Design Document for

[SOP Issues & Learning Solutions in Pharma]

By Valliammai Chidambaram
Purpose of the
Course

Audience
Description

Major Course
Objectives
(Terminal)

305335245.doc

Pharmaceutical and Clinical Research Organizations are subject to Federal regulatory

body inspections and audit because of their sensitive nature of work. These companies
have to follow strict documentation and training guidelines as part of good manufacturing
practice (GMP).Conformance to regulatory body guidelines is only possible by effective
training of employees.
The current training provided in Pharmaceutical Organizations is typically lengthy
reading material. This project describes a training approach for employees which is
immersive and mimics a real life business process. Objective is to familiarize them with
the adopted standard operating procedures (SOP) and work instructions (WI) documented
for their business process.
The target audience will be the operational staffs who are new to the business unit.
The primary target audience will be the employees in the IT department
responsible for carrying out the work(System Build Staff)
All business users
Regulatory & QA department
The Secondary target audience will be the Supervisors or the Secondary
Managers of the new hires or in other words manager to the person directly
performing the job.
1. Terminal Objective(TO) 1: Upon completion of the SOP Training, learner must
be able to determine the Overall Testing Strategy for testing of the computerized
system in pharmaceutical business process.
2. Terminal Objective(TO) 2: Upon completion of the SOP Training, learner must
be able to follow the steps for Manual System Test
3. Terminal Objective(TO) 3: Upon completion of the SOP Training, learner must
be able to follow the steps for User Acceptance Test
4. Terminal Objective(TO) 4: Upon completion of the SOP Training, learner must
be able to assemble and complete the final Documentation for Testing of the
Computerized system.

2/22/2016

Course Enabling
Objectives

Enabling Objectives for TO1:

1. Learner must be able to describe the process flow for testing of the computerized
system.
2. Learner must document the test strategy and test plan for testing of the computerized
system.
3. Obtain appropriate reviewer, approver signatures for test strategy and plan.
Enabling Objectives for TO2:
1. Develop Manual System Test Script
2. Execute the Manual system Test Script
3. Obtain appropriate reviewer, approver signatures for test scripts.
Enabling Objectives for TO3:
1. Develop User Acceptance Test Script
2. Execute the User Acceptance Test Script
3. Obtain appropriate reviewer, approver signatures for test scripts.
Enabling Objectives for TO4:
1. Document Defect Log and Minor Issue Log
2. Document the Test Summary Report
3. Obtain appropriate reviewer, approver signatures for executed test scripts, results and
Summary report.
4.Submit the Report to Quality Assurance

RLO Enabling
Objective

Upon Completion of the RLO, the learner will be able to describe the process
flow for testing of the computerized system.

Learning
Assessment for
Course

There will be assessment activities throughout the course for every module and
the learners will also be assessed with a mastery quiz upon completing the
course.

Learning
Assessment for
RLO

Learners will be presented with

1.Drag and Drop Quiz questions to identify the various components in the
process flow
2.Mastery Quiz - Multiple choice quiz questions, True/False and Fill in the
Blanks question to assess the learners knowledge on the entire module.

305335245.doc

2/22/2016

Instructional
Delivery method
for Course
(overall)

The training will be delivered online via a Learning Management system. This
delivery method is chosen since there is lot of flexibility in delivery, cost and
minimal interruption of daily work.

The instructional strategy for the RLO is a self-paced tutorial. The course content
Instructional
Strategy for RLO will comprise of absorb activities which presents the content required for the
learner to absorb followed by an assessment activity in the form of mastery quiz
which will help the learner to recall the learned information and reinforce the
concepts learned.
Media

Media types for the RLO include

Text material
Audio
Graphics & Images

508
Voiceover narrations wherever applicable
Accommodations
Visibility of Scrollbar in the player to pause, forward and review the training as
needed.
Sufficient time to complete the training

305335245.doc

2/22/2016

Course Structure The entire course will consist of four modules (one for each terminal objective)
Description
that will contain lessons and assessment activities associated with them. The
modules are sequenced in such a way that without reviewing n in module 1,
learner cannot proceed to module 2. In other words, module 1 is a pre requisite
for the module 2.
The description of the module and the lessons associated within each module are
described below.
Module 1 Overall testing strategy for testing of the computerized system.
Module 2 - Develop & Execute Manual system test
Module 3 - Develop & Execute User Acceptance test
Module 4 - Assemble and complete the final documentation

Seat Time of
Course

1.5 hours

Seat Time of
RLO

15 minutes

305335245.doc

2/22/2016

RLO Outline

Refer to Appendix A(Page 10 in the document) for detailed description on the

RLO Outline.
1. Introduction
2. Process Overview for testing of computerized system
3. Knowledge Check Drag & Drop/Matching Pattern question
4. Overview of Test Strategy/Test plan
5. Manual System Test process
6. User Acceptance test overview
7. Final Documentation
8. Mastery Quiz Multiple Choice/Fill in the blanks question

RLO Flowchart

Refer to Appendix B (page 12 in the document) for image of the flow chart.

Screens/Pages in
RLO

20 screens in the RLO training module including the introduction, conclusion and
assessment slides.

305335245.doc

2/22/2016

Knowledge
Checks or Other
Assessments or
Practices for
RLO

There will be one Knowledge check after the process flow which will contain 5
questions. There will be one final mastery quiz with 5 questions at the end of
training session after all the contents are covered.
__3__Dichotomous (T/F, Y/N, etc.)
__3__Multiple Choice
__2_Multiple Select
__2__Drag and Drop
____Custom describe; if appropriate, supply flowchart in an Appendix and
reference it here.
____Other

Rollovers/click
events
RLO Navigation

____Rollovers
__5__Click Events
Navigation features will include the following :
1.Menu of all the pages in the course content.
2.Glossary of the terminologies as Attachment
3.Previous Button and Next Button
4.Feedback Rationale after test question

305335245.doc

2/22/2016

Screen Layouts
for RLO

305335245.doc

2/22/2016

Screen Layouts
for RLO

305335245.doc

2/22/2016

Development
Tools for RLO

Microsoft Word
Microsoft Power point
Articulate Storyline

Ownership

Valli Chidambaram will develop the initial course; and Valli Chidambaram will
maintain the course. The training course is being developed for a pharmaceutical
service provider company.

Development
Time of entire
course and RLO

40 hours

Support
requirements for
RLO and course

The RLO and the course require input from the Information Technology (IT)
Software Testing team and Quality Assurance Team.

Project
Sign-off
[optional]

Please sign below indicating agreement with the proposed course plan and
approving start-up of the storyboard and development phases.

305335245.doc

Instructional Designer

Date

Project Manager/Sponsor

Date

2/22/2016

Appendix A RLO Course Outline

Topic

1.

Method

Objective
&
Assessmen
t

Storyline

Visuals

Lesson Introduction
Course Objective

Presentation

Overview of the process flow for testing

of the computerized system.

Presentation

Know the Process Sequence

Branching Screen Do you
the process overview and
sequence for testing of the
computerized system?
Knowledge Check

Presentation of facts

Overview of the Test Strategy

High level Process

definition and explanation

None

Test Plan

High level Process

definition and explanation

None

Manual System Test

High level Process

definition and explanation

None

User Acceptance Test

High level Process

definition and explanation

None

305335245.doc

(part of tutorial content)

Process Flow Graphic

(part of tutorial content)

Drag/Drop questions
Matching pattern
questions

Application of process

10

2/22/2016

Buttons for Yes/No; Yes lets

the learner continues in the
main course line; No takes the
learner to branching scenario
to review the facts and proceed
with the knowledge check.

Final Documentation Overview of the

documents to be submitted for testing of
the computerized system.

Presentation

Mastery Quiz

Application of the process

10

Conclusion & Summary

Presentation of facts

None

(part of tutorial content)

Multiple choice
questions
Drag and Drop
questions
Multiple Select
questions

None

Appendix B Flowchart

305335245.doc

11

None

2/22/2016

305335245.doc

12

2/22/2016