Medical device CSV/CSA that is faster, risk-based, and audit-ready

What's in it

This datasheet explains how Valgenesis iVal™ supports end-to-end, paperless device CSV/CSA by centralizing plans, risk assessments, protocols, execution results, deviations, and reports with secure e-signatures and immutable audit trails. It covers risk-based CSV/CSA aligned with ISO 14971 and FDA CSA principles, traceability to design controls and DHF/DMR/DHR artifacts, and AI-assisted capabilities for test generation, execution capture, and automated result verification, including claims of cutting cycle times by up to 80% and reducing manual steps by up to 40%.

You will also find integration and scalability details (connectors and APIs for systems like eQMS, PLM, MES, LIMS, ERP, and ALM/test tools), offline execution with sync, dashboard reporting KPIs, change-control links with re-validation recommendations, standards coverage (FDA 21 CFR Part 11/820, ISO 13485/14971, IEC 62304/62366, EU MDR/IVDR expectations, GAMP 5), and security controls such as ISO 27001 certification, RBAC, and encryption.

Who this is for

• CSV/CSA leaders and validation managers responsible for computerized system assurance in MedTech
• Quality assurance and quality systems leaders managing inspection readiness and data integrity controls
• Regulatory affairs and compliance teams preparing DHF/Technical File evidence and audit responses
• IT application owners and digital quality/IT compliance teams supporting validated QMS and production systems
• R&D and software engineering teams building and maintaining SaMD and SiMD solutions with design control traceability needs
• Manufacturing, operations, and engineering teams validating MES/LIMS/labeling/equipment software and coordinating changes
• Supplier quality and CMO/partner teams who need standardized validation packages and periodic reviews across sites

What it helps with

• Standardizing CSV/CSA templates and workflows across sites, suppliers, and CMOs
• Right-sizing testing using ISO 14971-aligned risk assessments and FDA CSA principles
• Keeping audit evidence inspection-ready with immutable audit trails, e-signatures, and exportable traceability
• Linking validation activities to design controls and DHF/DMR/DHR elements for end-to-end traceability
• Reducing manual work with AI-assisted authoring, execution capture, and automated result checks (including anomaly detection)
• Managing change impact with automatic links to affected requirements, tests, and documents plus risk-based re-validation guidance
• Supporting validation in restricted environments through offline execution with automatic synchronization
• Integrating validation records with enterprise systems via prebuilt connectors, REST APIs, webhooks, and import/export