often have a significant number of requirements. Tracing these requirements manually to avoid errors involves considerable time and effort. Our solution promotes automatic traceability between user requirements and test scripts, eliminating the need for manual traceability. This feature dramatically reduces the time needed to complete trace matrix generation—from weeks to minutes.
Reduced over-testing: "How much testing is required?" is one of the most frequently asked validation questions. Our automated validation planning tools ensure you focus your testing efforts on critical areas that may impact the product's quality, safety or efficacy. As a result, you execute the appropriate level of validation for each computer system.
Improve Your Computer System Validation Process with These Unique Features
Powering a productive team means using a powerful validation tool. With ValGenesis VLMS maintaining your organization's CSV process, you'll enjoy a host of robust features, including:
- Assessments powered by decision-tree logic
- Applied critical thinking with procedural risk assessments at a system and function level
- Change management summary with immediate change impact notification
- Automatic task notification, schedules, and nudging features with email
- Automatic validation inventory with validation statuses
- Integrated close-looped CSV lifecycle management with change control
- Dynamic electronic traceability matrix generation with forward and backward capabilities
- Electronic protocol execution
- Tightly coupled automated testing and robotic process automation integration
- 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."