DRS Communication

SAPHEGA System

Design Requirements/Specifications

BPS: SM020MM10 Communication

Revision History

Supersedes Modifications Current Version

New Creation 1.0

1.0 Amendments for wave 2:

6.1 Deleted point 2, delivery address, cause this is no issue for communication

7.2.3 Local requirements: Forms for Alliage Wave2

8.2 Added the functional limitation for Wave2 SM020MM10_LY15

9.3 SAPScript for Wave2

If functionality of using forms was not used in SAPHARMA, e.g. RfQ or Contracts: This has to be realized in SAPHEGA according SAP standard, based on the country specific purchase order form. For service entries one harmonized form for all Solvay companies has to be applied.

10.3 Supplement configurations steps more in detail

10.4 Applied all Wave2 relevant Forms to table 10.

Attachment A: Deleted the failure “Incorrect data”

2.0

2.0 MARIA Project

The next chapters where adaptedNo changes required

Chapter 6.1 – General Description

Chapter 6.3 – Explanations of Functions and Events

Chapter 7.2 – Local Requirements / Expectations

3.0

Table of Contents

Confidential Property of Solvay Pharmaceuticals of 14

nlceel01, 06/04/07,

Purchasing is already used by the R&D. Therefore I suggest not to have additional changes due to the MARIA project.

SAPHEGA System BPS: SM020MM10 CommunicationDesign Requirements/Specifications

1. Purpose ............................................................................................................................................................42. Scope ................................................................................................................................................................43. Terms and Abbreviations ..............................................................................................................................4

Table 1 – Terms and Abbreviations ...................................................................................................................44. References .......................................................................................................................................................45. Attachments ....................................................................................................................................................56. Description of the Master Data: Communication .......................................................................................5

6.1. General Description ..............................................................................................................................56.2. Inputs/Results .......................................................................................................................................56.3. Explanation of Functions and Events ...................................................................................................5

7. Requirements/Expectations ...........................................................................................................................77.1. Global Requirements/Expectations ......................................................................................................7Table 2 – Requirements/Expectations for BPS Communication .......................................................................77.2. Local Requirements/Expectations ........................................................................................................7

7.2.1. United States ..............................................................................................................................7Table 3 – Local Requirements/Expectations BPS: Communication for United States .....................................7

7.2.2. Canada ........................................................................................................................................7Table 4 – Local Requirements/Expectations BPS: Communication for Canada ..............................................7

7.2.3. Alliage Wave2 ............................................................................................................................8Table 4 – Local Requirements/Expectations BPS: Communication for Canada ..............................................8

7.2.4. Fournier Integration ...................................................................................................................8Table 5 – Local Requirements/Expectations BPS: Communication for Canada ..............................................8

7.2.5. MARIA Project ..........................................................................................................................8The following table describes the local requirements/expectations for BPS: Communication ..................8

Table 6 – Local Requirements/Expectations BPS: Communication for R&D Departments ............................88. Addressing Functional Limitations ..............................................................................................................8

8.1. Description of Functional Limitations ..................................................................................................9Table 5 – Functional Limitations .......................................................................................................................98.2. Strategies to Address Functional Limitations .......................................................................................9Table 6 – Strategies to Address Functional Limitations ....................................................................................9

9. Detailed Specifications for Additional Needed Developments ...................................................................99.1. Sapscript for the Unites States ..............................................................................................................99.2. Sapscript for Canada .............................................................................................................................99.3. Sapscript for Alliage Wave3 ...............................................................................................................10

10. Realization Matrix ........................................................................................................................................1010.1. Related Transactions ...........................................................................................................................10



Table 7 – Related Transactions for BPS Communication ...............................................................................1010.2. Role Description .................................................................................................................................11Table 8 – Role Description for BPS Communication .....................................................................................1110.3. Configuration ......................................................................................................................................11Table 9 – Related Configuration for BPS Communication .............................................................................1110.4. Development .......................................................................................................................................12Table 10 – Developments for BPS Communication ........................................................................................12



1. Purpose

This Design Requirements/Specifications document describes in detail the requirements and expectations as well as the setup and use of the BPS Communication. It provides formal documentation of the risk assessment and ERES relevancy of the Master Data as well as the designation of Global versus Local requirements for any given Master Data.

2. ScopeThe scope of this Design Requirements/Specifications document is limited to Communication only for the SAPHEGA System for Solvay.

3. Terms and Abbreviations

Table 1 – Terms and Abbreviations

Term or Abbreviation Description

DRS Design Requirements/Specifications

BPS Business Process Step

Lowest hierarchical level in the Solvay Pharmaceuticals Solution Map. Comprises a set of transactions usually carried out within one department with a well defined input and output.

ERES Assessment Assessment of the Business Process Step to determine whether Electronic Records and/or Electronic Signature are created or maintained according to the Risk Assessment SAPHEGA procedure

Risk Criticality Level Risk Criticality Level determined according to the Risk Assessment SAPHEGA procedure

R&D Research & Development

4. References

The following document(s) is (are) relevant for this document:

SAP Project and Validation Management Methodology (SOLID # 0000029349) Computerized System Validation Documentation for SAPHEGA (SOLID# 0000029346) SAPHEGA SM0XX_FS Master Data (SOLID# 0000035758) GOP SAPHEGA DRS Guidelines (SOLID# 0000029691)



5. Attachments

Attachment A – Functional Risk Assessment Worksheet

Attachment B – 21 CFR Part 11 Assessment Worksheet

6. Description of the Master Data: Communication

6.1. General Description

The Communication Master Data should support the following:

Message conditions: They are a means of communication with vendors in purchasing. The conditions under which a certain kind of output towards the vendor is generated by the system are defined.

Remarks: Communication Master Data (Delivery Address, Message Conditions) The delivery address should allow keeping address records to be used to inform the suppliers about

the target destination of their shipments. Message conditions should ensure that for every purchasing documents the correct transmission to

the vendor is triggered by the system (e.g. via the regular postal service as a normal printed document or as a fax).

6.2. Inputs/Results

Not applicable for a Master Data BPS.

6.3. Explanation of Functions and Events

"Messages" (documents in output form) are an important means of communication with vendors in Purchasing.

Messages can be transmitted both by the regular mail (postal service) and electronically. In the SAP System, the term "message" stands for both, letters and suchlike (communications in the conventional sense) as well as other documents such as RFQs, purchase orders and contracts, all of which serve as a means of communicating information to other parties. A message control facility that depends on a number of different criteria allows you to process and transmit such messages under certain conditions, subject to predefined restrictions.The configuration includes the following:

Texts for Messages

Standard texts for RFQs, purchase orders and contracts according are defined.

Forms (Layout Sets) for Messages

In this step, you can assign the layout sets for the following documents:



request for quotation (RFQ)

purchase order (purchase order)

outline agreement (contract)

service entry sheet

Output Control

In this section, you set up the message determination process. The message determination facility in Purchasing enables you to control message defaults by making certain assignments and groupings. This allows the system to determine and process valid messages according to predefined criteria. You can thus individually control the processing of document output on a vendor-by-vendor basis. The message determination facility is automatically activated in SAP standard.

Assign an output device to your purchasing groups

Fields Relevant to Printouts of Changes

In this step, you define:

Whether and in which purchasing documents a field is relevant to printouts of changes (change notices).

Which texts are included in change notices

Text output can be controlled via a text number (direct assignment) or a routine (indirect assignment).

7. Requirements/Expectations

7.1. Global Requirements/Expectations

Table 2 – Requirements/Expectations for BPS Communication

DRSID Requirements

CM: COMMUNICATION

SM020MM10_CM05 The communication process must support manual creation of output messages for RFQ’s; Purchase Orders, Service Orders and Contracts.

SM020MM10_CM10 The communication process must support automatic creation of output messages for RFQ’s; Purchase Orders, Service Orders and Contracts.

SM020MM10_CM15 The communication process must support manual creation of print and e-mail for Output Messages.


sapevent:DOCU_LINK/DS:GLOS.352AE77F88E65CD5E10000009B38F974


Table 2 – Requirements/Expectations for BPS Communication

DRSID Requirements

SM020MM10_CM20 The communication process must support automatic creation of print and e-mail for Output Messages.

7.2. Local Requirements/Expectations

7.2.1. United States

The following table describes the local requirements/expectations for BPS: Communication.

Table 3 – Local Requirements/Expectations BPS: Communication for United States

DRSID Description

LY: Layout

SM020MM10_LY05 The output documents must have a Solvay specific layout

7.2.2. Canada


Table 4 – Local Requirements/Expectations BPS: Communication for Canada

DRSID Description

LY: Layout

SM020MM10_LY10 The output documents must have a Solvay specific layout

7.2.3. Alliage Wave2



DRSID Description

LY: Layout

SM020MM10_LY15 The output documents / forms must have a specific layout, related to Solvay companies, plants, and purchase organizations in the different countries that are in scope for wave2.

7.2.4. Fournier Integration





DRSID Description

LY: Layout

SM020MM10_LY20 The output documents / forms must have a Core layout, related to Solvay companies, plants, and purchase organizations in the different countries that are in scope for forunier integration, and this should be later on roll out in other sites and countries

8. Addressing Functional Limitations

The next paragraphs list the functional limitations and approaches to solutions for this BPS.

8.1. Description of Functional Limitations

Table 5 – Functional Limitations

RelatedDRSID Functional Limitations

SM020MM10_LY05 The standard layouts by SAP are not Solvay specific




8.2. Strategies to Address Functional Limitations

Table 6 – Strategies to Address Functional Limitations

RelatedDRSID Functional Limitations Strategies

SM020MM10_LY05 A new Sapscript layout must be developed for the United States

SM020MM10_LY10 A new Sapscript layout must be developed for Canada

SM020MM10_LY15

The Sapscript forms have to be applied for Alliage Wave2.

The Forms are mentioned in table 10. Conversion has to be done, beginning with the purchase order, contracts and then RfQ. At least service entry sheets. It has to be taken care of the Solvay logos, header and footer texts.

SM020MM10_LY15 The Sapscript forms have to be applied for Fournier intégration.

The Forms are mentioned in table 10. Conversion has to be done, beginning with the



Table 6 – Strategies to Address Functional Limitations

RelatedDRSID Functional Limitations Strategies

purchase order, contracts and then RfQ. At least service entry sheets. It has to be taken care of the Solvay logos, header and footer texts.

9. Detailed Specifications for Additional Needed Developments

9.1. Sapscript for the Unites States

The forms ZUS_MEDRUCK2 and ZUS_MEDRUCK_CON from the US legacy system are converted into SAPHEGA as they are.

9.2. Sapscript for Canada

The form YFM_MEDRUCK from the Canadian legacy system is converted into SAPHEGA as it is.

9.3. Sapscript for Alliage Wave3

The forms mentioned in table 10 from the SAPHARMA legacy system has to be converted into SAPHEGA.

If functionality of using forms was not used in SAPHARMA, e.g. RfQ or Contracts: This has to be realized in SAPHEGA according SAP standard, based on the country specific purchase order form.

For service entries one harmonized form for all Solvay companies has to be applied.

10. Realization Matrix

The tables in the next three paragraphs show how the BPS Communication will be realized.

10.1. Related Transactions

Table 7 – Related Transactions for BPS Communication

Transaction Name In Scope

Logical Component Authorization Role

MB90Output Processing for Mat. Documents

Y SAP ECCYxxSM020_Ayyyzzzz



Table 7 – Related Transactions for BPS Communication

Transaction Name In Scope

Logical Component Authorization Role

ME99 Messages from Purchase Orders Y SAP ECC YxxSM020_Ayyyzzzz

ME9A Message Output: RFQs Y SAP ECC YxxSM020_Ayyyzzzz

ME9F Message Output: Purchase Orders Y SAP ECC YxxSM020_Ayyyzzzz

ME9K Message Output: Contracts Y SAP ECC YxxSM020_Ayyyzzzz

MEAN Delivery Addresses Y SAP ECC YxxSM020_Ayyyzzzz

MN01 Create Message: RFQ Y SAP ECC YxxSM020_Ayyyzzzz

MN02 Change Message: RFQ Y SAP ECC YxxSM020_Ayyyzzzz

MN04 Create Message: PO Y SAP ECC YxxSM020_Ayyyzzzz

MN05 Change Message: PO Y SAP ECC YxxSM020_Ayyyzzzz

MN07 Create Message: Outline Agreement Y SAP ECC YxxSM020_Ayyyzzzz

MN08 Change Message: Outline Agreement Y SAP ECC YxxSM020_Ayyyzzzz

MN13 Create Message: Service Entry Sheet Y SAP ECC YxxSM020_Ayyyzzzz

MN14 Change Message: Service Entry Sheet Y SAP ECC YxxSM020_Ayyyzzzz

MN24 Create Message: Shipping Notif. Y SAP ECC YxxSM020_Ayyyzzzz

MRM1 Create Message: Invoice Verification Y SAP ECC YxxSM020_Ayyyzzzz

MRM2 Change Message: Invoice Verification Y SAP ECC YxxSM020_Ayyyzzzz

MN03 Display Message: RFQ Y SAP ECC YZZSX999XX

MN06 Display Message: PO Y SAP ECC YZZSX999XX

MN09 Display Message: Outline Agreement Y SAP ECC YZZSX999XX

MN15 Display Message: Service Entry Sheet Y SAP ECC YZZSX999XX

MRM3 Display Message: Inv. Verification Y SAP ECC YZZSX999XX

10.2. Role Description

Table 8 – Role Description for BPS Communication

Role Short Description

YxxSM020_Ayyyzzzz Communication-Master Data

YZZSX999XX General Display SM



10.3. Configuration

The configuration done for this BPS is captured in documentation BC sets which are attached to configuration tab in the Solution Directory.

Table 9 – Related Configuration for BPS Communication

TypeLogical

Component

Object Description

IMG Object SAP ECC CHAPSIMG_CMMENUOLMEFN

Messages

IMG Object SAP ECC CHAPSIMG_CFMENUOLMEOMGD

Texts for Messages

IMG Object SAP ECC SIMG_OLMEANFRAGESE71

Adjust Form for Purchasing Documents

IMG Object SAP ECC SIMG_CFMENUOLMEOMFD

Assign Form and Output Program for RFQ

IMG Object SAP ECC SIMG_CFMENUOLMEOMFE

Assign Form and Output Program for Purchase Order

IMG Object SAP ECC SIMG_CFMENUOLMEOMFF

Assign Form and Output Program for Contract

IMG Object SAP ECC CHAPSIMG_CFMENUOLMEOMGG

Output Control

IMG Object SAP ECC SIMGOLMEM/30 Define Message Types for Request for QuotationIMG Object SAP ECC SIMGOLMEM/34 Define Message Types for Purchase OrderIMG Object SAP ECC SIMGOLMEM/38 Define Message Types for Outline AgreementIMG Object SAP ECC CFMENUOLMEOMF

S_AFields Relevant to Printouts of Changes

IMG Object SAP ECC SIMG_OLMELERFBLSE71

Adjust Form

IMG Object SAP ECC SIMG_CFMENUOLMEOMHQ

Assign Form for Service Entry Sheet

IMG Object SAP ECC SIMGOLMEM/75 Define Message Types for Service Entry SheetIMG Object SAP ECC SIMG_CFMENUOL

MEOMGFAssign Output Devices to Purchasing Groups

10.4. Development

The enhancements are captured in a technical document which is attached to the documentation tab in the Solution Directory. The objects in the table 10 are forms.



Table 10 – Developments for BPS Communication

Type Logical Component Object Name

PROG SAP ECC YUSM_FORM_PO Purchase Order US

PROG SAP ECC YUSM_FORM_CONT Contract US

PROG SAP ECC YCAM_FORM_PO Purchase Order Canada

PROG SAP ECC YZZM_SRV_ENTRY Service Entry

PROG SAP ECC YZZM_SRV_ENTRY_A4 Service Entry A4

PROG SAP ECC YATM_FORM_PO Purchase Form AT

PROG SAP ECC YBEM_FORM_PO Purchase Form BE

PROG SAP ECC YCHM_FORM_PO Purchase Form CH

PROG SAP ECC YDEM_FORM_PO Purchase Form DE

PROG SAP ECC YESM_FORM_PO Purchase Form ES

PROG SAP ECC YFRM_FORM_PO Purchase Form FR

PROG SAP ECC YIEM_FORM_PO Purchase Form IE

PROG SAP ECC YITM_FORM_PO Purchase Form IT

PROG SAP ECC YNLM_FORM_PO Purchase Form NL

PROG SAP ECC YPTM_FORM_PO Purchase Form PT

PROG SAP ECC YGBM_FORM_PO Purchase Form GB

.


SAPHEGA System BPS: SM020MM10 CommunicationDesign Requirements/Specifications Attachment A – Functional Risk Assessment

Attachment A – Functional Risk Assessment Worksheet

Failure DRSID Consequence Failure Cause Means of Detection P S D C Preventive Actions P’ S’ D’ C’

The Master Data cannot support the Business Process

SM020MM10_ALL

The Business process cannot be executed efficiently.

Wrong System set up

Visual Check 1 1 3 3 n/a

P = Probability of Occurrence; S = Severity of Occurrence; D = Probability of Detection; C = P*S*D (Risk Criticality) [Range 1-100]


SAPHEGA System BPS: SM020MM10 CommunicationDesign Requirements/Specifications Attachment B – 21 CFR Part 11 Assessment Worksheet

Attachment B – 21 CFR Part 11 Assessment Worksheet

Records GXP Risk ER ES Probability GAP Remarks and Notes

See Table 2 – Inputs/Outputs Yes/No Yes/No Yes/No High/Low Yes/No Add comments below.

N/A No N/A N/A


DRS Communication

Documents

Transcript of DRS Communication