This document describes an eLearning management system called webTraining designed for pharmaceutical companies and quality-focused organizations. Some key features include being 100% web-based and accessible from anywhere, fully compliant with 21 CFR Part 11 regulations, able to integrate with electronic document management systems and manufacturing execution systems, and offering comprehensive training management functionality such as needs assessment, planning, delivery, monitoring, and reporting across multiple international sites from a single centralized installation. The system aims to simplify training processes and documentation while ensuring regulatory compliance.

1. the eLearning Management System for pharmaceutical
industry and quality-oriented organizations
Copyright © 2012 Web Site srl
by

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. built on architecture of enterprise
level

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. features

6. full featured and complete
training needs
definition /
planning /updating
training needs
detection
sessions
scheduling
training
delivery
training status
monitoring

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. 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. 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. 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. 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. 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. 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. 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. usability
internet/intranet platform for:
system usability from any place
easy and intuitive user interface
easy (centralized) software deployment
and updating

16. compliance

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. 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. integration

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. 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. integration with MES
check for operator’s qualification at
Manufacturing Execution System login:
at material level
at equipment level
at procedures level

23. software life cycle

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. support
well defined SLA, procedures, reporting
dedicated team
specialized software for issues
management

26. summary

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. more info:
http://www.websiteitalia.com/#/en/prodotti/webtraining
Renzo Santarelli
general manager
renzo.santarelli@websiteitalia.com
+39 06 9320235
Web Site srl
Via Cavour, 20
00041 Albano Laziale (RM)
+39 06 9320235
contact us