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goBalto, developer of new generation web-based clinical research solutions, announced that it successfully completed a FDA 21 CFR Part 11 compliance audit of its goBalto Tracker™ Software-as-a-Service (SaaS) clinical trials application. Tracker's successful audit will help both sponsors/clinical research organizations and investigator sites running clinical trials comply with FDA rules and regulations governing electronic records and electronic signatures.
"The Tracker application demonstrated compliance with the current 21 CFR Part 11 industry standards feature set for security, data transfer, audit trails, and electronic signatures. No deficiencies were found. The implementation of security and electronic signature components is elegant and sets a new standard for web-based GxP applications," said David Nettleton, principal at Computer System Validation, who conducted the audit.
goBalto and David Nettleton found innovative ways to balance 21 CFR Part 11 compliance requirements with cutting-edge Agile software development practices, facilitating rapid response from the feedback of clinical trial professionals.