How to use this Template:

1. All sections with Black section header text are required. Section headers with Blue
text are recommended but optional.

2. All Black text shall remain in the document. All Blue text is to be deleted and
replaced with system specific information.

3. For all Spreadsheet validations, replace Business Owner with Spreadsheet Owner
and remove IT as a required approver.

4. For all Infrastructure validations, remove Business Owner as a required approver.

5. Additional content not already contained in the template can be added as

necessary.

6. Delete this page after creating the System Change Request.

Form: PHPR0216-04, Rev 2

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The following content provides instructions on completing the System Change Request
(SCR) form. DELETE THIS ENTIRE SECTION prior to publishing the completed SCR Form.
Section I – Request for Change
Header Complete the Header Information appropriately.
 Enter the Unique SCR ID in the format shown. The SCR ID is produced by the
Change Management System.
 Date SCR Opened

Part A – Change Description

 Type of change Classify the problem:
 An adaptive change adds new or modifies existing functionality of the system.
 A corrective change fixes existing functionality.

Classify the priority of this SCR:

 Priority of  A high priority change requests immediate action.
change  A normal priority change requests action via standard work prioritization
mechanisms.
 A low priority change can be safely delayed if necessary.
 This setting may be overridden during Demand Intake Board (DIB) review.

 Cause of Identify the appropriate Cause of Change. More than one answer may apply.
change  Select CAPA when the change is being triggered by a Corrective and Preventive
Action report.
 Select Internal Audit when the change is being triggered by a finding from an
internal audit.
 Select External Audit when the change is being triggered by a finding from an
external audit or investigation.
 Select Defect Discovery when the change is being triggered by a bug that requires
fixing.
 Select Process Improvement when the change is being triggered by changes to the
underlying quality system process that the system is automating.
 Select Regulatory Change when the change is being triggered by new or revised
laws, regulations, standards, and/or enforceable guidance that PH is required to
comply with.
 Select Other only when none of the above apply, and provide an explanation in the
description of the problem.

 Describe the Describe the problem being solved by this change by documenting the issue involved with
problem using the system in its present state. Describe how the system fails to support the current
business process, or how it needs to be adapted to support the new business process. Be
specific. Be succinct.

 Describe the Describe the desired system behavior in order to best support the business process.
desired Describe the outcome of the process (or process segment) in question. Employ user story
process format if applicable. Avoid designing the implementation of the solution.
outcome

 Justify the Explain why it’s important to implement this change. Link your explanation to the cause of
change change above. If possible, structure your explanation in terms of return on investment.

Part B – Quality and Regulatory User Requirements Specification

 Only complete this section for a validated application. Q&R user requirements may be found in eMatrix for
validated
 Document all user requirements that are part of this change. This may include:
o existing requirements that are being modified,
o new requirements that are being created,
o existing requirements that are being obsoleted,
o existing requirements that are not changing but are linked to functional requirements that are expected
to change.
 Include requirement ID, requirement description, and change indicator. If the change indicator is “Modify”,
include both the existing and proposed requirement text, labelled as such.

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Part C – Related Functional/Design Specifications
 Itemize all functional requirement specifications and design specifications that are expected to be impacted by
the change. This may include:
o existing requirements that are being modified,
o new requirements that are being created,
o existing requirements that are being obsoleted,
o existing requirements that are not changing but are linked to other requirements that are expected to
change.
 Design specifications may include configuration specifications, interface specifications, and report
specifications.
 Include requirement ID, requirement description, and change indicator. If the change indicator is “Modify”,
include both the existing and proposed requirement text, labelled as such.

Part D – Validation Document Assessment Formatted: French (France)

 Collaborate with IT, SQA, and Validation to determine which validation documents will require updates because
of this change.
 For each document requiring change, mark the check box and provide its document number (documents may
or may not apply depending on which validation life cycle is being used).
 In cases where a new document is being created because of this change, note “Create” in the Document
Number column.
 Add rows to and replicate rows of the table in Part D as necessary. Do not delete rows.

Part E – Business Process Document Assessment

 Itemize which business process documents will require updates because of this change.
 Business process documents may include but not be limited to policies, procedures, work instructions,
guidelines, and manuals.
 List each relevant document and provide its document number.
 In cases where a new document is being created because of this change, note “Create” in the Document
Number column.

Part F – Training Assessment

 Collaborate with Training to determine which existing training is impacted and which new training will be
created because of the change.
 Include the training title or number for existing, or indicate “Create” for new.
 Describe the training required as a result of the change.

Part G – Cross System Impact Assessment

 Analyse impact on other systems
 List the systems impacted and expected impact / change request details for those systems.

Part H – Risk Assessment

 Collaborate with all roles to determine the risk associated with the change.
 Consider patient safety, compliance, and business risk.
 If applicable, consider risk associated with the process change and the system change.
 Describe the risk associated with not implementing the change.

Part I – Section I Approval

 Once Parts A-H have been completed and reviewed, list (in Part I) the names associated with the approval
roles then submit the change form for approval.
 Section I approval may be combined with Section II approval if deemed appropriate by the CR team. If the
approvals are combined, this should be noted.
Section II – Qualification Protocols

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  In Parts J-M, there are two options for documenting the testing that will be performed as a result of this change:
o Develop the tests within the SCR form
 This option is most appropriate when the tests needed for the change do not already exist and are not
expected to be voluminous.
 Insert the tests into the appropriate area using the template associated with the validation life cycle
being used.
o Reference tests in external documents from within the SCR form
 This option is most appropriate when the tests needed for the change already exist or are expected to
be voluminous.
 These tests may have been created for a previous validation effort, are being created for this specific
change, or a combination of the two.
 References must include a document number and revision number, and test script IDs where
appropriate.
 References must be both unique and unambiguous.
Part N – Section II Approval
 Once Parts J-M have been completed and reviewed, list (in Part N) the names associated with the approval
roles.
 Submit the revised change form for approval by incrementing the revision of the approved SCR form.
Section III – Test Results (Qualification Environment)
 In Part O document the Change requests made to impacted systems (cross system impact)
 In Parts P-R, document the results of executing the qualification protocols in the qualification environment.
 Identify each test script executed, its status, and any associated deviations. Replace the red “x” with the actual
number of deviations.
 For each deviation, identify its number, its description, the script that generated it, and its status.
Part S – Section III Approval
 Once Parts O-R have been completed and reviewed, list (in Part S) the names associated with the approval
roles.
 Submit the revised change form for approval by incrementing the revision of the approved SCR form.
Section IV – Test Results (Production Environment)
 In Part T, document the results of executing the qualification protocols in the production environment
 If additional testing is performed in the production environment (for instance, Production Performance
Qualification), replicate and edit the table provided in the form.
 Identify each test script executed, its status, and any associated deviations. Replace the red “x” with the actual
number of deviations.
 For each deviation, identify its number, its description, the script that generated it, and its status.
Part U – Section IV Approval
 Once Part T has been completed and reviewed, list (in Part U) the names associated with the approval roles.
 Submit the revised change form for approval by incrementing the revision of the approved SCR form.

-------------------- DELETE THIS ENTIRE SECTION WHEN PUBLISHING THE SCR FORM ----------------

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 System Change Request - Error! Reference source not
found.<System Name>
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<Document #> Revision Error! Reference source not found.<Revision #>

SECTION I – Request for Change

<Document # Revision #>
To be completed by Business Owner Name: Rahul Tyagi
System MP1System Name> Revision <Revision>
SCR ID SCR_<application abbreviation>_<Ticket #> Date Request Opened:

PART A: Change Description – Required Formatted: Font color: Red

Classify the problem:

Type of change: Priority of change: Cause of change: ☐ Defect Discovery
☒☐ Adaptive ☐ P1 (High) ☐ CAPA ☐ Process Improvement
☐ Corrective ☐ P2 (Normal) ☐ Internal Audit ☐ Regulatory Change
☐ P3 (Low) ☐ External Audit ☐ Other (please describe below)
Describe the problem:
User not able to removed JOIG tax condition manually from billing documents for PMS Ext. warranty contract. For the PMS ext. warranty
contract type JOIG condition is not mandatory. Due to this reason accounting document not generated.

Describe the desired process outcome (in user story format if applicable):
Once necessary changes ha

Justify the change:

WBS element with GL for Line ID 824 is not maintain in the table in ZZCS_DP90_ACCDET, due to this entry not exist in the system
business user not able to post the document. Once WBS element is, maintain for line ID 824 in the table ZZCS_DP90_ACCDET
user post the pending documents which value around 4 crores.

PART B: User Requirements Specification

Indicate New,
Requirement ID Requirement text Modify, Obsolete, or
No Change

PART C: Related Functional/Design Specifications

Indicate New, Modify,
Specification ID Description Obsolete, or No
Change

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<Document # Revision #>

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PART D: Validation Document Assessment

<Document # Revision #>

As a result of this change, the following validation documents will have to Applicable Procedure Document Number
be updated or created (check all that apply):
☐ Quality System Impact Assessment PHPR0210
☐ Validation Scalability Evaluation PHPR0210
☐ 21 CFR Part 11 Assessment PHPR0210
☐ Traceability Matrix PHPR0211
☐ User Requirement Specifications PHPR0211
☐ System Risk Assessment PHPR0210
☐ Functional Requirements Specification PHPR0211
☐ Design Specification PHPR0212
☐ Configuration Management Plan PHPR0210
☐ Installation Qualification Protocol (QA) PHPR0213
☐ Operational Qualification Protocol PHPR0213
☐ Performance Qualification Protocol PHPR0213
☐ Installation Qualification Protocol (PRD) PHPR0213

PART E: Business Process Document Assessment - Required

As a result of this change, the following Business Documents Indicate Document Number (If update is required) or Create (for
(Policies, Procedures, Work Instructions, Guidelines, Manuals, etc.) new documents)
will have to be created or updated:
Now in production system for settlement posting there is GLs
maintain corresponding to the line ID 824. Line ID defines, which
category cost and revenue belong to and whether cost can be
capitalized or not.

Once missing entry maintained in the Table in ZZCS_DP90_ACCDET Formatted: Font: Calibri, Font color: Auto
business user able to post pending document which value more
than 4 crores. Formatted: Font: Calibri, Font color: Auto

Below is our assessment on how we want this in our SAP system,

this may help for further assessment & development.

For your reference we take an example of line ID 400 which is

already exist in the system:

We need same scenario for the line ID 824 in the MP1 production
system.

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PART F: Training Assessment - Required

Training Title/Training Number Describe training required for user community as a result of this change:
<Document # Revision #>
NA NA

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PART G: Cross System Impact Assessment - Required

Enter the results
<Document of the#>
# Revision Impact Assessment performed to determine if the change defined in this SCR has
any impact on systems dependent on receiving data. If no impact is determined, enter "None" in each
column. Otherwise, enter the System Name impacted and a description of the impact. Provide any System
Change Request information provided by the Stakeholders of the affected system(s). Approval of Section
1 confirms that approvers have reviewed the results of the Impact Assessment.

System name or reference Describe the expected impact on other systems/describe the expected change request details
MP1 NA

PART H: Risk Assessment - Required

Describe the risk associated with implementing/not implementing the change:

NA

PART I: Section I Approval

The following signatures authorize the implementation of the change as described above.

Name Role

Q&R

IT

Business Owner

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SECTION II – Qualification
<Document # Revision #> Protocols

PART J: Installation Qualification (IQ-QA)

Identify or document here the IQ-QA scripts to be executed

PART K: Operational Qualification (OQ)

Identify or document here the OQ scripts to be executed

PART L: Performance Qualification (PQ)

Identify or document here the PQ scripts to be executed

PART M: Installation Qualification (IQ-PRD)

Identify or document here the IQ-PRD scripts to be executed

PART N: Section II Approval

The following signatures approve the Qualification Protocols as described above.

Name Role

Q&R

IT

Business Owner

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SECTION III – Test Results (Qualification Environment)
PART O: Cross
<Document System
# Revision #> Change Request Status
The following change requests were directed to systems impacted by this change request.
Status
CR # Description
(Rejected/Pending/Completed)

PART P: IQ-QA Test Results

The Installation Qualification (IQ) Protocol was executed in the Qualification environment with X deviations encountered. The
test scripts and results are summarized below:
Status
Test Script # Revision # Run # Deviation # Results
(pass/ fail)

IQ-QA Test Deviations: Defects and test deviations identified during testing were documented on deviation forms and
investigated for cause. The following test deviations were encountered during test execution.
Deviation Status
Description Script # Comments
Number (Open/Closed)

PART Q: OQ Test Results

The Operational Qualification (OQ) Protocol was executed in the Qualification environment with X deviations encountered.
The test scripts and results are summarized below:
Status
Test Script # Revision # Run # Deviation # Results
(pass/ fail)

OQ Test Deviations: Defects and test deviations identified during testing were documented on deviation forms and
investigated for cause. The following test deviations were encountered during test execution.
Deviation Status
Description Script # Comments
Number (Open/Closed)

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The Operational Qualification (OQ) Protocol was executed in the Qualification environment with X deviations encountered.
The test scripts and results are summarized below:
<Document # Revision #>

PART R: PQ Test Results

The Performance Qualification (PQ) Protocol was executed in the Qualification environment with X deviations encountered. The test
scripts and results are summarized below:
Status
Test Script # Revision # Run # Deviation # Results
(pass/ fail)

PQ Test Deviations: Defects and test deviations identified during testing were documented on deviation forms and
investigated for cause. The following test deviations were encountered during test execution.
Deviation Status
Description Script # Comments
Number (Open/Closed)

PART S: Section III Approval

The following signatures approve the test results as described above and the release of the change for testing in the production
environment.

Name Role

Q&R

IT

Business Owner

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SECTION IV –Test Results (Production Environment)
PART T: IQ-PRD
<Document Test#>Results
# Revision

The Installation Qualification (IQ) Protocol was executed in the Production environment with X deviations encountered. The
test scripts and results are summarized below:
Status
Test Script # Revision # Run # Deviation # Results
(pass/ fail)

IQ-PRD Test Deviations: Defects and test deviations identified during testing were documented on deviation forms and
investigated for cause. The following test deviations were encountered during test execution.
Deviation Status
Description Script # Comments
Number (Open/Closed)

PART U: Section IV Approval

The following signatures approve the test results as described above, the release of the change for use in the production environment, and
the closure of this change request.

Name Role

Q&R

IT

Business Owner

REVISION HISTORY
Revision Date Author Description

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