Training information Management System …… for the Regulated Industries !!

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

2. The Industry Need !! • The FDA cGMP under 820.25 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 !!

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];

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

5. 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. 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. How will Nichelon5 Helps you??

8. Manage Training – Life cycle

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

11. 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. 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. 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. Organize the content

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

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

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

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

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

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

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

27. Configurable FeedbackTemplate User definable satisfaction template

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

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

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

34. 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

36. Group Training Plan

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

41. User definable Mail templates.

42. Configurable home page Dash-Boards

43. Drill down charts: First Chart: Show all the groups: with Group name

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

45. 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..

47. 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. Audit trails with changes and reasons captured as 21 CFR part 11

49. Technology:

50. .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