ATTP – Overview

ECC

Melanie Frank 30.10.2017

Agenda

• ATTP (Advanced Track and Trace Pharma) Introduction

• Data Migration from ECC; Aii/OER to ATTP
• ECC/ATTP Warehouse integration
• ECC/ATTP Warehouse integration enhancements
• Project Plan / Milestones

2
ATTP Introduction
Bricks in a coherent serialisation
solution

4
Bricks in a coherent serialisation solution
- and how to connect them

5
SAP Advanced Track & Trace for Pharmaceuticals
Functionality

ECC Integration Toolkit for WMS Object Event

Regulatory
• Master Data Integration Repository
functionality:
• Process Order • Real-time • Capture and store
• Argentina
• Batch verification with objects, events
• China
• Delivery data in and transactions
• EU
Repository • Optimized for
• Turkey
• Integration with HANA
• South Korea
Serial Number WMS processes: • Deployable on
• US
management receiving, classical DB
• Define and assign warehouse
serial number movements and Rules Framework
format & ranges goods issue • Predefined rules, possibility to customize
to production additional rules
lines/CMO
• Randomization Packaging Line Application Interface Framework (AIF)
• Import product Integration • Integration to ERP, WMS, Production Lines
master & Serial • Serial number systems, Business partners, Regulatory
Number files from request/response parties
external sources, • Production • Monitoring of messages with restart
e.g. China Aggregation options in case of transmission failure

Legend Integration Repository Message & Monitoring

To be System Landscape

Regulatory government Application interface framework

Regulatory
Regulatorygovernment
Regulatorygovernment
government AIF – restricted license included in SAP advanced Track
and Trace for Pharmaceuticals)

AIF content shipped for regulatory reporting and

PI/PO CMO/wholesaler messaging

CMOs

PI/PO
ECC ATTP /
CMOs
CMOs
CMOs
3PL
3PLs
3PLs
3PLs

PI/PO

Site
LineManager
manager
Line
Linemanager
manager
8
 ATTP Process Flow
Regulatory Government

6b 2
ECC AIF Monitoring,
Errors, alerts 8b
WM
functionality
ATTP
WM functionality Regulatory Reporting Import function 3PL support
6 Receive from
production functionality functionality
6a Receive
Event
(verify)
Reporting Reporting
Product
Master
S/N 8c
Scrap to TUR to CHN Import
Import Inbound Notification

Decommission
Repack Central Application functionality

Change Inventory Adjustment

Aggregation Event Repository Archiving Recovery / Backup
Label print
(auto unpack)

Commission 3PL
7 Pick & Pack SSCCs Data Retrieval Audit Trail
Security, Authorization 3PL Shipping
& Roles

Load & 7a Pick & Pack

8 Goods issue events
(verify) Master Serial Number Validation Returns
Data Management functionality
Info scan
hierarchy
8a Ship event
(verify)
Production functionality
Return
Return Event PO & Batch Serial Number
(verify) Pack Result
replication Request/response

Process order
4 release 3 5

1 Master
Data

Site Manager/CMO
 Training

Data Migration from Aii/OER to ATTP

Data Migration approach

• Integration of Master Data from ECC to ATTP, covered by

standard tools
• Migration of Serial Numbers from OER to ATTP, covered by
custom development and standard tools.
• 2 steps approach: Extraction (formatting, cleansing) + Loading
• Migration of Event Data from OER to ATTP, covered by
custom development.
• 2 steps approach: Extraction (cleansing) + Loading (Posting)
• Partial Migration (IDs not yet shipped to customer)
• Data reconciliation

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DM Suggested strategy

12
DM Integration of Master Data (1-4)

13
Master data in SAP ECC

• Material master (serialized or S&T) – Trade Items

– Existing data relevant to serialisation in current solution.

• Customer master – Business Partner

– These include direct customers, 3PLs, affiliates with own
warehouse facilities and customers where Roche serves as CMO.

• Vendor master (CMOs) – Business Partner

– Vendors are CMOs producing serialized finished goods for Roche.

• Plants – Locations (GLNs)

– Locations/GLNs are production sites and 3PLs.

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Co-existence of serialized and non-
serialized products
• Handled by master data setup in ECC
• Each material will be either:
• Non serialized
• Serialized
• Serialized and Traced
• Lot Managed
• =>Materials are managed for the flow they
must follow

15
Material master in ECC

16
Batch Master – new serialisation fields

17
Customer / Vendor master in ECC

18
Plants in ECC

19 Classification xxxx Author xxxx Approved by xxxx Version xx

 Training

ECC/ATTP Warehouse integration

Produce, Receive and Store Integration

SAP ECC SAP ATTP

1 Create PO

2 Outbound Delivery =
2 Release PO
initially integrated

4 Post GR 4 SSCC/SGTIN = Received

3 SSCC/SGTIN = Created
(Commissioned)
5 Move SU to
final location

6 Complete 3 Complete pallet prod.

Process ord.
Site Manager
Outbound Integration

SAP ECC SAP ATTP

1 Create SO

2 Create 2 Outbound Delivery

Outbound Del = initially integrated

3 Create pick TO 5 SSCC/SGTIN = Shipped

4 Confirm pick TO
5 Outbound Delivery
via scanner = closed/finished

5 Load and post 5 Shipping event created

GI via scanner
 ECC/ATTP Warehouse integration
enhancements

Example solutions for inspiration

Designed by NNIT

INTERNAL USE
ECC/ATTP Scanner programs
- example solutions – Designed by NNIT

1. Scanner programs built using

the warehouse toolbox building
blocks.

2. Full hierarchy retrieved from

ATTP repository using NNIT
proprietary optimized RFC.

3. All scanner programs updates

both ECC and ATTP and works
for all types of serialization
(and non-serialization).
Goods receipt by scanner
- example solution – Designed by NNIT

• Validate SSCC in ATTP

• Create SSCC as HU in ECC

• Use packaging instructions in

ECC

• Use data from both ECC and

ATTP

• Post GR in ECC
• Post receiving event in ATTP
Load and GI by scanner
- example solution – Designed by NNIT

• Validate HU in ECC
• Status and delivery

• Validate SSCC/HU in ATTP

• Status and quantity

• Post GI in ECC

• Post shipping event in ATTP

ATTP – Project Plan / Milestones
 Project Plan / Milestones
Steps Description

Entry phase Gain approval to do initiate and define (ensure resources

and financing, outlook on design, build and test)

Initiate & ● Extensive and detailed to reduce risks and define best
Two Step
Define realization plan
Approach ● With experienced external partner (NNIT on time &
material) and internal resources

Baseline Approval for project realization, including plan. Full costs

approval & resources ready

Realization ● Duration 12 months

(design, build, ● With NNIT (at fixed price) and internal resources
test)
Tasks Planned Start Planned Finish
Start Project Mai ‘17 Aug ‘17

Scope and Plan Project Sep ‘17 Mar ‘18

milestone -> Approve Baseline Mar ‘18
Execute Project Apr ‘18 Feb ‘19
Deploy Project Feb ‘19 Mar ‘19
Close Project Apr ‘19 Jun ‘19

Note: Dates for realization are best case. will be assessed as part of initiation & define phase
35
Template Version:
2017-1
Initiation and Define Phase work
streams
Project baseline

Master data integration (material master)

Define the
MDMs Review of Detailed
Define direct Define
involvement concept, design and
sync from ECC product master
versus ECC approach and specifications
to ATTP (4 ECC interfaces from
data based on high-level (FDS and
systems) MDMS to ATTP
the ATTP Add- Design TDS)
on to ECC

Transactional Data Migration

Analyze
Review of Detailed
Analyze Analyze Roche’s
Analyze Analyze data concept, design and
current issued alignment internal as-is Analyze data
events in OER structure in approach and specifications
and generated between AII Business fields in OER
OER high-level (FDS and
serial numbers and OER Partner
Design TDS)
landscape

Warehouse
Analyze ATTP Analyze
Define WM Detailed
required Define Define impact of Review of
processes with Define
updates based required business Brazil and US concept, design and
non-SAP verification specifications
on the current events and transaction warehouse not approach and
systems where points and (FDS and
flow between triggers per which will having SU or high-level
update to ATTP content TDS)
the 4 ERP ERP system update ATTP HU Design
is required
systems management
Questions

37
Back up slides

38
3
9
Welcome

• Elena Viñuela Diaz, Specialist on Migration to

ATTP

• Heidi Nielsen, SME ATTP and Master Data

• Sune Groth, SAP Warehouse Specialist

• Sven Stiegmann, SAP Logistics Specialist

• Maiken Borup-Mikkelsen, Enterprise Architect

and SME on Serialization
In brief
• NNIT is one of the three largest providers
of IT services in Denmark

• Focus areas: IT consultancy, development,

implementation and operations for life
sciences,
finance, public and other industries

• We deliver solid quality methodical

approaches, open and honest
communication, and a high sense of
delivering the right quality

• Trusted IT advisor to pharmaceutical

companies. Our experience can be deployed
to, e.g. the regulatory industries

• More than 2,800 employees

• Revenue in 2016 was DKK 2,765 million (Euro:

372 million)

• Head office in Soeborg, Denmark – offices

in: China, Switzerland, Germany, the US, the
Philippines and the Czech Republic

• Customers throughout Europe, the US and

China
Doing now what patients need next