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DHC VISION SFO

Digital document management for written rules of procedure (SFO) in financial institutions, with integrated training and process management.

Overview

DHC VISION SFO is a digital document management system (eDMS) developed by DHC Business Solutions for financial institutions required to maintain a "Schriftlich fixierte Ordnung" (SFO) — a written rules of procedure — in accordance with requirements set by the German Federal Financial Supervisory Authority (BaFin). The solution covers the full lifecycle of instructions, guidelines, and process descriptions, from creation and review through approval, release, distribution, and archiving.

The system automates management processes for SFO-relevant documents, provides dashboards and reporting for monitoring document status and validity, and forms part of an integrated management environment that also supports training management and business process management. It is designed for use in highly regulated industries and supports compliance with GxP guidelines and standards including FDA, EMA, PIC/S, ICH, and 21 CFR Part 11.

Document Management

  • Creation, review, and release of all documents with electronic signatures
  • Status management with system-supported calculation of validity periods and archiving durations
  • Target-group-specific distribution of new or changed documents
  • Customisable approval workflows
  • Task assignment to personal task overviews and via email
  • Systematic procedures for invalidation, validity extension, reactivation, and archiving
  • Complete change and version history
  • Revision-secure storage in freely definable structures
  • Support for common document types and customisable document templates
  • Upload and editing of any document format, with MS Office integration
  • Import of policies and similar documents
  • Best-practice workflows for release, invalidation, validity extension, reactivation, and archiving
  • Real-time publication and automatic PDF conversion
  • Full reference and usage tracking for documents
  • Collaborative comment function and intelligent handling of document correction suggestions
  • System-supported monitoring of document validity
  • Integration option with DHC VISION Training Management for closed document lifecycle processes

Training Management

  • Assignment of relevant training content via training areas and training profiles
  • Flexible target group definition
  • Adaptive planning of classroom training and training units
  • Automatic generation of skill sets per training profile
  • Intelligent calculation of re-qualification requirements with automatic scheduling
  • Differentiated tests for comprehension checks, including interactive question and task types
  • Determination, analysis, and documentation of training outcomes
  • Training status of the organisation by groups, roles, or individual employees
  • Role-specific training dashboards for management and trainers

Process Management

  • Modelling of a continuous process landscape with integration of all relevant organisational information
  • Process pyramid from enterprise process down to individual process steps
  • Support for common modelling methods including PLK, EPK, and BPMN
  • Level-specific definition of process methods
  • Drag-and-drop modelling with preset shapes and MS Visio support
  • Database- and method-supported modelling with object reuse (positions, roles, IT systems, etc.)
  • Customisable attribute sets and versioning
  • Workflows for process publication and RACI methodology
  • Automatic generation of organisational and process instructions
  • Real-time publication of model graphics with graphical navigation and drilldown
  • Integration of documents, risks, controls, and improvement suggestions

Risk Management

  • Documentation of operational and strategic risks with predefined attribute sets
  • Reference catalogues for risks, measures, and controls
  • Quantitative and qualitative risk assessment and risk strategy definition
  • Generation of risk maps for processes, organisational units, and IT applications
  • Risk dependency mapping and risk pyramid with aggregation and consolidation
  • Generation of risk portfolios and automatic creation of risk heat maps including gross/net comparison
  • Workflow-supported processing of optimisation and implementation measures
  • Reminder and escalation mechanisms, and reactive workflow activation upon risk occurrence

Continuous Improvement Process

  • Submission and management of improvement suggestions for processes and correction suggestions for documents
  • Evaluation of suggestions with notification to document or process owners
  • Graphical visualisation for authors when suggestions remain open
  • Planning and setting of implementation deadlines with automatic status management
  • Workflows for measure control and integration option with DHC VISION CAPA Management

Standards, Norms, and Regulations

  • Mapping of norms, standards, and laws including chapter structures and content
  • Intuitive navigation and use of chapters as master data
  • Multi-perspective display of all objects linked to a norm
  • One-click update functions for norm content
  • Lifecycle management of norm conformity with evaluation functions tracking conformity status, norm currency, and completeness of process and document assignments

Multisite and Multilingual Support

  • Client concept for international use with process harmonisation and standardisation methodology
  • Intelligent variant management
  • German and English as standard delivery languages; additional language packages available (Unicode-capable)
  • Specialised translator profiles and translation workflows for formal release of language variants
  • Simple switching between languages

Monitoring, Search, and Reporting

  • Standard reports on the status of processes, org charts, documents, acknowledgements, change suggestions, paper copies, and scheduling of reviews
  • RACI matrix for analysis and display of responsibilities across one or more processes
  • Process model comparison and variant comparison
  • Reports on staffing levels and process cost accounting
  • Direct export of selected reports to MS Excel
  • High-performance cognitive search with context-sensitive prioritisation of results
  • Full-text search with multiple filter options

Analytics and Business Intelligence

  • Role-specific dashboards with standard apps covering processes, documents, improvements, norms, and risks
  • Process dashboards showing counts of enterprise, business, and detail processes by status and location, with drilldown to individual process level
  • Document dashboards showing document counts by status and type, overdue management with 90-day forecast, and drilldown to individual document level with full lifecycle information
  • Improvement and norm dashboards showing improvement potentials, measures, and norm-related content with linked processes, audits, and findings
  • Risk dashboards showing average and total expected loss values, number of approved risks by status, and measures initiated for risk reduction

Notifications and Communication

  • Notification Event Modeling Framework for automated, targeted notification of individuals, roles, groups, or systems based on configurable events such as dates, threshold values, metrics, or new document versions
  • Flexible notification design including HTML formatting, multilingual support, and delivery to email, social media, and mobile devices
  • Rule-based communication along role-specific views (user, organisational, compliance)
  • Full audit trail for all notifications with complete traceability of who was informed, when, and with what content

Compliance and Security

  • Revision-secure storage and encryption of information objects
  • Fine-grained permission concept for access control
  • Timely reminders before deadlines expire and escalation triggers at critical points

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Record-Keeping System
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechMedical Devices
Development stage(s)
ManufacturingPost-Market & RWE
Target user(s)
QA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxPICH