Compliance at Replior
Built for Regulatory Standards, Designed for Trust
Compliance isn’t just a requirement in clinical trials—it’s the foundation of reliable, high-quality data. That’s why Replior builds compliance into every part of our platform.
Our Trial Online™ solutions are designed, developed, and tested according to the highest industry standards, including guidelines from the FDA, EMA, and ICH. This allows our system to meet Good Clinical Practice (GCP) requirements and support your regulatory needs.
Regulatory & Industry Standards
Replior adheres to key global regulations and guidelines, including:
FDA 21 CFR Part 11
Electronic records and electronic signatures
ICH E6 (R2) Good Clinical Practice (GCP)
EMA EudraLex Volume 4 Annex 11
Computerized systems in regulated environments
EMA Guidance on Computerized Systems and Electronic Data in Clinical Trials
GDPR & HIPAA
Data protection and patient privacy compliance
Each Trial Online release is fully qualified and documented, reducing your validation burden so you can focus on trial execution. Our platform is designed to scale with your study needs while maintaining strict compliance.
Quality at Every Stage
At Replior, quality is systematic and continuous. Every release undergoes a structured development, testing, and release process to maintain compliance and reliability.
Our Qualification Process
Development & Testing
• System Requirements: Defines product features and regulatory requirements
• Project Plan: Outlines activities and documentation for each release
Release & Project Management
• Test Plan: Establishes testing scope and objectives
• Test Cases: Validates functionality and compliance
• Test Results: Documents outcomes of all test scenarios
• Traceability Matrix: Maps requirements to test cases to confirm full coverage
• Test Report: Summarizes findings and compliance status
• Project Report: Documents activities and documentation for each release
Post-Release Documentation
• FDA 21 CFR Part 11 Fulfillment Report
• GDPR & HIPAA Compliance Report
• System User Manuals
• Installation Qualification Reports
• Release Notes
• Release Statement
Audit-Ready & Customer-Validated
Replior is regularly audited by sponsors, CROs, and regulatory bodies. We provide full documentation to support your compliance process and welcome on-site, remote, or postal audits.
