DHC VISION Complaint Management

DHC VISION Complaint Management is a software module from DHC Business Solutions designed to manage customer complaints, supplier complaints, and internal quality notifications across their full lifecycle. It is built for use in highly regulated industries such as pharmaceuticals, chemicals, and life sciences, where GxP compliance, traceability, and regulatory documentation are mandatory requirements.

The module supports the entire complaint process from initial recording through root cause analysis, corrective action, effectiveness review, and formal closure. It integrates with related quality processes including CAPA, deviation management, change management, and audit management, enabling end-to-end process coverage without data redundancy or media breaks. Standardised interfaces allow data exchange with third-party systems such as ERP and CRM platforms.

Digital Complaint Processes

• Pre-configured best-practice workflows for role-specific routing of complaints
• Robotic Process Automation (RPA) for automating repetitive, manual, or error-prone tasks across the complaint lifecycle
• Simple, fast, anonymous, and barrier-free complaint submission
• Intuitive and configurable input dialogs and templates
• Upload of supporting attachments such as documents, photos, scans, and emails directly to the record
• Cross-departmental coordination of tasks and statements
• Involvement of all relevant personnel throughout the processing workflow
• Integration with further quality processes including deviations, change management, and audits

Complaint Recording and Processing

• Full process support across the entire lifecycle of quality incidents
• Flexible filing structures based on time periods, triggers, objects, organisational units, or processes
• Configurable complaint types and pre-configured attribute sets for complaints, phases, and measures
• Recording of additional information such as occurrence date, complaint subject, customer, reporting person, responsible party, and criticality
• Pre-defined, customer-configurable best-practice workflows for routing, approval, notification, and escalation
• Flexible team assignment, scheduling, and deadline management
• Linking to external documents or information sources
• Flexible error and root cause analysis using configurable error and cause catalogues
• Use of action catalogues to support recurring measures and leverage historical experience
• System-supported effectiveness review and assessment of complaints and initiated measures
• Processes and methods are adaptable to industry-specific requirements

8D Report and Integration

• Generation and use of 8D reports throughout the complaint process
• Customisable 8D templates and customer-specific report generation
• Communication of complaint status and progress to customers or suppliers
• Ongoing intervention in active processes to adjust deadlines or involved parties
• Integration with CAPA and action management, document management, change management, and central master data management
• Access for external parties such as customers or suppliers
• Integration framework with predefined interfaces for connecting ERP, CRM, and other operational systems

Tracking, Reporting, and Monitoring

• Continuous traceability, control, and auditability of all complaints and measures
• Workflow monitoring with visual status indicators including traffic light displays
• Role-specific dashboards showing complaints and actions relevant to each user
• Management dashboards with real-time KPIs, complaint counts broken down by priority and status, and 45-day forecasts for complaint and action remaining durations
• Drill-down visualisation of active and completed complaint processes down to product level
• Time-based analyses covering quantities, triggers, affected products, error frequencies, throughput times per workflow step, deadline adherence, costs, and effectiveness
• Analyses for early identification of trends, frequencies, and risks
• High-performance, context-sensitive full-text search with extensive filters and selection parameters
• Excel export and datamart export for use in existing Business Intelligence systems

Notifications and Communication

• Notification Event Modeling Framework for automated, role-based notifications triggered by 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 aligned to role-specific views: user, organisational, and compliance perspectives
• Task rejection with mandatory commenting
• Full audit trail for all notifications, recording who was informed, when, and with what content

Analytics and Business Intelligence

• Interactive data analytics scenarios covering distribution by ingredient, batch, manufacturer, and supplier
• Time-based distribution analyses and period comparisons including severity trends
• Drill-downs to product level with visualisation of affected products, batches, ingredients, and suppliers
• Datamart provision for import into existing BI systems
• Management dashboard with breakdown of immediate measures, corrective measures, and preventive measures by status (open, in implementation, pending effectiveness review)
• Direct navigation to individual measures with full attribute, risk, workflow status, and completion date information

Regulatory Compliance and Security

• Electronic signatures and audit trails supporting compliance with 21 CFR Part 11 and Annex 11
• GxP-compliant implementation including standard validation templates and methodology
• Compliance with FDA, EMA, PIC/S, and ICH guidelines
• Classified under GAMP® software category 4, supporting straightforward configuration
• Revision-safe storage of all information and documents
• Flexible authorisation concept for access control
• Automated email reminders and escalation mechanisms for upcoming deadlines and threshold breaches
• Comprehensive master data management for processes, organisational units, products, machines, projects, and error or cause catalogues

Multisite and Multilingual Support

• Multi-client architecture for mapping international corporate structures
• Group-wide harmonised complaint management across multiple sites
• Management of global and site-specific error, cause, and action catalogues
• Standard delivery in German and English; translation tools support all Unicode-capable languages
• Easy switching between languages within the application

DHC VISION is web-based, supporting access from desktop and mobile devices worldwide. A Validation Package is available, consisting of Validation Accelerators (a complete documentation set) and Validation Services for adapting documentation to individual customer environments. The module can be combined with other DHC VISION components including SOP Control, Training Management, CAPA, Deviation, Change, and Audit Management to form an integrated quality management platform.