Sb-Csv-Oq-Vms-02 VMS

OPERATIONAL QUALIFICATION PROTOCOL
FOR VOLUNTEER MANAGEMENT SYSTEM

Document No. SB-CSV-OQ-VMS-02 Version 1.0.0 Date
Supersedes NA Page No.: Page 1 of 31
OPERATIONALQUALIFICATION
PROTOCOL
FOR
VOLUNTEER MANAGEMENT
SYSTEM
Tested by Date
Reviewed by Date
Pre-Approval Page
Prepared by:
Name Designation Department Signature Date
Reviewed by:
Approved by:
Tested by Date
Reviewed by Date
REVISION HISTORY
Version / Revision
Date Revised Reason for Revision
Number
00 NA Initial Document
Tested by Date
Reviewed by Date
Table of Contents
1.0 OBJECTIVE..............................................................................................................5
2.0 SCOPE......................................................................................................................5
3.0 RESPONSIBILITY....................................................................................................5
4.0 TESTING INSTRUCTIONS.......................................................................................6
5.0 TEST STRATEGY....................................................................................................7
5.1 Execution Team.........................................................................................7
5.2 Protocol Execution.....................................................................................8
5.3 Qualification Completion and Approval......................................................8
6.0 ACCEPTANCE CRITERIA.......................................................................................8

7.0 BRIEF DESCRIPTION OF SYSTEM........................................................................9
8.0 OPERATIONAL QUALIFICATION TESTS..............................................................9
8.1 Verification of Software Access Control and Security Policy....................10
8.2 Verification of Software Functionality.......................................................15
8.3 Verification of Process Challenge Tests...................................................19
9.0 DISCREPANCIES HANDLING DURING OPERATIONAL QUALIFICATION.......27

10.0 SUMMARY AND CONCLUSION............................................................................28
11.0 LIST OF ANNEXURES...........................................................................................29
12.0 ABBREVIATIONS..................................................................................................30
Tested by Date
Reviewed by Date
1.0 OBJECTIVE
The objective of developing and executing this protocol is to collect sufficient data
pertaining to the Volunteer Management System (VMS) define the qualification
requirements and acceptance criteria for the same. Successful completion of these
qualification requirements will provide assurance that the Volunteer Management
System has been operate as required in the processing environment.
2.0 SCOPE
This document is applicable to Volunteer Management System, installed at Synergen
Bio Pvt. Ltd., Shivajinagar, Pune facility.
This Protocol shall define the test procedures, documentation, references and
acceptance criteria to establish that the Volunteer Management System is installed
as intended in accordance with the guidelines laid down by the software developer
of.
3.0 RESPONSIBILITY
The validation group comprising of a representative from each of the following
departments shall be responsible for the overall compliance with this protocol:
 User
 Preparation of Operational Qualification Protocol.

 Execution of Operational Qualification Protocol.
 Completion of Operational Qualification Protocol/Report.
 IT Department
 To provide necessary documents required for Operational Qualification.

 Reviewing this Operational Qualification Protocol and final report.
 To co-ordinate during verification activities.
Tested by Date
Reviewed by Date
Validation/Quality Assurance/Management Representative
 Support the validation Agency in the preparation of Operational Qualification

protocol.
 Review of Operational Qualification protocol.
 Approval of the Operational Qualification protocol by management
representative.
 Responsible for the final review of the Operational qualification documents and its
compliance to meet the acceptance criteria of the Operational Qualification
Protocol.
 Support the validation agency in the Execution of Operational Qualification
Protocol.
 Review the Operational Qualification report.
 Approval of the Operational Qualification report by management representative.
4.0 TESTING INSTRUCTIONS

Following are the instructions for executing this protocol. Each tester or reviewer
executing any portion of this protocol must read these instructions prior to execution.
All questions or uncertainties must be resolved prior to executing this protocol.
Performing Tests and Recording Results
Record handwritten entries and test results in black ballpoint pen.
For each test, perform the instructions indicated in the “Procedure” section. Provide
annexure as objective evidence to support recordings made while executing the test.
In the "Actual Results" section, record the results and reference an annexure.
The annexure(s) for a test must be inserted in sequential order (e.g. Annexure 1,
Annexure 2, etc.) immediately behind the test to which it is referenced. A highlighter
may be used to emphasize data contained in an annexure.
Reviewing Test Results

After the tester signs the test result, a second person must review the test for the
following:
 An actual result has been recorded
 All referenced attachments are present
 The test signature block was correctly completed by the tester
 If the actual result does not match the expected result, a discrepancy form has
been initiated.
Resolving Discrepancies
Discrepancies include the following scenarios:
Tested by Date
Reviewed by Date
 Actual results for a test do not match expected results

 A test step is missing
 A test was incorrectly executed
 An observed test result was incorrectly recorded
Note: A typographical error only requires a “line-through” correction accompanied by

the person’s initials and date
Each discrepancy must be identified, the cause must be determined, the impact must
be assessed, and a resolution must be made. This is documented in a Discrepancy
Form.
Each deviation must be documented in a discrepancy form and inserted in the

Summary of Test Results section (section 9.0) of the report.
5.0 TEST STRATEGY

The satisfactory operational qualification of the Volunteer Management System shall
be verified by executing the qualification tests described in this protocol. The
successfully executed protocol documents verify that the Volunteer Management
System produces appropriate results as required and is satisfactorily integrated.
5.1 Execution Team

Mention below the list of personnel with their designation, full and short signatures
responsible for execution and review of Operational Qualification.
Short
Full Name Designation Full Signature
Signature
Tested by Date
Reviewed by Date
5.2 Protocol Execution

The satisfactory operation of the VMS software as regression test after successful
migration shall be verified by executing the qualification studies described in this
protocol. The successfully executed protocol documents that the VMS software is
operated as required and is satisfactorily integrated.
5.3 Qualification Completion and Approval

 Verify that all tests required by this protocol are completed, reconciled and attached
to this protocol.
 Verify that all amendments and discrepancies are documented, approved and
attached to this protocol.
 If all items in the Operational Qualification Protocol for Volunteer Management
System have been reviewed and found to be acceptable, sign the corresponding
block in the Qualification Completion and Approval form.
6.0 ACCEPTANCE CRITERIA

(A) General acceptance criteria are typically as given below:
 The operational capabilities of system demonstrated.
 The system is operating as intended and is under state of control.
 Operational features meet user requirements and user specifications.
(B) Specific acceptance criteria are defined for each verification activity.
(C) Functional test plan shall meet the specific acceptance criteria defined in the
respective tests.
Tested by Date
Reviewed by Date
7.0 BRIEF DESCRIPTION OF SYSTEM
The Entire system meant to maintain the data base for volunteers in the clinical
department. By taking the volunteer demographics and lab parameter information if
they are eligible for study, the experiment medicines are tested on these volunteers.
The system maintains the volunteer’s database and helps the enterprise to manage
enrollment of volunteers, and maintain the database for further study requirements.
The system has been designed to in support biometric identification of volunteers to
eliminate errors. VMS will be used to generate and record the data during volunteer
registration, screening and enrollment and other activities involved in clinical study
conduction. This software will be installed on different computers located at sites
involved in clinical study conduction.
Volunteer Management System interface is designed to collect process and print
report.
Capabilities include:
 Customizable data reports
 Advanced data management
8.0 OPERATIONAL QUALIFICATION TESTS
Sr.
Test Description
No.
1. Verification of Access Control and Security Policy
2. Verification of Software Functionality
3. Verification of Process Challenge
Tested by Date
Reviewed by Date
8.1 Verification of Software Access Control and Security Policy
Objective : To test software start-up access control functionality. Also to

verify applicable security policies for windows operating
system and Volunteer Management System.
Tools : Not Applicable
Required
Procedure : A. Access Control
 Click on Volunteer Management System Icon.
 Enter the User Name and password in the login
screen.
 Verify the selected functions and click OK.
 Login as administrator and verify the last generated
record.
 Click log out from the software.
B. Verify Security policies of Operating System and record
results in observation table.
C. Verify Security policies of Volunteer Management System if
feature available and record results in observation table.
Acceptance :  System should not allow software to start without active

Criteria user name and password. System should generate the
correct log record for user login and log out.
 Actual observations noted in respective tables should be
matched with following expected results.
o Minimum Password length 6 Character
o Password should be complex
o User ID should be unique
o Change password facility should be with user
o Logout facility should be available in system
o Access should be available for system start up
 Volunteer Management System should have multi-level
user rights
 Configuration facility and rights are configured as per
requirement specification document.
Reference : User Requirement Specification for Volunteer Management
System (SB-CSV-VMS-URS-01)
Tested by Date
Reviewed by Date
Verification Table:
(A) Verification of Access Control
Sr.
Specified Expected Actual Pass/ Tested
No Procedure
As Results Results Fail? By / Date
.
Application
Login with
software should
Administrat the User
1. open and
or User Name and
provide access
password.
of functions.
Login with
incorrect Application
Administrat
2. User name should not
or User
and open.
password
Login with
correct User Application
Administrat
3. name and should not
or User
incorrect open.
password
Login with
the
Application
Administrator
software should
Administrat rights and
4. open and
or User check the
provide access
available
of functions.
access
functions.
Login with
blank Application
Administrat
5. username should not
or User
and open.
password.
Login with
Application
Administrat username
6. should not
or User and blank
open.
password.
Tested by Date
Reviewed by Date
(B) For Operating System and Application Software

a. Security Policies Verification
Sr.N Procedur Expected Actual Pass/ Tested By /
Feature
o. e Result Result Fail? Date
Check Password
Password
Password length should
1. minimum
character be at least 6
Length
length characters.
System
Check
should not
username
Username & allow
&
2. Password generation of
password
Uniqueness same users
uniquenes
or
s
passwords.
Password
Check
Password combination
3. password
Complexity should be
complexity
complex.
b. User Addition/Deactivation Verification for Operating system

Sr.
Expected Actual Pass/ Tested By /
No Feature Procedure
Result Result Fail? Date
.
Login with System should
administrat allow creation
1. User
or rights & of new user
Creation
create a
new user.
Login with System should
administrat allow
2. User or rights & deactivation of
Deactivation deactivate user
an existing
user.
3. User Rights Login with System should
Tested by Date
Reviewed by Date
Sr.
Expected Actual Pass/ Tested By /
No Feature Procedure
Result Result Fail? Date
.
allow
administrat modification of
or rights & user rights.
modify
Modification
rights of an
existing
user.
Try to System should

4. change not allow
User
system changing.
date/time.
c. User Addition/Deactivation Verification for Volunteer Management System

Sr.N Expected Actual Pass/ Tested
Feature Procedure
o. Result Result Fail? By / Date
Login with System
administrat should allow
User
1. or rights & creation of
Creation
create a new user.
new user.
Login with System
User or rights & deactivation
2.
Deactivation deactivate of user.
an existing
user.
Login with System
or rights & modification
User Rights
3. modify of user
Modification
rights of an rights.
existing
user.
Tested by Date
Reviewed by Date
Remarks:
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
Meet the acceptance Criteria [ ] Yes [ ] No
Verified by : ______________ Date : _______________
Reviewed by : ______________ Date : _______________
Tested by Date
Reviewed by Date
8.2 Verification of Software Functionality
Objective : To verify that the Software function is in accordance to the

system operation.
Tools required : PC with Volunteer Management System loaded

Procedure : Select the menu/form from the system and verify the process
cycle as mentioned in the test data sheet.
Refer Operation SOP and verify each step for proper
behavior of software.
Acceptance : Data acquisition occurs smoothly and without any error

criteria message.
The configuration is active and channel is displaying the
parameters accordingly. Data/Record modification is allowed
as per defined policies. For any modification audit trail is
generated.
Both manual records and system log records are matching.
Software functions as defined in operation SOP.

Tested by Date
Reviewed by Date
Software Functionality Tests Table:

Sr. Operation Actual Pass/ Tested By /
Expected Result
No. Description Results Fail? Date
System will allow access
Log in with user only if the user has proper
1 authorization.
ID
System should allow

following process without
any error with proper user
authorization.
o Identify Volunteer
o Registration
o Screening data
Volunteer o Screening ID Card
2 Registration o Photo Update
Management o Proof update
o Modify Volunteer
o Add CMR /Update
CMR
o Study Enrollment
o Volunteer ID card
o Volunteer Bank Edit
System should allow

following function without
any error.
User o Change Password
3
Administration o Reset Password
o User Master
o Study Master
o Group Master
4 System should generate
Report following report without any
error.
 Modify Volunteer
Report
 Subject enrolled
report
 Screening List
Report
Tested by Date
Reviewed by Date
Sr. Operation Actual Pass/ Tested By /

Expected Result
No. Description Results Fail? Date
 Volunteer Block
Report
 Fit/Unfit Report
 Study History
 Study Verification
Log
 Verification Log
Verify that the System should generate the

5 CMR report CMR report
generation
Verify the System should perform
functions as function without any error.
6 per Operation
SOP for the
system.
Verify that the System should print the audit
audit trail is trail
7 printable in
non-editable
mode
Verify that the System should capture who,
audit trail has when, what and reason in the
8 who, when, audit trail
what and
reason for
activity
Verify that System should have
system has functionality to restrict the
9 functionality to deletion of any electronic
restrict the record
deletion of any
e-record
Tested by Date
Reviewed by Date
Remarks:
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
Verified by : ______________ Date : _______________
Reviewed by : ______________ Date : _______________
Tested by Date
Reviewed by Date
8.3 Verification of Process Challenge Tests
Objective : The objective of this test is to observe response of configured

Volunteer Management System against various automated checks
and controls (system locks) defined in User Requirement
Specifications document.
Tools : System with Software setup
required
Procedure : 1. Process wise system expectations for applicable processes.
2. List down individual process challenge scenario.
3. Right down actual results in each scenario.
4. Execute each scenario and capture screenshot for each step.
5. Record the results.
Acceptance : System should behave as per expected results mentioned into

criteria each test checkpoint.

Tested by Date
Reviewed by Date
Process Challenge Tests Table:
Sr. Tested By /
Description Expected Result Actual Result Pass/Fail
No Date
Only Authorized user
1. should access the
Authorization
system with User ID
and Password
System should not
2. Wrong allow access
Password software with wrong
password
System should allow
3. User to create user with
Creation only administrator
user
System should not
4. User allow creating same
Creation user which already
exists.
Password length
5.
User creation should be minimum 6
character for user
System should allow
6. User to modify the user
Modification with only
administrator user
System should not
7. User allow to modify the
Modification user with standard
user
System should allow
8. Group to create role based
creation group with
administrator
System should allow
9. to deactivate user
Deactivation
with only
administrator user
10. Deactivation System should not
allow to deactivate
user with standard
Tested by Date
Reviewed by Date
Sr. Tested By /
No Date
user
Operator/user should
get only that Menu
11.
Menu right which assigned to
that respected user in
menu rights.
Operator/user should
get only that
12. Functional functions which
right assigned to that
respected user in
functional rights.
13. Study code should be
Study Master
unique.
User should not save
study in study master
without following
fields.
1.Study Code
14. 2. Study Condition
Study Master
3. Molecule Name
4. No of Volunteers
5. No. of Proposed
volunteers
6.Period Date
System should not

allow to enter more
15.
Study Master than 10 period in the
no. of period column
in study master
Eligibility System should
check after display message
16.
biometric or relevant to Volunteer
manual previous
identification participation.
17. Eligibility System should
biometric or relevant to
manual
Restriction of
Tested by Date
Reviewed by Date
Sr. Tested By /
No Date
identification volunteer
18.
biometric or relevant to Eligibility
manual of volunteer for
identification screening
19.
biometric or relevant to Present
manual assignment of
identification volunteer in study
20.
biometric or relevant to 90 days
manual validity for previously
identification enrolled subjects
21. check after display message
biometric or
relevant to 21 days
manual
identification validity for screening
22. check after display message
biometric or
relevant to Currently
manual
identification assign study
System should allow
to identify the
23. Identification volunteer by thumb
of volunteer
impression of
volunteer
System should allow
identifying the
volunteer by
24. Identification manually with
of volunteer following field.
1.First name
2. Last name
25. Volunteer System should allow

Registration registering new
Tested by Date
Reviewed by Date
Sr. Tested By /
No Date
volunteer.
Each volunteer
26. Volunteer should get unique
Registration
VIN no.
Photo image should
27. Volunteer be capture for each
Registration volunteer during
registration
Thumb impression
28. Volunteer should capture for
Registration each volunteer during
registration
System should not
allow saving
registration without
following fields.
1. Volunteer name
2. DOB/Age
3.Gender
4. Address
5.Mobile No.
5. Height
6. weight
7. Age Proof
29. Volunteer 8.Education
Registration
9. Marital status
10.First language,
second language,
third language
11.Emergency
contact details
12.Personal Habits
13.Diet Status
14. Volunteer image
15. Thumb
Impression
30. CMR System should not

allow saving CMR
without following
Tested by Date
Reviewed by Date
Sr. Tested By /
No Date
fields.
1.VIN No.
2.Screen Date
3.Status
4. If status is selected
 Study code
 Molecule
name
 Subject No.
 Withdrawal
/dropout
details
 AE Details
 Last Sample
Date
 If Status
failed, Select
reason for fail
Verify the
System should allow
BMI
modification to modify the BMI for
31. for existing existing volunteer
volunteer and display the
and view record for ineligible
ineligible volunteer
volunteer
View the System should allow
32. record for to view the record for
registered
volunteer existing volunteer
Verify the
VIN System should
generation generate the VIN
33.
after after successful
successful registration of
registration volunteer
of volunteer
Remarks:
Tested by Date
Reviewed by Date
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
Verified by : ______________ Date : _______________
Reviewed by : ______________ Date : _______________
Tested by Date
Reviewed by Date
SUMMARY OF TEST RESULTS
This section summarizes the results of the testing and references any discrepancies
that have been documented during protocol test execution. The following text should
be used in this section:
Discrepancy
Tested
Test No. Verification Test Pass/Fail? Found?
By / Date
Yes/No
8.1 Verification of SOPs
Verification of Access
8.2 Control and Security
Policy
Verification of Power
8.3
Failure
Verification of Software
8.4
Functionality
Verification of Process
8.5
Challenge
Tested by Date
Reviewed by Date
9.0 DISCREPANCIES HANDLING DURING OPERATIONAL QUALIFICATION

For each discrepancy the discrepancy report shall be generated and necessary
corrective action taken as per procedure mentioned in Validation Master Plan.
Minor Discrepancy
Sr. Discrepancy Information
Major Discrepancy
Developmental work required/Not required:

(Attach details)
Critical Discrepancy
Developmental work required/Not required:

(Attach details)
Category A (minor): Discrepancy is accepted with deficiency

Category B (major): Provisional or conditional acceptance, discrepancy to be corrected
either by developer within stipulated time period
Category C (critical): Discrepancy to be rectified before proceeding further
Section completed by: ______________________________________

<Name>, <Title>, (Date)
<Department>
Tested by Date
Reviewed by Date
10.0 SUMMARY AND CONCLUSION

Summary
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
Conclusion
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
Compiled by: Date:
Tested by Date
Reviewed by Date
11.0 LIST OF ANNEXURES

This section provides summary of annexure attached with protocol as test
evidences.
Sr.
Description Of Annexure Test No.
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Tested by Date
Reviewed by Date
12.0 ABBREVIATIONS
ABBREVIATION FULL FORM
VMS Volunteer Management System
SBP Synergen Bio Pvt. Ltd.
VMP Validation Master Plan
URS User Requirement Specification
DS Design Specification
OQP Operational Qualification Protocol
QP Qualification Protocol
PC Personal Computer
QA Quality Assurance
SOP Standard Operating Procedure
NA Not Applicable
CSV Computer System Validation
RAM Random Access Memory
HDD Hard Disk Drive
MB Mega Byte
GB Giga Byte
PUN Pune
Tested by Date
Reviewed by Date
Post – Approval Page
By Rishitech Software.:
Prepared by:
By Synergen Bio Pvt Ltd.:

Reviewed by:
By Synergen Bio Pvt Ltd.:

Approved by:
Tested by Date
Reviewed by Date

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OPERATIONAL QUALIFICATION PROTOCOL

FOR VOLUNTEER MANAGEMENT SYSTEM

Name Designation Department Signature Date

Name Designation Department Signature Date

Name Designation Department Signature Date

6.0 ACCEPTANCE CRITERIA.......................................................................................8

9.0 DISCREPANCIES HANDLING DURING OPERATIONAL QUALIFICATION.......27

 Preparation of Operational Qualification Protocol.

 To provide necessary documents required for Operational Qualification.

Validation/Quality Assurance/Management Representative

 Support the validation Agency in the preparation of Operational Qualification

4.0 TESTING INSTRUCTIONS

Reviewing Test Results

 Actual results for a test do not match expected results

Note: A typographical error only requires a “line-through” correction accompanied by

Each deviation must be documented in a discrepancy form and inserted in the

5.0 TEST STRATEGY

5.1 Execution Team

5.2 Protocol Execution

5.3 Qualification Completion and Approval

6.0 ACCEPTANCE CRITERIA

7.0 BRIEF DESCRIPTION OF SYSTEM

8.0 OPERATIONAL QUALIFICATION TESTS

8.1 Verification of Software Access Control and Security Policy

Objective : To test software start-up access control functionality. Also to

Acceptance :  System should not allow software to start without active

(B) For Operating System and Application Software

b. User Addition/Deactivation Verification for Operating system

Try to System should

c. User Addition/Deactivation Verification for Volunteer Management System

Meet the acceptance Criteria [ ] Yes [ ] No

Verified by : ______________ Date : _______________

Reviewed by : ______________ Date : _______________

8.2 Verification of Software Functionality

Objective : To verify that the Software function is in accordance to the

Tools required : PC with Volunteer Management System loaded

Acceptance : Data acquisition occurs smoothly and without any error

Reference : User Requirement Specification for Volunteer Management

Software Functionality Tests Table:

System should allow

System should allow

Sr. Operation Actual Pass/ Tested By /

Verify that the System should generate the

Meet the acceptance Criteria [ ] Yes [ ] No

Verified by : ______________ Date : _______________

Reviewed by : ______________ Date : _______________

8.3 Verification of Process Challenge Tests

Objective : The objective of this test is to observe response of configured

Acceptance : System should behave as per expected results mentioned into

Reference : User Requirement Specification for Volunteer Management

Process Challenge Tests Table:

System should not

25. Volunteer System should allow

30. CMR System should not

Meet the acceptance Criteria [ ] Yes [ ] No

Verified by : ______________ Date : _______________

Reviewed by : ______________ Date : _______________

SUMMARY OF TEST RESULTS

9.0 DISCREPANCIES HANDLING DURING OPERATIONAL QUALIFICATION

Verified by : Date : _

Reviewed by : Date : _

Verified by : Date : _

Reviewed by : Date : _

Verified by : Date : _

Reviewed by : Date : _