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Health Agency Tracking (HATS) meets all requirements for the FDA's 21 CFR Part 11.
Winchester's systems engineering experience provides the perfect foundation on which to build dependable, consistent, secure, accurate and attributable Internet-based applications conforming to all GCP requirements for Data Integrity, System Reliability, Management Control, and Auditable Quality. HATS is designed to be in full compliance with International Conference on Harmonization and Good Clinical Practices (ICH-GCP), 21 CFR Part 11 Electronic Record and electronic signatures and FDA's "Guidance: Computerized Systems Used in Clinical Trial."
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Features and Benefits
Centralized management
Automatic notification and escalation to enforce action items, via electronic mail routing
Management of responses through appropriate states of development and approval
Automated document control
Consolidation of review and approval history and of actions associated with the query and response
Locking upon completion of controlled records
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