Training management software inclusive learning success control
The DHC VISION TRAINING solution digitizes all training phases, from planning to follow-up. Training may relate to specific topics such as hygiene or to documents such as SOPs. With the optional learning success control at the end of the “closed loop” processes, DHC VISION sets new standards in quality assurance and “regulatory compliance”.
Especially in highly regulated industries, training and qualification measures must be planned, carried out and documented in a traceable manner. Also, a detailed and verifyable documentation of training results is mandatory. To ensure compliance with applicable regulations, DHC VISION captures all training status information throughout the entire process. Training activities can be traced and controlled due to digital employee training processes with best-practice workflows. The result is an increase in transparency: It is easy to check on an employee’s training status with regard to relevant training items (e.g. SOPs or topics); training gaps become apparent.
Authorities and regulatory organizations, such as EMA or FDA, also require detailed documentation and proof of training results. The module DHC VISION Learning Success Control responds with differentiated tests, which make it easy to determine whether training content actually is understood. Different types of quizzes are available; multimedia elements can be included. Interactive online tests play a key role in employee training and certification; they allow for assessing training effectiveness and the successful transfer of training results to specific contexts of application.
Training planning and implementation
- Allocation of relevant training content via training areas and training profiles
- Flexible target group definition
- Automatic start of digital training
- Adaptive planning of classroom training and training units
- Generation of employee and training matrix
- Automatic creation of skillsets per training profile
- Visualization of training needs and training status
- Intelligent calculation of re-qualifications and automatic submission
- Use of predefined workflows (e.g. read and understood, learning success, training measure release)
- Planning of ad-hoc trainings
Learning success control
- Interactive online tests for closed-loop processes
- Differentiated tests to check comprehension
- Different types of interactive questions/tasks
- Easy creation of tests, online and via drag & drop
- Integration of multimedia elements
- Determination, analysis and documentation of training success
- Verification of correct application of instructions/topics
- Definition of individual evaluation methods and point allocation
- Automatic generation of training certificates completion of test
Tracking and monitoring
- Valuable information about the status of training activities (training progress, training results) through reports
- Training status of the organization by groups, roles or employees
- Employee training measures matrix (overall or area-specific)
- Workflow monitoring
- Overviews of open training measures and training certificates
- Automatic generation and provision of training certificates
- Role-specific training dashboards for management as well as trainers
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All options at a glance
- Flexible structuring and prioritization of training topics or programs
- Management of internal and external trainers
- Management of training content, subjects and documents:
- Digital training of an “instruction” (“read and understood”; self-study)
- Classroom training for instruction
- Classroom training not related to a document
- Target group definition: design of training areas, definition of persons responsible for training areas, assignment of employees to target groups
- Creation of central and target group-specific training profiles and generation of associated skillsets (linking employees to training content)
- Administration of internal and external trainings
- Support of prerequisites for assigning target groups to training measures via training areas and profiles
- Definition of due dates, planned training duration, repetition cycle for periodic trainings (frequency)
- Definition and nomination of target groups based on defined training criteria
- Determination of conditions and exceptions
- Identification and formation of target groups
- Assignment of relevant training content to target groups or trainees
- Re-certification workflow based on a dynamically calculated due dates
- Generation of a matrix of employees and training content (e.g. documents) of a training profile
- Flexible administration of employees and the content to be trained for specific profiles
- Automatic creation of a skillset per profile
- Flexible and traceable modifiation of target groups (areas) and training profiles due to changed employee structures or task areas
- Adaptive planning of training units with automatically generated training plans
- Detailed planning of training units with trainer, duration, location, type of performance review (e.g. online test/individual survey) and training class
- Integration of Microsoft Office applications (Word, Excel, Outlook)
- Definition of mandatory trainings and fixed training periods (full integration into SOP/document management; documents receive the status “released for training”)
- Automatic generation of mandatory trainings (as defined by the company) via training profiles; option to assign employees to multiple profiles
- Automatic generation of mandatory training tasks/units for new instructions and new versions of an instruction; applicable also to employees without PC workstation
- Use of predefined workflows for reading comprehension, verification of learning success or release
- Creation and planning of ad-hoc trainings or unplanned trainings
- Automated request to implement mandatory training measures within a defined period of time.
- System-controlled distribution of “Read and Understood” training (self-training) in case of content (e.g. instruction), new versions of training content (incl. training material), or new trainees assigned to a training profile
- Timely notification of trainers about upcoming training sessions
- Generation of training protocols for printout/upload and feedback forms with training results
- Automated generation of training certificates
- after completion of reading comprehension
- after “pass” feedback by the trainer
- after successful learning outcome check
- Automated creation of a follow-up training in case of failure
- Task assignment as well as training request via e-mail and DHC VISION Task
- Configurable reminder and escalation mechanisms for training execution within a defined training period
- Employee cockpits with personal training/compliance status
- Submission/confirmation of task completion, e.g. reading comprehension, via electronic signatures (21 CFR Part 11 compliant)
- Simultaneous or time-shifted training of employees (no quantitative limitation)
- Event-oriented cancellation – incl. notification and escalation scheme – of training results in case of new training obligation
- Visualization of the life cycle and training results per training unit
- Automatic creation of training protocols and certificates
- Online summaries (attendance, results) for trainers
- Fully traceable training history and status management
- Training progress and status reports
- Personalized training proofs or certificates of successful training
- Custom design of templates (e.g. name badges, manuals, feedback sheets) for classroom training
Learning success control
- Integration of learning success control (interactive online tests) and document management (controlled documents resp. SOPs) within closed loop processes (creation, testing, release for training, training, success control, publication/validation)
- Documentation and analysis of training success with direct reference to topics or documents
- Design of differentiated comprehension tests with input from the author resp. topic owner and based on the actual training content
- Use of different question types (fill-in-the-blanks, drag & drop, image hotspots, memory games, etc ) together with multimedia elements (interactive videos, animations, simulations etc.)
- Definition of assessment and grading methodology with minimum thresholds for passing tests
- Definition of the number of retests in case of failure
- Random display of exam questions; random generation of tests from test question pools
- Workflow for creating, checking and releasing an exam
- Automatic presentation of tests for reading comprehension
- Automatic calculation of the exam result
- Automatic creation of a personalized certificate based on minimum thresholds
- Predefined reports for continuous status learning progress tracking and monitoring of training areas, profiles or single trainings and training tasks.
- Reports on training status of employees or groups of employees in view of their qualification for critical processes or machines resp.for the assessment of retraining or further training needs
- Comprehensive selection parameters for targeted training needs assessements
- Employee training measures matrix (overall or area-specific)
- Matrix with training results per employee (passed, absent, failed, active, canceled, no training required)
- Display of numger of employees in need of training, number of training items, number of training activities, diagrams of training status and results
- Monitoring of workflow activities
- Elastic Search with high-performance search mechanisms as well as context-specific result preparation
- Overviews, also displayed directly on documents, of open tests and summaries of training evidence related to persons or documents resp. topics
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
- Interactive data analytics and business intelligence capabilities to diagnose current and future compliance
- Visualization of compliance KPIs for documents with mandatory acknowledgement
- Employee compliance: percentage and number of employees who have completed all mandatory tasks
- Organizational compliance: Overview of the compliance status of organizational areas
- Development of compliance KPIs over time
- Overview and detailed presentation of compliance-critical statuses
- Recommendation for action to improve compliance KPIs
- Cockpits with information on documents, training content, and mandatory (compliance-relevant) training measures as well as with details on training units (e.g., type of training, type of performance review, duration, location, trainer, life cycle, training results)
- Role-specific dashboards with relevant information for training managemer and trainers with sophisticate drill-down options (detailed view on employees, documents, trainings and measures):
- Trainings and Documents: visualization, number and processing status of training relevant documents, classification of document types, number of training relevant employees, number of training actions as well as their status).
- Status and validity: overdue management with status of document trainings (on schedule, overdue) as well as validity of documents incl. status information (overdue, under revision, still valid) incl. visualization of 90 days forecast
- Training measures: Training profile-related display of document and document-independent trainings, number of deposited employees, number of ongoing trainings (online vs. classroom) as well as degree of coverage of ongoing training measures (absolute and percentage)
- Skillset of employees: Display of all assigned profiles incl. the corresponding skill level and percentage coverage per profile as well as overall across all profiles incl. graphical representation of results of current and last trainings
- Skillset of the training profiles: Visualization of the training status as a matrix of documents/topics and employees
- Ensure legal compliance and certification through automation training actions, tasks, reminders, and escalations.
- Ensuring traceability of the status of training measures
- Complete and audit-proof documentation of training management or qualification levels
- Transparent training processes
- Conformity to 21 CFR Part 11, GxP Guidelines and a variety of other legal regulations
- Ensuring that employees are/will be trained in the applicable version of an instruction in a timely manner.
- Escalation when training deadlines expire
- Fine-granular authorization concept
- Multilingual (unicode-capable); standard scope of delivery: DE and EN
- Easy switching between language versions
- Sophisticated multi-client concept for group-wide training management
Insight into our customer relations
“We were looking for an integrated document, CAPA and process management tool for our Germany-wide branch network in order to digitise the creation, review, approval or training of our SOPs and processes, but also the application of our QM system. Among other things, this is connected with the goal of accelerating our processes and minimising risks. In addition to the beautiful design and the high level of user-friendliness, we were particularly convinced by the implementation concept and the validation expertise of DHC; in retrospect, this was also the case with the consultants during the implementation. DHC VISION has brought us significant steps forward in the field of our quality assurance.”
Validation and compliance consistently in view
DHC VISION is specially designed for use in highly regulated industries. The solution fulfills the GxP guidelines and directives of the FDA, EMA, PIC/S or ICH, as well as 21 CFR Part 11, both technologically and technically (business processes). The Validation Package is available for validating the system. Consisting of the Validation Accelerators (complete documentation set for validation) and the Validation Services for adapting the documentation to your individual situation.
The optimal solution for digital management and control of your specification documentation. Secure, controlled, traceable and compliant (including 21 CFR Part 11).
System processes for Change Control ensure precise management and communication of changes of any kind, from the beginning to the end.
Systematic and controlled documentation, analysis and resolution of non-conformancies to improve quality and compliance.
Whether they come from costumers, suppliers or internal processes – complaints are maneged in a controlled manner. This is done with the highest degree of regulatory (process) security.
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What types of training are supported in combination with DHC VISION SOP Management (controlled documents)?
The SOP Management module provides procedures for distributing documents to a defined group of people. They can be distributed either for information or for acknowledgement. If content needs to be formally trained, further processes are available in a dedicated Training Management module. For example, documents can be automatically forwarded to employees; they confirm that they have “read and understood” the content. The module also covers classroom training or classroom events; trainers receive announcements, participant lists, feedback forms, and much more.
Can DHC VISION Training Management also be used stand-alone?
The SOP Management module is our solution for managing and controlling specification documents. It also provides the basis for employee training. With DHC VISION, we focus on the holistic digitization of the document life cycle. This includes not only the release of documents; it also covers training management and the verification of learning success. Thus, we implement “closed loop processes” – from document creation to learning success monitoring.
DHC VISION beinhaltet hierzu Best-Practices für Qualitätsmanagementprozesse basierend auf über 20 Jahren Erfahrung. Das DHC VISION SOP Management, unsere Lösung zur Dokumentenlenkung, unterstützt darüber hinaus die Einhaltung der strengen Vorschriften und gewährleistet die Compliance-Konformität. Reports, Dashboards oder Monitoring-Mechanismen liefern jederzeit die notwendige Übersicht zum Status der Vorgabedokumentation, deren Gültigkeit sowie zur Nachvollziehbarkeit. Unternehmen sind damit jederzeit auskunftsfähig und bereit für ein Audit.
How does DHC VISION training management differ from learning management systems?
DHC VISION is designed for use in regulated industries, i.e., the pharmaceutical, chemical, medical technology industries. The system, in particular, targets the EMA and FDA regulated world. Hence, its focus is on training content provided in key documents; DHC VISION generates the proof of training required by regulation, which essentially is based on employees testifying that they have “read and understood” the document. The training status of employees commonly is checked in audits and inspections.
Learning Management Systems (LMS) are specialized in HR processes such as education and training, personnel development, or talent management. This usually includes course catalogs, learning media of various formats, e-learning courses to which employees can register themselves. LMS generally include authoring tools for the creation of multimedia learning content.
The validation of such system – not to mention their GxP-compliant development – is very time-consuming, if possible at all. Therefore, LMSs in the life sciences are often used for non-GxP-critical processes and training content only.
Our DHC VISION eDMS, by contrast, is specifically designed for the “validated” environment with its regulations on document management as well as training procedures and functions. The training solution focuses on specification documents, GxP or compliance topics, i.e., training measures and content required by law, regulation, or in-house guidelines – and where 100% traceability is required.