OPERATIONAL QUALIFICATION PROTOCOL FOR ERP

SYSTEM

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OPERATIONAL QUALIFICATION
PROTOCOL
FOR
ENTERPRISE RESOURCE PLANNING
SYSTEM
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APPROVAL PAGE

BY Arizona Automation & Technologies:

Prepare by:

Name Designation Signature Date

By Windlas Healthcare (P) Ltd.:

Review by:

Name Designation Signature Date

Approved by:

Name Designation Signature Date

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REVISION HISTORY

Version / Revision
Date Revised Reason for Revision
Number
00 First Release
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TABLE OF CONTENTS
1.0 OBJECTIVE ................................................................................................................................5
2.0 SCOPE.........................................................................................................................................5
3.0 RESPONSIBILITIES ..................................................................................................................5
4.0 TESTING INSTRUCTIONS ......................................................................................................6
5.0 TEST STRATEGY......................................................................................................................7
5.1 EXECUTION TEAM ..................................................................................................................7
6.0 ACCEPTANCE CRITERIA .......................................................................................................8
7.0 OPERATIONAL QUALIFICATION TESTS ............................................................................8
7.1 VERIFICATION OF MASTER AND MODULE WISE SYSTEM FUNCTIONALITY .........9
7.2 VERIFICATION OF OPERATIONAL SOPS .........................................................................11
8.0 SUMMARY OF TEST RESULTS ...........................................................................................12
9.0 DISCREPANCIES HANDLING DURING INSTALLATION QUALIFICATION ...............13
10.0 CONCLUSION AND SUMMARY ..........................................................................................14
11.0 LIST OF ANNEXURE .............................................................................................................16
12.0 ABBREVIATION .....................................................................................................................17
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1.0 OBJECTIVE
The objective of the operational qualification is to establish documented evidence that the ERP system
is operating as per operational requirement Windlas Healthcare (P) Ltd.

2.0 SCOPE
This operational qualification is applicable to installed ERP system at the Windlas Healthcare (P) Ltd..
Since this application is being utilized at Dehradun, Uttarakhand.

3.0 RESPONSIBILITIES
The validation group comprising of a representative from each of the following departments shall be
responsible for the overall compliance with this Protocol cum report:
• Arizona Automation & Technologies

To verify all manuals, drawings and documentation or any other data necessary for the
preparation and execution of this Protocol cum report.

Preparation of Protocol.

Assistance in execution of tests.

Report Preparation

Discrepancy reporting

• IT Department

To provide necessary documents required for qualification.

To co-ordinate during verification activities.

To witness of the qualification activity.

Execution and review of tests.

Discrepancy closures.

Verification of tests

• Quality Assurance

Support the validation Agency in the preparation of Qualification Protocol.

Approve Qualification Protocol.

Support the validation agency in the Execution of Qualification Protocol.

Review of documents & Discrepancy closures.

Final report verification and approvals.
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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. You must resolve any questions or
uncertainties you have prior to executing this Protocol. Once these instructions are completely
understood, make an entry in the signature table on the following page.
Performing Tests and Recording Results
Record handwritten entries and test results in blue ball point pen.
For each test, perform the instructions indicated in the procedure section of each test. Provide annexure
as objective evidence to support recordings made while executing the test.
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.
Verifying and Reviewing Test Results
After the tester signs the test result, separate persons must verify and review the test for the following:
• An actual result has been recorded
• Any reference annexure are present
• The test signature block was correctly completed by the tester
• If the actual result does not match the expected result, a discrepancy report form has been
initiated.
Resolving Discrepancies
Discrepancies include the following scenarios:
• Actual results for a test do not match expected results
• Non availability of appropriate documentation
• Non availability of required Standard Operating Procedures

Note: A typographical error only requires a “line-through” correction accompanied by the person’s
initials and date (If required, with justification)
Each discrepancy must be identified, the cause must be determined, the impact must be assessed, and a
resolution must be made. Each discrepancy must be enlisted in Discrepancies Handling during
Qualification ANNEXURE and documented in a Discrepancy Report Form.
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5.0 TEST STRATEGY

The satisfactory Operational qualification of the ERP system shall be verified by executing the qualification
tests described in this protocol. The successfully executed protocol documents verify that the ERP 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.

Full Short
Full Name Designation
Signature/Date Signature/Date
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6.0 ACCEPTANCE CRITERIA

The acceptance criteria includes,

• To demonstrate the operational capabilities of the system.

• To ensure that the system is operating as intended and is under state of control.
• Operational features to meet system requirement and system specification.

7.0 OPERATIONAL QUALIFICATION TESTS

Sr. No. Verification Activity

7.1 Verification of Master and Module wise System Functionality

A. Quality control/Assurance module

B. Sales/PPIC

C. Manufacturing Module

D. Ware house Module

7.2 Verification of Operational SOPs

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7.1 Verification of Master and Module wise System Functionality

Objective : This test verifies Process functionality, challenges and audit trails
of all modules and it’s Workflow in Quality database.

A. Quality control/Assurance module

B. Sales and PPIC Module
C. Manufacturing Module
D. Ware house module

Tools required : ERP system Quality setup

Procedure : Process Functionality

1. Login to ERP system in Quality Setup.
2. Execute transactions for following module as per various
processes listed in the Test Table.

A. Quality control/Assurance module

B. Sales and PPIC Module
C. Manufacturing Module
D. Ware house module

3. Execute transaction to create new record.

a. Enter test data for mandatory fields and save the record.
b. Note down discrepancy if any, after record creation.
c. Capture screenshots of each step as evidence.

Process Challenges
1. List down process wise system expectations for applicable
processes.
2. Execute each process challenge and capture screenshot for
each step.
3. Record the results into test table.

Audit Trail
1. Verify generation of audit trail for following process as per
the Test Table.

A. Quality control/Assurance module

B. Sales and PPIC Module
C. Manufacturing Module
D. Ware house module
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2. Verify the audit trail information in each process by either

login as administrator for selected processes or viewing the
same with user rights, as per configuration.
3. Capture the screen shots of generated audit trail as evidence.
4. Record the results in test table.

Acceptance : 1. After new record creation, system should display proper

criteria message and test data should match with display data of that
record.
2. System should behave as per expected results mentioned into
each test checkpoint
3. System should generate audit trail for change/modify, edit,
delete records operations.
• Audit trail is system generated and audit logs should be
available.
• Audit trail is secured from intentional and accidental
modification.
• It should be independent. i.e. cannot be turned off by users.

Reference : 1. Annexure-1 Verification of Process Cycle

2. Annexure-2 Verification of Audit Trail
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7.2 Verification of Operational SOPs

Objective : To Identify and review availability of Operation SOPs relevant to ERP

system’s use in manufacturing, to check correctness of SOPs, to verify
whether all the SOPs have adequate information covered.

Tools required : Not Required

Procedure : Review existing Operation Standard Operating Procedures (SOPs)
referred by users at Plant for day to day operations.
A. Identification of SOPs
1. The executor will check whether all SOPs are available or not.
2. Note down the details of SOP number, title in Test Table.

B. Check the correctness of the SOPs

1. Verify the steps and information mentioned in each SOP with
installed ERP system.
2. Verify that SOPs are approved by Authorized person prior to use.

Acceptance : 1. All SOPs as listed in Annexure-3 shall be in place with their current
criteria revisions available.
2. SOPs shall display proper information for ERP operation and give
proper direction to user to navigate in ERP.
3. SOPs shall have proper document name, number and signed by
Authorised person prior to use.
4. Latest release/version of SOP is being used by users with updated
information of ERP configuration.

Reference : Annexure -3 Verification of Operational SOPs.

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8.0 SUMMARY OF TEST RESULTS

Discrepancy
Test Pass/ Checked By /
Verification Activity Found?
No. Fail? Date
Yes/No
Verification of Master and Module
7.1
wise Activity

E. Sales and PPIC Module

F. Ware house Module

G. Manufacturing Module

H. Quality control/Assurance
module

7.2 Verification of Operational SOPs

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9.0 DISCREPANCIES HANDLING DURING INSTALLATION QUALIFICATION

Record each discrepancy in the table below and attach the completed discrepancy form(s). (Note: Mark a line
through any remaining blank lines in the table, then initial and date)
Minor Discrepancy (Category A)
Sr. Discrepancy Information

Major Discrepancy (Category B)

Sr. Discrepancy Information

Developmental work required/Not required:

(Attach details)
Critical Discrepancy (Category C)
Sr. Discrepancy Information

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
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10.0 CONCLUSION AND SUMMARY

Summary
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Conclusion
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11.0 LIST OF ANNEXURE

This section provides summary of Annexure attached with protocol as test evidences.
Reference Test
Sr. No. Description Of Annexure
No.
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12.0 ABBREVIATION

Abbreviation Full form

ERP Enterprise Resource Planning

OQP Operational Qualification Protocol

SOP Standard Operating Procedure

GAMP Good Automated Manufacturing Practices

URS User Requirement Specification

SOP Standard Operating Procedure

IT Information Technology

QA Quality Assurance

NA Not Applicable