Computer System Validation Software Designed to Minimize Frustration and Maximize Efficiency
Test, validate and document according to current compliance best practices.
Your Practical Checklist for Transitioning to Computer Software Assurance (CSA)
ReadUnderstanding Digital Validation: How does it work?
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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 or CSA 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. Applied critical thinking functionality allows you to perform more accurate risk assessments using decision tree logic and other empowering features, ensuring you execute the appropriate level of validation for each system.