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the Training Management System for pharmaceutical industry and quality oriented organizations

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  1. 1. the eLearning Management System for pharmaceutical industry and quality-oriented organizations Copyright © 2012 Web Site srl by
  2. 2. designed thinking to the world ItalySpain UK Germany SwitzerlandBelgiumUSA India Brazil 100% web based can be used from anywhere, using a simple, last generation multi-language accessible by each user in his/her own language (Unicode support) centralized installation system easy to manage and update, while guaranteeing maximum autonomy to each site tested on the ground chosen by some of the largest pharmaceutical companies for their plants worldwide
  3. 3. built on architecture of enterprise level
  4. 4. system users supervisor checks qualification status of his/her department trainer trains people: he/she is able to prepare courses and manage sessions training office central or departmental, has to manage the system: the group is enabled to use all the webTraining’s functionalities, within its sphere of responsibility system administrator creates profiles and users, assigns access rights to functions; checks audit-trail trainee he/she is able to do self- enrollment, self-training and self-exam
  5. 5. features
  6. 6. full featured and complete training needs definition / planning /updating training needs detection sessions scheduling training delivery training status monitoring
  7. 7. definition of training needs by specifying:  the role of each employee  the business activities (tasks) for each role  the training courses required to be qualified for each activity analyst Quality Control Blood Testing Trending Documenting and Investigating … Course . . . . . . . . . . . . . Investigation and Retest … Strip Sampling Activity … Results Trending
  8. 8. planning of complementary trainings easy, flexible and powerful management of individual training plans  centralized general planning (coarse-grained)  distributed refinement (by supervisor) monitoring of distributed planning activities monitoring of execution against planned courses comprehensive final certification
  9. 9. automatic detection of training needs for:  new employees and contractors  changes of role  addition of new activities  revision of procedures  re-training and from individually planned courses
  10. 10. session management courses preparation with complex training material (PDF, PowerPoint, off-the-shelf courseware, SCORM, Internet/Intranet sites, …) and questionnaires creation & management of training sessions monitoring of training session status electronic training notification/reminder, grouped by recipient, through flexible scheduling system and customizable texts
  11. 11. classroom / on-the-job self-service flexible training delivery  downloading of training material  powerful results registration by trainer  trainee’s e-signature  scanning of manually signed training cards  on line self-enrollment  on line self-training  on line self-examination  automatic registration of training result  view/print own qualification against role’s courses and training plan
  12. 12. paperless every attendance has trainer’s and trainee’s e- signature backup functions for uploading of manually signed documents single access point to personal documents (training cards, questionnaires, certificates, etc.) system-generated or scanned
  13. 13. certification issuing starting training package individual training plan periodic certification of individual qualification  the process is repeatable for each new activity assigned to the employee, thus allowing reduction of training cycle time and increase of productivity
  14. 14. rich reporting system complete set of reporting features to:  monitor training status at all levels (individual, department, site)  analyze amount of training hours, results, attended courses, organizational and role changes, etc. KPI on training gaps, training effectiveness Business Intelligence module to create instant and personalized analysis
  15. 15. usability internet/intranet platform for: system usability from any place easy and intuitive user interface easy (centralized) software deployment and updating
  16. 16. compliance
  17. 17. standards-compliant  is in compliance with 21 CFR part 11 rule:  electronic signature  recording for data changes  flexible access rights management  recording for accesses and not authorized accesses management  audit-trail analysis
  18. 18. traceability  all the changes are tracked through the item versioning:  role changes  activity changes  role revision  activity revision  course revision  the training status is available per any given time period
  19. 19. integration
  20. 20. integration with eDMS  flexible support for complex issuing processes of new SOPs:  SOP pre-release training management with notification to DMS of training result  new SOP or new edition when the training is not required  possibility to treat the SOP and related forms as unique training object  capability to receive an electronic questionnaire from DMS, approved together with the referred SOP  capability to treat small changes to SOPs without generating training gaps
  21. 21. eDMS Connector Integration Agent webTraining Database webTRAINING Application webTRAINING Integration Module webTRAINING Connectors Integration Queues eDMS eDMS Database Document Management 1 - The Connector periodically captures new documents from eDMS … 2 - and copies them into Integration Queues 3 - The Integration Agent reads new document from Integration Queues … 4 - and creates related training object and course 5 - Training Office member completes course, selects trainees (from a list provided by the system), organizes training sessions, closes training on new procedure 6 - The system generates a message for the eDMS with the training result 9 - The eDMS promotes or withdraws the procedure according to the training result 7 - The Connector reads result from Integration Queues … 8 - and passes it to eDMS 1 2 3 4 5 6 7 8 9 integration module
  22. 22. integration with MES check for operator’s qualification at Manufacturing Execution System login: at material level at equipment level at procedures level
  23. 23. software life cycle
  24. 24. evolution and maintenance activities governed by corporate methodology  guided by GAMP (Good Automated Manufacturing Practice)  audited by some of the largest pharmaceutical companies  ISO 9001:2008 certified
  25. 25. support well defined SLA, procedures, reporting dedicated team specialized software for issues management
  26. 26. summary
  27. 27. 100% “21 cfr part 11 compliant” 100% web based internationalized installed on a single central site for all company’s plants built on enterprise level architecture full featured paperless easy to use
  28. 28. more info: Renzo Santarelli general manager +39 06 9320235 Web Site srl Via Cavour, 20 00041 Albano Laziale (RM) +39 06 9320235 contact us