INSTITUT TEKNOLOGI PERAK

E-3-10,GREENTOWN SQUARE,
JALAN DATO’ SERI AHMAD SAID,
30450, IPOH, PERAK

KERTAS PENERANGAN
( INFORMATION SHEET )

KOD DAN NAMA PROGRAM / MC-091-2:2013- INDUSTRIAL AUTOMATION ENGINEERING

PROGRAM’S CODE & NAME SUPPORT SERVICE
TAHAP / LEVEL L2

NO. DAN TAJUK UNIT

KOMPETENSI / C04- INDUSTRIAL AUTOMATION INSTALLATION
COMPETENCY UNIT NO. AND
TITLE

1. EXAMINE INDUSTRIAL AUTOMATION SYSTEM

INSTALLATION INSTRUCTION.
2. PREPARE INDUSTRIAL AUTOMATION SYSTEM
NO. DAN PENYATAAN INSTALLATION REQUIREMENTS.
AKTIVITI KERJA / WORK 3. PERFORM INDUSTRIAL AUTOMATION SYSTEM
ACTIVITIES NO. AND INSTALLATION IMPLEMENTATION
STATEMENT 4. PERFORM INDUSTRIAL AUTOMATION SYSTEM TRIAL
RUN.
5. PERFORM INDUSTRIAL AUTOMATION SYSTEM TRIAL
RUN RECORD SUBMISSION

NO. KOD / CODE NUM. MC-091-2:2013-C04/P(3/3) Muka : 1 Drp : 22

TAJUK/TITLE :
SYSTEM TRIAL RUN RECORD SUBMISSION

TUJUAN/PURPOSE :

This information paper aims to provide knowledge to the trainers about industrial automation
system
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PENERANGAN/INFORMATION :
I. INTRODUCTION
This document addresses issues pertaining to computerized systems used to create,
modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the
Food and Drug Administration (FDA). These data form the basis for the Agency's decisions
regarding the safety and efficacy of new human and animal drugs, biologics, medical
devices, and certain food and color additives. As such, these data have broad public health
significance and must be of the highest quality and integrity. FDA established the ioresearch
Monitoring (BIMO) Program of inspections and audits to monitor the conduct and reporting of
clinical trials to ensure that data from these trials meet the highest standards of quality and
integrity and conform to FDA's regulations. FDA's acceptance of data from clinical trials for
decision-making purposes is dependent upon its ability to verify the quality and integrity of
such data during its onsite inspections and audits. To be acceptable the data should meet
certain fundamental elements of quality whether collected or recorded electronically or on
paper. Data should be attributable, original, accurate, contemporaneous, and legible. For
example, attributable data can be traced to individuals responsible for observing and
recording the data. In an automated system, attributability could be achieved by a computer
system designed to identify individuals responsible for any input. This guidance addresses
how these elements of data quality might be satisfied where computerized systems are
being used to create, modify, maintain, archive, retrieve, or transmit clinical data. Although
the primary focus of this guidance is on computerized systems used at clinical sites to collect
data, the principles set forth may also be appropriate for computerized systems at contract
research organizations, data management centers, and sponsors. Persons using the data
from computerized systems should have confidence that the data are no less reliable than
data in paper form.
Computerized medical devices, diagnostic laboratory instruments and instruments in
analytical laboratories that are used in clinical trials are not the focus of this guidance. This
guidance does not address electronic submissions or methods of their transmission to the
Agency.
This guidance document reflects long-standing regulations covering clinical trial
records. It also addresses requirements of the Electronic Records/Electronic Signatures rule
(21 CFR part 11).
The principles in this guidance may be applied where source documents are created
(1) in hardcopy and later entered into a computerized system, (2) by direct entry by a human
into a computerized system, and (3) automatically by a computerized system.

II. DEFINITIONS
Audit Trail means, for the purposes of this guidance, a secure, computer generated,
time-stamped electronic record that allows reconstruction of the course of events relating to
the creation, modification, and deletion of an electronic record.

Certified Copy means a copy of original information that has been verified, as indicated by
dated signature, as an exact copy having all of the same attributes and information as the
original.

Commit means a saving action, which creates or modifies, or an action which deletes, an
electronic record or portion of an electronic record. An example is pressing the key of a
keyboard that causes information to be saved to durable medium.

Computerized System means, for the purpose of this guidance, computer hardware,
software, and associated documents (e.g., user manual) that create, modify, maintain,
archive, retrieve, or transmit in digital form information related to the conduct of a
clinical trial.
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Direct Entry means recording data where an electronic record is the original capture of
the data. Examples are the keying by an individual of original observations into the
system, or automatic recording by the system of the output of a balance that measures
subject’s body weight.

Electronic Case Report Form (e-CRF) means an auditable electronic record designed
to record information required by the clinical trial protocol to be reported to the sponsor
on each trial subject.

Electronic Patient Diary means an electronic record into which a subject participating in
a clinical trial directly enters observations or directly responds to an evaluation checklist.

Electronic Record means any combination of text, graphics, data, audio, pictorial, or any
other information representation in digital form that is created, modified, maintained,
archived, retrieved, or distributed by a computer system.

Electronic Signature means a computer data compilation of any symbol or series of

symbols, executed, adopted, or authorized by an individual to be the legally binding
equivalent of the individual's handwritten signature.

Software Validation means confirmation by examination and provision of objective

evidence that software specifications conform to user needs and intended uses, and that
the particular requirements implemented through the software can be consistently
fulfilled. For the purposes of this document, design level validation is that portion of the
software validation that takes place in parts of the software life cycle before the software
is delivered to the end user.

Source Documents means original documents and records including, but not limited to,
hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries
or evaluation checklists, pharmacy dispensing records, recorded data from automated
instruments, copies or transcriptions certified after verification as being accurate and
complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays,
subject files, and records kept at the pharmacy, at the laboratories, and at medicotechnical
departments involved in the clinical trial.

Transmit means, for the purposes of this guidance, to transfer data within or among
clinical study sites, contract research organizations, data management centers, or
sponsors. Other Agency guidance covers transmission from sponsors to the Agency.

III. GENERAL PRINCIPLES

A. Each study protocol should identify at which steps a computerized system will
be used to create, modify, maintain, archive, retrieve, or transmit data.

B. For each study, documentation should identify what software and, if known,
what hardware is to be used in computerized systems that create, modify, maintain,
archive, retrieve, or transmit data. This documentation should be
retained as part of study records.

C. Source documents should be retained to enable a reconstruction and

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evaluation of the trial.

D. When original observations are entered directly into a computerized system,

the electronic record is the source document.

E. The design of a computerized system should ensure that all applicable

regulatory requirements for recordkeeping and record retention in clinical
trials are met with the same degree of confidence as is provided with paper
systems.

F. Clinical investigators should retain either the original or a certified copy of all
source documents sent to a sponsor or contract research organization,
including query resolution correspondence.

G. Any change to a record required to be maintained should not obscure the

original information. The record should clearly indicate that a change was
made and clearly provide a means to locate and read the prior information.

H. Changes to data that are stored on electronic media will always require an
audit trail, in accordance with 21 CFR 11.10(e). Documentation should
include who made the changes, when, and why they were made.

I. The FDA may inspect all records that are intended to support submissions to
the Agency, regardless of how they were created or maintained.

J. Data should be retrievable in such a fashion that all information regarding

each individual subject in a study is attributable to that subject.

K. Computerized systems should be designed: (1) So that all requirements

assigned to these systems in a study protocol are satisfied (e.g., data are
recorded in metric units, requirements that the study be blinded); and, (2) to
preclude errors in data creation, modification, maintenance, archiving,
retrieval, or transmission.

L. Security measures should be in place to prevent unauthorized access to the

data and to the computerized system.

IV. STANDARD OPERATING PROCEDURES

Standard Operating Procedures (SOPs) pertinent to the use of the computerized system
should be available on site.

SOPs should be established for, but not limited to:

 System Setup/Installation
 Data Collection and Handling
 System Maintenance
 Data Backup, Recovery, and Contingency Plans
 Security
 Change Control
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A. Industrial Automation Systems

Complex industrial automation systems need to be flexible to adapt to changing business
requirements and to become more robust against failures during runtime. Melik-Merkumians
et al. proposed an ontology-based Engineering Knowledge Base [7] to provide relevant
design time and runtime engineering knowledge in machine understandable form to be able
to better identify and respond to failures. The authors used an example of an educational
model of an industrial process plant to simulate complex industrial batch processes, such as
the processes typically implemented in like refineries, breweries, or pharmaceutical plants. It
consists of two tanks holding the process fluids. The liquid levels of the tanks are checked
by several analog and digital sensors. The lower tank also contains a pump which either
transports the process fluid into the upper tank, or is used to mix up the process fluid
in the lower tank. Also the lower tank contains a heater and a temperature sensor to heat the
process fluid to specified temperatures. This educational model of an industrial process plant
is also used as use case in this paper to demonstrate the proposed requirements elicitation
at enforcement of safety requirements at runtime for industrial automation systems.
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9780538737074
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And Productivity Techniques, ISBN: 9788120336025.
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quality management, ISBN: 9781861523983
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Training: The Key to Staff Success, ISBN: 9781569911044
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ISBN: 9780072436617
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Training: Unleashing Employee Expertise into the Workplace, ISBN: 978-1576752425
11. Heeringa SG.,West BT, Berglund PA., CRC Press,2010, Applied Survey Data Analysis,
ISBN: 978-1-4200-8066-7
12. Richard Shell, Taylor & Francis, 2000, Handbook Of Industrial Automation, ISBN:
9780824703738
13. Clarence T. Jones, Brilliant-Training, 1996, Patrick-Turner's Industrial Automation
Dictionary, ISBN: 9781889101019