Computer Information System Department New Jersey Institute of Technology Newark, NJ 07102 Human Machine Interface In Partial Fulfillment of the Course Requirement for: CIS 490 – 001 Proposed to: Prof. Osama Eljabiri Proposed by: Chang, Evelyn A. Ding, Daniel Javier, Melissa Kim, Chiyong Pina, Glenys
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Computer Information System Department
New Jersey Institute of Technology Newark, NJ 07102
Human Machine Interface
In Partial Fulfillment of the Course Requirement for: CIS 490 – 001
Proposed to: Prof. Osama Eljabiri
Proposed by: Chang, Evelyn A.
Ding, Daniel Javier, Melissa Kim, Chiyong Pina, Glenys
3.4.2 DFD Diagram 11/14/02 11/21/02 3.4.2.1 Grammatical Analysis 11/14/02 11/21/02 Chiyong Kim 3.4.2.2 Context Diagram 11/14/02 11/21/02 Chiyong Kim 3.4.2.2.1 AS-IS Context Diagram 11/14/02 11/21/02 Chiyong Kim 3.4.2.2.2 TO-BE Context Diagram 11/14/02 11/21/02 Chiyong Kim 3.4.2.3 General Context Diagram 11/14/02 11/21/02 Chiyong Kim 3.4.2.4 Decompositions 11/14/02 11/21/02 Chiyong Kim 3.4.3 Data Dictionary 11/22/02 11/28/02 Chiyong Kim 4. Requirement Specification 12 11/14/02 11/28/02 4.1 Structured English 11/14/02 11/28/02 Chiyong Kim 4.2 Decision Trees 11/14/02 11/28/02 Chiyong Kim 4.3 Decision Tables 11/14/02 11/28/02 Chiyong Kim 5. Qualification 7 11/21/02 11/28/02 5.1 Performance Qualification 11/21/02 11/28/02 Evelyn Chang 5.2 Operational Qualification 11/21/02 11/28/02 Evelyn Chang 5.3 Installation Qualification 11/21/02 11/28/02 Evelyn Chang 6. System Design 9 11/22/02 12/03/02 6.1 ERM Model 11/22/02 12/03/02 Daniel Ding 6.2 Structured Chart 11/22/02 12/03/02 Chiyong Kim 6.3 User Interface Design 11/22/02 12/03/02 6.3.1 AS-IS User Interface Design 11/22/02 12/03/02 Evelyn Chang
Glenys Pina 6.3.2 TO-BE User Interface Design 11/22/02 12/03/02 Evelyn Chang 6.4 Database Design 11/22/02 12/03/02 6.4.1 AS-IS Database Design 11/22/02 12/03/02 Daniel Ding 6.4.2 TO-BE Database Design 11/22/02 12/03/02 Daniel Ding 7. System Architectural Model 9 11/22/02 12/03/02 7.1 AS-IS Architectural Model 11/22/02 12/03/02 Evelyn Chang 7.2 TO-BE Architectural Model 11/22/02 12/03/02 Evelyn Chang
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2.2.2 Project Milestones
PHASE (DATE) PHASE IMPLEMENTED
START END
ALLOCATED RESOURCES
PHASE DESCRIPTION
PHASE IA– Introduction
09/25/02 09/28/02
Evelyn Chang Daniel Ding Chiyong Kim Melissa Javier Glenys Pina
The following tasks were completed during this phase, Interviewing Project Sponsor, Project Scope, and History
PHASE IB - Project Planning
09/29/02 10/11/02
Evelyn Chang Daniel Ding Chiyong Kim Melissa Javier Glenys Pina
The following tasks were completed during this phase, Background, Problem statement, Previous work, Methodologies and glossary
PHASE IIA - Project Management
10/12/02 10/21/02 Evelyn Chang Glenys Pina
The following tasks were completed during this phase, Project Team and Roles, WBS, Project Milestones, Preliminary Project Plan, Baseline Plan
PHASE IIB - Project Management
10/17/02 10/21/21 Evelyn Chang Melissa Javier Glenys Pina
The following tasks were completed during this phase, Feasibility Studies, and Risk Management
PHASE IIIA – Analysis
10/22/02 11/08/02
Evelyn Chang Daniel Ding Melissa Javier Glenys Pina
The following tasks were completed during this phase, Stakeholder Identification, and Requirements Gathering
PHASE IIIB – Analysis
11/09/02 11/28/02
Evelyn Chang Chiyong Kim Melissa Javier Glenys Pina
The following tasks were completed during this phase, Documenting and Modeling Requirements, Requirement Specification, and System Qualification
PHASE IVA - Design
11/22/02 12/03/02
Evelyn Chang Daniel Ding Chiyong Kim Glenys Pina
The following tasks were completed during this phase, ERM Model, Structure Chart, User Interface Design, Database Design, and System Architectural Models
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2.2.3 Preliminary Project Plan
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2.2.4 Baseline Plan
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2.3 Feasibility Study: Cost Benefit Analysis
2.3.1 Economic Feasibility
TANGIBLE BENEFITS WORKSHEET
HMI
Year 1 through 5
A. Cost Reduction or Avoidance $ 12,000
B. Increased Flexibility 7,000
C. Increased Speed of Activity 12,000
D. Improvement in management planning or control 18,000
The project has a budget of nearly $ 70,000.00. The number of members on the project
team is 5. The HMI for NIRO Fluid Bed Processor involves a number of parties. The basic data
for the system is readily available so the creation of the system will not be a large undertaking.
Project Structure
The project involves upgrading the HMI for NIRO Fluid Bed Processor with ISQL
database software, which is available for analysts to examine and study. Therefore, the
requirements for the project are highly structured and easily obtainable.
Time Constraints
1. The duration of this project lasts weeks, months, or even years. During such a long
period, many changes may occurs, most of which are difficult to predict. Such changes
may have a significant impact on project costs, technology, and resources. The longer
the duration of the project, the more uncertain are the execution times and costs.
2. This project is complex in nature, involving many interrelated activities and participants
from both within the organization and outside it (e.g., suppliers, subcontractor). (Our
example is highly simplified for the purpose of easier demonstration.)
3. Delays in completion time may be very costly. Penalties for delays may amount to
thousands of dollars per day. Completing projects late may result in lost opportunities
and ill will as well.
4. Project activities are sequential. Some activities cannot start until others are completed.
Systems Interdependence
The system is composed of more than 100 parts. It is mutually dependent only to its
components that made it to a system and not to any other system. In order for the NIRO Fluid
Bed Dryer to fully be functional, the components have to be commissioned upon then the
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installations of the parts. Without these components that the system is interdependent with,
the entire system is not functional.
Quality
The quality to produce drug depends on the operations of the system. The system has
to be maintained orderly and meet all its calibration dues. For security health reasons, the
equipments have to be tested and qualified before making any processes.
Clarity
Before the processes are being executed, any confusion to the system is already been
eliminated during the validation phase of the project. The validation phase helps in eliminating
unnecessary or confusing features of the system to avoid risk to the process. Otherwise, if the
confusion is this present upon execution of a process, the operator has to re-train to fully
understand how the system works.
Efficiency
For security issues, every drug company must produce efficient quality of drug products.
Without efficiency of the system due to over due of the calibration or out of tolerance of the
equipment, the batch products are not secured to be in compliant to the FDA’s regulation.
Thus, may caused fatal results upon taken by the patients. All parts of the equipment have to
be calibrated, maintained and properly cleaned.
Traceability
It is important to have back up copies of all the history of equipment. Tracing files
manually is a tough job. The system is designed to store information that could easily be
traced.
There are some instance that when making drug batches, there are pass and reject
tablets. In case where the FDA request for a copy of the file months ago, it is easy to supply
the needs if the system can trace the procedures.
In order to track the previous document of a specific procedure, the administrator can
go back to day and time the product was made.
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Familiarity with Technology or Application Area
The development group is familiar with the technology that will likely be used to
construct the system. However, the user group is not familiar with the application area since
they don’t understand the technical diagrams and the components in the system. Furthermore,
they are intimidated to use the system due to this lack of understanding.
Project Size
The project is huge. Since the basic data for the system is readily available, the creation of the system will not be large undertaking. Section 1.01 Risk: High
Project Structure
The requirements for the project are highly structured and obtainable. The existing HMI for NIRO Fluid Bed Processor is available for analysts to examine and study. Section 1.02 Risk: Medium High
Time Constraint
The duration of this project lasts 12 months period. During such a long period, many changes may occurs, most of which are difficult to predict. Such changes may have a significant impact on project costs, technology, and resources. The longer the duration of the project, the more uncertain are the execution times and costs. Section 1.04 Risk: High
System Interdependence
The good feature about this system is that it is not interdependent among other system but dependent to its components, such as process airflow, atomizing air, etc. Without these components that the system is interdependent with, the entire system is not functional. Section 1.05 Risk: Low
Quality
For health reasons, the quality of the product is extremely important. Section 1.08 Risk: Extremely High
Clarity
Before the processes are being executed, any confusion to the system is already been eliminated during the validation phase of the project. The validation phase helps in eliminating unnecessary or confusing features of the system to avoid risk to the process. Section 1.06 Risk: Low
Efficiency For security issues, every drug company must produce efficient
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quality of drug products. Without efficiency of the system due to over due of the calibration or out of tolerance of the equipment, the batch products are not secured to be in compliant to the FDA’s regulation. Thus, may caused fatal results upon taken by the patients. All parts of the equipment have to be calibrated, maintained and properly cleaned. Section1.07 Risk: Extremely High
Traceability
It is important to have back up copies of all records. When making drug batches, there are pass and reject tablets. In case where the FDA request for a copy of the file months ago, it is easy to supply the needs if the system can trace the procedure. In order to track the previous document of a specific procedure, the administrator can go back to day and time the product was made. Section 1.09 Risk: Medium High
Familiarity with Technology or Application Area
The development group is familiar with the technology that will likely be used to construct the system, since they will simply upgrade current system capabilities. The user group is not familiar with the application area. The users who operate the systems slightly understand the technical diagrams and the components in the system. Section 1.03 Risk: Medium Low
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3. Project Analysis
3.1 Stakeholder Identification
Machine Operators
Machine Operators are very important stakeholders to the system because they interact
with the system in a constant daily-basis. They interact with the system automatically by
using the different screens. They are responsible for monitoring and controlling the production
of materials. Machine operators have access to the operator’s screen, air preparation screen,
alarm screen, and trend screens.
Management Personnel (Department Supervisors and Department Managers)
Department Supervisors and Managers have access to the system according to their
department. They are responsible for monitoring and controlling the production of materials.
They have access to the operator’s screen, air preparation screen, alarm screen, and trend
screens. They are also authorized to abort and to halt batches.
Stakeholders
Maintenance Personnel
Management Personnel
Machine Operators
Electrical Engineers
Department Supervisors
Department Managers
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Maintenance Personnel
Maintenance Personnel has the same level of interaction as the trained operator. In
addition to the automatic interaction they can manually control the system. They can start and
stop all machine motors, and open and close all valves to perform system maintenance on a
daily basis.
Electrical Engineers
Electrical Engineers have full access to the system. They have administrative access to
the system, such as the ability to create new user accounts, reset user passwords. Electrical
Engineers also troubleshoot hardware and application problems, as well as, networking
problems. They also maintain the communication between the two servers (ISQL server and
terminal server).
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3.2 Gathering Requirements
3.2.1 Interviewing (Informal)
See Attached.
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3.2.2 USE-CASE Scenarios
A Use Case Scenario is distinctive interaction that a user has with the system in order to
achieve a particular purpose. It provides the basis of communication between the sponsors and
the developers in planning the project. The Use Case Scenario captures some user-visible
functions. A diagram is created soon after to have better picture.
Actor: Machine Operator
HMI System: The trained operator is in front of the HMI system, which displays
different options the user can select from.
Main System Interface: After selecting the login option from the HMI System, the
HMI main system interface displays the login screen.
Login Screen: The Machine Operator uses the virtual keyboard to input his/her User-
ID and password. The User-ID and password are compared to the one stored on the database.
If the wrong user name and/or password are entered, an error message will be display, and
he/she will be asked to re-enter the information. If User-ID and password are verified, the
machine operator is logged on to the system and with his/her proper level of authorization and
security.
Logon to System: Once the machine operator is logged on to the system, he/she will
be able to select from a list of displayed options: inflation/deflation of the container and filter
gaskets, raising and lowering of the dryer filter, and spray test.
Perform Task 1: The machine operator press the INFLATE/DEFLATE FILTER
GASKET button on the screen to inflate or deflate the filter sealing gasket and the upper
container gasket and the inlet plenum gasket.
Perform Task 2: The machine operator presses the RAISE or LOWER button on the
screen to raise or lower the exhaust air filter. The operator clicks and holds the button to
actuate the cylinder. This method is useful to install the exhaust filter and the filter gasket.
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Perform Task 3: The machine operator presses the ON button on the screen to turn on
the Fluid Bed chamber light.
Perform Task 4: Press the FILTER SHAKE button on the screen to initiate the shake
sequence. Once the button is activated the system will automatically close the appropriate
dumpers stroke the cylinders. If the batch is loaded and running the activation button will
shake the bags. If the funning is not running the activation button will shake the filters as an
end of batch shake.
Perform Task 4: The machine operator press the AIR PREP UNIT button on the
screen to view the air preparation screen, process outputs for chilled water and steam supply,
the dew-point and dry bulb temperatures, face and the by-pass temper position as well as the
actual inlet temperature.
Perform Task 5: The machine operator presses the CLEAR button on the screen to go
back to the main menu.
Perform Task 6: the machine operator presses the RECIPE VIEW BUTTON on the
screen to display the current or last recipe run on the system.
File Records: The machine operator press the BATCH REPORT on the screen to view
the batch report for the current run.
Print Screen: The machine operator presses the PRINT SCREEN button on the screen
to print batch report.
Cancel a Task 1: The machine operator press the WIP SYSTEM button on the screen
to operate automated wash sequence.
Cancel a Task 2: The machine operator press the PRODUCT PULSE button on the
screen when available to close the air flow damper and reposition the valve to its original
position.
Log Off: The machine operator presses the LOG OFF button on the screen to end the
batch.
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Actor: Maintenance Personnel
HMI System: The system administrator is in front of the HMI system, which displays
different options the user can select from.
Main System Interface: After selecting the login option from the HMI System, the
HMI main system interface displays the login screen.
Login Screen: The System Administrator uses the virtual keyboard to input his/her
User-ID and password. The User-ID and password are compared to the one stored on the
database. If the wrong user name and/or password are entered, an error message will be
display, and he/she will be asked to re-enter the information. If User-ID and password are
verified, the machine operator is logged on to the system and with his/her proper level of
authorization and security.
Logon to System: Once the system administrator is logged on to the system, he/she
will be able to select from a list of displayed options: process airflow, air prep airflow,
atomizing air, solution flow, or inlet temp on the operator’s screen.
Task 1: The system administrator presses the PROCESS AIRFLOW button on the
screen to display the controller window, then press the ENTER button when finish.
Task 2: The system administrator presses the AIRPREP AIRFLOW button on the
screen to view or change the process set point, then press the ENTER button when finish.
Task 3: The system administrator presses the ATOMIZING AIR button on the screen
to view or change the controller outputs, then press the ENTER button when finish.
Task 4: The system administrator presses the SOLUTION FLOW button on the screen
to view or change the process variables, then press the ENTER button when finish.
Task 5: The system administrator presses the SHAKEUP SETUP button to view the
several shake parameters.
Task 5: The system administrator presses the SHAKEUP TIME AND SHAKE DOWN
TIME button to control the up and down time of the shake cylinder during the shake cycle.
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Log Off: The maintenance personnel press the LOG OFF button on the screen to end
the batch.
Actor: Management Personnel (Department Supervisors and Department Managers)
HMI System: The Management Personnel is in front of the HMI system, which displays
different options the user can select from.
Main System Interface: After selecting the login option from the HMI System, the
HMI main system interface displays the login screen.
Login Screen: The Management Personnel uses the virtual keyboard to input his/her
User-ID and password. The User-ID and password are compared to the one stored on the
database. If the wrong user name and/or password are entered, an error message will be
display, and he/she will be asked to re-enter the information. If User-ID and password are
verified, the machine operator is logged on to the system and with his/her proper level of
authorization and security.
Logon to System: Once the management personnel are logged on to the system,
he/she will be able to select from a list of displayed options: process airflow, air prep airflow,
atomizing air, solution flow, or inlet temp on the operator’s screen.
Task 1: The management personnel presses the CONFIGURE button on the screen to
display the I/O simulation switch, which allows for operator training with all processor I/O
disabled.
Task 2: The management personnel press the ABORT button on the screen to end the
batch.
Task 3: The management personnel press the RECIPE EDIT button on the screen to
edit a recipe.
Task 4: The management personnel press the EDIT FUNCTION button on the screen
to edit a value or create a recipe.
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Log Off: The management personnel press the LOG OFF button on the screen to end
the batch.
Actor: Electrical Engineer
HMI System: The Electrical Engineer is in front of the HMI system, which displays
different options the user can select from.
Main System Interface: After selecting the login option from the HMI System, the
HMI main system interface displays the login screen.
Login Screen: The Electrical Engineer uses the virtual keyboard to input his/her User-
ID and password. The User-ID and password are compared to the one stored on the database.
If the wrong user name and/or password are entered, an error message will be display, and
he/she will be asked to re-enter the information. If User-ID and password are verified, the
machine operator is logged on to the system and with his/her proper level of authorization and
security.
Logon to System: Once the Electrical Engineer is logged on to the system, he/she will
be able to select from a list of displayed options: process airflow, air prep airflow, atomizing
air, solution flow, or inlet temp on the operator’s screen.
Task 1: The electrical engineer presses the PID tuning button on the screen to access
the control loop tuning, such as setting the control loop’s GAIN, RESET and TIME. The control
tolerance and deviation alarm time settings are also set/on these screens.
Task 2: The electrical engineer presses the CHANGE PASSWORD button on the screen
to change current users’ password for the system.
Task 3: The electrical engineer presses the WINDOWS button on the screen to retrieve
the batch files, report and the alarm files.
Log Off: The electrical engineer presses the LOG OFF button on the screen to end the
batch.
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Actor: IT Personnel
HMI System: The IT Personnel is in front of the HMI system, which displays different
options the user can select from.
Main System Interface: After selecting the login option from the HMI System, the
HMI main system interface displays the login screen.
Login Screen: The IT Personnel uses the virtual keyboard to input his/her User-ID and
password. The User-ID and password are compared to the one stored on the database. If the
wrong user name and/or password are entered, an error message will be display, and he/she
will be asked to re-enter the information. If User-ID and password are verified, the machine
operator is logged on to the system and with his/her proper level of authorization and security.
Logon to System: Once the IT Personnel are logged on to the system, he/she will be
able to configure the network connection of the system.
Log Off: The IT Personnel presses the LOG OFF button on the screen to end the batch.
Actor: Validation Specialist
HMI System: The Validation Specialist is in front of the HMI system, which displays
different options the user can select from.
Main System Interface: After selecting the login option from the HMI System, the
HMI main system interface displays the login screen.
Login Screen: The Validation Specialist uses the virtual keyboard to input his/her
User-ID and password. The User-ID and password are compared to the one stored on the
database. If the wrong user name and/or password are entered, an error message will be
display, and he/she will be asked to re-enter the information. If User-ID and password are
verified, the machine operator is logged on to the system and with his/her proper level of
authorization and security.
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Logon to System: Once the Validation Specialist is logged on to the system, he/she
will be able to commission the system requirements and specifications.
Log Off: The Validation Specialist presses the LOG OFF button on the screen to end the
batch.
Actor: ISQA Compliance Specialist/QA Specialist
HMI System: The ISQA Compliance Specialist/QA Specialist is in front of the HMI
system, which displays different options the user can select from.
Main System Interface: After selecting the login option from the HMI System, the
HMI main system interface displays the login screen.
Login Screen: The ISQA Compliance Specialist/QA Specialist uses the virtual keyboard
to input his/her User-ID and password. The User-ID and password are compared to the one
stored on the database. If the wrong user name and/or password are entered, an error
message will be display, and he/she will be asked to re-enter the information. If User-ID and
password are verified, the machine operator is logged on to the system and with his/her proper
level of authorization and security.
Logon to System: Once the ISQA Compliance Specialist/QA Specialist is logged on to
the system, he/she will be able to document the procedures and specifications of the system.
Log Off: The ISQA Compliance Specialist/QA Specialist presses the LOG OFF button on
the screen to end the batch.
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3.2.3 Brainstorming
Ability to Acquire Production Data in
Full Resolution
User Friendly
Security and Authentication
Ability to Acquire Production Data in
Real Time
Application Role
Touch Screen HMI
Available 24/7 Redundancy
Ability to Raise Alarms
Can be customized for Any Assembly
Line
Reduce Expenses and Resources in Assembly
Line Control and Monitoring
Privacy of Proprietary Information
HMI Layout Design
Email Notification
Computerized Production
Line Control
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Categorization
Speed
• HMI Layout Design • Ability to Acquire Production Data in Real Time
Convenience
• Computerized Production Line Control • User Friendly
• Email notification
• Available 24/7, Redundancy
• Touch Screen HMI
Security
• Security and Authentication
• Application Role
• Privacy of Proprietary Information
Efficiency
• Ability to Acquire Production Data in Full Resolution
Functional specification denotes the behavior of the system and how its components are
integrated. These specifications therefore describe HOW the system has been designed to
obtain the WHAT specified in the Requirement Specification.
Interface Requirement - The system has an interface (HMI), which would operate and
perform a process. The interface should be user-friendly and allow users to navigate various
graphical screens without interference to the process being executed. It has constant network
connectivity. It allows the Industrial SQL Server to collect data from the primary network
controller.
Database Requirement – The system database is the central storage of critical data;
the system has the support for the Universal Time Code to eliminate issues with time zones
and daylight savings; the system is capable to remote buffering data at the I/O device server,
so that the data can still be stored at a later time if connection to I/O is lost.
Back up and Support Requirement – The system is capable of having the software
and data it contains regularly backed-up to a separate storage device over the network.
Alarm Management Requirement – The alarm in the system will initiate when a
communication connection loss to any controllers. The system will automatically display new
alarms regardless of where the operator is within the interface.
Reporting Requirement – the system will provide the ability to produce a Data Report
that will include time and corresponding temperature (in Min, max, avg.), humidity (in min,
max, avg.) and/or airflow direction. The system is capable of generating screen shot reports
and hardcopy. The system has the ability to produce the history of the alarms.
Performance Requirement – The system runs on NT 4.0 and Windows 2000
operating system. The systems also automatically adjust for daylight saving time change.
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4.3 Design Specification
The Design Specification method describes how the systems have been designed in
terms of the components that build it. It describes each single component in terms of purpose,
specific characteristics and configure for the correct functioning. One of the design functions is
how the system treats software architecture as a set of run-time entities, including tasks and
external input/output elements, which interact either via messages or shared data structures.
Every task has a single thread of execution and represents program units that may be
executed concurrently.
In this project, the interface, InTouch application, is designed to allow users to create
an application in Windows 95/98/2000 (or later) and run the application on the Windows NT
4.0 SP4 (or later) operating system or vice versa. The application is interchangeable and runs
on either platform without requiring conversions of either application. It even allows Managers
and Supervisors the ability to view a continuous HMI application process in real time.
In addition, the interface (InTouch application) is also designed to support OCX controls,
ActiveX controls and Object Linking and Embedding (OLE). This method could easily select and
add OCX and ActiveX controls to any application windows and toolbar to handle control events.
The system has an interface (HMI), which would operate and perform a process. The
interface should be user-friendly and allow users to navigate various graphical screens without
interference to the process being executed. It has constant network connectivity. It allows the
Industrial SQL Server to collect data from the primary network controller.
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5. Qualification
Qualification is the validation phase, which is part of every production projects. The
main purpose of having validated project documents is to secure that equipment being
configured in the facility is properly installed and meet all the necessary requirements and
specifications. Thus, does not produce any impact to the production of drugs. Validation
process is divided into 3 types: Installation Qualification (IQ), Operational Qualification (OQ),
and Performance Qualification (PM).
5.1 Installation Qualification (IQ)
The purpose of this IQ documentation is to generate proper documentation as evidence,
that all the hardware and software components are properly configured according to the
approved requirements and specifications. The Validation specialists provide this documents in
direct compliance with the FDA.
The purpose of the IQ is to demonstrate that all of the expected components are
present and properly configured, that all of the instruments have the expected accuracy and
precision and that the services (power, connections, etc.) are appropriate for the correct
functioning of the system. Any exceptional conditions encountered during the IQ that could
impact process integrity or product reproducibility, are identified, investigated, and
documented (including justification, correction, and any necessary re-qualification studies).
A written IQ protocol is provided by the Validation Specialist/Validation Engineers to
follow the steps of configurations. Prior to conventional operations, the protocol, which is the
systematic method in checking the static attributes of the system, has to be performed. The IQ
protocol describes all the important major/minor components of the system. These include
system and equipment operation, maintenance, cleaning and/or sanitization.
After the installation of the system is completed, it is commissioned to verify and
confirm that the design specification is being followed. Engineering drawings, manuals, data
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sheets, and purchase orders is used to document proper installation and placement. An
evaluation is confirmed for proper connection and installation of supporting services and
components, such as filters, piping, valves, gauges, controls, etc., calibration scope for control,
monitoring (HMI), and recording instruments, such as pressure gauges, temperature sensor,
timers, differential pressure transmitter, etc. that could impact the efficacy, integrity and
quality of the product, that supports the system utilities, such as water, steam, electric, etc.
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5.2 Operational Qualification (OQ)
The purpose of the Operational Qualification (OQ) is to demonstrate that the system
behaves as specified in the expected conditions and that its components are properly
integrated. After satisfactory completion of the system and/or equipment IQ execution, OQ is
performed to check the operational tests, measurements, and control tolerances of key
parameters that are critical for the proper operation of the system.
A written OQ protocol is implemented to test objectives, methodologies, and acceptance
criteria, which it involves in testing and measuring of the system’s key operational parameters
upon the execution. The operational data obtained from the instruments, indicators, gauges,
and sensor upon testing is monitored and evaluated. “Any "worse case" challenges to the
system/equipment are defined and incorporated into the testing strategy to challenge the
system/equipment capacity (Control)”.
Prior to the protocol execution of the OQ to all critical process instrumentations, all the
process, control, monitoring and recording instruments, such as pressure gauges, temperature
sensors, timers, etc., that could impact the product integrity, quality, or effectiveness are
calibrated. The calibration of the process instrumentation that is being used to gather the
qualification data is checked at the end of the study to establish confidence in qualification. Any
equipment found out of calibration at the end of a process validation study indicates that the
process has not been operating in a state of control and cannot be considered validated. Any
exceptional conditions encountered during the OQ are to be identified, investigated, and
documented (including justification, correction, and any necessary re-qualification studies).
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5.3 Performance Qualification (PQ)
Performance Qualification is performed after a successful completion of the Installation
and Operational Qualifications (IQ/OQ) execution. Prior to execution, the test objectives,
methodologies, and acceptance are well defined in the PQ documentation. The purpose of the
PQ is to demonstrate if the system operating with input parameters produces the results that
satisfy the pre-established specification. In providing the assurance of the process, the critical
systems or processes requiring PQ is validated. This purpose is to test the ability of the system
or process to perform the intended function (over time) within the defined upper and lower
process variable limits. It is important that if OQ could be executed for system component, PQ
always must be done for complete system (Control).
The performance of the steam sterilization, crucial utility systems (HVAC, Purified USP
Water System), and cleaning and sanitization is being studied in PQ. A sufficient number of
replicate studies are performed to demonstrate the ability of the system/equipment to achieve
reproducible results. Testing may include analysis for chemical, physical, and microbiological
constituents. Any exceptional conditions encountered during the PQ will be identified,
investigated, and documented, which includes justification, correction, and any necessary re-
qualification studies (Control).
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6. System Design
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6.1 Structured Chart
1.0Translate
and TransferOperator
Command
3.0RetrieveReal-time
Data
8.0Update
Database
5.0ProduceReports
2.0Update User
Log File
7.0Create User
6.0Backup and
Restore
1.1TranslateOperatorCommand
1.2Authentic
ationProcess
1.3TransferOperatorCommand
1.2.1ReceiveLoginData
1.2.2VerifyUser
1.2.3Approve
Login
2.1Recieve
Request forUpdating
2.2Check
User LogFile
2.3Create
New LogFile
2.4Update
User Log
3.1TranslateOperator
Command
3.2Request
for Update
3.3ReceiveMachine
Data
3.4Display
Real-timeData
4.0ControlMachine
4.1TranslateOperatorCommand
4.2Request for
Update
4.3TransferControl
Command
5.1Retrieve
Dataand Transfer
5.2Produce
UserReports
5.3ProduceMachineReports
5.4Generate
ManagementReports
6.1TransferRequest
6.2Backup
Database
6.3Restore
Database
7.1Receive
New UserInformation
7.2Verify New
User
7.3Update
User DataFile
Operator Commands
Request
Operator Commands
Login Data
Login Data
Login Data
User Name UserName
Current User Data
Request for Update
Current User Data
UserData Request
Formmatted User Data
Operator Commands
Operator Commands
Update DataCommands Machine Data Realtime Data
Operator Commands
Realtime Data
Operator Commands
Commands UserData
Command Request
Machine Data
User Data
User DataMachine Data
User Report MachineReport
Reports
Management Report
System Commands
System Commands
Commands RequestBackup
RequestRestore
User Data
User Data
New User Info.Request forVerification
New User Info.
User Data
Requestfor Update
USER DATAFILE ISQL
Update Info.
New User Info.
USER LOG FILE
Formmatted User Data
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User Interface Design
6.1.1 AS-IS User Interface Design
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6.3.2 TO-BE User Interface Design
See Attached
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6.2 Database Design
6.2.1 AS-IS Database Design
The “InSQL Service Control” utility was launched to start the InSQL Server:
Pressed “GO”, and then “Yes” to confirm the start:
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The following shows all services started up with no errors:
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6.2.2 TO-BE Database Design
The benefits of the new and enhanced database have the following features and functionality:
New Features Functions
Dynamic Configuration This feature has room for modification and additions to the InSQL without restarting the InSQL.
UDT Date Time Stamps for All Data
This feature eliminates problems with time zones and daylight saving by supporting the Universal Time Code.
Manual Data Import/Logging
It supports storage of externally collected data – e.g., CSV data, remote data collector, etc.
Insert/Update Capability on Stored Data
This feature allows modification of stored data – maybe incorrect date due to faulty I/O device. But, keeps an audit trail of the changes, and the user have the option of reporting against the original or the changed data.
Dynamically Re-route I/O Server Source
This feature allows for redundant I/O servers for InSQL – i.e., the switching of I/O sources does not have to be done at the InTouch terminal level. Various Redundancy Architectures will be provided.
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7. System Architectural Method
7.1 System Architectural Method (AS-IS Model)
New Production Network
SQL Server Workstation Industrial SQL Server Terminal Server
Router
System Architectural Design
Network Controllers(previously installed)
Network Controller(new)
Bus Hub
Field Controllers(previously installed)
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7.2 System Architectural Method (TO-BE Model)
New Production Network
SQL Server Workstation Industrial SQL Server Terminal Server
Router
Network Controllers(previously installed)
Network Controller(new)
Bus Hub
Field Controllers(previously installed)
Bus Hub (New)
Field Controllers (New)
(Project Proposed)
HMI HMI
HMI
HMI HMIHMIHMI
HMIHMI HMI HMIHMI
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8. References
Mody, Rashesh. From Buttons & Dials to Object-Oriented Graphics & Portals: A Short History of
the Windows-Based Human Machine Interface. IAN Instrumentation & Automation News. p.5.
(eds) October 2002
Verma, Harsh, Ph.D. Lecture on UML and Use Cases for Object-oriented Analysis. MIT E-
Commerce Architecture Project. 2002
IEEE Std 1074-1991. IEEE Standard for Developing Life Cycle Processes. New York, NY:
Institute of Electrical and Electronics Engineers, 1991.
Institute of Electrical and Electronics Engineers. IEEE Standard Computer Dictionary: A
Compilation of IEEE Standard Computer Glossaries. New York, NY: 1990.
IRIS Networks of Centres of Excellence Project Proposal. Human-Machine Interfaces Theme.
October 2000.
Caron, Richard. System Features Description v1.0 Final. Building Management Systems. 22
April 2002.
Caron, Richard. Required Specification for Purchased System v1.0 Final. Building Management
Systems. 20 May 2002.
Evans, Michael W. & Marciniak, John. Software Quality Assurance and Management. New York,
NY: John Wiley & Sons, Inc., 1987.
IRIS Networks of Centres of Excellence Project Proposal. Human-Machine Interfaces Theme.