UG-104 Elements of Intellect eQMS Employee Training - Administrator Guideline

Elements of Intellect’s Quality
Management System:
Employee Training
Document #: UG-104 Revision: A
Document Type: Administrator 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 a member of the

Administrator User.
Formatting used in this user guide:

• 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
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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 ................................................................................................. 7
8.1 Personal Navigation Panel....................................................................................................... 9
9.0 Employee Training Process Overview (High-Level Description) ................................................ 12
10.0 Training Course, Training Schedule and Training Records Tables ............................................ 13
11.0 Settings Tab .............................................................................................................................. 14
11.1 Switch Course ID Assignment to Manual from Automatic ...................................................... 14
11.2 Add/Edit/Delete Course Categories ....................................................................................... 15
11.3 Edit Disclaimers ..................................................................................................................... 16
12.0 Editing Training Course Details ................................................................................................. 17
12.1 Macro That Runs on SAVE .................................................................................................... 18
12.2 SCHEDULE TRAINING Macro .............................................................................................. 19
12.3 RELEASE TRAINING COURSE Macro ................................................................................. 19
12.4 EDIT TRAINING COURSE Macro ......................................................................................... 20
12.5 OBSOLETE TRAINING COUSE Macro ................................................................................. 20
13.0 Editing Training Schedule Details .............................................................................................. 21
13.1 Macro That Runs On Save .................................................................................................... 22
13.2 START TRAINING Macro ...................................................................................................... 23
13.3 CANCEL SCHEDULING Macro ............................................................................................. 24
13.4 UPDATE LIST OF TRAINEES macro .................................................................................... 24
14.0 Training Record Details ............................................................................................................. 25
14.1 Workflow for Training Records ............................................................................................... 25
14.2 Accessing Training Record Details ........................................................................................ 26
14.3 SET FIELDS UPON STARTING TRAINING Macro ............................................................... 27
14.4 POPULATE QUIZ QUESTIONS Macro ................................................................................. 27
14.5 VALIDATE QUESTIONS Macro............................................................................................. 28
14.6 SET DEPARTMENT HEADS Macro ...................................................................................... 28
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14.7 SET HEALTH TO OPEN Macro ............................................................................................. 29

14.8 SET RECIPIENT Macro ......................................................................................................... 29
14.9 EMAIL FOR ASSIGNMENT Macro ........................................................................................ 30
14.10 EMAIL FOR OVERDUE Macro .............................................................................................. 31
14.11 RESCHEDULE TRAINING Macro ......................................................................................... 32
14.12 Update Status Macro (from Workflow) ................................................................................... 33
15.0 Overnight Macros ...................................................................................................................... 34
15.1 MARK OVERDUE TRAINING RECORDS ............................................................................. 35
15.2 MARK EXPIRED TRAINING RECORDS ............................................................................... 36
15.3 AUTOSCHEDULE TRAINING COURSES ............................................................................. 36
15.4 START SCHEDULED TRAINING RECORDS ....................................................................... 37
16.0 FAQs......................................................................................................................................... 38
17.0 Intellect Forum .......................................................................................................................... 39
18.0 Summary of Quality Systems Requirements ............................................................................. 39
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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 and the User belonging to the User Group Designers.
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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.
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4.0 DEFINITIONS
Term Definition
A quality management system (QMS) is a formalized system

QMS 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, read,
User Group
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 to

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

Workflow
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) platform and the Designer is required to have the
basic understanding of the platform. 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).
After logging in, open My Dashboard. The user (Administrator) has privileges to the
following:
1. Web Apps: This includes access to all apps of eQMS environment.
2. System App: This includes:
a. Designer Control Panel: Insert new template and modify existing templates.
b. Administrator module to access User & User Groups, Workflow
Management, System Tables and System Variables.
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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
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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 to UG-
105 Elements of eQMS Employee
Training App – End User Guideline,
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 and
reviewing a course.
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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.
REPORTS
•This tab includes out-of-the-box reports including Reports by
Employee, Reports by Job Title, Reports by Department.
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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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 to UG-105
Elements of eQMS Employee Training Module – End User Guideline 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 TRAINING COURSE, TRAINING SCHEDULE AND TRAINING

RECORDS TABLES
Training tables are hidden from other users except Administrators and Designers. The
tables can be found in the Employee Training App on the TRAINING MANAGEMENT tab.
They include the Main Training Course Table, Main Training Schedule Table and Main
Training Record Table.
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11.0 SETTINGS TAB

The SETTINGS tab includes several options for out of the box configuration including
how the system numbers training courses, a list of course categories and disclaimers
used in the program.
11.1 SWITCH COURSE ID ASSIGNMENT TO MANUAL FROM AUTOMATIC

By default, the system will automatically assign the Course ID. Visit the SETTINGS tab
to switch the assignment of Training Course IDs to Manual (or back).
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11.2 ADD/EDIT/DELETE COURSE CATEGORIES

At the bottom of the SETTINGS tab is a link to System Tables.
Data in the Course Category table is used by the Category dropdown when adding New
Training Course. Click the Course Category Table and you will be provided buttons for
IMPORT, EDIT TABLE, EXPORT, IMPORT, and DELETE records.
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11.3 EDIT DISCLAIMERS

Before a user can complete a training, they check off and affirm a two-part disclaimer
statement.
At the bottom of the SETTINGS tab is a link to System Tables. Click the Disclaimer
Option table to edit the text “I confirm that I agree with the above statement. With this
check mark, I sign this area.”
At the bottom of the SETTINGS tab is a link to Onscreen Instructions. Open to edit the
text “Hereby I acknowledge that I have read and completed this training course in the
allotted time. All fields are reflective of my understanding.”
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12.0 EDITING TRAINING COURSE DETAILS

At the bottom of a course’s Course Details screen is an Admin Tools section that is only
visible to Designers and Administrators. Click the Admin Tools to open a page with
options for making basic edits.
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To make edits to a course, click the Training Course Locked option box No. Go back to
the course and make your changes.
After making changes, remember to click Save, return to the Admin Tools and toggle
Training Course Locked back to Yes and click Save.
12.1 MACRO THAT RUNS ON SAVE

At the top right in the Designer panel access the PROPERTIES button, which is next to the SAVE
button. A dialog box will open and on the Advanced tab are buttons to open the On Open and On
Save macros.
The macro below saves related documents to the admin panel. Then, if the system is set to
automatically assign Training Course ID then this macro will add “TC-“ before the autonumber.
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12.2 SCHEDULE TRAINING MACRO

The SCHEDULE TRAINING macro button is clicked by the user when they are done filling out
the details of the training. This macro is saving all the course details to the Main Training Schedule
table (see Section 10).
12.3 RELEASE TRAINING COURSE MACRO

This macro button is clicked by the user when they are ready to release the course. It checks for
required fields then releases the training course by updating relevant fields.
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12.4 EDIT TRAINING COURSE MACRO

This macro button has the visible properties set to when a course is active and the Current User
is the same user that is listed in the Created By field. The macro shows fields for editing.
12.5 OBSOLETE TRAINING COUSE MACRO

This macro button is visible only when the Status is Active. It sets the Status to Obsolete and
updates the Modified By and Modified On fields.
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13.0 EDITING TRAINING SCHEDULE DETAILS

At the bottom of a Training Schedule Details screen is an Admin Tools section that is only
visible to Designers and Administrators. Click the Admin Tools to open a page with
options for making basic edits. To make edits to a course, click the Locked option box
No. Go back to the training schedule and make your changes
After making changes, remember to click Save, return to the Admin Tools and toggle
Locked back to Yes and click Save.
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13.1 MACRO THAT RUNS ON SAVE

At the top right in the Designer panel access the PROPERTIES button, which is next to
the SAVE button. A dialog box will open and on the Advanced tab are buttons to open
the On Open and On Save macros.
The macro below saves the list of Trainees to the Training Schedule table.
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13.2 START TRAINING MACRO

The START TRAINING macro button is clicked by the user. It validates fields, updates the Status
and locks the record. Then it creates a Training Record and blank quiz for each trainee. The
Training Record will then show up in each trainee’s Personal Navigation panel.
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13.3 CANCEL SCHEDULING MACRO

The CANCEL SCHEDULEING macro changes the Status field to Cancelled. It is only set to be
visible if the Status field is not Open or Cancelled
13.4 UPDATE LIST OF TRAINEES MACRO

The UPDATE LIST OF TRAINEES macro button is set to be visible when the record is not locked
(on the Admin screen).
The Macro looks up members of the Add Department and adds them to the trainee list. It then
looks up all users with the same Add Job Title(s).
Note: The out-of-the-box configuration includes all members of every department chosen AND
all members with every job title chosen.
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14.0 TRAINING RECORD

DETAILS
14.1 WORKFLOW FOR TRAINING
RECORDS
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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14.2 ACCESSING TRAINING RECORD DETAILS

Each training record has a set of fields that the
system modifies from generation of the training
record to the close of the training record.
Find the Training Record you wish to change
using one of the Search methods found in the
UG-105 Elements of eQMS Employee
Training Module – User Guideline. Open the
record you wish to modify.
Click the Admin Tools at the bottom of the
Training Record. Details can be accessed on
the Admin Tools screen.
There are several macro buttons on this
screen that are detailed below.
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14.3 SET FIELDS UPON STARTING TRAINING MACRO

The SET FIELDS UPON STARTING macro is started by the START TRAINING macro button
(see Section 13.2). The SET FIELDS UPON STARTING macro sets the Due Date to Complete
and sets an expiration date (if Training Frequency was set in the Course Details screen), after
which the trainee will have to take the training again.
14.4 POPULATE QUIZ QUESTIONS MACRO

The POPULATE QUIZ QUESTIONS macro is started by the START TRAINING macro button
(see Section 13.2). The POPULATE QUIZ QUESTIONS macro creates a quiz for each trainee
based on the quiz that was created during the creation of the course.
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14.5 VALIDATE QUESTIONS MACRO

The VALIDATE QUESTIONS macro is called by the Validate questions step in the Training
Records workflow (see Section 14.1). This process compares the trainee’s answers to the correct
answers that the trainer set during the course quiz setup.
14.6 SET DEPARTMENT HEADS MACRO

The SET DEPARTENT HEADS macro is used to find the correct department head for the trainee
so that another macro can do something. For example, if a trainer marks a trainee’s quiz as fail
then the Department Head is sent an email. It is called by Training Record\Workflow\Trainer
Review\Next
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14.7 SET HEALTH TO OPEN MACRO

The SET HEALTH TO OPEN macro is called by four other macros:
• Training Record\Workflow\Complete Training\On Next Step\
• Training Record\Workflow\Quiz\On Next Step\
• Training Record\Workflow\Trainer Review\On Next Step\
• Training Record\Workflow\Dept. Head Review\On Next Step\
14.8 SET RECIPIENT MACRO

This macro is used to set the email recipients addresses before sending an email. The SET
RECIPIENT macro is called by the MARK OVERDUE TRAINING RECORDS macro which runs
nightly.
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14.9 EMAIL FOR ASSIGNMENT MACRO

Each training record that is generated is assigned to a trainee. The EMAIL FOR ASSIGNMENT
macro sends an email to each trainee that they’ve been enrolled in a training.
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14.10 EMAIL FOR OVERDUE MACRO

The EMAIL FOR OVERDUE macro is called by a macro that runs each night: MARK OVERDUE
TRAINING RECORDS (see Section 15.1). The EMAIL FOR OVERDUE macro sends an email
reminder to each trainee the day after their training was due if it was not yet completed.
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14.11 RESCHEDULE TRAINING MACRO

The RESCHEDULE TRAINING macro button can be clicked by a Department Head during the
Dept. Head Review step in the training workflow (see Section 14.1 for more information). The
RESCHEDULE TRAINING macro generates a new training record using some details from the
failed training. This prompts the trainee to retake the training.
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14.12 UPDATE STATUS MACRO (FROM WORKFLOW)

The UPDATE STATUS macro is found in the Update Status step in the workflow (see Section
14.1). It sets the Status field in the training record to Passed or Failed and sets the Record Health
to Closed.
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15.0 OVERNIGHT MACROS

There are four macros associated with the Employee Training App that run nightly. They can be
found in the Administrator App, in the Scheduled Macros group under Actions for Employee
Training Module.
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15.1 MARK OVERDUE TRAINING RECORDS

The MARK OVERDUE TRAINING RECORDS button is one of the macros that runs nightly. If the
Due Date to Complete is earlier than today (the current date), the macro marks the audit overdue
and sends an email to the person the audit is assigned to. The email is sent by triggering the SET
RECIPIENT macro (see Section 14.8) and the EMAIL FOR OVERDUE macro (see Section
14.10).
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15.2 MARK EXPIRED TRAINING RECORDS

Sometimes trainers will specify that a training must be repeated regularly, on an annual basis for
example. See Section 12, Training Frequency field and Automatically Schedule Training field
for more information. The MARK EXPIRED TRAINING RECORDS checks the expiration date
and marks the record as expired if appropriate.
15.3 AUTOSCHEDULE TRAINING COURSES

This macro finds records that are expired and then runs the RESCHEDULE TRAINING macro
(see section 14.11).
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15.4 START SCHEDULED TRAINING RECORDS

This macro looks for training schedules that have expired and then runs the START TRAINING
macro (see Section 13.2).
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16.0 FAQS
16.1 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.
16.2 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.
16.3 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
16.4 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
16.5 HOW DO I EDIT THE TEXT 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
16.6 HOW DO I EDIT THE DISCLAIMER ON THE TRAINING SCREEN?

The default when people complete a training is to click a checkbox confirming “Hereby I
acknowledge that I have read and completed this training course in the allotted time. All
fields are reflective of my understanding.” Below are the steps to change the wording of
this statement:
Login as Administrator  Open Employee Training App  Open SETTINGS tab 
Onscreen Instructions  then make your revisions
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16.7 HOW DO 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.
16.8 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.
17.0 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
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18.0 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
Page | 39
Intellect.
App
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)
Page | 40
Intellect.
App

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.
Page | 41
Intellect.
App
1270 &1271
(Human Cells,
Tissues and
Cellular and
Tissue based
Products
Page | 42
Intellect.

UG-104 Elements of Intellect eQMS Employee Training - Administrator Guideline

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Elements of Intellect’s Quality

Document Type: Administrator 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 a member of the

Formatting used in this user guide:

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-104 Revision: A

Document #: UG-104 Revision: A

14.7 SET HEALTH TO OPEN Macro ............................................................................................. 29

Document #: UG-104 Revision: A

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

Document #: UG-104 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,

21 CFR PART 820 Quality System Regulation

21 CFR PART 1270 &

Document #: UG-104 Revision: A

A quality management system (QMS) is a formalized system

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 to

A workflow is a visual representation of sequence of steps to

A macro is a collection of instructions to automate the

Instance An individual record in a table.

Document #: UG-104 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-104 Revision: A

7.0 LOGGING INTO INTELLECT EQMS SUITE

A. Log into Intellect eQMS

Document #: UG-104 Revision: A

Document #: UG-104 Revision: A

8.0 ARCHITECTURE: EMPLOYEE TRAINING

Document #: UG-104 Revision: A

App Swticher Allows users to switch between different applications in Intellect

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8.1 PERSONAL NAVIGATION PANEL

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•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.

Document #: UG-104 Revision: A

Customer Service No Access to Training App

Document Control No Access to Training App

Purchasing No Access to Training App

Document #: UG-104 Revision: A

9.0 EMPLOYEE TRAINING PROCESS OVERVIEW (HIGH-LEVEL

•Create New Training Course to link controlled documents or external