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!!
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