QA Department

Code: QA-R-xx
Business Material Master List for
Issue.: 01
SAP S/4 HANA Issue Date: xx/xx/20xx

Business Material Master List

of

SAP S/4 HANA

Installation Qualification Protocol

1
Pre-Approval

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 QA Department
Code: QA-R-xx
Business Material Master List for
Issue.: 01
SAP S/4 HANA Issue Date: xx/xx/20xx

Title Name Signature Date

Validation Officer Osama Mahmoud

Prepared by:
IT Engineer Tamer

Validation Officer Mohamed Nagy

Checked &
Reviewed and
Approved by:
QA Director Dr. Mona Sherif

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 QA Department
Code: QA-R-xx
Business Material Master List for
Issue.: 01
SAP S/4 HANA Issue Date: xx/xx/20xx

2 Table of Content
S.N Title Page #
1 Installation Qualification Pre-approval 2
2 Table of content 3
3 Document Control 4
4 Objective 4
5 Scope 4-5
6 Roles and Responsibilities 6-7
7 Protocol Execution Instructions 8
8 Glossary 9
9 Introduction and system description 10-11
10 System Identification and Architecture 12-13
11 Requalification Frequency 14
12 Signature List 14
13 References 14
14 Installation Qualification Tests 15
14-1 Test 01: Documentations Verification 15
14-2 Test 02: Verification of Sensors Location 16
14-3 Test 02: Verification of Systems Hardware Components 17
14-4 Test 03: Verification of Communication Cables 18
14-5 Test 05: Verification of Electrical Drawings 19
14-6 Test 06: Verification of Power Utilities 20
14-7 Test 07: General Inspection of DDC Panels 21
14-8 Test 08: Verification of Input / Output Configuration and Availability 22
14-9 Test 09: Verification USB Dongle Physical Secured Connection 23
15-A Appendix A : Deviations 24
15-B Appendix B : Changes 25
16 Conclusion and Final Report 26
17 Installation Qualification Post-approval 27

3 Document Control
3.1 Revision History

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 QA Department
Code: QA-R-xx
Business Material Master List for
Issue.: 01
SAP S/4 HANA Issue Date: xx/xx/20xx

Issue. Date Page Section Revision Summary Developed by

1 Initial Osama Mahmoud

4 Objective
The objective of this protocol is to have a documented evidence & provide assurance that the SAP
S/4 HANA is installed as required in the processing environment and meets design requirements
and specifications. Successful completion of these qualification requirements will provide
assurance that the SAP S/4 HANA Servers with infrastructure installed as required in the
processing environment.

5 Scope
This protocol is applicable for the ERP system SAP S/4 HANA, that manage APEX business through
a GXP and non-GXP modules.
GxP modules:
1-Quality Management Module.
2-Material Management & Warehouse Management Module.
3-Production Planning Module.
Non-GxP modules:
1-Financial and Controlling Module.
2-Sales and Distribution Module.
And included some enhancements that assure a high degree of performance for APEX business
with the following components:
S. No. Module Enhancement GxP / Non-GxP
01 QM COA for Raw Material GxP
02 COA for Packaging GxP
03 COA for Finished product GxP
04 Forms for Automatic & Manual Notification GxP
05 Form for Change control Request GxP
06 Form for Customer Complaint GxP
07 Form for SOPs GxP
08 Recurring inspection (the logic) GxP
09 Stability Study (inspection types & logic) GxP
10 Sending email for all UD's GxP
11 Sending email for recurring GxP
12 QN for procurement GxP
13 QN for production GxP
14 QN for Customer Complaint GxP
15 QN for Recall GxP
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 QA Department
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Business Material Master List for
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16 Sending email for GR GxP

17 Sending email when the operation completed GxP
18 MM Batch coding enhancement GxP
19 Dispensing label GxP
20 GRA GxP
21 Pallet identification label GxP
22 Receiving / Quarantine GxP
23 P.O GxP
24 WM Stock Report Non-Gxp
25 PP Change Quantity in Process Order GxP
26 FICO Customer / Vendor Statement Non-Gxp
27 Customer / Vendor Open Items Non-Gxp
28 Customer / Vendor Correspondence Non-Gxp
29 Cash Receipt / Cash Payment Non-Gxp
30 Check Receipt Non-Gxp
31 Check Form Non-Gxp
32 SD Tender quotation form Non-Gxp
33 Tender quotation Report Non-Gxp
34 private quotation form Non-Gxp
35 billing form Non-Gxp
36 delivery note form Non-Gxp
37 Z tables for in market sales Non-Gxp
38 Pricing routine Non-Gxp

Out of Scope: All non-GxP modules that do not have GxP requirements financial module.

8 Glossary
 QM: Quality Management.
 MM: Material Management.
 WM: Warehouse Management.
 PP: Production Planning.
 FICO: Finance and Controlling Module.
 SD: Sales and Distribution.

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 QA Department
Code: QA-R-xx
Business Material Master List for
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SAP S/4 HANA Issue Date: xx/xx/20xx

 Business Process List - Materials Management

Sr. No Module Process Name Process Step Transaction Code

BP/MM/01 Master Data Creation

BP/MM/02 APEX Procurement Process

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Code: QA-R-xx
Business Material Master List for
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BP/MM/03 External Service Procurement Process

BP/MM/04 Procurement Return to Vendor

BP/MM/05 Subcontracting

BP/MM/06 Goods receipt Processing with Inbound Delivery WM-IM

BP/MM/07 Goods receipt from production order with inspection

BP/MM/08 Goods issue to a cost center

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Code: QA-R-xx
Business Material Master List for
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SAP S/4 HANA Issue Date: xx/xx/20xx

BP/MM/09 Goods issue for a delivery

BP/MM/10 Physical Inventory / Inventory Count and Adjustment

 Business Process List - Quality Management

Sr. No Module Process Name Process Step Transaction Code

BP/QM/01 Master Data Creation

BP/QM/02 Goods Receipts inspection with vendor evaluation

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 QA Department
Code: QA-R-xx
Business Material Master List for
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BP/QM/03 QM in Manufacturing for Process Goods

BP/QM/04 Inspection at Goods receipts from production

BP/QM/05 Stock transfer inspection

BP/QM/06 Inspection for delivery to customer with order

BP/QM/07 Sales returns with Quality Management

BP/QM/08 Quality Notification (Recall)

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Code: QA-R-xx
Business Material Master List for
Issue.: 01
SAP S/4 HANA Issue Date: xx/xx/20xx

BP/QM/09 Miscellaneous inspection (Manual)

BP/QM/10 Recurring Inspection

 Business Process List – Production Planning

Sr. No Module Process Name Process Step Transaction Code

BP/PP/01 Master Data Creation

BP/PP/02 Bill of Material (BOM)

Bill of Material (BOM)

BP/PP/03 Resource for manufacturing

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 QA Department
Code: QA-R-xx
Business Material Master List for
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BP/PP/04 Master recipe

BP/PP/05 Make-to-Stock Production – Process Industry

BP/PP/06 Make-to-Order Production - Finished Goods Sales and Final Assembly

BP/PP/07 Rework Processing - Stock-Manufactured Material

BP/PP/08 Subcontracting

BP/PP/09 Material Requirements Planning

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 QA Department
Code: QA-R-xx
Business Material Master List for
Issue.: 01
SAP S/4 HANA Issue Date: xx/xx/20xx

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