DHC VISION Audit Management

DHC VISION Audit Management is a software solution for planning, executing, documenting, and following up on audits within an integrated management system. It supports organisations of all sizes and industries, covering internal and external audits across a wide range of audit types, including process, product, system, customer, supplier, surveillance, repeat, third-party, and GxP audits. The platform integrates with other quality processes so that auditors and participants have direct access to relevant information such as process descriptions, work instructions, and organisational data.

All audit process steps are automated through a workflow engine. The solution provides reporting, time-point-based analyses, ad hoc and progress reports, as well as data analytics and business intelligence functions with interactive analysis scenarios. It is designed to meet GxP requirements and is compliant with 21 CFR Part 11 and FDA guidelines.

Master Data and Templates

• Master data management for processes, organisational units, IT systems, products, machines, projects, buildings, and similar objects
• Templates for the full audit documentation set, including plans, announcements, checklists, self-assessments, and reports
• Management of internal and external auditors
• Creation of flexible, reusable question catalogues and checklists with freely definable questions and question groups
• Automatic generation of catalogue structures as an Explorer tree and export of checklists to MS Excel
• Templates for standards-based question catalogues
• Documentation of central guidelines, programmes, and evaluation procedures
• Automatic generation and assignment of self-assessments linked to checklists
• Management of regulations, directives, laws, and standards

Audit Planning and Scheduling

• Flexible configuration of audit areas with defined responsibilities and assigned auditors
• Automatic generation of audit plans per area for the current and following year
• Manual creation of audits with attributes including name, scope, objective, type, team, lead auditor, basis, rough scheduling, and location
• Automated creation of audits according to defined cycles or recommended follow-up audits
• Support for a broad range of audit types (process, system, product, project) and audit categories (customer, supplier, internal, certification, third party, regulatory authority, ad hoc, IT)
• Integration of all audits into the audit plan for scheduling and resource planning
• Central planning via audit plan or individual planning per audit
• Rough scheduling at audit creation followed by detailed planning of individual audit phases through to completion
• Integration with Microsoft Office applications (Word, Excel, Outlook)
• Notification of defined audit participants by email and in the personal task inbox
• Rules for audit cycles, repetitions, reminders, and escalation
• Graphical audit planning and workflow status management
• Generation of an annual audit programme to support yearly planning and specification of planned activities

Audit Preparation

• Definition of the audit approach across three scenarios: standard checklist, new checklist, or without checklist
• Definition of concrete scope and relevance rating of individual questions
• Customisation of checklists with MS Excel integration
• Option to configure a self-assessment, automatically generated as an extract of the checklist
• Drafting of the agenda and description of audit objectives
• Dispatch of the generated audit announcement including tasks and self-assessment by email, as a file, or in print
• Offline-capable self-assessment completion by the audited area via MS Excel

Audit Execution

• Use of a web front-end as well as MS Word and MS Excel
• Automatic provision of self-assessment results
• Execution according to defined procedure using checklists or interview forms with check-out/check-in functionality
• Recording of recommendations, observations, and findings, either automatically from checklist responses or entered manually in DHC VISION, including assignment to audit questions or independent of questions
• Attachment or linking of supplementary information such as emails, scans, presentations, documents, and images
• Three-level assessment of the audit result ("satisfactory", "partially satisfactory", "not satisfactory")
• Multi-level rating of individual findings from "highly critical" to "not relevant"
• Assignment of responsibilities for findings and measures

Audit Closure

• Automated generation of the audit report with finalisation via MS Word
• Workflow-supported statements on findings to coordinate the further course of action
• Configurable overall audit assessment ("successful", "successful with conditions", "not successful")
• Recommendation and rough scheduling of a follow-up audit, which is automatically created in time for planning
• Digital processes for document and report control including creation, review, approval, and publication
• Predefined workflows for systematic and traceable processing of measures
• Flexible scheduling and deadline assignment for measure processing and target achievement
• Status management for audits, findings, and measures
• Version management for documents and reports
• Task distribution to the personal DHC VISION task inbox and by email
• Reminder and escalation mechanisms for timely task completion
• Absence and deputy rules
• Electronic signatures compliant with 21 CFR Part 11

Follow-Up, Tracking, and Reporting

• Progress reports on processing status with clear display of implementation deadlines
• Day-accurate plan/actual deviation analysis for audit planning optimisation with calendar view
• Various reports and ad hoc reports with data filters for tracking recommendations, findings, measures, audits, and documents
• Generated annual audit reports covering all audit results and open findings or deviations for the year
• Time-point-based analysis with visualisation of distribution by audit type, audit subject, monthly distribution, current status, and final assessment of quality and schedule adherence
• Straightforward derivation of CAPAs (corrective and preventive actions)

Analytics and Decision Support

• Analysis functions for finalising audit reports and annual reports, and for analysing annual performance and audit results
• Role-specific dashboard for management showing open and started audits by status, number of findings, and number of open measures by processing status
• Drill-down to individual audits, measures, or findings with status information on planned dates, type, location, and sources
• Multi-perspective visualisation of audit core data including base data, responsibilities, lifecycle status, key documents, findings, measures, predecessor audits, and change history
• Detailed view of findings including classification, originating audit, trigger, responsibilities, descriptions, statements, and assigned measures
• Detailed view of measures including type, priority, implementation risk and degree, lifecycle, descriptions, objectives, and effectiveness assessment
• Export capability to BI systems via data marts
• High-performance, context-sensitive, filterable full-text search

Notifications 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 design of notifications including HTML formatting, multilingual support, and delivery to various channels including email, social media, and mobile devices
• Role-based communication rules with views for user, organisational, and compliance perspectives
• Task rejection with mandatory commenting
• Full audit trail for all notifications, recording who was informed, when, with what content, and about what

Multisite and Multilangu