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Nichelon5 CMS
T h e Tr a i n i n g M a n a g e m e n t S y s t e m
 Identify Plan

The Difference Matters

to You

Nichelon5 CMS addresses every practical Who should be trained & on What How – Group Training Plan
aspect of training management
Job Description When - Training Calendar
Designed to meet 21 CFR Part 11 People Groups Where - Venue
electronic signature, data & access security
norms
Content Groups What - Training Method
Qualified Trainers Question Banks
Built-in content management (Document
Management System) with version control

Facilitates training by document review
for senior management
Comprehensive range of training scenarios
- class room, external, on-the-job and
computer, training
Training Management with automated
document review, and planning /
archiving tools for scheduled, unscheduled
and completed trainings
Scalable Enterprise Architecture to support
growth and multiple sites
Managing GMP personnel competency levels and status across the enterprise is a big challenge for
Training Coordinators and Department Managers. Systematic planning, execution and the required
testing effectiveness make this an extremely difficult task. Quick tracing of records from numerous
archives is an even bigger challenge, as evidenced by the huge number of reported 483s observations
(non-compliance), related to training and training records.
Nichelon5 CMS is designed to meet these challenges with regulatory compliance through paperless
management of the entire training life cycle – from initial planning to the training event, the exam
evaluation, training certification and post training effectiveness; all with complete traceability.
Nichelon5 CMS offers complete configurability, integrated version management of the course material,
extensive question banks and more. Closed-loop tracking of the entire training cycle and electronic
signatures ensures compliance to GMP Training needs and 21 CFR part 11 guidelines. The Nichelon5
CMS comprehensive functionality also makes managing non-compliance issues a breeze.

Dash boards and easily customizable

reports for quick information access

Implementation & Maintenance as per

GAMP guidelines
 Execute Evaluate Track

Schedule Training Trainer Feedback Training Status by Groups

Batch Trainees Long / Short Term Evaluation Training Records of a Person
Mark Attendance Test Results & Certification Training Calendars
Prepare Exam Questions Training Cost Drill-down Dashboard
On-line / Offline Exam Re-training Need Analysis Transaction Audit Trails

Comprehensive and Closed Loop Training Process and Tracking

The Nichelon5 CMS will, as its most basic function, organize your Courses, Training Events and manage & track the training records of all employees
across your organization. Yet, Nichelon5's CMS does much more than simply manage this information. It is also a powerful tool for automating your
workforce qualification. Utilizing the automated job descriptions as a baseline, each employee has their own customized training plan with both required
& elective activities clearly detailed with automatically populated training dates. Once the plan is in place, the Nichelon5 CMS then automatically tracks
the lifecycle of each training event from emailed notification of upcoming events to the capturing of the
training event, the generation of the Training Record that gives a transparent qualification status with
automated periodical management checks for effectiveness.

The net result is that your training program is under control, your employees are qualified to perform
their job and you can monitor everyone's progress by simply logging into the system It also provides you
the capabilities of integrating your training process and you will be in compliance with your corporate
management and regulatory agencies training requirements.

Training status Tracking

To be planned
List of the candidates whose training is yet to be
planned
Skipped
Candidates who have not responded will go into
the “Skipped” status and will be listed for to be
planned
Absentees
who did not attend after confirmation will be
listed as “Absentees

To be Retrained
Candidates who have taken an exam but did not
pass will be to be planned
Qualified
Candidates who have taken an exam and passed
are considered “Qualified
Quick Access Panel
Reports and Analytics Key Range of Reports
Training Schedule (calendar)
Reports that can be tracked for a particular employee
Job Responsibility (Role & Individual)
Employee Training Status
Job Responsibility Employee Document Read confirmation
Training Card
Group Training Plan
EMPLOYEE Training History
TRAINING Scheduled Trainings Date-wise Course Sessions
STATUS Attendance Report
Training Evaluation Documents to be reviewed
Qualified Trainers
Training History Record
Course Session(s) Duration
Training Evaluation Record

Alert & Task Control ER&ES Rule Compliant

SOP training on CGLP for new joinees
Training on Validation & Documentation
Nichelon5 CMS is built on a robust Web Technology Enterprise Grade application architecture and thus is
capable of easily meeting the requirements of both large, enterprise wide and small company implementations
with equal ease. Nichelon5 CMS is designed to work in a regulatory environment and so complies with the
stringent regulations on electronic documents and electronic signatures. This can allow for a security
enforcement policy that is in line with the ER & ES rules. It also provides a complete audit trail for master
records registration and maintenance and training programs registration & approval. It comes with the
advantages of Role-based security and separate, configurable security profiles for electronic signature and
application authentication.

What's more! It is designed on 100% web Technology to ensure low cost of ownership.

See what Nichelon can do for you

Take the first step towards reducing your risk of Training System 483 observations and the consequence of
Task Alerts non-compliance by considering Nichelon5 CSM to efficiently manage organizational trainings, knowledge
transfer and to ensure keeping of compliant training records.
Email Alerts Call us on 91 40 23811322 or log on to www.nichelon.com today.

SOP training Alerts

Training Announcements
n i c h e l o n
Infotech Services Pvt. Ltd.

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Nichelon has positioned itself to provide world class Training Information Management Solutions to the
Quality Intensive and Regulated Industries of BioPharmaceuticals. The solution is constructed on a proven
risk prevention based compliance framework. The Company's emphasis on Comprehensiveness of Solutions,
all-round Quality, Operational Ease, Cost effectiveness, and Exemplary Post-implementation Support have
enabled Nichelon to gain the respect of a host of reputed clients.

US & Europe: Asia Pacific:

1701 McFarland Rd., Suite 200 B-36, Sanathnagar Industrial Estate
Pittsburgh PA 15216-1812 Sanathnagar, Hyderabad-500018, India
TollFree: 1 888 510 LIMS Ph.: 91-40-23811322
Office: 1 (412) 499 3442 Fax.: 91-40-23817922
Email: info@nichelon.com
URL: www.nichelon.com