New generation digital deviation management
DHC VISION DEVIATION Management is the optimal software solution when it comes to managing deviations systematically and in compliance with FDA or EMA regulations. DHC VISION supports the control of any deviation, internal or external. Controlled procedures, data analytics, and business intelligence functions as well as the appealing design and excellent usability of the software stand for “Efficient Compliance”.
Deviation management is an essential part of the QMS in EMA- and FDA-regulated industries. Process and handling, therefore, have to meet high standards. Deviation management is complex: A high number of people are involved in the process; close integration with other procedures (e.g. CAPA) is needed; and dependencies on “long-term measures” are a challenge to effective deviation management.This is true, in particular, when paper-based or outdated procedures are in place.
DHC VISION provides the necessary systematics as well as the needed integration with pertaining processes. The software reduces lead times and risks significantly; it adds efficiency and transparency to operational quality processes. From recording to formal closure, deviations are documented completely and in digital form; they are routed in a compliant way. At the same time, DHC VISION stands for maximum security; it comes with solid best practice workflows, digital signatures, and a variety of smart mechanisms (Part 11 compliant). Users see personal tasks and procedures; they are reminded of deadlines; and they are notified by early warning indicators. Seamlessly integrated processes allow for exact traceability over the entire life cycle of a deviation. Comprehensive reporting (e.g., on PQR) provides the best possible overview of processing status, priorities and criticalities of deviations and measures. Dashboards visualize real-time information relevant for decision-making.
Compact information on all processes related to our deviation management software and the complete range of functions are available in the factsheet on DHC VISION Deviation Management.
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Digital and automated deviation processes
- RPA: Process and workflow automation of repetitive, formerly manual, time-consuming or error-prone tasks in deviation management
- Precise control of deviations via pre-configured best-practice workflows
- Involvement of all relevant stakeholders in the handling process
- Control of tasks and statements across divisions or departments
- Intuitive and customizable input dialogs and forms
- Seamless integration of further quality processes such as complaints, changes, etc.
- Upload of necessary attachments such as documents, images, etc. directly to the process
- Seamless documentation
Tracking and monitoring
- Clear representation of tasks and activities
- Role-specific dashboards on deviations and measures
- Real-time information on all quality-relevant aspects
- Evaluations for timely identification of potentials, trends, frequencies, or risks
- Time-related analyses of ongoing measures with visualization of lead times and adherence to schedules as well as a variety of other qualitative aspects such as criticality and degree of effectiveness
- Generation of deviation reports (8D, internal, external, customer-specific reports)
- Permanent traceability, e.g., through comprehensive ad hoc reports
Regulatory compliance and complete 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
- Notifications, reminders and escalations in case of delegated tasks, deadlines, time limits or threshold violations
Insight into our customer relations
“We are now focusing on digitization and, thus, can handle the more complex GxP requirements in a cost-neutral way. Our growth is triggered by value-creating processes rather than G&A costs. We have significantly reduced turnaround times for GxP-relevant documents, need less resources for manual process handling, see more process efficiency and significantly lower risks.”
ITM Isotopen Technologien München AG
All options at a glance
Acquisition and processing / editing
- End-to-end process support throughout the entire lifecycle of deviations, Out of Specifications (OOS) or Non-Conformities (NCs).
- Flexible structuring of deviations according to time periods, triggers, affected objects, organizational units, processes, etc.
- Intuitive recording via web dialogs
- Configurable deviation types
- Use of templates along the entire deviation processing chain
- User-centric provision of task dialogs, entry masks and forms
- Pre-configured attribute set for deviations, phases, and measures
- Description of deviations with additional information such as date of occurrence, deviation object (also in text form), complaining customer, reporting person, responsible person or criticality
- Pre-defined yet configurable best-practice workflows for targeted control, forwarding, approval, deployment,
- Notification and escalation of deviations, related information/documents and initiated actions
- Easy definition of the team and responsible parties as well as flexible scheduling and deadline setting
- Linking to external information or documents
- Capture of additional information and notes
- Notification notifications about upcoming deadlines, analyses, tasks, or exceeded thresholds
- Upload of any information and media files (photos, scans, e-mails, etc.) for detailed description of deviations
- Provision of error and cause catalogs to accelerate analysis and identification
- Use of flexible action catalogs to provide the best possible support for recurring actions or increase efficiency when initiating actions (use of historical experience)
- Flexible error and cause analysis depending on the company, or, e.g., per risk classification
- System-supported effectiveness testing and evaluation of deviation and initiated measures
- Processes and methods adaptable to industry-specific requirements
8D Report and Integration
- Generation and use of an 8D report along the deviation process
- Easy customization of the 8D template
- Ability to store and generate customer-specific reports tailored to individual requirements
- Medium for communicating deviation status/progress with customers, suppliers, or internal departments
- Options to intervene in ongoing processes to adjust dates, deadlines or persons/groups involved
- Seamless integration with CAPA/action management, document or change management as well as central master data management for fully traceable, compliance-compliant processes
- Clear presentation and fast status tracking of all initiated measures
- Possibility of integrating Ishikawa diagrams as well as the 5-Why method for systematic identification and presentation of error causes
- Third parties access, e.g., for customers or suppliers
- Integration framework with predefined interfaces for connecting operational (third-party) systems such as ERP or CRM systems
Monitoring / Surveillance and search
- Status reports and life cycle evaluations with comprehensive selection parameters
- Time-related analyses of ongoing deviations and quality anomalies with graphical display of status, quantities, triggers, affected “products”, errors, frequencies, lead 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 scenarios for diagnosing the state of affairs in deviation management
- Overviews of deviations related to, e.g., ingredients, batches, manufacturers/suppliers
- Presentation of relevant aspects, e.g., the severity level, over time and comparisons over time periods
- Drill-down options to product level
- Visualization of number of affected products, batches, ingredients, suppliers, etc.
- Provision of a so-called datamart; pool for data import and data use in existing BI systems
- Role-specific dashboard for management with clear representations of meaningful or decision-relevant real-time information
- Number of deviations and breakdown by priority and status
- Visualization of the remaining time of deviations and the remaining time of measures with 45-day forecast showing the status as well as overdue items
- Number of immediate actions, number of corrective actions, number of preventive actions
- Breakdown to the respective status, incl. number of deviations, “open”, “in implementation” and “for effectiveness review”.
- Drill down to the deviation level with status information on measures, documents, responsibilities and display of the 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 selected selection parameter) with task attributes or properties, risk, evaluation, workflow status and completion date
- Deep Access to existing activities or workflow tasks
- Direct access to the specific measure or deviations with a view of all multi-perspective core information such as sub-measures, additional information, the triggering objects, affected objects or the graphical measure life cycle with PLAN/ACTUAL comparison
Compliance and security / safety
- Controlled deviation management with fully traceable, systematized processes
- Use of electrical signatures and audit trails for compliance with 21 CFR Part 11 and Annex 11
- GxP-compliant implementation including standard validation templates and methodology
- Ensures compliance to regulatory requirements from laws or standards
- Easy configuration (DHC VISION complies with GAMP® software category 4)
- Reminders and escalation mechanisms
- Automated e-mailing 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
- Web-based for easy 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 a group-wide, harmonized deviation management
- Clear management of wide-ranging deviation activities and global or site-specific error, cause and action catalogs
- Intuitive translation of deviation documentation and reports, including formal approval of the language variant via separate translation profiles
- Language packages for international use; standard scope of delivery: DE and EN
- Tools for translating the software interface into all Unicode-capable 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”.
System processes for Change Control ensure precise management and communication of changes of any kind, from the beginning to the end.
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What is meant by deviations?
In very general terms, a deviation is understood as the non-fulfillment of a desired regularity or a standard condition. The term is used in domains such as cost control or statistics; in quality management, it usually refers to the difference between an agreed target, a planned value, or target state on the one hand, and the actual value or actual state on the other. In regulated industries, deviations are often quality anomalies or defects, out of specifications, non-conformities, or process deviations. In the broadest sense, such phenomena are deviations from the defined target state, e.g., deviations in the recipe, the filling quantity, or technical process parameters in production. In the life sciences, such deviations generally trigger further investigations. It is important to discriminate deviations from “changes”: Deviations are unplanned; changes, by contrast, are planned.
To give an example: Even a change of a few millimeters in the folding direction of the package insert in a drug box triggers a deviation process. The stance of regulatory authorities such as the FDA or EMA toward the detection of deviations is: Once deviations are identified, they must not be covered up or downplayed; rather, detailed investigations are required – and they have to be documented.
When analyzing deviations, it is important to first separate what is “conspicuous” or “extraordinary” from what is “less important”. Then, it is possible to focus on appropriate actions to eliminate the causes of such conspicuities. Prompt action can prevent greater damage, for example, if individual batches have to be blocked for delivery. There is a fluid transition from detecting irregularities to remediate actions, i.e., from the deviation to the CAPA process.
Why are digital processes recommended for managing deviations?
Deviations, e.g., in everyday pharmaceutical work, are mass phenomena; they quickly reach unmanageable dimensions. The deviation process must meet high standards; shortcuts or improvised approaches to solutions are not allowed. At the same time, many people are involved in the deviation process. The deviation process, thus, is complex. This is due also to the close interlocking with other processes such as corrective actions; additional complexity is added through the dependencies on “long-term measures” in place. Therefore, paper-based methods cannot cope with the flood of information and the complexity of the tasks.
Software for deviation management supports thorough documentation in line with regulatory requirements; it automates relevant workflows, from the first to the last step.
What are the reporting requirements in deviation management?
Every deviation, as well as every complaint, is initially a risk and thus a potential damage. Classifying a deviation in terms of criticality provides an initial assessment and, thus, an indication of the damage it may cause. Quality site reports cover deviation analyses in all conceivable cross-relationships to products, raw materials, processes, and suppliers.
Here, too, management reports follow the top-down approach of the information pyramid. Here, the first thing of interest is an overall view of the current deviation situation, and this is always target group-specific in the data aggregation. How many deviations are currently in which processing status? What trend is discernible? Is there an increase or decrease in deviations and the associated number of deviations? Do the number of still open deviations predominate or are the majority of deviations already in the effectiveness review? Which deviations are overdue for processing? Are accumulations of deviations detectable at certain company locations?
As always with such metrics and reports, it’s all about complete traceability and regulatory compliance.