Nichelon

5 CMS

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

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 !!

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];



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

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.

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

How will Nichelon5 Helps you??

Manage Training – Life cycle

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

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)

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 !

GROUPING...

To reduce Repetitive entry !

 Types of grouping:    Employees  Subjects  Roles Courses  Questions  Groups 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

Organize the content

Sub-cat 1 (1-1) Topic (1-1-1) Topic (1-1-2) Topic (1-1-3) Category 1 Sub Cat 2 (1-2) Topic (1-2-1) Topic 1-2-2 Topic 1-2-3 Sub cat 3 (1-3) Topic 1-3-1 Topic2 1-3-2 Topic 1-3-3 Sub-cat 1 (1-1) Topic 1-2-2 Document 1 Category 1 Sub Cat 2 (1-2) Topic (1-2-1) Document 2 Sub cat 3 (1-3) Topic 1-2-3 Document 3

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

Job Responsibility:

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

Plan • How – Group Training Plan.

• When -- Calendar • By whom- Trainer Qualification • Where- Venue

Course Registration:

Easy selection of the topics through drill down tree structure.

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

Trainer Qualification.

Re-qualification of the trainer Courses, for which trainer is qualified

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

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.

Types of Trainings

To suite the industry

Nichelon5

facilitates: 1.

Internal Class Room Training 2.

3.

External Training Content Delivery with Examination (Online document Delivery) 4.

Content delivery with Review (On-line Document Delivery with Read confirmation)

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

Configurable Templates

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

Configurable Feedback Template

User definable satisfaction template

Batch Formation:

Forma a batch from: •Responded •Nominated & •Not responded (on line) candidates

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

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

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.

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

Training status

    Qualified candidates will get certificate.

Candidates not responded re-listed for training will go into Skipped status and will be Candidates not attended absentees after confirmation will be listed into Candidates given exam but failed re-training will be disqualified and listed for

Group Training Plan

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.

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

Auto Mails through Lotus Notes/ Out look

Auto mails on a wide range of information triggers.

User definable Mail templates.

Configurable home page Dash-Boards

Drill down charts:

First Chart: Show all the groups: with Group name

Drill down chart:

Subgroups: Click on any group: It displays all the subgroups in it.

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..

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

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

Technology:

.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

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

N-tier Web Architecture.

Messaging services Status query services Mail Response Services DB (SQL/ ORACLE) Data Access Layer Business Logic ASP.net

User Interface Layer IE5.5

Highly scalable architecture

ERP Instruments Interface MES

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

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

Nichelon5 integration

 Nichelon can be configured to integrate with other applications such as Human Resource records management systems and external email services.

 Integration ensures that employee information remains consistent across the entire enterprise.

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

Employee Medical Registration

Captures Employee details Next Medical examination due date Medical examination centre

Nichelon5

… Align your forces, for a better tomorrow!!