Regulatory architecture
Designing for inspection-ready clinical operations.
Learn about the platform’s approach to controlled electronic records, role-based access, auditability, and risk-based verification. Customer qualification and procedural controls remain deployment-specific.
Validation evidence should travel with the platform.
TrialScale is architected around FDA Computer Software Assurance and GAMP 5 Category 4 risk-based approaches so QA teams can evaluate controlled records, verification evidence, and system changes without rebuilding the validation story from scratch.
Continuous traceability
Requirements-to-test mapping maintained through automated testing and continuous integration.
Verification protocols
Standardized test scripts and qualification procedures intended to accelerate internal IQ/OQ validation.
Security & privacy controls
Role-based access control, encrypted data at rest and in transit, and HIPAA BAA availability for PHI protection.
21 CFR Part 11 architecture
Cryptographic audit trails, controlled electronic signatures, identity verification, and reason-for-change capture.