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

Nichelon5 CMS

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 dateIncreased 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), HyderabadAjanta Pharma , AurangabadTrident Pharma HyderabadMatrix 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 Roles GroupsSubjects CoursesQuestions Question Banks

Advantages of grouping featureReduce entry of repetitive informationQuickly assign employees to applicable

GMP and SOP training subjects and courses

Simplified administration

Organize the content

Category 1

Sub Cat 2(1-2)

Sub cat 3(1-3)

Sub-cat 1(1-1)

Topic(1-2-1)

Topic1-2-3

Topic1-2-2

Topic(1-1-1)

Topic1-3-1

Topic1-3-3

Topic21-3-2

Topic(1-1-2)

Topic(1-1-3)

Category 1

Sub Cat 2(1-2)

Sub cat 3(1-3)

Sub-cat 1(1-1)

Topic(1-2-1)

Topic1-2-3

Topic1-2-2

Document 2 Document 3Document 1

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 Training2. External Training3. 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 EvaluationTraining FeedbackSatisfaction Scale TemplateTrainer 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 testingQuestion paper sent to candidates as

per attendance recordDynamic selection of Questions from

Question Banks as per the topicsQuestions 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 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

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-signOnce 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 employeeTraining Certificates for the qualified candidatesTrainer Qualification CertificatesEmployees that have met the certification

requirements for a courseEmployees that have completed trainingEmployees that were absent from a training courseEmployees 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 industriesNicehlon5 is completely 21 CFR part 11

compliant.Audit trails on all the functionsAudit ready reportsFool proof record storingDocument 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

SO

A L

ayer

DB (SQL/ ORACLE)

Data Access Layer

User Interface LayerIE5.5

Business LogicASP.net

Tra

nsac

tion

inte

rfac

e L

ayer

Messaging

services

Mail Response Services

Status query

services

ERP

MES

InstrumentsInterface

Highly scalable architecture

N-tier Web Architecture.

Benefits

Scalable solution that is simple to manageImproved training documentation consistencyDocuments are easily retrievableConsistency and quality of work enhancedSecure application with unlimited number of

different roles with varying levels of accessEnforces compliance with 21 CFR Part 11

Key Features of Nichelon5

GroupingSchedulingDynamic TestingVersion Control of Training DocsDrill down Reports to last record levelGraphical 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 Medical examination centreNext Medical examination due date

Nichelon5

… Align your forces, for a better tomorrow!!