Complaints – Opportunities for continuous improvement
With the COMPLAINT processes in DHC VISION, complaints, whether from customers, suppliers or of an internal nature, are managed in a controlled manner. User-friendly from recording to formal closure, DHC VISION also offers the highest level of regulatory (process) security. “Efficient Quality” – this is what business intelligence functions and interactive data analytics scenarios stand for.
Complaints damage customer satisfaction and reputation. In an emergency, they can have a threatening impact on the company. However, if handled correctly, they also have positive effects: They prompt the optimization of processes to improve product quality, as organizations can learn from mistakes. Processes quickly become complex and non-transparent: A high number of people involved; reporting requirements; close integration with other processes such as CAPA or CHANGE management; or the dependencies on the resulting “long-term measures” – all this contributes to high process complexity. Hence, the entire handling process of each complaint must be safe and compliant at all times and the life cycle be traceable at all times.
DHC VISION offers a variety of methods for recording complaints, identifying their causes and errors, resolving them, and eliminating them for the future. Best practice workflows guide complaints and associated CAPAs through the enterprise in a targeted, controlled manner. Interactive data analytics scenarios enable detailed diagnostics; role-specific dashboards for management provide clear representations of real-time information relevant to decision-making. Electronic signatures and audit trails ensure Part 11 compliance. Standardized interfaces are available for exchanging relevant data (materials, products, batches, suppliers, customers, etc.) with third-party systems (e.g. ERP). In combination with other modules for CAPA, deviation, change or audit management, seamless processes are created without media breaks and redundancies.
Digital complaint processes
- Target group-specific management of complaints through pre-configured best-practice workflows
- RPA: process (and workflow) automation of repetitive, formerly manual, time-consuming or error-prone tasks in the entire lifecycle of complaints
- Simple, fast, anonymous, and accessible complaint reporting
- Intuitive and customizable input dialogs / templates
- Upload of necessary or supplementary attachments such as documents, images, etc. directly to the process
- Involvement of all relevant persons in the handling process
- Cross-departmental and cross-divisional control of tasks and statements
- Seamless integration of further quality processes such as deviations, change control, audits, etc.
Tracking, Reporting, Monitoring, Search
- Permanent traceability and control of all complaints or measures
- Workflow monitoring with visualization of status
- Role-specific, personalized dashboards on relevant complaints and measures
- Comprehensive target group-specific (management) reports with role-specific dashboards, KPIs and decision-relevant real-time information, incl. a variety of filters and selection parameters, export option to BI systems through so-called datamarts.
- Drill-down visualization of ongoing and completed complaint processes
- Evaluations for timely identification of potentials, trends, frequencies or risks
- Time-related analyses of ongoing measures with visualization of throughput times and adherence to schedules as well as a variety of other qualitative aspects such as criticality and degree of effectiveness
- High-performance, context-sensitive, (full-text) searches with filters
Regulatory compliance and gapless traceability
- Audit-proof management of all information and documents
- Complete traceability and control via audit trails, version control, deadlines or formal changes
- Fulfillment of GxP requirements and assurance of FDA and ISO compliance
- Electronic signatures and detailed audit trails ensure compliance with 21 CFR Part 11
- Notification management: Notifications, reminders and escalations in the event of delegated tasks, deadlines, time limits or threshold violations
Compact information on all processes related to controlled documents and the complete range of functions are available in the factsheet on DHC VISION COMPLAINT Management.
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Insight into our customer relations
“The decision was made in favor of DHC VISION because we were convinced by the compactness of the system and the synergy potential of the integrated quality management solution. Decisive for our decision were also the validation expertise of DHC and last but not least the recommendation and references of other companies in the chemical and pharmaceutical sector.”
All options at a glance
Capture and processing
- Consistent process support over the entire life cycle of quality incidents
- Flexible design of the filing structure according to any criteria (time periods, triggers, objects, organizational units, processes, etc.)
- Simple entry of complaints via intuitive web dialogue
- Configurable complaint types
- Use of templates along the entire complaint handling process
- User-centric provision of task dialogues, entry masks and forms
- Pre-configured attribute set for complaints, phases of complaint handling, measures
- Description of complaints with additional information such as date of occurrence, subject of complaint (also in text form), complaining customer, reporting person, responsible person, criticality of complaint
- Pre-defined yet configurable best practice workflows for targeted control, forwarding, approval, provision, notification and escalation of complaints, related information/documents and initiated actions
- Easy definition of the team and responsible persons as well as flexible scheduling and deadline setting
- Linking to external information or documents
- Capture of additional information and notes
- Notifications of upcoming deadlines, analyses, deadlines, tasks or when threshold values are exceeded
- Processes and methods adaptable to industry-specific requirements
- Upload any information and media files (photos, scans, e-mails, etc) for detailed description of complaint reasons
- Flexible defect and root cause analysis depending on the company, customer or risk classification
- Use of error and cause catalogs to accelerate analysis and identification
- Use of flexible catalogs of measures to provide the best possible support for recurring measures or to increase efficiency when initiating measures (use of historical experience)
- System-supported effectiveness testing and evaluation of complaints and initiated measures
8D Report and Integration
- Generation and use of an 8D report along the complaint process
- Easy customization of the 8D template
- Possibility to store and generate company-specific reports tailored to actual requirements
- Medium for communication of complaint status/progress with customers or suppliers
- Permanent intervention in ongoing processes to correct set dates, deadlines or persons/groups involved
- Seamless integration into CAPA/action management, document or change management as well as central master data management for the implementation of fully traceable, compliant processes
- Clear presentation and fast status tracking of all initiated measures
- Accessibility also for third parties such as customers or suppliers
- Integration framework with predefined interfaces for connecting operational (third-party) systems such as ERP or CRM systems
Monitoring and search
- Status reports and life cycle evaluations with comprehensive selection parameters
- Time-related analyses of ongoing complaints and quality anomalies with graphical display of status, quantities, triggers, affected “products”, errors, frequencies, throughput times (also per workflow step), adherence to deadlines, costs, efficiency or implementation risks
- Extensive functions, reports and filters for status tracking and tracking of running processes and deadlines
- Excel export
- Context-sensitive, high-performance (full-text) search with comprehensive filters and selection parameters
- Workflow monitoring, incl. traffic lights for status visualization
- Notification when set limits are reached and/or exceeded
Events, notifications, communication
- Notification Event Modeling Framework for automated, accurate and timely notification of people, roles/groups or systems about the status value of definable events such as date, threshold, metric, new document versions.
- Flexible and appealing design of notifications (including HTML); also multilingual, to different recipient systems (email, social media, mobile gadgets etc.
- Rules and communication by creating messages along role-based interests and views (user view, organizational view, compliance view).
- All notifications are subject to an audit trail
- Full traceability of who was informed about what, when, with what content
Analytics and Business Intelligence
- Interactive data analytics complaint management assessment:
- Overviews of complaints related to ingredients, batches, manufacturers/suppliers etc.
- Occurrence of events over time and comparisions, e.g., of severity levels, according to time periods
- Drill-downs to product level
- Visualization of number of affected products, batches, ingredients, suppliers, etc.
- Provision of a datamart (data pool) for import and use in Business Intelligence (BI) systems
- Role-specific management dashboards with clear visualization of relevant real-time information
- Number of complaints and breakdown by priority and status
- Visualization of the remaining time of complaints and the remaining time of measures with a 45-day forecast showing status and overdues
- Number of immediate actions, number of corrective actions, number of preventive actions
- Breakdown and number of complaints with status “open”, “in implementation” and “for effectiveness check”.
- Drill-down to complaint level with status information on measures, documents, responsibilities; display of trigger, workflow status, priority and due date
- Navigation to the level of individual tasks with status information (triggering object, affected object, task type, responsibilities)
- Clear display of all tasks (according to selection parameter) with task attributes or properties, risk, evaluation, workflow status and completion date
- Access to activities or workflow tasks
- Direct access to specific actions or complaints with a view of information such as sub-actions, additional information, triggering objects, affected objects or the graphical action life cycle with PLAN/ACTUAL comparison
Compliance and security
- Controlled complaint management with fully traceable, systematized processes
- Use of electronic signatures and audit trails for compliance with 21 CFR Part 11 and Annex 11
- GxP-compliant implementation including standard validation templates and methodology
- Compliance with regulatory requirements
- Easy configuration (compliance with GAMP® software category 4)
- Reminders and escalation mechanisms
- Automated e-mail dispatch with sufficient interval to upcoming deadlines or due dates
- Audit-proof storage of information and data
- Flexible authorization concept to ensure the highest security standards
- Easy web-based and worldwide access, also via mobile devices
- Comprehensive master data management for processes, organizational units, IT systems, products, machines, projects, buildings, etc. or for setting up error or cause catalogs
Multisite and Multilanguage
- Intelligent client concept for mapping international group structures
- Realization of group-wide, harmonized complaint management
- Clear management of complaints activities across the board and global or site-specific catalogs of errors, causes and measures
- Language packages for international use; standard scope of delivery: DE and EN
- Tools for software interface translation to all Unicode languages
- Easy switching between languages
Validation and compliance consistently in view
DHC VISION is specially designed for use in highly regulated industries. The solution fulfills GxP guidelines and directives of the FDA, EMA, PIC/S or ICH, as well as 21 CFR Part 11, for both technology and business processes. The Validation Package is available for system validation; it consists of “Validation Accelerators” (complete documentation set for validation) and Validation Services for adapting the documentation to a specific system configuration.
The optimal solution for digital management and control of your specification documentation. Secure, controlled, traceable and compliant (including 21 CFR Part 11).
The perfect and seamlessly integrable addition to SOP management. Digital processes set new standards in “Training Compliance”.
Systematic and controlled documentation, analysis and resolution of non-conformancies to improve quality and compliance.
Indispensable for an integrated management system. An entirely digital and user-friendly audit process. The ideal addition to the other quality modules.
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What is meant by “complaints”?
A complaint under 21 CFR Part 820.3 (b) means written, electronic, or oral communication that indicates deficiencies in the identity, quality, durability, reliability, safety, effectiveness, or performance of a product released for distribution. Complaints come from the outside; a pre-market product deficiency, by contrast, is a deviation.
Whenever customers file complaints, they have to be taken seriously; complaints require further investigation. Complaint management is a center piece in quality assurance; the manufacturer’s duty of care applies, as product defects impinge on customer satisfaction; they even may be a risk to patient safety and health.
And yet, if handled correctly complaints also may have a positive effect: They may contribute to optimizing product quality processes both on the supplier or customer side as well as on the manufacturer side and with regard to internal quality processes.
Is there also a digital solution for complaints management?
Manufacturers of medical devices, for example, must keep records of complaints. Procedures and standards must be defined for accepting, evaluating, and investigating complaints. A software system controls the entire handling process of each complaint in accordance with regulations in place and throughout the entire life cycle of a complaint; maximum traceability is expected. DHC VISION offers a wide range of methods and tools to record complaints, to identify their causes and errors, to take remedial action, and to avoid them in the future.
Of particular interest is the analysis of complaint data. In-depth investigations focus on the detection of trends; they also analyze the status quo and investigate underlying error and cause patterns.
What are the relevant requirements for complaint protocols under 21 CFR Part 820.198?
The investigation report should include the following items (eCFR: 21 CFR 820.198 — Complaint files.).
- Name of the product
- Date of receipt of the complaint
- Identification number(s) and control number(s) of the product
- Name, address, and telephone number of the person filing a complaint
- Nature and details of the complaint
- dates and results of the investigation
- corrective action taken
- responses, if any, to the person who reported the complaint.