1. Nichelon5 CMS Training information Management System
……for the Regulated Industries !! 1

2. The Industry Need !! Not Documented… Not Trained !!
The FDA cGMP under Personnel (b) Training. "Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented."
Not Documented… Not Trained !! 2

3. One of the many 483s on Training!
You hired a new Quality System Manager but did not provide this employee with quality system training [FDA-483 item 7]; 3

4.  Nichelon 5 What is in the name:
Two very appropriate and meaningful words make this newly coined word, Nichelon!!.
Niche: A special area of demand for a product or service:
Echelon: A similar formation of groups, units, or individuals
Niche & Echelon  Nichelon
5 is a number often used for indicating highest maturity of a company, or a person. Just like level5 company, level 5 leader. …… Nichelon5 CMS 4

5. Nichelon5: what is in the Name??
In the present knowledge driven world, managing the competency is the key success factor and scale to measure business maturity. Systematic approach towards competency management of the team would yield greater business achievements, which will eventually lead to becoming a level 5 company.
We strongly believe, our software application helps a company to achieve aligning their team by systematically managing the competency of each individual to achieve a level 5 status in their business. Our software application, Nichelon5, helps the company to align their every individual of the team to be competent to taken on the world.
Regulated industry ‘Niche’, would be greatly benefited by Nicehlon5, as it enforces compliance to the required Competency management Norms. 5

6. Pharma Industry Challenges
Increased FDA Regulations on the GMP training.
Need for OJT records to be up to date
Increased cost of Non conformance due to non availability of Training Records
Increased cost of record keeping, tracing and compiling the reports. 6

7. Companies Using N5 Aurobindo ( 3 units), Hyderabad
Ajanta Pharma , Aurangabad
Trident Pharma Hyderabad
Matrix laboratories (Enterprise wide)
Hetero Drugs (Enterprise wide)
Audited by regulatory bodies like : FDA, MHRA in the client locations 7

8. How will Nichelon5 Helps you??8

9. Manage Training – Life cycle9

10. 10

11. Who should be trained, on What Group People - Group Content
Identify
Who should be trained, on What
Group People - Group Content
Job Responsibility 11

12. Simple Process Step 1: Organize your training content by:
Category Sub-Category Topic Docs
Eg: Production  Sifting Handling Pellets  SOPs
Step 2: Select topics from one or more subcategories to form a Course.
Step 3: Combine set of courses to Make a Group Training plan (GTP)‏ 12

13. Step 2: Organize People into Competency groups/Subgropus
Eg: Production, QA, QC, RA, Warehouse
Step 3: Map GTP to Groups and Sub groups!!
….. Training needs created accordingly! 13

14. GROUPING... To reduce Repetitive entry !
Types of grouping:
Employees  Roles  Groups
Subjects  Courses
Questions  Question Banks
Advantages of grouping feature
Reduce entry of repetitive information
Quickly assign employees to applicable GMP and SOP training subjects and courses
Simplified administration 14

15. Organize the content 15

16. One time masters!
Course: Each training course consists of a set of Topics from one or many categories.
Training Plan: A Set of courses for a group of people have to undergo during a set period
Courses wise Training needs will be listed in one screen for Planning a Training Session 16

17. Job Responsibility:
Job Responsibility can be created and stored with version control & audit trails. 17

18. How – Group Training Plan. When -- Calendar
By whom- Trainer Qualification
Where- Venue 18

19. Course Registration:
Easy selection of the topics through drill down tree structure. 19

20. Automatic Training need creation:
Candidates training requirements are mapped and listed against each course
If a new person joins the team, allot the person to a group/ subgroup, automatically all the training needs will be created for that person.
Training department can plan the training based on the course, thorough more than one session, as per the need 20

21. Trainer Qualification.
Re-qualification of the trainer
Courses, for which trainer is qualified 21

22. 22

23. Choose trainer, Venue and Training Method Batch people for training
Execute
Schedule Training
Choose trainer, Venue and Training Method
Batch people for training
Prepare Question Banks 23

24. SCHEDULING
Automatically schedule training courses based on subject and course, date, time and duration, instructor, and employees to attend.
Instructors can be assigned to teach a subject through scheduling feature
Assign training rooms
Automatically or manually invite employees to training session. 24

25. Types of Trainings To suite the industry Nichelon5 facilitates:
Internal Class Room Training
External Training
Content Delivery with Examination- (Online document Delivery)‏
Content delivery with Review
(On-line Document Delivery with Read confirmation)‏ 25

26. Type of Trainings Evaluation: 1. Long Term 2. Shop-floor
Training Feedback 26

27. Configurable Templates
Configurable Templates, to suite to your needs
Immediate Evaluation
Long Term Evaluation
Training Feedback
Satisfaction Scale Template
Trainer Feedback 27

28. Configurable Feedback Template
User definable satisfaction template 28

29. Batch Formation: Forma a batch from: Responded Nominated &
Not responded (on- line) candidates 29

30. Prepare Question Paper & Release
Evaluate
Mark Attendance
Prepare Question Paper & Release
Long Term & Short term Evaluation/ Feedback
Evaluate Answer sheets & Certify 30

31. Testing & Qualification.
Online or Off line testing
Question paper sent to candidates as per attendance record
Dynamic selection of Questions from Question Banks as per the topics
Questions selected randomly or Manually 31

32. Dynamic Testing
Either essay or multiple choice questions can be created by trainer and the weight of each question decided by them.
Tests can be comprised of both types of questions.
Multiple choice, True or False questions, can be evaluated by the system Automatically.
Once essay questions are scored, an employees results are calculated and employee training record is updated dynamically. 32

33. Track training status by groups Pull training records of a person
View training calendars
Various reports 33

34. 34

35. Training status Qualified candidates will get certificate.
Candidates not responded will go into Skipped status and will be re-listed for training
Candidates not attended after confirmation will be listed into absentees
Candidates given exam but failed will be disqualified and listed for re-training 35

36. 36

37. Group Training Plan 37

38. Content Review
As a part of training for the senior management, documents (SOPs) are sent for Review.
System sends a Document link through internal Mail
Document can be opened through the link
Reading Confirmation obtained while closing the file with E-sign
Once Read confirmation is done, training records updated. 38

39. Report Generation Nichelon5 can generate any report that
Employees trained on specific Training plan.
Courses assigned to an employee
Training Certificates for the qualified candidates
Trainer Qualification Certificates
Employees that have met the certification requirements for a course
Employees that have completed training
Employees that were absent from a training course
Employees that need to be re-certified 39

40. Auto Mails through Lotus Notes/ Out look
Auto mails on a wide range of information triggers. 40

41. 41

42. User definable Mail templates.42

43. Configurable home page Dash-Boards43

44. Drill down charts: First Chart: Show all the groups: with Group name44

45. Drill down chart:
Subgroups: Click on any group: It displays all the subgroups in it. 45

46. Drill down chart:
User training status information: Click on any information it gives the status information.
Click on any of the figures it gives information about the session and other details.. 46

47. 47

48. 21 CFR compliant Nichelon5 designed for regulated industries
Nicehlon5 is completely 21 CFR part 11 compliant.
Audit trails on all the functions
Audit ready reports
Fool proof record storing
Document Management for Training material 48

49. Audit trails with changes and reasons captured as 21 CFR part 1149

50. Technology: 50

51. .Net Technology
Ninchelon5 is a web based application built on Microsoft’s distributed .Net architecture.
Provides maximum flexibility and scalability for the application.
Nichelon5 can be installed on Lan, Wan, Intranet or Internet.
This distributed architecture consists of multiple tiers that isolate the complexity of distributed processing and provide support for multiple databases, security settings, and end user configuration options
21 CFR Part 11 Compliant system 51

52. Application Architecture
Developed on MS ASP.net
Nichelon5 versions are developed on specially designed OOPS model to suite the regulated industry practices. (GLP)‏
Increased configurability of the objects
Flexible architecture to Communicate with external applications 52

53. Transaction interface
N-tier Web Architecture.
SOA Layer
DB (SQL/ ORACLE)‏
Messaging
services
ERP
Data Access Layer
Status
query
services
Instruments
Interface
Transaction interface
Layer
Business Logic
ASP.net
Mail
Response
Services
MES
User Interface Layer
IE5.5
Highly scalable architecture 53

54. Benefits Scalable solution that is simple to manage
Improved training documentation consistency
Documents are easily retrievable
Consistency and quality of work enhanced
Secure application with unlimited number of different roles with varying levels of access
Enforces compliance with 21 CFR Part 11 54

55. Key Features of Nichelon5
Grouping
Scheduling
Dynamic Testing
Version Control of Training Docs
Drill down Reports to last record level
Graphical Representation of the status 55

56. Nichelon5 integration
Nichelon can be configured to integrate with other applications such as Human Resource records management systems and external services.
Integration ensures that employee information remains consistent across the entire enterprise. 56

57. External training Cost
Captures following details:
No. of training hours
Cost per hour
Registration Charges
Training venue 57

58. Employee Medical Registration
Captures Employee details Medical examination centre
Next Medical examination due date 58

59. Nichelon5
… Align your forces, for a better tomorrow!! 59