INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL

INSTALLATION AND OPERATIONAL QUALIFICATION

Page 1 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL

Details of Equipment/System
User Department INFORMATION TECHNOLOGY

Stage of Qualification INSTALLATION AND OPERATIONAL QUALIFICATION

Software Name & Version No. Biométric Software COSEC Centra V. 14.31

CPPB/IT/BSC-01,
CPGB/IT/BAR-01, CPGB/IT/BAR-02, CPGB/IT/BAR-03,
Equipment Id’s
CPGB/IT/BAR-04,
CPCB/IT/BAR-01, CPCB/IT/BAR-02

Equip. Location/ Room No. MAIN ENTRANCE GATE & CEPHA BLOCK

Equip. Make MATRIX

Equip. Model COSEC / FOT

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 2 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

TABLE OF CONTENTS

S No Content Page No

1.0 Pre Approval 03

2.0 Objective 04

3.0 Scope 04

4.0 System Description 04

5.0 Responsibilities 06

6.0 Pre- Requisite 07

7.0 Methodology 07

8.0 Discrepancy and Corrective action report 33

9.0 Annexures 34

10.0 Summary 35

11.0 Conclusions 35

12.0 Abbreviation 35

13.0 References 35

14.0 Post Approval 36

Change History

Date Version CC Ref No. Revision summary

00 CC/PRI/19-006 New document

1.0 PRE APPROVAL:

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 3 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
Signing of approval page of this document indicates the agreement with the Qualification approach
described in this document. If any modification approach becomes necessary, a revision through
change control shall be prepared, checked and approved. This document cannot be executed unless
approved.

Name Designation Department Signature /date

Prepared / Compiled by:

Reviewed by:

Approved by:

2.0 OBJECTIVE

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 4 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
The objective of this Installation and Operational Qualification Protocol is to provide high degree
of assurance and reliability about the Installation of the Biometric Access (CPPB/IT/BSC-01)
Manufactured by MATRIX, Installed at Main Entrance Gate and Cepha Block Entrance in Cronus
Pharma Specialties India Private Limited.
3.0 SCOPE
The scope of this protocol applies for the Installation and Operational qualification of Biometric
Access (CPPB/IT/BSC-01) Supplied by MATRIX by following the below mentioned test
functions.
 Identification and verification of documents
 Test system identification
 Verification of PC configuration integrity, Compatibility and software installation
 Verification of user access levels
 Verification of communication
 Verification power utility
 Verification of system healthiness
 Verification of startup and shutdown process
 Verification access control and authority checks
 Verification of security configuration
 Verification of display function keys and command buttons
 Verification of power failure condition
 Verification of communication failure
 Verification of database backup and restoration
4.0 SYSTEM DESCRIPTION
 Biometrics is the measurement and statistical analysis of people's unique physical and
behavioral characteristics.
 The technology is mainly used for identification and access control, or for identifying
individuals who are under surveillance.

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 5 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
 The basic premise of biometric authentication is that every person can be accurately
identified by his or her intrinsic physical or behavioral traits.
 The term biometrics is derived from the Greek words bio meaning life and metric meaning to
measure.
 In addition to security, the driving force behind biometric verification has been convenience
 As there are no passwords to remember or security tokens to carry. Some biometric methods,
such as measuring a person's gait, can operate with no direct contact with the person being
authenticated.
Components of biometric devices include:
 A reader or scanning device to record the biometric factor being authenticated.

 Software to convert the scanned biometric data into a standardized digital format and to
compare match points of the observed data with stored data.

 A database to securely store biometric data for comparison.

The schematic diagram is shown below:

System

Ethernet Network

Biometric-1 Biometric-2
(IN) (OUT)

5.0 RESPONSIBILITIES

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 6 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
THE GROUP COMPRISING OF REPRESENTATIVES FROM EACH OF THE
FOLLOWING DEPARTMENTS SHOWN IN THE TABLE BELOW AND THEY SHALL
BE RESPONSIBLE FOR THE OVERALL COMPLIANCE WITH THIS PROTOCOL.

Department Responsibility

Shall be trained on protocol methodology.

User
Support for the execution of the study.
Department
Review of the Protocol and summary.

Shall be trained on protocol methodology.

Engineering
Support for the execution of the study.
Department
Review of the Protocol and summary.

Preparation of the protocol.

Providing training on execution of the Study.
QA-CSV
Execution of the study/verification.
Closure of the study and necessary discrepancy (if any) handling.

Review and approval of the Protocol.

QA Department Monitoring of the Execution.
Review and approval of the Summary report.

5.1 IDENTIFICATION OF EXECUTORS

S. No Name Of The Executor Dept & Designation Sign & Date

Verified by (QA):

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 7 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
6.0 PRE-REQUISITE
Training: Before processing for the qualification, the respective validation team shall be trained
on the concept of validation. The training document shall be verified and shall be satisfactory.
Refer attachment for group training record).
7.0 METHODOLOGY
Following test procedures are followed to qualify the equipment for its installation and operational
qualification.
7.1 Identification and verification of documents
7.1.1 Objective
To identify and verify all the documents associated with the equipment are available.
7.1.2 References & Tools required
Not applicable.
7.1.3 Test procedure
 Verify the availability of various general documents as mentioned in the data sheet 7.1.
 Record the document details and locations at which documents are available in respective
column.
7.1.4 Acceptance criteria
All the documents shall be available at the time of execution of this protocol.
Data Sheet 7.1
General documentation
Available Checked by Verified by
Title Document No.
Yes/ No/NA Sign / date Sign/Date
Purchase Order
Manual
Others (if any)
Meet the acceptance Criteria [ ] Yes [ ] No
Remarks

Reviewed by: ______________ Date: _______________

7.2 Test system identification

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 8 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
7.2.1 Objective
This test sheet of the IQ is intended to identify which system is being validated.
7.2.2 Procedure
1. Identify the system and record the following details:
 Equipment name
 Equipment ID.
 Manufacturer
 Location
2. Record the identification source. (i.e. Nameplates, Room location tag etc.)
7.2.3 Acceptance criteria
Physically recorded details of the system should match with the expected result specified in the
verification table.
Data Sheet 7.2
System Identification
Checked
Verification Discrepancy? Tested By
Description As Observed By
Source (Yes / No) Sign/Date
Sign/Date
Equipment COSEC Centra V.
Name 14.31
CPGB/IT/BAR-01
CPGB/IT/BAR-02
CPGB/IT/BAR-03
Equipment ID’s CPGB/IT/BAR-04
CPCB/IT.BAR-01
CPCB/IT.BAR-02

Manufacturer MATRIX
Main Entrance Gate
Location
Cepha Block Entrance

Meet the acceptance Criteria [ ] Yes [ ] No

Remarks:
Reviewed by: ______________ Date: _______________

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 9 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
7.3 Verification of PC configuration integrity, compatibility and software installation
7.3.3.1 Objective
To verify that the PC configuration integrity, compatibility and software installation
7.3.3.2 Procedure
 Record the software systems used for the Computer System configuration.
 Verify the application software package installation path.
7.3.3.3 Acceptance criteria
All system software shall be installed properly.
Data Sheet 7.3

PC configuration integrity, compatibility and software installation verification

Checked
Discrepancy? Tested By
Description Specified Actual Result By
(Yes / No) Sign/Date
Sign/Date

Operating System

Manufacturer Dell

Intel (R) Xeon (R)

Computer
Gold-6130 CPU
Processor
@2.10GHz
Windows Server
Operating
2012 R2 Data
System
Center

RAM 16.00 GB

Keyboard Standard

00330-80000-
Product Id
00000-AA041

Application Software

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 10 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Checked
Discrepancy? Tested By
Description Specified Actual Result By
(Yes / No) Sign/Date
Sign/Date

Application COSEC Centra

Software

Software
Version 14.31
Version
Software C:/Programmfiles/
Installation Matrix/ COSEC
Path Integrate

Make MATRIX

Meet the acceptance Criteria [ ] Yes [ ] No

Remarks:

Reviewed by: _____________ Date: _______________

7.4 Verification of user access levels

7.4.1 Objective
The objective of this test is to verify the user access levels.
7.4.2 Procedure
Physically verify the following details of security configuration:
 Number of access levels.
 Record the observations in the verification table.
7.4.3 Acceptance Criteria
Observed result should match with the expected result mentioned in the verification table.
Data Sheet 7.4

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 11 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
Verification table for user access levels
User access levels
Checked
Sr. Test Discrepancy Done By
Expected Result Actual Result By
No. Procedure ?(Y/N) Sign/Date
Sign/Date
Biometric Access
There should be
Verify the different levels of
system security access
logical available in the
security. system.
Note down
1. User :
the levels of
security Logical Security
access Available: Yes / No
available in Admin Level:
the system Logical Security
Available: Yes / No
For Software
Verify the There should be one
system level of security
logical access available in
security.
the system.
Note down
2. the levels of
security Admin Level:
access Logical Security
available in Available: Yes / No
the system
Meet the acceptance Criteria [ ] Yes [ ] No
Remarks:

Reviewed by: ______________ Date: _______________

7.5 Verification of communication
7.5.1 Objective
To verify the communication used for interfacing between system components to software.

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 12 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
7.5.2 Procedure
Hardware and software related Communication.
7.5.3 Acceptance criteria
Details of the communication mode used for the system shall be identified.
Data Sheet 7.5

Verification of communication

Available? Tested By Checked By

Details Specified Actual
(Yes / No) Sign/Date Sign/Date

Biometric to the
System As observed
communication mode
Communication mode details from Biometric to Computer System

Biometric Access (IN)

As observed
Device IP
Biometric Access
(OUT) As observed
Device IP

IP Address As observed

DNS Servers As observed

DNS Suffix As observed

Driver version As observed

Meet the acceptance Criteria [ ] Yes [ ] No

Remarks:

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 13 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Reviewed by: ______________ Date: _______________

7.6 Verification of power utility

7.6.1 Objective
To verify that the electrical utility has been installed and is available as specified.
7.6.2 Tools required
Clamp meter/Digital multimeter
7.6.3 Procedure

 Power on the system and put the multimeter in AC voltage measurement range and
measure the voltage at terminal end.

 Note down the voltage reading in the test data sheet. Repeat above step for all system
modules those are separately powered.
7.6.4 Acceptance criteria
Recorded measurements for voltage shall be within the specified range.

Data Sheet 7.6

Verification of power utility

Sr. Tested By Checked By

Test Procedure Specified Actual
No. Sign/Date Sign/Date

Power on the system and set

Voltage: 110 VAC
the multi meter in AC voltage
1. measurement range and to 240 VAC
measure the voltage at system
terminal end
2. Power on the system and set
the multi meter in AC voltage Rating
measurement range and Not More Than 5V
measure the voltage between

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 14 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Sr. Tested By Checked By

Test Procedure Specified Actual
No. Sign/Date Sign/Date

neutral and earth terminal of

Computerized System

Test instrument used

Checked
Calibrated Calibration Tested By
Test Instrument Make Model By
Date Due Date Sign/Date
Sign/Date

Meet the acceptance Criteria [ ] Yes [ ] No

Remarks:

Reviewed by: ______________ Date: _______________

7.7 Verification of system healthiness

7.7.1 Objective
To verify the normal operation of the System by turning ON the supply.
7.7.2 Procedure

 Turn System power to ON Position.

 Document status of the indicators on computer device.

7.7.3 Acceptance criteria
All the Hardware resources and software environment should be OK, No error message displayed.
Data Sheet 7.7
Verification of system healthiness

Tested By Checked By
Details Specified Actual
Sign/Date Sign/Date

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 15 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
Meet the acceptance Criteria [ ] Yes [ ] No
Remarks:

Reviewed by: ______________ Date: _______________

7.8 Verification of software startup and shutdown process
7.8.1 Objective
To verify Software startup and Shutdown Process.
7.8.2 Procedure

 Login with valuable user in software.

 Logout user to exit Software.

7.8.3 Acceptance criteria
User login successful into the software without any problem.
Data Sheet 7.8
Verification of software startup and shutdown process

Tested By Checked By
Procedure Expected Result Actual
Sign/Date Sign/Date

Double Click on COSEC

Software Start-up software and login with
Procedure valuable user to Enter User Id,
Password
Software
Exit select Function to exit
Shutdown
Software
Procedure
Meet the acceptance Criteria [ ] Yes [ ] No
Remarks:

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 16 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Reviewed by: ______________ Date: _______________

7.9 Verification of access control and authority checks

7.9.1 Objective
To verify the access control and the authorities assigned to different user levels.
7.9.2 Procedure
For Biometric Access Control

 Enter correct finger.

 Enter wrong finger.

For System Software Access Control

 Enter correct user name and correct password

 Enter correct user name and wrong password

7.9.3 Acceptance criteria

For Biometric Access

 Check In/Check Out should be successful upon entering correct Finger.

 Check In/Check Out fail upon entry of wrong finger.

For Software

 Login should be successful upon entering correct user name and correct password.

 Login should fail upon entry of incorrect login details.

Data Sheet 7.9

Verification of access controls

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 17 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Administrator Level User Level

Checked
Tested By
Procedure By
Expected Actual Expected Actual Sign/Date
Sign/Date
result result result result

For Biometric Access

Check
Check in/check
Enter correct in/Check out
out should be
finger should be
successful
successful
Check
Enter wrong Check in/check
in/check out
finger out should fail
should fail

Administrator Level
Tested By Checked By
Procedure
Sign/Date Sign/Date
Expected result Actual result
For Software
Enter correct user
Login should be
name and correct
successful
password
Enter correct user
name and wrong Login should be fail
password
Enter wrong user
name and correct Login should be fail
password
Enter wrong user
name and wrong Login should be fail
password

Meet the acceptance Criteria [ ] Yes [ ] No

Remarks:

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 18 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Reviewed by: ______________ Date: _______________

7.10 Verification of security configuration
7.10.1 Objective
To verify the security configuration.
7.10.2 Procedure

 Check & verify security functions available for system access

7.10.3 Acceptance criteria
For Biometric Access
 At least two access levels (User & Admin) shall be available in the operating system and
three access levels shall be available in the software
Data Sheet 7.10
Verification of security configuration

Tested By Checked By
Procedure Expected result Actual result
Sign/Date Sign/Date

System should allow to

User creation
create a new user

System should not accept

Password length the password whose length
is less than 6 characters
System should not allow to
User uniqueness create a new user with
existing user name

System should allow to

User deletion
remove the selected user
Meet the acceptance Criteria [ ] Yes [ ] No
Remarks:

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 19 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Reviewed by: ______________ Date: _______________

7.11Verification of display function keys and command buttons
7.11.1 Objective
To verify the intended to identify form openings and operations of main menu items of main
screens/forms that is the task bar pane screens or popularly called as the drop down menus.
7.11.2 Procedure

 Login into the system with correct security level to enable all functions.

 Click on the Menu-bar items in the software the detail check of these software features.
7.11.3 Acceptance criteria

 Each menu bar item shall expand as described in the manual.

Data Sheet 7.10

Verification of display function keys and command buttons

Keys/ Pass / Tested By Checked By

Expected Result Actual Result
Command Fail Sign/Date Sign/Date

For Biometric Access

Main Menu Screen
To Navigate User
User Mgt.
Mgt. Screen
To Navigate User
User Role
Role Screen
To Navigate Comm.
Comm.
Screen
To Navigate System
System
Screen
To Navigate
Personalize
Personalize Screen

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 20 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Keys/ Pass / Tested By Checked By

Expected Result Actual Result
Command Fail Sign/Date Sign/Date

To Navigate Data
Data Mgt.
Mgt. Screen
Access To Navigate Access
Control Control Screen
USB To Navigate USB
Manager Manager Screen
To Navigate
Attendance
Attendance Search
Search
Screen
Short To Navigate Short
Message Message Screen
To Navigate Work
Work Code
Code Screen
To Navigate
Autotest
Autotest Screen
To Navigate System
System Info
Info Screen
User Management Screen
To Add New User
New User
Screen
To navigate All
All Users
Users Screen
Display To Display Style
Style Screen
User Role Screen
User To User Defined
Defined
Role 1 Role 1 Screen

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 21 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Keys/ Pass / Tested By Checked By

Expected Result Actual Result
Command Fail Sign/Date Sign/Date

User To User Defined

Defined
Role 2 Role 2Screen

User To User Defined

Defined
Role 3 Role 3 Screen

Comm. Screen

Ethernet To Ethernet Screen

To Serial Comm
Serial Comm
Screen
PC To PC Connection
Connection Screen

ADMS To ADMS Screen

Wiegand To Wiegand Setup

Setup Screen
System Screen
To Date Time
Date Time
Screen
To Attendance
Attendance
Screen
To Finger print
Finger print
Screen

Reset To Reset Screen

USB To USB Upgrade

Upgrade Screen
Personalize Screen

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 22 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Keys/ Pass / Tested By Checked By

Expected Result Actual Result
Command Fail Sign/Date Sign/Date

User To User interface

interface Screen

Voice To Voice Screen

Punch State To Punch State

Options Options Screen
Shortcut key To Shortcut key
mappings mappings Screen
Data Management Screen
To Delete Data
Delete Data
Screen
To Backup Data
Backup Data
Screen
To Restore Data
Restore Data
Screen
Access Control Screen
Access To Access Control
Control
Options Options Screen

Time To Time Schedule

Schedule Screen

Holidays To Holidays Screen

Access To Access Groups

Groups Screen
Combined To Combined
Verification Verification Screen

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 23 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Keys/ Pass / Tested By Checked By

Expected Result Actual Result
Command Fail Sign/Date Sign/Date

Anti- To Anti-passback
passback
Setup Setup Screen

Duress To Duress Options

Options Screen
USB Manager Screen
To Download
Download
Screen

Upload To Upload Screen

Download To Download
Options Options Screen
Short Message Screen
New To New Message
Message Screen

Public To Public Messages

Messages Screen

Personal To Personal
Messages Messages Screen

Drafts To Drafts Messages

Messages Screen

Message To Message Options

Options Screen

Work Code Screen

New Work To New Work Code
Code Screen
All Work To All Work Codes
Codes Screen

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 24 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Keys/ Pass / Tested By Checked By

Expected Result Actual Result
Command Fail Sign/Date Sign/Date

Work Code To Work Code

Options Options Screen

System Info Screen

Device To Device Capacity

Capacity Screen
To Device Info
Device Info
Screen
Firmware To Device Info
Info Screen

For System Software

Main Screen

User Id To Enter User Id

Password To Enter Password

Login To Login

Close To Cancel

Home Screen

Admin To Admin Screen

Users To Users Screen

Devices To Devices Screen

Shift and To Navigate Shift

Schedules and Schedules

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 25 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Keys/ Pass / Tested By Checked By

Expected Result Actual Result
Command Fail Sign/Date Sign/Date

Enterprise To Navigate
Structure Enterprise Structure
Access To Navigate Access
Control Control
Time and To Navigate Time
Attendance and Attendance
Leave To Navigate Leave
Management Management
Visitor To Navigate Visitor
Management Management
To Navigate
Cafeteria
Cafeteria
Management
Management
Contact To Navigate Contact
Workers Workers
Management Management
Job To Navigate Job
Processing Processing and
and Costing Costing
Field Visit To Navigate Field
Management Visit Management
Report To Navigate Report
Builder Builder

Admin Screen

System To Create Software

Accounts users
Global To Policy for Users
Policy

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 26 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Keys/ Pass / Tested By Checked By

Expected Result Actual Result
Command Fail Sign/Date Sign/Date

To Department
Department
Screen

Shift To Shift Screen

Grade To Grade Screen

Employee To Employee Group

Group Screen
To Bank Master
Bank Master
Screen
To Dispensary
Dispensary
Screen

Category To Category Screen

To Employee
Employee
Screen

Transaction Screen

Manual To Manual Entry

Entry Screen
Data To Data
Maintenance Maintenance Screen
Holiday To Holiday Entry
Entry Screen
Leave Management
Leave To Leave Master
Master Screen
Leave To Leave Accrual
Accrual Screen

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 27 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Keys/ Pass / Tested By Checked By

Expected Result Actual Result
Command Fail Sign/Date Sign/Date

Leave To Leave
Application Application Screen
Admin Screen
Time Office To Time Office
policies policies Screen
To Data Process
Data Process
Screen
Database To Database Setting
Setting Screen
To SMS Setting
SMS Setting
Screen
To Bulk SMS
Bulk SMS
Screen
Email To Email Setting
Setting Screen
User To User Manage
Manage Screen
Repots Screen
Daily To Daily Reports
Reports Screen
Monthly To Monthly Reports
Reports Screen

Leave To Leave Screen

Customised To Customised
Report Report Screen
Payroll
Employee To Employee Setup
Setup Screen

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 28 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Keys/ Pass / Tested By Checked By

Expected Result Actual Result
Command Fail Sign/Date Sign/Date

Payroll To Payroll Setup

Setup Screen
Formula To Formula Setup
Setup Screen
Payroll To Payroll
Processing Processing Screen
Performance To Performance
Maintain Maintain Screen
Loan/ To Loan/
Advance Advance Setup
Setup Screen
Reports To Reports Screen

Meet the acceptance Criteria [ ] Yes [ ] No

Remarks:

Reviewed by: ______________ Date: _______________

7.12 Verification of power failure condition

7.12.1 Objective
To verify power failure.
7.12.2 Procedure
 Start the system and trip the power to the system.
 Restore the power supply and restart the system.
7.12.3 Acceptance criteria

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 29 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
 When power is restored the system must start without any error.
 Viewing and uploading of the historical data must be normal and error free.

Data Sheet 7.12

Verification of power failure

Tested By Checked By
Procedure Expected Result Actual
Sign/Date Sign/Date

Before power System should run in healthy

failure condition

During power
System should stop
failure

System should start

After power
automatically and after restart
resume
data should be available

Meet the acceptance Criteria [ ] Yes [ ] No

Remarks:

Reviewed by: ______________ Date: _______________

7.13 Verification of communication failure conditions
7.13.1 Objective
To verify communication failure.
7.13.2 Procedure

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 30 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
 Operate the system.

 While the system is operating, detach communication cable. Verify the display on system.

 Wait for 5 minutes then connect the communication cable that was removed.

 Verify the operation in the step 2 are unchanged after the communication failure occurs.
7.13.3 Acceptance criteria
The communication is restored the system must start without any error.
Data Sheet 7.3.13
Verification of communication failure

Tested By Checked By
Procedure Expected Result Actual
Sign/Date Sign/Date

Before
System should run in healthy
communication
condition
failure
During
Error message should display
communication
on system
failure
After
Error message should disappear
communication
on system
resume

Meet the acceptance Criteria [ ] Yes [ ] No

Remarks:

Reviewed by: ______________ Date: _______________

7.14 Verification of database backup and restore
7.14.1 Objective
The objective of this test is to verify the data base backup and restoration.
7.14.2 Procedure
Database backup

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 31 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
 Login to the system as administrator.

 Click on data management key and click on the data backup.

Data Restoration

 Login to the system as administrator.

 Click on data management key and click on the data restore.

7.14.3 Acceptance criteria
 Observed details of the backup and restoration in the system should match with the
expected result specified in verification table
Data Sheet 7.14
Verification of communication failure

Tested By Checked By
Procedure Expected Result Actual
Sign/Date Sign/Date

Data backup to the external

Data Backup
device successfully.

Data restoration from the

Data Restore
external device successfully.

Meet the acceptance Criteria [ ] Yes [ ] No

Remarks:

Reviewed by: ______________ Date: _______________

7.15 Installation and operational qualification test status

Discrepancy
Test Pass/Fail
Critical Feature Found
Number
Pass Fail Yes No

1 Identification and verification of documents

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 32 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
Discrepancy
Test Pass/Fail
Critical Feature Found
Number
Pass Fail Yes No

2 Test system identification

Verification of PC configuration integrity,

3
Compatibility and software installation

4 Verification of user access levels

5 Verification of communication

6 Verification power utility

7 Verification of system healthiness

8 Verification of startup and shutdown process

Verification access control and authority

9
checks

10 Verification security configuration

Verification of display function keys and

11
command buttons

12 Verification of power failure condition

13 Verification of communication failure

Verification of data base backup and

14
restoration
Checked by:
Sign/Date
Meet the acceptance Criteria [ ] Yes [ ] No

Remarks:

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 33 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Reviewed by: ______________ Date: _______________

8.0 Discrepancy and Corrective action report
8.1 Deviation

8.2 Impact on operation

8.3 Justification for acceptance

Prepared By/ date: Reviewed by/ Date: Approved By/ Date:

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 34 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00
9.0 Annexures

S. No. Name of Annexure Annexure No.

10.0 Summary

11.0 Conclusion

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 35 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

12.0 Abbreviation

Abbreviations Description
IOQ Installation And Operational Qualification
NA Not Applicable
CC Change Control
RAM Random Access Memory
Y Yes
N No
HDD Hard Disk
CPU Central Processing Unit

13.0 References
A. Validation Master Plan (SOP no: CPL/QA/017)
B. Qualification SOP’S (SOP no: CPL/QA/009)
C. Operational Manual

14.0 POST APPROVAL

Signing of Report page of this document indicates the acceptance of Installation and
Operational Qualification approach described in this document.

Name Designation Department Signature /date

Prepared / Compiled by:

Format No. CPL/QA/009/F01-00

 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
INSTALLATION AND OPERATIONAL QUALIFICATION
Page 36 of 36
PROTOCOL FOR BIOMETRIC ACCESS
Protocol No.: Effective
Equipment ID: CPPB/IT/BSC-01 Date
IOQ/CPGB/PRI/BIO-01-00

Reviewed by:

Approved by:

Format No. CPL/QA/009/F01-00