Yes, Castor CDMS is a fully validated computerized system.
Castor adheres to a rigorous Software Development Life Cycle (SDLC) based on GAMP 5 (Category 4 - Configured Software) principles and operates under an ISO 9001 and ISO 27001 certified Quality Management System.
1. How Castor Validates the Platform (Vendor Validation)
For every software release, Castor follows a formalized, risk-based validation procedure:
- Automated & Manual Testing: Continuous integration pipelines run thousands of automated unit, integration, and regression tests, supplemented by formal manual exploratory and qualification testing.
- Audit Trail & Data Integrity Verification: Core functions—including user authentication, electronic signatures, time stamps, and immutable audit trails—are systematically tested to ensure compliance with FDA 21 CFR Part 11 and EU Annex 11.
- Release Validation Certificates: Each release concludes with a formal validation summary and a published Release Certificate confirming the software is fit for intended use.
2. Study-Level Validation (Shared Responsibility)
Computerized system validation in clinical trials operates on a shared responsibility model:
- Core Software (Castor): Castor provides the validated, compliant platform.
- Study-Specific eCRF (Sponsor / Study Team): Because each clinical trial has unique forms, visit schedules, validation checks, and calculations, the sponsor or study builder is responsible for validating the study design.
- We provide dedicated guidance to assist teams with this step: see our guide on Performing User Acceptance Testing (UAT) in EDC/CDMS.
Documentation & Compliance Statements
- View our annual 21 CFR Part 11 Statements of Compliance.
- View Release Notes and Release Certificates published for your platform version in the Help Center.
- For vendor audit requests, Validation Summaries, or third-party audit documentation, please contact Castor Support.