Validate with Precision. Comply with Confidence.
Build trust in your safety systems with proven validation strategies that ensure compliance, data integrity, and audit readiness.
Start with a Smart Plan for Validation Success
We create detailed Validation Master Plans (VMPs) tailored to your safety system, regulatory environment, and business goals—ensuring structured, compliant validation from day one.
Fully Validate Your PV Platform
We validate systems like Argus, ARISg, and Veeva through a full CSV lifecycle—including URS, FS, Risk Assessments, and IQ/OQ/PQ protocols—to meet global standards.
Move Data Securely. Prove Its Integrity.
We validate data migration processes through field-level checks, audit trail verification, and ALCOA+ principles—ensuring your safety data is accurate, consistent, and complete.
E2B Validation & Test Submissions
We test your ICSR transmission setup with EMA, FDA, and other authorities—verifying schema conformity, acknowledgment handling, and edge-case scenarios.
Part 11 & Annex 11 Compliance
Ensure your safety platform meets FDA 21 CFR Part 11 and EU Annex 11 standards—including audit trails, electronic signatures, access controls, and data retention policies.
Vendor Audit & Validation Review
We assess third-party systems and cloud providers for validation readiness and GxP compliance—protecting your data across the full ecosystem.
Supported Safety Systems
We validate popular PV platforms like Oracle Argus, ARISg, and Veeva Vault—whether deployed on-premises or in the cloud.