SOP Issues & Learning Solutions in Pharma

Terminal Objective
The learner must be able to identify and follow sequential steps as well as
conditional branching for the development and maintenance of the computerized
system as defined in the SOP.
Enabling Objectives

Identify the sequential steps and conditional branching for a new system
development.
Identify the process flow for change to an existing system which might be
new enhancements or maintenance
Identify the process flow for testing of a computerized system
Identify the process flow for retiring a system.

Pre-instructional Strategy
This will be an audio visual which will present an overview of the different process
flows of Information Technology (IT) Life cycle. The content will comprise the main
sections of the adopted SOP for IT development.
Enabling Objective

To identify the
sequential and
conditional
branching for a new
system
development

Level on
Blooms
Taxonomy*

Fact, concept,
principle,
rule,
procedure,
interpersonal,
or attitude?

Learner Activity

Delivery Method

(What would learners

do to master this
objective?)

(Group
presentation/lecture,
self-paced, or small
group)

Cognitive
Analysis &
Application

Procedure

Review the SOP

training and
practice unlimited
attempts of
knowledge check
questions to master
the content

Self-Paced Online
Training

To identify the
process flow for
change to an
existing system
which might be
enhancement or
maintenance

Cognitive
Analysis &
Application

Procedure

Review the SOP

training and
attempt multiple
quiz questions

Self-Paced Online
Training

To identify the
process flow for
testing of the
computerized
systems.

Cognitive
Analysis &
Application

Procedure

Review the SOP

training and
complete drag and
drop interactive
questions

Self-Paced Online
Training

To identify the
process flow for
retiring a system.

Cognitive
Analysis &
Application

Procedure

Review the SOP

training and fill the
missing
components in the
process flow.

Self-Paced Online
Training