F2C (O2C,ILOL,ILXOLX) CR Template Quick Guide Change Control in Solution Manager

Quick Guide – F2C (O2C,IL/OL, ILX/OLX) CR template

Version Date Comment

1 17-Nov-2020
2 18-Aug-2021
3 25-Nov-2021
Initial creation
Minor corrections: HPQC changed to HP ALM, OQ/PQ changed to
FT/RT, update of referenced change cycles
GxP Impact Analysis tab maintained:
Is the new Transaction /ABAP program to be developed
relevant for Segregation of Duties or Critical Access?
Yes / No:
If Yes, are operational measures in place or is GRC Ruleset
maintained accordingly?
Yes / No (provide justification and measures)

4 07.03.2023 Including details on Testing and its Impact Assessment

5 28.09.2023
Removal of misc GHQ evidences
Removal of “N/A” in Technical Impact Assessment and GxP
Impact Assessment
Description of Change: Inclusion of SOP Impact assessment under
section “Training Impact”
Reason for Change: included comment under “Demand ID”

Change Request - „How to fill out“

All fields highlighted with * are mandatory and have to be filled before approving the CR.
Do not use the other (non-mandatory) fields!

Section “Details”
Change Cycle/Phase:
Version of the Change Request. Setting an Former “Project” field, maintain with cycle for
approved CR into status “rework” creates a Deployment or Maintenance
new version that needs to be approved Approval Procedure:
again! Attention! Some activities are Normal Approval Procedure
performed by Solman only for Risk
Description / version 1, e.g. the creation of GxP-High, GxP Low or non-GxP change based on
title of the document placeholders in ITEMS! affect processes
Change Request
– only 40
characters
possible!

Enter users according

Role Assignment Log! IS
System Lead = IT SME
SO/PO = GPO

1 Fill out CR no 8xxxxxxxxx if it

relates to a previous change
F2C (O2C,ILOL,ILXOLX) CR Template Quick Guide Change Control in Solution Manager

INFO:
Change Cycle/Phase: Choose 1 below-
8000001258 GBS S4HANA Maintenance
8000001147 GBS S4HANA Monthly Release
GxP Risk: ☐GxP-low ☐GxP-high ☐ non-GxP
Routine Change: ☐Yes ☐ No
Target System ID: 7100001669
BI-Config Item: BI-AS-SAP-GBS-ERP
External Reference: CRxxxxxxxxxx

Section “Text”

Description of Change
• NECESSARY: Process/system change description.
• NECESSARY: BPML, AAPs, SLC documentation (URS, FS, RA), the GBS role mapping table, GBS rule book of critical
authorizations, Enterprise Data Catalogue and/or training materials.
• TESTING: Either HP ALM Testing or no Testing with clear justification incl. impact assessment.
• IF: For mass data changes: refer chapter 6.3 in training BI_GBS_004.
• IF: Second version of CR: include a Document History and describe the changes compared to the previous version

Change Version History:

Version 1: Initial Version
Version 2: XXXXX

Description of Change:
What will be changed?! Provide heads-up of the CR. Description from business perspective
– do not be too technical!

Changes to intended use of a process:

What will be changed on the process L4 & what’s the resulting impact? I.e. new Interface,
instead of process step a you are using not alternative option b. etc. Does this change
overall change the intended use the process?

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F2C (O2C,ILOL,ILXOLX) CR Template Quick Guide Change Control in Solution Manager

Changes to Roles & Authorizations:

New Roles needed for ....
or: no impact

SLC Documentation:

L4 based URS, FS, RA, FT, RT, SDS, DTP (eDTP), DTR (eDTR), SDS
(Deployment or Master BPML) / SAP Note

Testing

FTP/FTR/Regression Test

Provide detailed impact analysis to define need and intensity of formal Testing within HP
ALM, based on risk to the business (patient, product, process, Data Integrity), criticality
and complexity of the change. If formal testing is required, a HP ALM Test must be
conducted – hence it might be that Testplans must be updated or newly created. If no
formal Test within HP ALM will be done, an impact analysis/ justification must be given in
the Change Request

L4 Process/es:
Fill out (Ex: OL_030_010_LOC_BR)

Training and/or SOP Impact:

Training needed or new training material and why?

Any impact (minor or major) on (local) SOPs?

Or: no impact on Training Material or SOPs

Comment: If impact on local SOPs cannot me foreseen at the time of CR creation, please
provide a comment that this information will be provided before PtP of the change. Please
align with local Key Users if local SOPs are impacted by your change.

Reason for Change

• NECESSARY: Incident # or DEMAND#
• IF Applicable: Deviation/CAPA no., Defect ID, Scope Change Request, myservice ticket number

Choose one of the options (options (e.g. if Service Now Ticket is the trigger, remove all
other options)

Why is it necessary to implement this change:

Please explain why

Incident Ticket no:

SPF Work Item:

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F2C (O2C,ILOL,ILXOLX) CR Template Quick Guide Change Control in Solution Manager

Scope Change Request:

Demand ID:
next to the Demand ID, the content (summary) should be provided as Demands do not
follow GxP records retention (if not already included under the first section of this tab
“Why is it necessary to implement this change”)

Deviation/Defect ID:

Technical Change Description (To be filled-out by IT)

• NECESSARY: describe change on technical level & list affected system components, developments & configuration (SAP add-on,
OSS note).
• IF: new peripherals/system components (e.g. mobile device) necessary.
• IF: bug-fix, provide impacted FS ID.

You do not need to include all options, just the one that is applicable for this CR
Related FS-IDs: (for bugfixes)
Add related FS ID’s for functional related issues

Customizing:
Customizing path and what will be customized.

Development:
What will be developed? RICEF Name and what will be done. If new RICEF to be created
please explain here.

Configuration:

What will be configured?

Peripherals and new system components:

e.g. mobile devices, new printer etc. needed?

Implementation Prerequisites
Based on the request and required changes, describe if there are any prerequisites or activities that need to be fulfilled before the
change can be implemented in the production environment. Required activities could be e. g Supplier Qualification, local change
requests, technical installation plan / report, SOP´s etc. Also describe dependencies to other Change Requests, referring to the Change
Request ID and Documenting system (also from other / interfacing systems).
Prerequisites:
Supplier Qualification,
local change requests,
technical installation plan / report (required in case of manual import), SOP´s etc

If no prerequisites, please write: no prerequisites for the implementation of this change

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F2C (O2C,ILOL,ILXOLX) CR Template Quick Guide Change Control in Solution Manager

GxP Impact Analysis

• Impact on processes & roles:
o NECESSARY: Ex: OL_030_010_LOC_BR
• Impact on sites:
o NECESSARY: 1. Which site affected? Exp:BR3317. If all sites affected, write Exp: 'all sites in China according to
Master BPML' 2. What must be done at LOC? Exp: LOC change, LOC SLC, LOC test.
• Rationale for the risk classification of the change:
o NECESSARY: Criteria: Complexity & possible impact of the change. Exp: Low complexity with low impact to
product quality or safety (LOW RISK). This change is very complex or/and has high possible impact. (HIGH RISK)
For Impact Assessments do not only write “N/A” if no impact is foreseen. Instead, clearly
state e.g. “No impact on XXX”
Impact on Process/es & Roles:
Fill out or ‘Refer to Description of Change’

Impacted Live-Sites:
All live Sites according to current master BPML are impacted.
All required activities will be done from template team. <-
- If not, then write which live site is impacted and need special communication and informa
tion.

Rationale for the risk classification of the change:

Based on the impact assessment make an overall assessment of the risk of the proposed
changes with regards to GxP criticality and identified impact.
Criteria to decide if a change is of high or low risk are: complexity (of the process or
change) and the possible impact of the change. A change that is very complex or / and has
much impact has to be considered as high risk change. If in doubt, choose the higher value.

Data Assessment (Automatically generated in Solman- no need to copy-paste):

Does the change include direct changes to data or records?
☐ Yes ☐ No
If Yes: Changes on non
GxP data of a non
Are changes recorded in the Audit Trail of the record?
GxP process in the
☐ Yes ☐ No (provide justification and measures): database or data
repository:
Is the new Transaction /ABAP program to be developed relevant for Segregation of Duties or
As justification for
Critical Access?
choosing “no”, the
Yes / No: following
If Yes, are operational measures in place or is GRC Ruleset maintained accordingly? statement can be
Yes / No (provide justification and measures) included.

No Audit trail
required as
changed data is
non GxP

Technical Impact Analysis (To be filled-out by IT)

Identify potential side effects of the change from the technical perspective on a high level, e.g. on interfaces or other modules of the
application system. If these side effects lead to pre-requisites for the implementation in the production environment those have to be
considered for the field 'Prerequisites for Implementation‘. Impact in technical documentation like Organizational Structure, Site
Enablement or Soft. Config needs to be assessed. If the planned change happens to affect additional systems and leads to a change in
that system (e. g. interfaces / Business role updates in SAM) the Validation Manager should link to the respective change as
“Prerequisite for Implementation”.
e.g. EWM: storage and shipping temperature conditions must be identically customized within BI-AS-SAP-GBS-ERP and BI-AS-
SAPEWM. All effected sites and / or systems should be listed and the impact should be explained, e. g. on local systems. All affected
developments and / or configuration and their potential impact should be explained.

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 F2C (O2C,ILOL,ILXOLX) CR Template Quick Guide Change Control in Solution Manager

For Technical Impact Assessments do not only write “N/A” if no impact is foreseen.
Instead, clearly state e.g. “No impact on e.g. other systems or interfaces is foreseen. No
side effects are expected”

Side effects (Interfaces/Modules):

Identify potential side effects of the Change from technical perspective on high level, e.g. in
terfaces or modules.

Impact on other Systems:

All effected systems should be listed with explained impact.

Developments, Customizing and/or configuration:

Identify potential side effects or impact on (other) developments, customizing or
configuration

Section “Scope”

Insert a change:

• Normal change & Deployments to assign transports

• Change without transports for documentation changes or Fields are normally filled-out automatically. For
systems not connected to the transport mechanism, doesn’t
Routine changes, input Incident no.
require a Change Document, Scope will be empty.

When Scope is empty, “No result found” is displayed in the Scope section, and Solution Manager displays
a warning near the top of the window every time the CR is opened. The details of the warning indicate
the warning can be ignored when the Scope should be blank. When the Ready-for-closeout is initiated,
Solution Manager displays a pop-up window reminding that Scope is empty and gives opportunity to
confirm that is acceptable. Once confirmed, the warning message about Scope no longer appears.

If a documentation-only CR includes testing (such as regression test when an interface partner is

upgraded), the information, such as HPALM IDs, that would normally be entered in the “Test Comments”
of a change (not available because there is no technical change) should be entered in the “Summary of
Change” of the CR when preparing for close-out.

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F2C (O2C,ILOL,ILXOLX) CR Template Quick Guide Change Control in Solution Manager

Section “Approval”
If additional approvers are required,
they can be entered here. This is only
authorized for VM/SME roles.
Approval roles and users don’t need to
be filled, the regular workflow is
created automatically.

Attention!
When entering additional approvers make sure to keep the correct sequence
(i.e. “Review” before “Approval”!
Don’t insert new signatures at the end of the list, but at the correct point:
select the row under which the new entry shall be created (e.g. select “Review
(VM)” to insert an additional VM signature.

Section “Planned Documents”

Click on “create” to plan a document (ITEMS, HPALM,
I4C). For ITEMS, only placeholders will be created. If
no ITEMS document is planned – no ITEMS folder will
be created!
Within this section plan ALL SLC deliverables
that are needed due to the CR. This includes
also FT / RT test plans and reports that will not
Not to be filled
be stored in ITEMS but in HPQC.
out

Select the document type and add a description (free

text). The description text does not have to match the
You can personalize the view and switch from
exact naming convention of the actual document.
“paging” to “scrolling”; this makes it easier have
an overview on all planned documents (esp. if
there are many!)
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F2C (O2C,ILOL,ILXOLX) CR Template Quick Guide Change Control in Solution Manager

Attention:
Search for the ITEMS folder that was created with the Solman CR ID. It should contain the
placeholder created in the Solman planning. Please drag & drop the templates or
documents you need to work with ON the corresponding placeholder so it will be replaced
by the actual document:

When a CR includes test documents (plan and/or report) in HPALM in the Planned Documents section,
then upon completion in HPALM, update the entries in the Planned Documents section. Select the row of
the document in Planned Documents, click the Doc. Ref. button, and change the Document Status value
to Effective. Supporting identification information may optionally be entered in the Reason field.

In case of multiple documents to plan within the CR, an upload template is also available for you to use
and maintain via xlsx format. Important to take note is to input the correct system & document type.
Incorrect spelling & other shortcuts on names will result to error on upload. Fill-out the form which can be
found under the link below and upload via the ‘UPLOAD’ button on Planned document section.

https://boehringer.sharepoint.com/:f:/r/sites/z365sapsolutionmanagercommunity/Shared%20Document
s/General/Planned%20Document%20Upload%20Feature?csf=1&web=1&e=5cE7Dv

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F2C (O2C,ILOL,ILXOLX) CR Template Quick Guide Change Control in Solution Manager

Section “Solution Documentation”

To add the GBS Maintenance Project (carrier for the Business Blueprint)
select the Maintenance branch from the BI_Solution and press Search to
find all the available elements. You can select from Single elements or
Multiple elements.

Type of element will be available (Folder/Scenario), all the elements

needed to construct the blueprint related with the CR must be added.

Other sections:

NOT TO BE FILLED