UG-105 Elements of Intellect eQMS Employee Training - End User Guideline

Elements of Intellect’s Quality
Management System:
Employee Training
Document #: UG-105 Revision: A
Document Type: User Guideline Status: Released
Department Owner: Quality Date Effective: September 17, 2018
Document Owner: Tejas Puranik Author: Paul Dionne
Notes: This document is established to provide a guideline for an End User.
Formatting:
• Field Names are in Bold
• Personal Navigation items in Italics
• TABS labels in All Caps
• BUTTONS in Bold All Caps
Role Approver Signature Date
Chief Customer Officer James L. de Vera See EDMS See EDMS
Chief Technology Officer Selim Ozyel See EDMS See EDMS
Chief Marketing Officer & VP

Peter Hargittay See EDMS See EDMS
Business Development
Vice President Peter Cutler See EDMS See EDMS
This confidential document is the property of Intellect and shall not be reproduced, distributed, disclosed or used without the express written consent of
Intellect.
Elements of Intellect eQMS: Employee Training
App
Table of Contents
1.0 Introduction ................................................................................................................................. 1
2.0 Scope .......................................................................................................................................... 1
3.0 External References .................................................................................................................... 2
4.0 Definitions ................................................................................................................................... 3
5.0 General Requirements ................................................................................................................ 4
6.0 Intellect Out-Of-The-Box User Groups ........................................................................................ 4
7.0 Logging Into Intellect Eqms Suite ................................................................................................ 5
8.0 Architecture: Employee Training ................................................................................................. 6
8.1 Personal Navigation Panel....................................................................................................... 7
9.0 Employee Training Process Overview (High-Level Description) ................................................ 10
10.0 Create And Manage Training Courses ...................................................................................... 11
10.1 Create A New Training Course .............................................................................................. 11
10.1.1 Create Through Personal Training Tab ........................................................................... 11
10.1.2 Create Through A Controlled Document ......................................................................... 11
10.1.3 Create Through Training Management Tab .................................................................... 12
10.2 Enter New Training Course Information ................................................................................. 13
10.3 Create Quizzes ...................................................................................................................... 17
10.4 Start The Training .................................................................................................................. 19
11.0 Create And Manage Training Scheduling .................................................................................. 20
11.1.1 From The Navigation Panel ............................................................................................ 20
11.1.2 From An Existing Course ................................................................................................ 20
11.2 Enter Training Course Details ................................................................................................ 21
11.3 Build A List Of Enrollees ........................................................................................................ 22
11.4 Start Training ......................................................................................................................... 22
12.0 Complete Training (Workflow View) .......................................................................................... 24
12.1 Start A Training Activity ......................................................................................................... 25
12.1.1 Through Personal Navigation ......................................................................................... 25
12.1.2 Through Dashboard ........................................................................................................ 25
12.2 Complete Training ................................................................................................................. 26
12.3 Trainer Review Of Results ..................................................................................................... 29
12.4 Department Head Review Of Training Or Quiz Results ......................................................... 30
13.0 Searching Records, Courses And Schedules ............................................................................ 30
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13.1 Search My Training Records ................................................................................................. 31

13.2 Search My Staff’s Training Records....................................................................................... 32
13.3 Training Management: Search My Schedulings ..................................................................... 33
13.4 Training Management: Search My Training Courses ............................................................. 34
13.5 Using Main Search Tab ......................................................................................................... 34
13.5.1 Search Training Records ................................................................................................ 35
13.5.2 Search Training Courses ................................................................................................ 35
13.5.3 Search Training Schedules ............................................................................................. 36
14.0 Report Tab ................................................................................................................................ 36
14.1 Reports By “Employee” .......................................................................................................... 36
14.2 Reports By “Department” ....................................................................................................... 37
14.3 Reports By “Job Title” ............................................................................................................ 38
14.4 Miscellaneous Reports .......................................................................................................... 39
15.0 FAQS ........................................................................................................................................ 39
16.0 Intellect Forum .......................................................................................................................... 40
17.0 Summary Of Quality Systems Requirements ............................................................................ 40
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1.0 INTRODUCTION
The business value of training is to help ensure that employees have the required
knowledge to successfully complete work. Government regulators, ISO representatives,
customers and other auditing entities may require an auditable trail of training. If it has
not been documented that an employee received training related to their work, then
auditing entities will not consider that employee qualified to do the work. Proper training
also reduces the chance of scrap, rework or recalls by ensuring compliance with the
company’s established policies and procedures.
Employee Training is an application where training courses are created (either from
documents or independently), scheduled and conducted, quizzes are administered and
periodic training schedules are automated for certain departments and/or employees. The
icon for the Employee Training App can be found on the Dashboard after logging in. If the
Dashboard is not available, navigate to the top of the page, click the upside-down triangle
icon next to the current app in use, and select ‘Employee Training’ from the list of apps.
The eQMS Employee Training App is designed to track the training on controlled
documents in the Document Control App and it can be used to create and support other
training.
The purpose of this document is to provide a detailed explanation of the following:

a. Fundamental features of Intellect’s out-of-the-box Quality Management System
Employee Training App
b. Steps on creating a training course through release
c. Steps on creating a training schedule through release
d. Assign employees to scheduled trainings
e. Complete trainings
f. Manage training records
Topics covered in this document will help you become proficient with Employee Training
Application.
2.0 SCOPE
The scope of this document is limited to Intellect’s out-of-the-box configuration for the
Employee Training App.
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3.0 EXTERNAL REFERENCES

Intellect eQMS Employee Training App complies to the following ISO and FDA standards;
but are not limited to:
Standard Name
ISO 14001 Environmental Management
ISO 13485 Medical Devices
21 CFR PART 11 Electronic Records; Electronic Signatures
21 CFR PART 111 Dietary Supplements
Current good manufacturing practice in manufacturing,

21 CFR PART 210 & 211
processing, packing, or holding of drugs; general
Current good manufacturing practice for blood and blood

21 CFR PART 606
components
21 CFR PART 820 Quality System Regulation
21 CFR PART 1270 &

Human cells, tissues, and cellular and tissue-based products
1271
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This confidential document is the property of Intellect and shall not be reproduced, distributed, disclosed or used without the express written
consent of Intellect.
App
4.0 DEFINITIONS
Term Definition
A quality management system (QMS) is a formalized

QMS system that documents processes, procedures, and
responsibilities for achieving quality policies and objectives.
OOTB Out-of-the-Box
User An entity that has an authority to use eQMS suite of apps.
A collection of users with similar roles and responsibilities in

the system. Individual users inherit their rights to access,
User Group
read, write, edit or delete data in the system depending on
the User Groups they belong to.
Template is a form used for designing the layout, adding
Template
calculations and setting up connections between fields.
A table contains copy of the template (Form) with the ability

Table
to store information/data for multiple instances (records).
A workflow is a visual representation of sequence of steps

Workflow
to complete an activity.
A macro is a collection of instructions to automate the

Macros
performance an activity.
A document of such importance that because of its nature,
requires review and sign-off before becoming official.
Controlled Document Examples of Controlled Documents include policies,
standard operating procedures, designs, data-sheets,
contracts, applications, plans etc…
Instance An individual record in a table.
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5.0 GENERAL REQUIREMENTS

The Intellect Enterprise Quality Management System (eQMS) is designed on our
Business Process Management (BPM). Refer “Introduction to BPM Platform” under
Intellect University App on Intellect Connect site (connect.intellect.com) for more
information.
6.0 INTELLECT OUT-OF-THE-BOX USER GROUPS
User Group Description of Access
Access to the SETTINGS tab in each of the apps in eQMS.

Administrators
Full access to the Administrator App.
Customer Service Access only to the Complaint Management App.
Full access to all eQMS apps. Access to the Designer App

Designers including ability to add/remove fields, add/remove macros
and change workflows.
Access to the EXECUTIVE tab under dashboard app. Can be
Executives secondary approvers for Document Change Request activity
in the Document Control App.
General User General access to all apps in eQMS.
Access to MY DEPARTMENT tab in the Dashboard App.

Management
Management group access to all apps in eQMS.
Responsible to review the different processes when
Quality Control
submitted.
For new employees in training. Limited access to the
Trainee
Document Control and Employee Training Apps.
Document Set Effective date and Version #, ability to edit document
Administrator fields. Access to Document Control App.
Can access the previous versions of the document and
Document Control
approve document changes
No access to any eQMS Apps. May only access Activities
Purchasing
assigned to them.
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7.0 LOGGING INTO INTELLECT EQMS SUITE

Intellect eQMS Login page is displayed once you open the URL, which is typically
formed as: https://yoursitename.intellect.com.
Intellect eQMS login screen allows you to do the following:
A. Log into Intellect eQMS

B. Change your password
C. Open in New Window
D. Remember Me
Note: The system is set to time-out after 60
minutes of inactivity (this can be changed
based on your company’s requirements).
Depending on the user’s access, the

Dashboard on the Home application is
displayed after logging-in. Navigate and
open the Employee Training App.
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8.0 ARCHITECTURE: EMPLOYEE TRAINING

All Intellect QMS documents have the same layout that includes following elements:
A. App Switcher D. Application Explorer Tabs
B. User Profile E. Sub-Content Tabs
C. Left Side Bar F. Display Setting
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App Swticher Allows users to switch between different applications in Intellect

eQMS
User Profile
Displays logged in user credentials
Left Side Bar Incorporates Personal Navigation to view My Training Activites and
Insert New Training Schedule or New Training Course
Application
Explorer Tabs Allows user to view their training records. Depending on access, it
also allows users to manage their staff training.
Sub-Content
Tabs Allows user to view training in categories of In Progress, Completed,
Soon to be Expired, or to search records
Drop-Down
Drop-down to hide Header and Side Bar
8.1 PERSONAL NAVIGATION PANEL

This allows users to view their
training in progress and allows user
to create a new training schedule or
new training course. Refer Section
10 for step-by-step instructions on
creating a New Training Course,
Section 11 for creating a New
Training Schedule and Section 12
for completing a training.
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•This includes different sub-tabs: In Progress, Completed, Soon to be

MY TRAINING Expired, Search My Training Records.
RECORDS •These sub-tabs allow logged-in user to navigate to their respective
trainings and take action where appropriate.
MY STAFF’S
TRAINING •This tab can be used to view training records for the user’s staff.
RECORDS
•This tab can be used to manage training including adding/removing

TRAINING
enrollees, modifying dates, updating course info, updating schedule
MANAGEMENT
info, cancelling classes and making courses obsole.
SEARCH •In this tab, select one or more search criteria.
•This tab includes out-of-the-box reports including Reports by

REPORTS
Employee, Reports by Job Title, Reports by Department. Contact your
administrator, or see UG-104, User Guide: Administrator, Employee
Training App
HELP
•This tab includes a selection of tools, videos, and documents as
onscreen instruction for the users
•This tab is used to set up and edit training categories, disclaimers and
SETTINGS switch between Automatic or Manual assignment of Training Course
ID.
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This confidential document is the property of Intellect and shall not be reproduced, distributed, disclosed or used without the express written consent
of Intellect.
App
Please note the access to the above tabs depends on the user’s group access. Refer to the table below.
My Staff’s
Tabs My Training Training
Training Search Reports Help Settings
Records Management
Records
User Group
Administrator X X X X X X X
Customer Service No Access to Training App
Designer X X X X X X X
Executives X X X X X X
General User X X X X X X
Management X X X X X X
Quality Control X X X X X X
Trainee X X X X X X
Document
No Access to Training App
Administrator
Document Control No Access to Training App
Purchasing No Access to Training App
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9.0 EMPLOYEE TRAINING PROCESS OVERVIEW (HIGH-LEVEL

DESCRIPTION)
The out-of-the-box Employee Training App is an application where courses can be
created, scheduled, and records of trainings are automatically retained. Refer section
10.0 for step-by-step instructions for building a course, Section 11.0 for scheduling
the training and Section 12.0 for completing course requirements.
The Employee Training workflow can use documents stored in the Document Control
App. Controlled documents and external training materials can be combined in a
course. Then the course is scheduled and individual users who need to complete the
training are selected and enrolled.
•Add related documents into Document Control App for approval (if
required) and/or create list of relevant external links.
Prepare
•Create New Training Course to link controlled documents or external

links, assign training frequency, assign course to departments, create
Create quizzes to assess knowledge.
Course
•Create New Training Schedule to assign a subject matter expert as

trainer, build a list of trainees (by department, title or individually).
Schedule
Course
•Trainees read materials, take quiz and attest that they have completed
the course. Results are routed to the course trainer for confirmation.
Complete
Training
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10.0 CREATE AND MANAGE TRAINING COURSES

The Training Couse needs to be created before training can be scheduled. This helps
ensure trainings are standardized. Additionally, courses are often built on controlled
documents.
✓ Check that documents are in the Document Control App and have been
approved/released.
✓ Check that the same training course has not already been created (see Section
13 for search options).
✓ Gather links to external sources.
Courses are created through the Document Control App (Training tab, “Create Training
Course”) or through the Employee Training App. The process for creating a Training
Course is the same from either starting point.
NOTE: Save frequently during the process of creating new courses.
Follow below steps for creating a new course
10.1 CREATE A NEW TRAINING COURSE
10.1.1 CREATE THROUGH PERSONAL TRAINING TAB

• On the left side, the Personal Navigation has the category
Insert New at the bottom. Click the plus sign and it opens
the options for a New Training Schedule or a New Training
Course. Click on New Training Course.
• This directs the user to a new draft page with several blank
fields.
Skip to 10.2 for the next steps on Entering Course information
10.1.2 CREATE THROUGH A CONTROLLED DOCUMENT

• From the Document Control App, navigate to the document that will be the
focus of the training. On the document details screen, click the TRAINING tab.
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• Next to Training needed on this document, click Yes to reveal the CREATE
TRAINING COURSE button.
Skip to 10.2 for the next steps on entering course information
10.1.3 CREATE THROUGH TRAINING MANAGEMENT TAB

• On the TRAINING MANAGEMENT Tab, click the Main Training Course Table
in the bottom left side of the screen. This will present you with a list of all
courses, including obsolete.
• Click the INSERT button
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Skip to 10.2 for the next steps on entering course information.
10.2 ENTER NEW TRAINING COURSE INFORMATION
• Fill out the desired information, entering text or selecting from the drop down
lists as appropriate. Select Course IDs and Course Names according to your
company’s naming convention.
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Note: When using dropdowns in the data entry process, if a selection is missing,
contact your system administrator to add the option.
• Course ID is an auto-generate field and creates an ID once the user clicks

“Save” button.
• Course Name: Enter a brief name, which will be used throughout the eQMS
to describe this course.
• Category: Presents a drop down of Category options for the training course. If
a necessary Category is missing, contact your system administrator to add the
option. Refer UG 102 when using dropdowns in the data entry process.
• Subject: The subject field is optional and can be used as a broad description.
This description shows up in some reports.
• Objective: Enter a brief objective for the course.
• Additional material: Click on the EDIT HYPERLINK button to add the name
and location URL of videos or presentations used in the training course. This
field allows for a link to training resources that are not controlled in the
Document Control App. Examples may include links to relevant pages on
government regulator or ISO websites.
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• Due Within: number of days employees will have to complete the scheduled
training course before the system identifies the training as overdue. In other
words, if 7 is entered here and a training is released on August 1st then all
users enrolled in the course will have a due date of August 7th.
• Training Frequency: Some trainings should happen on a quarterly, semi-
annual or annual basis and then the employee is required to retake the course.
Such courses can be automatically scheduled by the system. The training
frequency field is used to indicate when the training needs to re-occur. Enter
the number of days between training (example 1 year = 365 days).
• Automatically Schedule Training: If the system is to automatically schedule
and start the training for each enrollee in accordance with the frequency set in
Training Frequency, then click on the “Yes” option.
• SAVE: At this time save the data that has been entered.
• Departments and Job Titles: Use the drop-down lists of departments and job
titles that are required to have this training course.
In some instances, a field has the option to select multiple entries. When a user
clicks the button next to a field, the system gives them an option to select more
than just one answer for that field. For example, when tselecting Required for
”
Department or Required for Job Title for a course, select the primary
o
department or job title and press the + button to add another department or job
r
title. The user can add multiple selections as well as use
“ the minus symbol to
remove a selection.
• Documents: This section is the

place to add documents related to
the training course. Click on the
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ADD button to pull up a list of the active documents in the system.
Click in the white box in front of the

Document ID that needs to be added to
the training course. Multiple documents are
selected by clicking in their respective
white boxes. Click on ADD DOCUMENT to
import the document information into the
course.
A search of the documents is done by

clicking on the SEARCH button in the pop-up list.
All of the fields of the document control app regarding documents are displayed on
the screen in a pop-up box.
Select the parameters to search and fill in
the information needed. Then click on
search to have the system find all the
documents that fit the parameters
selected. Once the list is displayed, click
in the white box in front of the Document
ID and click the ADD DOCUMENT button
to import the document information into
the course.
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Note: The process can be stopped at any time by clicking on the “Save” button and exiting
the application. When the application is re-accessed, the activity is displayed on the
personal navigation pane.
10.3 CREATE QUIZZES

Your customers, auditors and regulators will expect you to demonstrate that individuals
who undertook training understood what they learned. Check with them for testing
requirements, but a 10-question multiple-choice quiz is considered a minimum.
• Quiz: The system has a place to add quiz questions and answers. The questions can
be multiple choice, true/false, yes/no. Select Yes to start entering quiz information. If
no quiz is required, click No and continue to the next step.
Click the INSERT ROW button to add the first quiz question.
At the Question prompt, type the first question of the quiz, then under Answer
Options click the INSERT ROW button.
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Add the first answer choice. Click the INSERT ROW button again to add additional
answer choices. If the answers need to appear in a particular order, either add them
in the specified order or number the Question Appear in Order identifier in the
correct column. Click the CLOSE button to save and finish.
Note: Numbers do not have to be sequential. For example, you can number just 3
questions as 10, 25, 39… and questions will appear in the correct order. Decimal
values will be rounded (10.1 becomes 10 and 10.6 becomes 11).
In the Question Setting tab, select the correct answer from the pull-down list in
the Correct Answer field. If the answers had Appear in Order specified, add
the specifiers in the order desired in the Question Appear in Order field.
Separate the specifiers by a comma (,).
Click the CLOSE button to complete the first question. To add more questions
and answers, complete the task by inserting another row in the quiz table.
To edit the existing questions or answers, click the EDIT TABLE button. To
remove a question, click the DELETE button and follow the instructions on the
screen.
• Training Records: During course creation, this section is empty. Once the
course has been released for use and training scheduled, a list of the training
scheduled is displayed.
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10.4 START THE TRAINING

• Release Training Course: At the bottom of the screen, a button is displayed
to release the course for use. Double check all the information added for
accuracy before releasing the course.
After clicking the RELEASE TRAINING COURSE button, the Status changes
from “Draft” to “Active”. To change any of the course information after this time,
click on the EDIT TRAINING COURSE button. The user may also be able to
archive or make a course obsolete depending on their user permissions.
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11.0 CREATE AND MANAGE TRAINING SCHEDULING

There are two ways to schedule training
A. From the Personal Navigation Pane (see Section 11.1.1)
B. From an existing course (see Section 11.1.2)
Both processes are very similar.
11.1.1 FROM THE NAVIGATION PANEL

• On the left side, the Personal Navigation pane has the category Insert New at
the bottom. Click the plus sign and it opens the options for a New Training
Schedule or a New Training Course. Click on New Training Schedule.
Skip to section 11.2 to Enter Training Course Details
11.1.2 FROM AN EXISTING COURSE

Click on the SEARCH tab at the top of the screen. Once inside the search screen, click
on TRAINING COURSES. Using the text fields, pull down lists or question responses,
complete information about the course needed. When your search criteria has been
populated, click on the SEARCH button.
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Select the course needed by clicking on the Course ID. The information about the
course is displayed on the screen. At the bottom of the Training Course Details
group-box you will find a SCHEDULE TRAINING button.
Skip to section 11.2 to Enter Training Course Details
11.2 ENTER TRAINING COURSE DETAILS

This directs the user to a new draft page with several blank fields.
Note: When using dropdowns in the data entry process, if a selection is missing,
contact your system administrator to add the option.
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• Course: Select the Course from the drop-down list of active courses.
• Date: Select the date for the training to begin.
• Trainer: Select the trainer from the down-down list of employees.
11.3 BUILD A LIST OF ENROLLEES

TRAINEES tab: Select the departments and job titles that require the training.
After selecting them (multiples can be selected as described in the course set up
section), click on the UPDATE LIST OF TRAINEES button.
The list of trainees is amendable once the list has been populated. Click on ADD
or DELETE to add or remove individuals from the list of trainees.
11.4 START TRAINING

Return to the top of the screen to start the training. Click the START TRAINING
button to engage the training process.
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Each enrollee will immediately be sent a notification of their training with a due
date.
A pop-up window confirms that the training has been scheduled.
To cancel the scheduling, click on the CANCEL SCHEDULING button. The system
cancels the scheduled training and shows this at the bottom of the screen.
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12.0 COMPLETE TRAINING (WORKFLOW VIEW)
The out-of-the-box configuration for

the Employee Training App uses a
Workflow for each user assigned to a
training. The workflow starts (Start)
with the assignment of the training to
the individual along with an assigned
deadline for completion. The individual
will see the assigned training in their
My Dashboard app, in their Employee
Training App and in Personal
Navigation.
Once the employee finishes the
training (Complete Training), they
take a quiz if (Quiz) if required by the
administrator. The system will
automatically validate the responses
(Validate Questions) and route a
review of the training (Trainer
Review) and quiz results to the course
trainer.
If the course trainer marks the results
FAIL, then a notification is sent to the
Department Head (Dept Head
Review) for further review and the
record is marked as fail. Alternatively, if the trainer marks the results as passed then
no Department Head review is required, and the training results are updated with a
pass grade (Update Status)
If the course trainer marks the results PASS, the grade reflects that the individual is
deemed qualified on this particular subject. The training record is stored for future
access when necessary for internal audits, customer audits or third-party audits such
as government regulators, ISO certifying body or other auditing entities.
The workflow is diagram of steps that the trainee, trainer and supervisor complete in
the process.
• White icons are not started
• Green icons are completed
• Yellow icons are in progress
• Red icons are overdue
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• Each shape of on the workflow represents a different type of activity

o Manual activities (trapezoid) mean that a user is required to do
something on the system to finfish the activity
o Automated activities (rectangles) are steps that are run by the system
without instruction
o Decision boxes (diamonds) are for routing the process based on user
input or automated activities.
Note: Detailed instructions on creating courses is included in the Employee
Training App training document.
12.1 START A TRAINING ACTIVITY

There are two ways to begin training
A. From Personal Navigation (see Section 12.1.1)
B. From Dashboard (see Section 12.1.2)
Both processes are very similar.
12.1.1 THROUGH PERSONAL NAVIGATION

The users check and see what activities require their attention
by viewing the My Training Activities in their personal
navigation on the left side of the screen. This is typically blank
for new users.
• Listed first is the activity that is due next for training
along with the training Schedule ID beside it.
• When an activity from the My Training Activities is
selected, the page that opens is the next activity step in
the workflow. Action is required by the user to continue
the process of the workflow.
Skip down to 12.2 - Complete Training for next steps.
12.1.2 THROUGH DASHBOARD

Users see all their open activities in their dashboard. The
Employee Training App is located second, but may vary
depending on the apps a user has access to. Because of the
importance of training, there is also a separate EMPLOYEE
TRAINING tab.
• Listed first is the activity that is due next for training along with the training
Schedule ID beside it.
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• When an activity from the My Training Activities is selected, the page that
opens is the next activity step in the workflow. Action is required by the user to
continue the process of the workflow.
Skip down to 11.8 - Complete Training for next steps.
12.2 COMPLETE TRAINING

• The trainee selects one of the Complete Training activities. The screen below
appears on the screen.
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The trainee reads the document provided (if a document has been added to the
training course) and reads the disclaimer sentence. They then click in front of the
statement “I confirm that I agree with the above statement”, and click the TRAINING
COMPLETED button.
Note: Both the disclaimer sentence and acknowledgement statement are fully
changeable by your administrator.
If a quiz was set up with the course, the quiz questions are now displayed on the
screen. The trainee clicks the EDIT TABLE button to be able to answer the questions.
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The answers are selected from the pull-down lists. Once all questions are answered,
the trainee clicks on SUBMIT QUIZ button. If a question is left unanswered, a pop-up
box reminds the trainee to complete all questions.
The trainee now sees a screen that informs them that their part in the training has
been completed.
The Trainer now receives notification that a training is ready for evaluation.
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12.3 TRAINER REVIEW OF RESULTS

After an individual completes a training the result is
forwarded to the trainer assigned to the course (see 11.2
Enter Course Details). The trainer can assign a PASS or
FAIL grade to the results.
• If the trainer selects PASS the training is completed.
• If the trainer selects FAIL, the training results will be
forwarded to the Department Head to review.
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12.4 DEPARTMENT HEAD REVIEW OF TRAINING OR QUIZ RESULTS

If the trainer marked the training results as FAIL, then the results are routed to the
employee’s department head listed in the User Profile. The department head decides
to either close the training as FAIL or reschedule the training for a future date.
When the training is rescheduled, the training process begins again with the trainee
receiving notification that training has been scheduled.
13.0 SEARCHING RECORDS, COURSES AND SCHEDULES

The out-of-the-box configuration for the Employee Training App allows all users with
access to the app to search and read all employee training records, all courses and
all scheduled trainings. See Section 6.0 Intellect out-of-the-box User Groups for
additional information.
The SEARCH tab offers a way to look for training records. training courses, or training
scheduled by fields in the database. Enter one or more of the parameters in search
screen and click the SEARCH button. Records matching the parameters selected are
displayed on the screen.
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13.1 SEARCH MY TRAINING RECORDS
Use this screen to find your own personal training records. Clicking on a field will
automatically check the checkbox and include it in the search string. Be sure to
uncheck any fields that you no longer want to search on. Results will be displayed in
a table format with additional columns for Training Record ID, Due Date to
Complete and the Training Schedule.
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13.2 SEARCH MY STAFF’S TRAINING RECORDS
Use this screen to find personal training records for anyone whose User Profile has
you listed as their supervisor. Clicking on a field will automatically check the checkbox
and include it in the search string. Be sure to uncheck any fields that you no longer
want to search on. Results will be displayed in a table format with additional columns
for Training Record ID, Employee Name, Due Date to Complete and the Training
Schedule.
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13.3 TRAINING MANAGEMENT: SEARCH MY SCHEDULINGS
Use this screen to find a schedule of courses meeting your criteria. Clicking on a field
will automatically check the checkbox and include it in the search string. Be sure to
uncheck any fields that you no longer want to search on. Results will be displayed in
a table format with additional columns for Training Schedule ID and Scheduled On.
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13.4 TRAINING MANAGEMENT: SEARCH MY TRAINING COURSES
Use this screen to generate a list of courses matching your search criteria. Clicking
on a field will automatically check the checkbox and include it in the search string. Be
sure to uncheck any fields that you no longer want to search on. Results will be
displayed in a table format with a column for each of the searchable fields.
13.5 USING MAIN SEARCH TAB

The Employee Training App includes a major tab to search records. Under that tab
you will find sub tabs for Training Records (11.16.1 below), Training Courses (11.16.2
below) and Training Schedules (11.16.3 below).
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13.5.1 SEARCH TRAINING RECORDS

Use this screen for searching all training records in the system for every user. Clicking on a
field will automatically check the checkbox and include it in the search string. Be sure to
uncheck any fields that you no longer want to search on. Results will be displayed in a table
format with a column for each of the fields listed on the search screen.
13.5.2 SEARCH TRAINING COURSES

Use this screen to find existing (including obsoleted) courses. Clicking on a field will
automatically check the checkbox and include it in the search string. Be sure to uncheck any
fields that you no longer want to search on. Results will be displayed in a table format with
additional information on Subject and Objectives for each course. If searching for when a
course is/was offered Skip to 13.5.3 Search Training Schedules.
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13.5.3 SEARCH TRAINING SCHEDULES
To find when courses are being offered use this screen. Clicking on a field will automatically
check the checkbox and include it in the search string. Be sure to uncheck any fields that you
no longer want to search on. Results will be displayed in a table with columns for each of the
search fields on the screen (including a list of trainees).
14.0 REPORT TAB

Four sets of reports are available through the REPORTS tab: Reports by Employee, Reports by
Department, Reports by Job Title and Miscellaneous Reports.
14.1 REPORTS BY “EMPLOYEE”

The first set of reports are the Reports by Employee. These display the training information for
individual employees. Select the employee whose records you wish to see from the pull-down
list of employees and click the UPDATE REPORT button.
You will be provided three reports: Employee’s Training Records (along with status indicators
for In Progress, Under Review, Passed or Failed), a pie chart of Pass vs Fails and a list of
Completed Training Records.
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14.2 REPORTS BY “DEPARTMENT”

The second report displays required training by the department selected. Select the department
from the drop-down list and click the UPDATE REPORT button.
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14.3 REPORTS BY “JOB TITLE”

The third report is training required by job title. Select the job title from the drop-down list
and click the UPDATE REPORT button.
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14.4 MISCELLANEOUS REPORTS

The last report is Miscellaneous Reports. This report is currently empty. Contact your
administrator to have special reports created and saved here.
15.0 FAQS
15.1 How do I Obsolete a Course?
Login  SEARCH TAB  Find the course you want to change  Click the Course ID
Under Additional Information, click the OBSOLETE TRAINING COURSE button.
15.2 If I obsolete a course will the scheduled trainings be removed from each
enrollee’s activity list?
No. Once assigned to enrollees a course needs to be completed.
15.3 How do I lock/unlock a Course or Training Schedule?

Login as Designer  Open Employee Training App  Use the SEARCH tab to find the
related Course or Training you want to unlock  Open Admin Tools  Select appropriate
radio button for Document Locked field
15.4 How do I edit the list of Course Categories?

Login as Administrator  Open Employee Training App  Open SETTINGS tab  Open
System Tables  Open Course Category Table
15.5 How do I edit the list of the standard Disclaimer?

The default disclaimer (other than when signing the training before completing) “I confirm
that I agree with the above statement. With this check mark, I sign this area.” Below are
the steps to change the wording of this statement:
Login as Administrator  Open Employee Training App  Open SETTINGS tab  Open
System Tables  Open Disclaimer Option Table  Click Edit Table  then make your
revisions
15.6 How do I edit the Disclaimer on the training screen?

The default when people complete a training is to click a checkbox confirming “I confirm
that I agree with the above statement. With this check mark, I sign this area.” Below are
the steps to change the wording of this statement:
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Login as Administrator  Open Employee Training App  Open SETTINGS tab 

Onscreen Instructions  then make your revisions
15.7 How do I change the assignment of Course IDs from Automatic to Manual?
Login as Administrator  Open Employee Training App  Open SETTINGS tab  Click
the appropriate option button in the App Console group box.
15.8 In MY TRAINING RECORDS tab some of my training records are set to Expire on
the SOON TO BE EXPIRED tab, what does that mean?
When setting up a course, there is an option to Automatically Reschedule Training in
number of days (e.g. 365 days). When that time period ends, the original training will be
considered expired and the trainee will be required to retake the training. This ensures
people are up to date on and their understanding of the topic remains fresh.
16.0 INTELLECT FORUM

Share your knowledge or discuss your ideas or questions with the entire Intellect
ecosystem at www.intellect.com/forum
Please note: This forum is for discussion only. If you have any support issues, please go
to connect.intellect.com to create a service ticket.
17.0 SUMMARY OF QUALITY SYSTEMS REQUIREMENTS
New/changed How to Meet

Standard Intellect Solution
requirement Requirements
Add regulators as suppliers to

be able to show that all are
identified. Put compliance
Compliance Obligations
Document Control, documents in Document
ISO 14001 (strengthened
suppliers Control to be able to set short
requirements)
review times to show that they
are reviewed frequently
enough to stay current
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Add users (doctors, hospitals,

pharmacies) outside the
company to list of system
ISO 13485 User training Training users. Show when
documentation changes they
are notified and trained on the
changes.
Show the 3 separate sites for

each customer and explain the
process of developing in the
Validation of electronic Need to have validation for
design site, publishing into the
systems basic apps for customers.
testing site and when all
issues resolved, publish to the
live (production) site.
11 (Electronic Show how the user

records; Authenticity of electronic User permissions, audit trail permissions are set up, show
Electronic records version control of changes how the system tracks
signatures) changes made
Requirement for 2
passwords for signing/
approving records. System
Signing of records records date, time, name See solution
and title of signer. Signature
permanently linked to
record
Show that training can be

automatically started when a
111 (Dietary
Training Employee Training document is revised, a new
Supplements)
employee starts or when an
employee is promoted

210 & 211 (drug
products &
finished
pharmaceuticals)
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606 (Blood and automatically started when a
Blood Training Employee Training document is revised, a new
Components) employee starts or when an
Quality Policy, Organization

Chart, and Quality Plan should
Management all be entered into the
Responsibility (Quality document control app. The
Policy, Organization chart effectiveness of the QMS and
with responsibilities and Management Review are
Document Control,
authority, Appointment of demonstrated by the
Training, dashboard,
management dashboards, the appointment
system control
representative, of the management
effectiveness of QMS, representative can be done
management review, through the system controls
quality planning) (they would potentially be the
administrator and have control
of the system)

document is revised, a new
Personnel
820 (Quality Training, User setup employee starts or when an
(Training/qualifications)
System employee is promoted. During
Regulations) User Setup, a resume could
be added.
Examples of approved labels

and packaging would be
entered into the Document
Label and Packaging Control App with change
Document Control, Training
Control history and approval. When
changes were made,
appropriate personnel would
be trained.
Installation instructions would

be entered into document
control. Distributors would be
Installation Document Control, Training in the system and trained on
changes to the installation
instructions when they
occurred.
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1270 &1271
(Human Cells,
Tissues and
Cellular and
Tissue based
Products
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UG-105 Elements of Intellect eQMS Employee Training - End User Guideline

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Elements of Intellect’s Quality

Document Type: User Guideline Status: Released

Department Owner: Quality Date Effective: September 17, 2018

Document Owner: Tejas Puranik Author: Paul Dionne

Notes: This document is established to provide a guideline for an End User.

Role Approver Signature Date

Chief Customer Officer James L. de Vera See EDMS See EDMS

Chief Technology Officer Selim Ozyel See EDMS See EDMS

Chief Marketing Officer & VP

Vice President Peter Cutler See EDMS See EDMS

Document #: UG-105 Revision: A

Document #: UG-105 Revision: A

13.1 Search My Training Records ................................................................................................. 31

Document #: UG-105 Revision: A

The purpose of this document is to provide a detailed explanation of the following:

Document #: UG-105 Revision: A

3.0 EXTERNAL REFERENCES

ISO 14001 Environmental Management

ISO 13485 Medical Devices

21 CFR PART 11 Electronic Records; Electronic Signatures

21 CFR PART 111 Dietary Supplements

Current good manufacturing practice in manufacturing,

Current good manufacturing practice for blood and blood

21 CFR PART 820 Quality System Regulation

21 CFR PART 1270 &

Document #: UG-105 Revision: A

A quality management system (QMS) is a formalized

User An entity that has an authority to use eQMS suite of apps.

A collection of users with similar roles and responsibilities in

A table contains copy of the template (Form) with the ability

A workflow is a visual representation of sequence of steps

A macro is a collection of instructions to automate the

Instance An individual record in a table.

Document #: UG-105 Revision: A

5.0 GENERAL REQUIREMENTS

6.0 INTELLECT OUT-OF-THE-BOX USER GROUPS

User Group Description of Access

Access to the SETTINGS tab in each of the apps in eQMS.

Customer Service Access only to the Complaint Management App.

Full access to all eQMS apps. Access to the Designer App

General User General access to all apps in eQMS.

Access to MY DEPARTMENT tab in the Dashboard App.

Document #: UG-105 Revision: A

7.0 LOGGING INTO INTELLECT EQMS SUITE

A. Log into Intellect eQMS

Depending on the user’s access, the

Document #: UG-105 Revision: A

8.0 ARCHITECTURE: EMPLOYEE TRAINING

Document #: UG-105 Revision: A

App Swticher Allows users to switch between different applications in Intellect

8.1 PERSONAL NAVIGATION PANEL

Document #: UG-105 Revision: A

•This includes different sub-tabs: In Progress, Completed, Soon to be

•This tab can be used to manage training including adding/removing

SEARCH •In this tab, select one or more search criteria.

•This tab includes out-of-the-box reports including Reports by

Document #: UG-105 Revision: A

Customer Service No Access to Training App

Document Control No Access to Training App

Purchasing No Access to Training App

Document #: UG-105 Revision: A

9.0 EMPLOYEE TRAINING PROCESS OVERVIEW (HIGH-LEVEL

•Create New Training Course to link controlled documents or external