PERFORMANCE QUALIFICATION PROTOCOL FOR ERP

SYSTEM

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PERFORMANCE QUALIFICATION
PROTOCOL
FOR
ENTERPRISE RESOURCE PLANNING
SYSTEM
 PERFORMANCE QUALIFICATION PROTOCOL FOR ERP
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

Approve 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 PERFORMANCE QUALIFICATION TESTS ..........................................................................8
7.1 Verification of Masters and Module wise System Functionality ................................................9
7.2 Verification of User Management of ERP System ...................................................................11
7.3 Verification of Reports ..............................................................................................................12
8.0 SUMMARY OF TEST RESULTS ...........................................................................................13
9.0 DISCREPANCIES HANDLING DURING PERFORMANCE QUALIFICATION ...............14
10.0 CONCLUSION STATEMENT ................................................................................................15
11.0 LIST OF ANNEXURE .............................................................................................................17
12.0 ABBREVIATION .....................................................................................................................18
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1.0 OBJECTIVE
The objective of the performance qualification is to establish documented evidence that the ERP system is
operating as per User requirement specifications and design qualification.

2.0 SCOPE

This performance qualification is applicable to installed ERP system at the Windlas Healthcare (P) Ltd.

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.

• Arizona Automation & Technologies

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

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 performance 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 Performance 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 PERFORMANCE QUALIFICATION TESTS

Sr. No. Test Description

7.1 Verification of Masters and Module wise System Functionality of ERP
A. Quality Control/ Assurance Module
B. Sales and PPIC Module
C. Warehouse Module
D. Manufacturer Module

7.2 Verification of User Management of ERP

7.3 Verify system generate report and Electronics signature available for ERP System
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7.1 Verification of Masters and Module wise System Functionality

Objective : This test verifies system functionality, and audit trails of available ERP
modules and it’s Workflow in Live database.
A. Quality Control/ Assurance
B. Sales and PPIC
C. Warehouse Module
D. Manufacturer Module

Tools required : ERP system Live setup

Procedure : Process/System Functionality

1. Login to ERP system in Live Setup.
2. Execute transactions for following available module as per various
processes listed in the annexure 2.
A. Quality Control/ Assurance
B. Sales and PPIC
C. Warehouse Module
D. Manufacturer Module
3. Execute transaction to create new record.
a. Enter 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.

Audit Trail
1. Verify generation of audit trail for following available module wise
process in live setup as per the Test Table.
A. Quality Control/ Assurance
B. Sales and PPIC
C. Warehouse Module
D. Manufacturer Module

2. Verify the audit trail information(only for the process being carried
online during the period qualification) by either login as
administrator for selected processes or viewing the same with user
rights, as per configurationCapture the screen shots of generated
audit trail as evidence.
3. Record the results in test table.
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Acceptance : 1. After new record creation, system should display proper message
criteria and data should match with display data of that record.
2. 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. Execution will be done and reported as per Annexure – 2 and Audit
trail Annexure – 3 of Performance Qualification Report.
2. Design Qualification
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7.2 Verification of User Management of ERP System

Objective : This test verifies user management of Enterprise Resource Planning which is
given to users for accessing and operating ERP Business Process System at
site.

Tools required : ERP System Live setup

Procedure : 1. Verification of ERP System Policy

2. Verification for access level and user right
3. Verify the access rights as per Authorization Matrix.
4. Note down the observations in the Annexure – 1.

Acceptance : 1. System shall allow login with the correct combination of User and
criteria password only.
2. User should be allowed to have access of predefined transaction only.
Also, password policies for each user should be properly defined.

Reference : 1. Execution will be done and reported as per Annexure – 1 of Performance

Qualification Report.
2. Design Qualification
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7.3 Verification of Reports

Objective : To identify and verify system generate report and Electronics signature
available for ERP System.

Tools required : Printer

Procedure : 1. Verify that the system generate report and Electronics signature with
date & time stamp, Report Format No., Company Name and, Report
Name, Operator Name, Batch No., Printed By.
2. Verify that the system generate audit trail report with date & time
Printed By.
3. Attach all printouts to the appropriate annexure of this Report.
4. Execution will be done and reported as per Annexure – 4 and
Annexure – 3 of Performance Qualification Report.

Acceptance : 1. Report shall be system generate and cover all necessary details with
criteria date & time stamp, Report Format No., Company Name and, Report
Name, Operator Name, Batch No., Printed By.
2. Report Shall be match with expected result.

Reference : 1. Execution will be done and reported as per Annexure – 4 of

Performance Qualification Report.
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8.0 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
Checked
Test No. Verification Test Pass/Fail Found?
By / Date
Yes/No
Verification of Masters and Module wise
7.1
System Functionality
A. Quality Control/ Assurance Module

B. Sales and PPIC Module

C. Warehouse Module

D. Manufacturer Module

7.2 Verification of User Management of ERP

Verification of system generate report and

7.3 Electronics signature available for ERP
System.
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9.0 DISCREPANCIES HANDLING DURING PERFORMANCE 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

Section completed by: ______________________________________

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10.0 CONCLUSION STATEMENT

Summary

Performance Qualification of ERP System has been performed using the Live Server “windlass
healthcare Pvt. Ltd. – WHC2016-whc-nav13.whc.com” The Various activities associated with the
departments of windlas healthcare which are being governed through ERP standardization has been
verified against the design functionality

In Performance qualification, the ERP transactions has been performed by user for all the activities , In
this flow of activity,

• User management has been verified

• Transaction approval mechanism wherever applicable
• Audit trail of (only for the process being carried online during the period qualification)
each execution has been verified
• system generate Report with Electronics signature has been verified

It is observed that the system is functioning as intended and in accordance with the lay down procedure
which is going to be used for routine ERP operations

The Records of activities are maintained in the annexures in the form of screen shots for the evidence
which are verified by QA of Windlas and Arizona Automation & Technologies, the validation agency
on behalf of Windlas to execute the qualification of ERP
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Conclusion

Based on this summary we can conclude that the system is meeting the acceptance criteria for its
acceptance and can be released further for the next stage of qualification where the same set up will be
tested on the live server “windlass healthcare Pvt. Ltd. – WHC2016-whc-nav13.whc.com” for the
process that will run in routine
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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

PQP Performance Qualification Protocol

GAMP Good Automated Manufacturing Practices

URS User Requirement Specification

DQ Design Qualification

IT Information Technology

QA Quality Assurance

NA Not Applicable