eTMF

DHC VISION eTMF is a document management system for clinical trials, developed by DHC Business Solutions. It is designed for organisations that need to structure, classify, and manage their Trial Master File (TMF) documentation in accordance with Good Clinical Practice (GCP) standards. The solution addresses common audit findings such as incomplete TMFs, outdated documents, and fragmented end-of-study consolidation, which can lead to delays in regulatory approval or study failure.

The system implements the Drug Information Association (DIA) reference model as its structural foundation and is built for use in highly regulated environments. It supports compliance with GxP guidelines and the requirements of the FDA, EMA, PIC/S, and ICH, including 21 CFR Part 11 for electronic records and electronic signatures.

Study and Document Administration

• Full implementation of the DIA reference model for digital document management
• Template-based creation and flexible configuration of individual studies
• Simple structuring of TMFs for individual studies
• Management and tracking of documents stored externally, for example at investigator sites
• Creation of common types of study documents
• Granular roles and permissions concept for studies and study documents
• Flexible access control for filing structures and individual documents
• Auditable document filing within individual studies
• Import, migration, and classification of documents
• Automated assignment of unique document numbers with configurable prefixes
• Flexible document coding and freely definable properties and attributes
• System-supported calculation of revision cycles and archiving periods
• Integration with Microsoft Office products (Word, Excel, PowerPoint, Outlook)
• Simple assignment of responsibilities, roles, sites, and countries from master data
• Document changes restricted to authorised persons only
• Full master data management

Document Creation and Control

• Over 50 document templates and best-practice workflows for editing, review, and approval processes
• Electronic signatures compliant with 21 CFR Part 11
• Workflow-based document creation, review, and release
• Traceable versioning of all documents including full version history
• New versions generated only from currently approved and valid versions
• Automatic status assignment for documents
• Predefined workflows with intuitive assignment of workflow participants
• Definition and assignment of tasks within document workflows
• Notifications on task assignment and completion
• Support for serial or parallel review and approval cycles
• Out-of-office assistant and deputy rules
• Study lifecycle management and status management
• Automatic status transitions (e.g. "in progress", "under review", "pending approval")
• Automated version management including supersession and archiving of previous versions

Publication and Distribution

• Automatic conversion of created documents to PDF
• Real-time publication
• Targeted distribution of new or changed documents to defined audiences
• Distribution for information or acknowledgement to groups or individuals
• Customer-specific modelling and configuration of approval workflows
• Task distribution to personal task inbox and by email including a direct link to the document
• Optional integration with DHC VISION Training Management

Document Review and Lifecycle

• Predefined workflows for supersession, invalidation, validity extension, reactivation, and archiving
• Date- and period-controlled cyclical document review resubmission
• Manual, document-specific definition of resubmission dates
• Direct revision or validity extension initiated from the resubmission process
• Reminder and escalation mechanisms for deadline compliance including lead times
• Full reference and usage tracking for documents
• Support for invalidation of documents by authorised persons
• Dynamic display and processing of document-specific correction suggestions
• Editing of new versions while the currently valid version remains active

Analytics and Reporting

• Document counts by status and type
• Overdue management showing document validity including status information
• Drilldown to individual documents with status and detail information
• Display of key document attributes and properties
• Quick view of individual documents including associated attachments
• High-performance Cognitive Search
• Full-text search across document content and attributes
• Extensive selection parameters supporting a wide range of use cases
• Configurable status reports and reports for resubmission planning
• System-supported monitoring of document validity
• Reminder and escalation mechanisms for documents with limited validity
• Comprehensive status tracking (traceability)
• Workflow monitoring
• Interactive data analytics and business intelligence functions
• Diagnosis of current and future compliance status

Attachments and References

• Creation of documents and information as accompanying attachments or supplementary information
• References to further documents such as checklists and scans, including multi-selection
• Links and references to related objects such as processes, sites, persons, and countries
• Targeted modification of supplementary information and references without affecting the main document
• Automatic version and status management for attachments
• Intelligent notification system

Notifications and Communication

• Notification Event Modeling Framework for automated, precise, and timely notification of individuals, roles, groups, or systems
• Flexible notification design including HTML formatting, multilingual support, and delivery to external actors such as investigator sites
• Rule-based communication through role-oriented messages covering user, organisational, and compliance perspectives
• Notifications recorded in the audit trail
• Full traceability of information events and content

Security and Compliance

• Revision-proof storage and management of documents in freely definable structures
• Complete version and change history via audit trail
• Write protection for already signed or approved documents
• 21 CFR Part 11 conformity for electronic records and electronic signatures
• Granular roles and permissions concept for studies and study documents
• Predefined roles, profiles, user groups, and permissions

Integration and Connectivity

• Integration of eTMF with broader digital compliance processes within the DHC VISION platform
• Connection to the DHC VISION document management system
• Combination of study documentation with DHC VISION Training Management
• Integration with DHC VISION Deviation Management for handling non-conformances
• Integration with DHC VISION Change Management for managing changes

DHC VISION eTMF is designed specifically for highly regulated industries and meets GxP guidelines as well as FDA, EMA, PIC/S, and ICH requirements. A Validation Package is available, comprising Validation Accelerators (a complete documentation set for system validation) and Validation Services to adapt the documentation to individual customer environments. The platform also connects with related DHC VISION modules including SOP Control, Training Management, CAPA, Deviation Management, Complaints, Change Management, and Audit Management.