DHC VISION Deviation Management

DHC VISION Deviation Management is a software solution from DHC Business Solutions designed for organisations that need to manage deviations in a systematic, digitally documented, and regulatory-compliant manner. It is aimed at companies operating in EMA- and FDA-regulated industries, supporting the control of both internal manufacturing deviations and supplier-related non-conformities as part of a broader quality management system (QMS).

The solution covers the full lifecycle of a deviation — from initial capture through to formal closure — with routing based on best-practice workflows, electronic signatures, and audit trails that meet 21 CFR Part 11 and Annex 11 requirements. It connects deviation management with related quality processes such as CAPA, change management, and document management, and provides real-time dashboards and reporting functions to support decision-making and regulatory reporting such as the Product Quality Review (PQR).

Digital and Automated Deviation Processes

• Robotic Process Automation (RPA) for repetitive, manual, or error-prone tasks within deviation management
• Pre-configured best-practice workflows for targeted routing of deviations
• Involvement of all relevant personnel across departments in the processing workflow
• Cross-departmental management of tasks and statements
• Intuitive and customisable input dialogs and forms
• Integration with other quality processes including complaints, change management, and CAPA
• Direct upload of attachments such as documents, images, photos, scans, and emails to the relevant record
• Complete, gap-free documentation throughout the process

Capture and Processing

• End-to-end process support across the full lifecycle of deviations, Out of Specifications (OOS), and Non-Conformities (NCs)
• Flexible structuring of deviations by time period, trigger, affected object, organisational unit, or process
• Web-based intuitive capture dialog
• Configurable deviation types and pre-configured attribute sets for deviations, processing phases, and measures
• Use of templates throughout the deviation handling process
• Recording of additional information such as occurrence date, deviation subject, reporting person, responsible party, and criticality
• Pre-defined, customer-individually configurable best-practice workflows for routing, approval, notification, and escalation
• Flexible team assignment, scheduling, and deadline setting
• Linking to external information or documents and upload of any media files
• Error and root cause catalogues to accelerate analysis and identification
• Flexible action catalogues supporting recurring measures and use of historical experience values
• Flexible root cause analysis configurable by company or risk classification
• System-supported effectiveness review and assessment of deviations and initiated measures
• Processes and methods adaptable to industry-specific requirements

8D Report and Integration

• Generation and use of 8D reports throughout the deviation process
• Simple adaptation of the 8D template and generation of customer-specific reports
• Communication medium for sharing deviation status and progress with customers, suppliers, or internal departments
• Ability to intervene in ongoing processes to correct deadlines or involved parties
• Integration with Ishikawa diagrams and the 5-Why method for systematic root cause identification
• Access for external third parties such as customers or suppliers
• Integration framework with predefined interfaces for connecting third-party systems such as ERP and CRM
• Seamless integration with CAPA/action management, document management, change management, and central master data management

Tracking and Monitoring

• Role-specific dashboards for deviations and measures assigned to the user
• Real-time information on all quality-relevant aspects
• Analyses for timely identification of trends, frequencies, potentials, and risks
• Time-based analyses of ongoing measures with visualisation of throughput times, schedule adherence, criticality, and effectiveness
• Generation of deviation reports including 8D, internal, external, and customer-specific formats
• Permanent traceability through ad hoc reports
• Status reports and lifecycle evaluations with extensive selection parameters
• Graphical representation of status, quantities, triggers, affected products, errors, frequencies, throughput times per workflow step, costs, and implementation risks
• Excel export and high-performance full-text search with comprehensive filters
• Workflow monitoring with traffic-light status visualisation
• Notification upon reaching or exceeding defined threshold values

Notifications, Events, and Communication

• Notification Event Modeling Framework for automated, precise, and timely 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
• Role-based communication rules covering user, organisational, and compliance perspectives
• Task rejection with mandatory commenting
• All notifications are subject to an audit trail with full traceability of who was informed, when, and with what content

Analytics and Business Intelligence

• Interactive data analytics for deviation management, including distribution by ingredient, batch, manufacturer, and supplier
• Time-based distribution and period comparisons, including severity, with drilldowns to product level
• Provision of a datamart for import and use in existing BI systems
• Management dashboard with real-time information including number of deviations broken down by priority and status
• Visualisation of remaining runtime for deviations and measures with a 45-day forecast and display of overdue items
• Breakdown of immediate, corrective, and preventive measures by status: open, in implementation, and pending effectiveness review
• Drilldown to deviation level with status information on measures, documents, responsibilities, workflow status, priority, and due date
• Navigation to individual measure level with attributes, risk, assessment, workflow status, and completion date
• Direct access to measures and deviations with multi-perspective core information including sub-measures, triggering objects, affected objects, and a graphical measure lifecycle with plan/actual comparison

Regulatory Compliance and Traceability

• Audit-proof storage of all information and documents
• Full traceability and control via audit trails, version control, deadlines, and formal change records
• Compliance with GxP requirements and FDA, EMA, PIC/S, and ICH guidelines
• Electronic signatures and detailed audit trails for 21 CFR Part 11 and Annex 11 compliance
• GxP-compliant implementation including standard validation templates and methodology
• DHC VISION corresponds to GAMP® software category 4
• A Validation Package is available, consisting of Validation Accelerators (complete documentation set) and Validation Services for adaptation to individual requirements
• Flexible authorisation concept to ensure high security standards
• Revision-proof storage of information and data
• Automated email notifications with sufficient lead time before upcoming deadlines or due dates

Multisite and Multilanguage Support

• Multi-client concept for mapping international corporate structures
• Group-wide, harmonised deviation management across sites
• Management of global and site-specific error, root cause, and action catalogues
• Intuitive translation of deviation documentation and reports with formal approval of language variants via separate translation profiles
• Standard delivery includes German and English language packages; software interface can be