ECR Overview Training - v2

Welcome
Manage Master Data
Engineering Change Request Process

3 Hours
Course Description
Overview:
ÊThis course covers the transactions to be performed in CLARA P96 in order to
create and change master data to support Clinical Packaging as part of the
Engineering Change Request (ECR) process.
Audience:
ÊPTDS Production Services
ÊClinical Packaging Operations
ÊBPM Data Operations
ÊQA Master Data Management
ÊClinical Packaging Quality Lot Disposition
ÊSSF IMP Change Control
Duration:
Ê This course will take approximately 3 hours to complete.
Abbreviation – PTD:CLARA002
For Training Purposes Only Title - PTD CLARA ALL:ECR Overview *
v1 -
Learning Objectives
After completing this course, you will be able

to:
1 Explain the change control process for Clinical Packaging recipe
and material master data changes in CLARA (P96)
2 Perform your function in one of the following roles in the ECR

process in the CLARA (P96) system:
1. Change Requester
2. Change Assessor
3. Change Approver
4. Change Deployer
5. Change Verifier
v1 -
Agenda
We will cover the following

topics:
• Process Overview
• Demo and user practice in test system (C96 110) for the following
transaction:
• ECM Monitor- ZM96_ECM
v1 -
Process Overview
v1 -
HORACE Project 10 Overview
HORACE Project 10 is focused on harmonizing

“produce quality product” processes for clinical
finished goods supply by:
•Implementing the best practices from Kaiseraugst and
SSF
•Adapting the organization and roles/responsibilities in
SSF/Kaiseraugst in order to support the new
processes
•Moving to a single IT platform (SAP CLARA) to
support the new processes
v1 -
Engineering Change Request (ECR) Overview
What is an ECR?
•An Engineering Change Request workflow in the CLARA
P96 system that enables change control of GMP master
data creation and changes.
Why the new ECR Tool?
•Enable the Master Data change control and deployment
in one system
✓ Simplified, and standardized workflow
✓ Reduces the data entry for Requestor
✓ Reduces the change control and data deployment
lead times
What’s Changing?
Current Process New Process
• Change control for Clinical • Change control for Clinical

Packaging master data in Packaging master data in CLARA
Trackwise P96
• Change Control steps • Change Control steps including

including assessments and assessments and deployment
deployment documented as documented as workflow steps*
action items in Trackwise in CLARA P96
• Clinical Packaging uses post- • No post-execution change control

execution change control. required due to simplified
workflow steps
• Change Control approves to
execute change record in • Change Control approves to
Trackwise execute data change in CLARA
P96
* LIMS build will continue to be an action item in a L1 CR in Trackwise
Engineering Change Request Process - SSF
v1 -
Engineering Change Request Workflows - SSF
Change Type 101 SSF-Execution PDM with QAMDM Assessment
ECR Status Check ECR ECR Approve ECR Convert ECR Close ECO Release ECO
Checked
Business Function ECR Sent for Assessment ECR Assmt & Deployment Verification Close ECR
Approval
E-signature SSF_OWNER- <Skip> MFG_OPS -Assessor, DATA_OPS- DATA_OPS- SSF_OWNER-
Requestor DATA_OPS-Assessor Deployer Deployer Requestor
QAMDM-Assessor , QAMDM- QAMDM-
PTD_QALD-Assessor Deployer Deployer
SSF_QLTY-Approver
Use the Change Type 101 workflow when you have a GMP data change for an
SSF Clinical Packaging material.
v1 -
Engineering Change Request Workflows - SSF
Change Type 102 SSF-Execution PDM w/o QAMDM Assessment
Checked
Business Function ECR Sent for Assessment ECR Assmt & Deployment Verification Close ECR
Approval
E-signature SSF_OWNER- <Skip> MFG_OPS -Assessor, DATA_OPS- DATA_OPS- SSF_OWNER-
Requestor PTD_QALD-Assessor Deployer Deployer Requestor
DATA_OPS-Assessor, QAMDM- QAMDM-
SSF_QLTY-Approver Deployer Deployer
Use the Change Type 102 workflow when you require a new material for SSF
Clinical Packaging.
v1 -
Engineering Change Request Process - CMO
v1 -
Engineering Change Request Workflows- CMO
Change Type CMO-Execution PDM with QAMDM Assessment
104
Checked
Business ECR Sent for Assessment ECR Assmt & Deployment Verification Close ECR
Function Approval
E-signature CMO_OWNER- <Skip> DATA_OPS-Assessor, DATA_OPS- DATA_OPS- CMO_OWNER-
Requestor QAMDM-Assessor Deployer Deployer Requestor
CMO_QLTY-Approver QAMDM- QAMDM-
Deployer Deployer
Use the Change Type 104 workflow when you have a GMP data change for a
CMO Clinical Packaging material.
v1 -
Engineering Change Request Workflows- CMO
Change Type CMO-Execution PDM w/o QAMDM Assessment
105
Checked
Business ECR Sent for Assessment ECR Assmt & Deployment Verification Close ECR
Function Approval
E-signature CMO_OWNER- <Skip> DATA_OPS-Assessor, DATA_OPS- DATA_OPS- CMO_OWNER-
Requestor CMO_QLTY-Approver Deployer Deployer Requestor
QAMDM- QAMDM-
Deployer Deployer
Use the Change Type 105 workflow when you require a new material for Clinical
Packaging at a CMO.
v1 -
Business Roles in ECR Workflow
• Requester
• Assessor
• Approver
• Deployer
• Verifier Abbreviation – PTD:CLARA002

v1 -
Business Roles Defined
Requester (Change Owner)

The person initiating the ECR to create/change Clinical Packaging master data. This person is
called the Change Owner in Trackwise.
Assessor
The various groups in the ECR workflow who assess and approve the master data in the ECR
before it is approved by the Change Approver (QA Change Control).
Approver
The group which approves the ECR after the Change Assessors have completed their
assessments. Their approval is the last step before data deployment. QA Change Control
acts as Approver.
Deployer & Verifier
Group(s) who deploy and verify the data in CLARA P96 and then record the Engineering
Change Number.
v1 -
Scenario for Instructor Demo and Practice
Material 3906722 produced in CMO Fisher Horsham requires a new artwork

code in the Material Class-Characteristics.
Sub Title: CMO Master Data Change Type 104
➲Input:
➲ Completed PDM form
➲Output:
➲ Closed ECR
v1 -
Create ECR
System: CLARA
T-Code : ZM96_ECM
Input :
• Completed PDM
Output :
• Created ECR
Business Role:
•PTDS Production
Services – Requester
v1 -
Engineering Change Record (ECR) Process
Create ECR - Requester
1. Select
transaction
code
ZM96_ECM
2. Click .
v1 -
1. Select radio
button next to
ECR creation
2. Click .
v1 -
1. Select value
for Change
Type based
on the data
change
scenario.
2. Click .
v1 -
1. Fill out the following fields:
• Change Description
• Change Summary
• Change Justification
• Change Driver
• Target Date
2. Click to upload the PDM
and DPI, as necessary, as an
attachment.
3. Click to save the ECR.
Note: Once the ECR has been
saved, the Requester cannot
delete attachments and the
S&Js. If the S&Js need to be
revised include the original
language.
v1 -
Send for Assessment - Requester
1. Select radio
button next to
ECR creation
2. Click .
3. In the next screen,
select the ECR
number that you
want to send for
assessment.
v1 -
1. Click next to
System Status
field.
2. The status
window will
appear. In this
window, click .
3. You will receive a
prompt asking if
you want to
proceed with
initiating the
workflow. Select
Yes.
v1 -
1. Type in your
password.
2. Click .
Note: Your role

appears in the
signature to be
Executed box as
initiating the
workflow is the
role of the
Requester.
v1 -
1. Click to change
the status of the
ECR to Approve
ECR
2. Click .
3. Click to save
changes to the
ECR.
v1 -
Assess ECR
System: CLARA
T-Code :
ZM96_ECM
Input :
• Notification of
created ECR
Output :
• Assessed ECR
Business Role:
•Data Operations
•QAMDM
v1 -
Perform Assessment - Assessor
1. Upon receipt
of email
notification,
begin the
assessment
process
2. Select
transaction
code
ZM96_ECM
3. Click .
v1 -
1. Select radio
button next to
ECR creation
2. Click .
select the ECR
number that you
want to assess.
v1 -
1. Check the PDM

and other
attachments by
clicking on .
2. To approve the
ECR, click next
to system status .
3. In the Status pop-
up window, Click
next to Approve
ECR
v1 -
1. Select the signature

that you are authorized
to execute.
2. Type in your password.
3. Click .
4. The Status pop-up will
appear. Click
5. Click to save
changes to the ECR.
Note: The assessment
process is the same for
each assessor. The ECR
needs to be approved by
all assessors required for
that data change scenario
before the data is
Abbreviation – PTD:CLARA002 approved by Change
For Training Purposes Only Title - PTD CLARA ALL:ECR Overview Control and deployed *
v1 -
Approve ECR
System: CLARA
T-Code :
ZM96_ECM
Input :
• Notification of
assessed ECR
Output :
• Approved ECR
Business Role:
•Small Molecule
Change Control
v1 -
Perform Approval – Change Control Approver
1. Upon receipt
of email
notification,
begin the
approval
process
2. Select
transaction
code
ZM96_ECM
3. Click .
v1 -
1. Select radio
button next to
ECR creation
2. Click .
select the ECR
number that you
want to approve.
v1 -
1. Check the PDM and other

attachments by clicking on
2. Enter the following data as
appropriate:
• Batch Rel Restriction
• Restricted Batch #s
• Associated Records.
3. Click next to System
Status field.
4. In the status window pop-
up, click next to Approve
CR.
v1 -

to execute.
3. Click .
appear. Click .
5. Click to save
changes to the ECR.
v1 -
Deploy ECR
System: CLARA
T-Code :
ZM96_ECM
Input :
• Notification of
approved ECR
Output :
• Deployed data per
ECR
•Converted ECO
Business Role:
•Data Operations
•QAMDM
v1 -
Deploy Data – Data Operations and QAMDM
1. Upon receipt
of email
notification,
begin the
deployment
process
2. Select
transaction
code
ZM96_ECM
3. Click .
v1 -
1. Select radio
button next to
ECR creation
2. Click .
select the ECR
number that you
want to assess.
v1 -
1.Click to open
attachment to view PDM.
2.Enter master data in
CLARA P96 system.
3.Enter ECN data.
4.Click next to System
Status field.
5.In the status window
pop-up, click next to
Convert ECR.
v1 -

to execute.
3. Click .
appear. Click .
5. Click to save
changes to the ECR.
Verify Data
System: CLARA
T-Code :
ZM96_ECM
Input :
• Deployed Data
•Converted ECO
Output :
• Verified data per
ECO
Business Role:
•Data Operations
•QAMDM
v1 -
Verify Data – Data Operations and QAMDM
1. Upon receipt
of email
notification,
begin the
deployment
process
2. Select
transaction
code
ZM96_ECM
3. Click .
v1 -
1. Select radio
button next to
ECR creation
2. Click .
select the ECR
number that you
want to assess.
v1 -
1.Verify the data in

CLARA P96 per standard
process.
Status field.
Close ECO.
v1 -

to execute.
3. Click .
appear. Click .
5. Click to save
changes to the ECR.
v1 -
Release ECR
System: CLARA
T-Code :
ZM96_ECM
Input :
• Deployed and
verified data
•Converted ECO
Output :
• Closed ECO
Business Role:
•PTDS Production
v1 -
Release ECR – Requester
1. Upon receipt
of email
notification,
begin the
deployment
process
2. Select
transaction
code
ZM96_ECM
3. Click .
v1 -
1. Select radio
button next to
ECR creation
2. Click .
select the ECR
number that you
want to assess.
v1 -
1.Verify that data has

been properly deployed.
Status field.
Release ECO.
v1 -

to execute.
3. Click .
4. A pop-up will appear to
verify that you want to
release the ECR, select
yes.
appear. Click .
6. Click to save
changes to the ECR.
v1 -
Lock ECR
System: CLARA
T-Code :
ZM96_ECM
Input :
• Created ECR with
an error caught in
the first
assessment
Output :
• Revised ECR
Business Role:
•PTDS Production
•Data Operations
v1 -
Lock ECR – First Assessor
1. To send the ECR

back to the
Requester for
corrections, click
next to System
Status field.
2. In the status window
pop-up, click next
to Lock.
v1 -
Lock ECR – First Assessor

to execute.
3. Click .
appear. Click
5. Click to save
changes to the ECR.
The ECR will now be
locked and sent
notification to the
Requester.
v1 -
Unlock ECR - Requester
1. Upon receipt of
the email
notification that
the ECR has been
locked, select
radio button next
to ECR creation
2. Click .
select the ECR
number that you
want to send for
assessment.
1. Correct the ECR per

the assessor’s
request.
2. To unlock the ECR,
click next to the
System Status.
3. Click next to
Unlock.
4. Upon receipt of the
warning message
that the ECR will be
unlocked, click .
v1 -
1. Type in your
password.
2. Click to move the
ECR into unlocked
status.
3. Once the ECR is
locked, the Requester
can make the
appropriate changes
and resend for
assessment.
Note: Do not delete prior
attachments
v1 -
Cancel Signatory Process and Lock ECR
System: CLARA
T-Code :
ZM96_ECM
Input :
• Created ECR with an
error caught in an
assessment or
approval following the
first assessment
Output :
• Revised ECR
Business Role:
•PTDS Production
•QAMDM
v1 -
Cancel Signatory Process and Lock ECR –
Assessor/Approver/Deployer
1. If the ECR has been

approved by the first
Assessor, the following
Assessor or Approver
needs to cancel the
signatory process to
lock the ECR
2. To cancel the
signatory process,
click next
to System Status field.
Approve ECR.

to execute.
3. Click .
appear. Click
5. Click to save
changes to the ECR.
1. Now that the

Cancel signatory
process has been
completed, you
can lock the ECR.
To lock the ECR,
select radio button
next to ECR
Change
2. Click .
select the ECR
number that you
want to lock.
v1 -
1. Click next to
System Status field.
pop-up, click next
to Lock.
v1 -

to execute.
3. Click .
appear. Click
5. Click to save
changes to the ECR.
The ECR will now be
locked and sent back to
the Requester.
v1 -
ECR/ECO Reports
SAP Standard Report: Transaction - CC07
1. Enter the Created by

UNIX Id.
2. Select the appropriate
ECR status check
Boxes and execute.
v1 -
ECR/ECO Reports
1. ECRs List will

be displayed
2. Double Clink on
ECR Number to
display ECR
workflow status
v1 -
ECR/ECO Reports
1. Clink on
Change
Documents Tab
to view the
change
documents
v1 -
Knowledge Check #1
Q. What transaction is run to create an ECR?
a COR6
)
b) ZC96_AUTOPACK
c) ZM96_ECM
v1 -
ECR/ECO Reports
• SAP Custom Query: Transaction – SQ01
Add MASTERDATA user group to user
profile
User Profile maintenance: System-> User Profile-> Own Data

> Parameters tab
Add following to Parameter

ID
v1 -
ECR/ECO Reports
• SAP Custom Query: Transaction – SQ01
Step 1: Execute the transaction
SQ01
Step 2: Select the Query “ECM_SIGNATURES” and click

execute
v1 -
ECR/ECO Reports
• SAP Custom Query: Transaction – SQ01 continue……
Step 3: Select the variant “US_ECR_2ASSESS ” and
click o.k
Step 4: Selection variables (ECRs ready to assess/Approve past 30 days) loaded and click execute
v1 -
ECR/ECO Reports
Step 5: Analyze the report and complete
assessment/approval
Note: we can see the approval status, approved by, date and time, and also know the pending
approval
based on the required Signatures for ECR Approval in Table A (see slide 72).
v1 -
ECR/ECO Reports
Step 6: Double Click on the ECR Number to complete Assessment/Approval →Take to ECR Change
screen
Step 7: Complete Assessment/Approval and Save →Take to ECR Query

Report
v1 -
ECR/ECO Reports
Required Signatures for ECR Approval
Table A.
v1 -
ECR/ECO Reports
Continue all the above step1 to step 7 for the following reports:
1.US_ECR_2DEPLOY- US ECRs Ready for Deployment
➢ To find out the ECRs pending for deployment by Data ops and/or
QAMDM
2.US_ECR_2VERIFY- US ECRs Ready for Verification

➢ To find out the ECRs pending for verification by Data ops and/or
QAMDM
3.US_ECR_2CLOSE- US ECRs Ready for Closure by

➢ To find out the ECRs pending for closure by ECR Requestors
For Training Purposes Only Abbreviation – PTD:CLARA002

Title - PTD CLARA ALL:ECR Overview *
v1 -
Knowledge Check #1
Q. What transaction is run to create an ECR?
a COR6
)
b) ZC96_AUTOPACK
c) ZM96_ECM
Knowledge Check #1
Q. As the first assessor, what do you do to reject an ECR?
a Cancel the signatory process

)
b) Lock the ECR
c) Reject the ECR

Knowledge Check #1
Q. What does ECR stand for?
a Electronic Change Request

)
b) Engineering Change Request
c) Engineering Change Record

Summary
You should now be able

to:
➲ Explain the change control process for Clinical Packaging recipe and material
master data changes in CLARA P96
➲ Perform your function in one of the following roles in the ECR process in the CLARA
P96 system
➲ Change Requester
➲ Change Assessor
➲ Change Approver
➲ Change Deployer
➲ Change Verifier
v1 -
Next Steps
What to do next:
➲Access to CLARA will be granted upon the following:

➲ Completion of this course
➲Subsequent access privileges will require an ENROLL request submission.
v1 -
Login
• The portal is https://oneportal.roche.com/irj/portal

• After login:
1. Choose your work area "Forward" in right-upper corner of the
screen.
2. Set this area as default. This only needs to be done on the first
login.
2. In the left-upper corner activate SSO:
v1 -
Questions
Contacts
Ê Process: PTD Quality Systems – Colette Jue

Ê System: SSF IMP change Control – Simon Chan
Ê HORCE P10 Project: Prasad Bav
v1 -
Approval Matrix
Area of Responsibility Approved by Date
ECR Process Colette Jue 18April 2013
ECR Configuration & Design Prasad Bav and Julien Thumm 18April 2013
ECR SMEs Prasad Bav, Julien Thumm 18April 2013

Jenny Kempenich & Anke Schwerdt
Vishal Shah 22April 2013

PTD Training Manager
v1 -
Appendices
Appendix A - Engineering Change Request Process – Global
Appendix B - Engineering Change Request Process – QM Data
Appendix C - QM Data Change Request Workflows
Appendix D - Engineering Change Request Process – Materials

Shared with R3P
Appendix E - Materials Shared with R3P Engineering Change

Request Workflows
Appendix A - Engineering Change Request Process - Global
Appendix B - Engineering Change Request Process – QM Data
Appendix C - QM Data Change Request Workflows
Change Type 103 Global QM Data Without Assessment
Checked
Business Function ECR Sent for Assessment ECR Assmt & Approval Deployment Verification Close ECR
E-signature QMD_OWNER- <Skip> SSF_PTQS-Approver QAMDM- QAMDM- QMD_OWNER-
Requestor Deployer Deployer Requestor
Change Type 108 Global QM Data with SSF QALD Assessment
Checked
Business Function ECR Sent for ECR Assmt & Approval Deployment Verification Close ECR
Assessment
E-signature QMD_OWNER- <Skip> SSF_QALD-Assessor, QAMDM- QAMDM- QMD_OWNER-
Requestor SSF_PTQS -Approver Deployer Deployer Requestor
Change Type 109 Global QM Data with CMO QALD Assessment
Checked
E-signature QMD_OWNER- <Skip> CMO_QLTY-Assessor, QAMDM- QAMDM- QMD_OWNER-
Requestor SSF_PTQS -Approver Deployer Deployer Requestor
Appendix D - Engineering Change Request Process – Materials Shared with
R3P
Appendix E - Materials Shared with R3P Engineering Change Request Workflows
Change Type 106 Materials Shared with R3P - SSF
Checked
E-signature DATA_OPS- Requestor <Skip> QAMDM-Assessor DATA_OPS- DATA_OPS- DATA_OPS-
SSF_QLTY-Approver Deployer Deployer Requestor
QAMDM- QAMDM-
Deployer Deployer
Change Type 107 Materials Shared with R3P - CMO
Checked
E-signature DATA_OPS- Requestor <Skip> QAMDM-Assessor, DATA_OPS- DATA_OPS- DATA_OPS-
CMO_QLTY-Approver Deployer Deployer Requestor
QAMDM- QAMDM-
Deployer Deployer
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Welcome

Manage Master Data

Engineering Change Request Process

After completing this course, you will be able

2 Perform your function in one of the following roles in the ECR

We will cover the following

HORACE Project 10 is focused on harmonizing

• Change control for Clinical • Change control for Clinical

• Change Control steps • Change Control steps including

• Clinical Packaging uses post- • No post-execution change control

• Verifier Abbreviation – PTD:CLARA002

Requester (Change Owner)

Material 3906722 produced in CMO Fisher Horsham requires a new artwork

Sub Title: CMO Master Data Change Type 104

Note: Your role

1. Check the PDM

1. Select the signature

1. Check the PDM and other

1. Select the signature

1. Select the signature

1.Verify the data in

1. Select the signature

1.Verify that data has

1. Select the signature

1. To send the ECR

1. Select the signature

1. Correct the ECR per

1. If the ECR has been

1. Select the signature

1. Now that the

1. Select the signature

1. Enter the Created by

1. ECRs List will

Q. What transaction is run to create an ECR?

User Profile maintenance: System-> User Profile-> Own Data

Add following to Parameter

Step 2: Select the Query “ECM_SIGNATURES” and click

Step 7: Complete Assessment/Approval and Save →Take to ECR Query

2.US_ECR_2VERIFY- US ECRs Ready for Verification

3.US_ECR_2CLOSE- US ECRs Ready for Closure by

For Training Purposes Only Abbreviation – PTD:CLARA002

Q. What transaction is run to create an ECR?

Q. As the first assessor, what do you do to reject an ECR?

a Cancel the signatory process

b) Lock the ECR

c) Reject the ECR

Q. What does ECR stand for?

a Electronic Change Request

b) Engineering Change Request

c) Engineering Change Record

You should now be able

➲Access to CLARA will be granted upon the following:

➲Subsequent access privileges will require an ENROLL request submission.

• The portal is https://oneportal.roche.com/irj/portal

2. In the left-upper corner activate SSO:

Ê Process: PTD Quality Systems – Colette Jue

Area of Responsibility Approved by Date

ECR Process Colette Jue 18April 2013

ECR SMEs Prasad Bav, Julien Thumm 18April 2013

Vishal Shah 22April 2013

Appendix A - Engineering Change Request Process – Global

Appendix B - Engineering Change Request Process – QM Data

Appendix C - QM Data Change Request Workflows