DHC VISION Policy Management

DHC VISION Policy Management is a software module from DHC Business Solutions designed for the fully digital administration of policies and regulatory documents. It addresses the complete lifecycle of a policy — from creation, review, and approval through to distribution, monitoring, archiving, and invalidation — within a single, audit-trail-enabled system. The solution is aimed at organisations in regulated industries that need to demonstrate compliance with regulatory requirements such as GxP guidelines, FDA, EMA, PIC/S, ICH, and 21 CFR Part 11.

All processes run through automated digital workflows, providing detailed traceability of who made changes, when, and what actions were taken at each stage. Dashboards and analytics functions give management a continuous view of the compliance status across the organisation. The module can be connected to other DHC VISION components — including Training Management, Change Control, and Audit — to support an integrated management system.

Policy Administration

• Secure creation, review, and approval of policies
• Support for common document types beyond policies
• Standardisation through more than 50 document templates and workflows
• Flexible document coding and automated assignment of unique document numbers with prefix
• Compliance with electronic signatures, including 21 CFR Part 11
• Status management with automatic status transitions
• Recall and restart of workflows by the initiator
• Comment function and comment document within the workflow for communication
• System-supported calculation of validity periods and archiving durations
• Revision counting for existing documents and system-supported version history
• Freely definable document attributes and properties
• Integration with Microsoft Office products (Word, Excel, PowerPoint, Outlook)
• Definition of responsibilities and scopes of application
• Editing restricted to authorised persons only
• Full master data management

Policy Distribution and Control

• Target-group-specific distribution of new or changed documents
• Distribution for information or acknowledgement to individuals or groups
• Task notifications sent by email and to personal task inboxes
• Real-time publication with automatic PDF conversion
• Best-practice workflows for editing, review, and approval processes
• Serial and parallel review and approval cycles
• Absence assistant and deputy rules
• Rejection, refusal, or delegation of tasks (with mandatory comment)
• Procedures for invalidation, validity extension, reactivation, and archiving
• Automatic archiving of the previous version when a new version comes into effect
• Optional integration with DHC VISION Training Management

Policy Review

• Date- and period-controlled submission of policies for review
• Manual definition of the due review date
• Direct revision run or validity extension from the review process
• Reminder and escalation mechanisms
• Complete reference and usage evidence for policies
• Support for invalidation of policies
• Dynamic display and processing of all policy-related correction proposals
• Editing of new versions without losing the validity of the current version
• Predefined procedures for invalidation, validity extension, reactivation, and archiving

Monitoring and Reporting

• Comprehensive reports and dashboards for policy oversight
• Full traceability and change and version history (audit trail)
• High-performance Cognitive Search with full-text search across policy content and attributes
• Extensive filter and selection functions with a wide range of selection parameters
• Predefined status reports and reports for planning review submissions
• System-supported monitoring of policy validity
• Reminder and escalation mechanisms
• Workflow monitoring with graphical status visualisation (traffic lights)
• Traceability mechanisms for comprehensive status tracking

Analytics and Business Intelligence

• Role-specific dashboards showing number of policies by status and type
• Overdue management including validity status information
• Visualisation of a 90-day forecast
• Drilldown to individual policies with status and detail information
• Quick view of individual policies including associated documents
• Adaptive and interactive data analytics for diagnosing current and future compliance
• Visualisation of compliance KPIs for policies requiring mandatory acknowledgement
• Overview of compliance status by organisational unit
• Time-series development of compliance KPIs
• Overview and detail of compliance-critical states with recommended actions
• Employee compliance: percentage and number of employees with 100% training completion

Notifications and Communication

• Notification Event Modeling Framework for automated, precise, and timely notification of persons, roles, groups, or systems based on configurable events such as dates, thresholds, measured values, 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)
• All notifications are subject to an audit trail with full traceability of who was informed, when, and with what content

Controlled Printing

• Display of all documents in PDF with automatic conversion regardless of status
• Single, multiple, and batch print functions
• Workflow for traceable printing of policies
• Printing of valid documents including print date, time, and validity period
• Watermark identification of authorised copies
• Reports on distributed paper copies
• Informational print, daily copy, and training copy options

Associated Attachments and References

• Creation of additional documents or information as associated attachments or supplementary information
• References to further policies, checklists, or forms
• Links to related objects such as processes, organisational units, IT systems, and products
• Automatic version and status management for attachments

Security and Access Control

• Revision-safe storage and management of policies
• Freely definable filing structure
• Complete version and change history (audit trail)
• Write protection for already signed or approved documents
• 21 CFR Part 11 conformity for electronic records and electronic signatures
• Fine-grained permission concept with predefined roles, profiles, user groups, and authorisations

Multisite Capability

• Multi-client concept for group-wide policy management across sites
• Adaptation of global policies to local requirements without redundancy
• Management of global and site-specific policy variants
• Translation of policies including formal approval of translations

DHC VISION Policy Management is designed for use in highly regulated industries and meets GxP guidelines as well as requirements from the FDA, EMA, PIC/S, ICH, and 21 CFR Part 11. A Validation Package — comprising Validation Accelerators (a complete documentation set for validation) and Validation Services — is available to support system validation. The module integrates with other DHC VISION components including Training Management, Schriftlich fixierte Ordnung (SFO), Change Control, and Audit Management.