Inspection-ready trial master file management
Omega eTMF — Electronic Trial Master File
Omega's own electronic Trial Master File platform: the essential document set of every clinical trial — collected, classified and archived in an inspection-ready structure from start to close-out.
基準:
21 CFR Part 11
İKU Temel Dokümanlar
ALCOA+
KVKK
主な特長
Artifact taxonomy
Trial master file organized into zones, sections and artifacts for direct evidence retrieval.
Metadata & search
Full-text search and filtering by study, document type, country and date.
Versioning & audit trail
Every upload and approval recorded; prior versions always retrievable.
Part 11 e-signatures
Approval workflows with compliant electronic signatures.
Inspection-ready archive
Retention policies and export packages that respond to authority requests in minutes.
Role-based access
Access and task assignment by role and study team.