sap tt pharmacompliance

SAP Track & Trace forPharmaceutical Compliance

Peer Laslo SAP Deutschland SE & Co KGNovember 2014

© 2014 SAP SE or an SAP affiliate company. All rights reserved. 2Public

Public ComplianceReady?

Affected Business Areas / MarketRelevant Public PolicyProduction control EnterpriseValidation Process integrationProduction control Shop floorPSE Production Serialization Execution Level3Connection Production Machine Level2 to Level3Warehouse integrationData Handling > Global OER (Object Event Repository)Local AII (Auto Id Infrastructure) Data Persitance + Process ControlGlobal Serial Number ManagementContract Manufacturing Role (Provider / Customer)Compliance Reporting > SAP RCS

How to become Public Compliance Ready


Agenda

• Process Options• Serialization in Pharma• Advanced Serial Number Management• Plant Serialization Execution• Compliance Reporting• CMO/Subcontracting• Warehouse Integration• SAP Consulting Service


Process Optionssimplified Supply Chain

PharmaBrand Owner

Wholesaler HospitalsPharmacies

Pedigree

Track & Trace

End-2-End

Supply ChainDataVerification Request

Serialization

PharmaBrand Owner


PharmaBrand Owner


PharmaBrand Owner


Serialization data are stored at the Manufacturer and canbe used for authentication.

Authentication may be requested (manually) by anymember of the supply chain on a packSEe level.

Serialization data are entered into a central database bythe manufacturer.

Authentication can be done at any point in time by anymember of the supply chain on a packSEe level.Authentication is mandatory at the point-of-dispense.

Serialization data are entered into a central database bythe manufacturer.

SEgregation Data are either entered into the centraldatabase or sent to the supply chain partner.

Every supply chain participant has to report materialmovements into the central database.

Authentication can be done at any point in time by anymember of the supply chain on any level.

Serialization data and SEgregation data are sent to thenext supply chain partner along the entire supply chainincluding the entire history.

Authentication can be done at any point in time by anymember of the supply chain on a packSEe level.


Agenda

• Process Options• SAP Auto ID Approach• Serialization in Pharma• Advanced Serial Number Management• Plant Serialization Execution• Compliance Reporting• CMO/Subcontracting• Warehouse Integration• SAP Consulting Service


SAP OER based Track &Trace Solution – Enterprise View

Transport

Wholesale

Warehouse

Consumer

AfterSalesService

Manufacturing


SAP OER based Track &Trace Solution Global View

Manufacturing& Packing

Transport

Wholesale

Warehouse

Consumer

Pharmacy

AfterSalesService


What Does SAP Provide?

System integration services:value generation with Auto IDPhysics and device expertise

PartnerPartner

ProductionLine Edgeexecution

Processorchestration

Enterpriseapplications

Read, write, and transmitdata to systems

ManSEe hardwareCleanse dataOperator workflow

Translate raw data tobusiness execution

Enrich core functionswith auto-ID data

Decision support andexecute transactionsFunction

Deviceintegration/DevicemanSEement

SAP ERP

SAP OERQueryinterface

Captureinterface

Line

Con

trol

er

Delivery


Drill down into standard manufacturing process

10© 2014 SAP SE or an SAP affiliate company. All rights reserved.

Process steps

Central numberrangemanSEement inSAP OER

Distribution to AIIcentral

Create Serializedobjects optionalrandomized

Distributeserialized objectsas bucket to LocalSystems, CMO’sor 3rd partyLogistics

Optionalenhancement todistribute numberpools assigned toproduction orders

NumberrangemanSEement

Serializationat packSEingline

Build uphierarchy

Pack/unpack

Assigndelivery


Receiveserialized objectswith additionalcontent likeGTINSerial numberBatch numberexpiry date

Standardinterface to OER

Flexible codingStructuree.g. EAN 128HIBC …are supported

Access to uploaddate is passwordprotected

Advanced errorhandling



Build uphierarchy

Pack/unpack

Assigndelivery

Process steps


ReceiveHierarchyto load inAII/OERe.g. Packbundlecasepalletflexible toadditionalhierarchies likee.g. blister

Step 2+3+4 canbe integrated toone interface file



Build uphierarchy

Pack/unpack

Assigndelivery

Process steps


Receive updatedObject structure(new buildstructure viainterface in OERif this will beperformed inthird partysystem

Alternative repalleting withmobile devices isa standardprocess in SAPAII

© SAP 2011 Peer Laslo / PSEe 13



Build uphierarchy

Pack/unpack

Assigndelivery

Process steps


Receive updatedpalletinformation infrom third partysystems in OER

AlternativeDeliveryAssignment inSAP AII is astandardprocess, usingmobile devices

Optionalautomatic HUgeneration inSAP SD isstandardfunctionality

Delivery

© SAP 2011 Peer Laslo / PSEe 14



Build uphierarchy

Pack/unpack

Assigndelivery

Process steps


Agenda



1

2

3

Serialization inPharma

Prepare Production

Global Serial Number ManagementMaintain serial numbers on enterprise level

Execute Production

Plant Serialization ExecutionExecute serialization on shop floor level. High data persitance

Store serialization data local for SEgregating

Report Production

Regulatory Reporting for SAP OERReport serialnumbers with respect to relevant authorities


4

5

Serialization inPharma

CMO Integration

Data Transfer Serialization Data forsingle items to CMOProcess PO and serialdata to and from CMO

Integration in Warehouse and Distribution-centerSeamless transfer of Hierarchy data andInteger exception process handlingPerform all process like pack / unpack , QM sample


Agenda



Advanced Serial Number Management


Central Number Range Management:Process Flow

Consecutive Number Range Request

After the initial number ranges were distributed, they canbe consumed by the local AII instance or any externalsystems which are connected to the local instance(packSEing line systems, device controllers). Once thenumber of consumed serial numbers reaches a certainthreshold percentSEe, a new number range request istriggered automatically.

SAP AII sends a request to the repository for a new number rangeSAP OER. The request is sent via SAP PI, using the same interfacesas the initial number range request: ‘NumberRangeRequest’ and‘NumberRangeConfirmation’.The actual alert threshold and the size of number range intervals canbe defined vai the the number range administration user interface(SAP Easy Access screen Auto-ID Infrastructure Master Data

Number Ranges.)

PI interface‚NumberRangeConfirmation‘

PI interface‚NumberRange

Request‘


Object Event Repository Menu: Central Number RangeAdministration

Selection ProfileQuery for existingnumber ranges

Display ProfileRetrieve detailedinformation on numberranges that were foundbased on the specifiedselection criteria

Number rangeobject ID (GTIN,SSCC, …)

Intervalinformation

Informationon currentconsumption

Status information

Editing options (Create,Delete, Edit, Block, AllocateNumber Ranges)


Agenda



SAP Plant Serialization Execution


SAP Plant Serialization ExecutionFull integration from shop floor to global repository over al levels

Line Level

Plant Level

Enterprise Level

PSE Add On (ABAP) for

Auto ID Infrastructure



Line Level

Plant Level

Enterprise Level

PSE Satellite for .NET

SAP PSE AII add on (ABAP)


Agenda



Regulatory Reporting with SAP OERBusiness requirements

SAP OERglobal repository for serialization data

production warehousing distribution / sales

Turkey MOH China SFDA

Business requirements

Need for a functionality that …

Handles the creation, transfer andacknowledgement of notifications toauthorities to achieve regulatorycomplianceManSEes the requirements of multipleauthorities within one global solutionProvides one central source ofinformation, offering full visibility intothe global process of regulatoryreportingOffers process control and exceptionresolution mechanisms like userapproval and retriggering ofnotificationsAllows flexible configuration ofnotification types & characteristics toeasily incorporate new requirements

RegulatoryReportingOER Solution Add-on


Regulatory Reporting with SAP OERSolution architecture

SAP OER

Receiver 1(ITS

turkey)

Receiver 2(PTS

turkey)

Receiver 3(SFDAChina)

Generic Notification

SAP PO

Anyreceiver

ITS msg Any formatPTS msg SFDA msg

AII CMO 3rd party DC

EPCIS event

OER Notification ViewFlexible configuration

Automatic creation & transferof notifications

Process control & visibility


Agenda



Todays Pharma OEM realityincreased complexity

HQPharma 1

HQPharma 2

HQPharma 3

Plant 1 Plant 2 CMO Plant 1 Plant 2 CMO Plant 1 Plant 2 CMO

Enterprise Level

Plant Level

PackSEingLine Level

PackSEing orders forSerialized Items

HQPharma 2

ASN Comunication


Reduce complexity

HQPharma 1

HQPharma 2

HQPharma 3

Plant 1 Plant 2 CMO Plant 1 Plant 2 CMO Plant 1 Plant 2 CMO

Enterprise Level

Plant Level

PackSEingLine Level

PackSEing orders forSerialized Items



CMOLine Level

CMOPlant Level

Enterprise Level

PSE Satellite for .NET

SAP PSE AII add on (ABAP)


SAP cloud based manufacturing executionFull integration from shop floor to global repository over al levels

CMOPlant Level

EnterpriseLevel

PSESatellite

.NET

SAP PSEAII add on (ABAP)

SAP PSE order data

SAP PSE order data

Serialized data

Serialized data

CMOLine Level


Contract Manufacturing Serial Number Management


Agenda



Warehouse Integration

Site 3Inventory ManagementIM or (WM w/o HU Mgmt

Site 2Warehouse ManagementWM

Site 1Extended WarehouseManagementEWM

OERERP

MM

WM

EWM

Scanner

Printer

Scanner

Printer

Scanner

Printer

Serialisationextension




Agenda



Public ComplianceReady?

Definition of involved PartiesBusinessWarehouseITValidationEngineering

User Requirement SpecificationDevelopment SpecificationRoadmap PilotRoadmap DeploymentGlobal Enterprise IT Strategy

Relevant Steps


Serialization Execution in Process IndustryBest Practice Assessment – Interface Map


Creating Project Task Structure


Serialization Execution in Process IndustryBest Practice Assessment

Workshop Content / Means Results Participants

Scope ofImplementation

Affected Business Areas / MarketPublic Policy in Target MarketCMO Customer RoleCMO Provider Role

Affected MarketsAffected CMO Relations

Product OwnerLegal CounselCMO PurchaseProduction PlanningCMO Sales

Serializationcreation, print &labeling

Production control EnterpriseProduction control Shop FloorProduction Serialization Execution Level3Connection Production Machine Level2

Gap Analysis ProductionProcessDelta Analysis IntegrationTechnology

Production PlanningShop FloorTechnology

Serializationhandling &storSEe

Data Handling Global OER (Object EventRepository)Local AII (Auto ID Infrastructure)Serial Number Management

Gap Analysis ITInfrastructureGap Analysis Serial NumberManagement

ITPublic Policy Ownerper product

Serializationservices

Compliance ReportingPublic (Internet etc.) ReportingGBT (Global Batch Traceability)

Relevance of Public Policiesand External ReportingRelevance between GBT toTrack & Trace

Product OwnerLegal CounselPR

Presentation ofResults

Technical Vision of To-Be-Landscape, Interfaces & Roadmap(OER, Link to Printers, Link to Supplier, Link to Authorities, ...)Roadmap Pilot – ScheduleRoadmap Deployment – Schedule

1

2

3

4


Public ComplianceReady

Affected Business Areas / MarketRelevant Public PolicyProduction control EnterpriseProduction control Shop floorPSE Production Serialization Execution Level3Connection Production Machine Level2 to Level3Warehouse integrationData Handling > Global OER (Object Event Repository)Local AII (Auto Id Infrastructure) Data Persitance + Process ControlGlobal Serial Number ManagementContract Manufacturing Role (Provider / Customer)Compliance Reporting > SAP RCS

How to become Public Compliance ready

© 2014 SAP SE or an SAP affiliate company. All rights reserved.

Contact:

Peer Laslo

Business Development ManSEerTrack & Trace in Process Industry

SAP Deutschland SE & Co. KGRosenthaler Strasse 3010178 Berlin

Mobile: +49 160 90823032Fax: +49 6227 78-44658Mail: [email protected]

Back-up


APENDIX

• Hierarchy• SAP Solution Details• Securpharm Approach


Serialisation requirements: increased packSEing complexity

Device Level

Singelpack

GTIN

Batch

Expiry dateSerial number

Serial number

Serial number

Serial number

Case

GTIN•Serial number

•HierarchySerial number single pack

Serial number single pack



Pallet

SSCC•Hierarchy

Serial number case

Serial number case

Serial number case


APENDIX



SAP Object Event Repository

SAP Object Event Repository

AUTO-ID RepositoryEvent ManagementSecurity Services

QUERY INTERFACE

CAPTURE INTERFACEGlobal Repository

tSEged product flow at multiple locations, multiplelocal processes

Central Number range ManagementSupports homogenous serialization based onconfigurable rules

Hierarchiesinterrelated tracking of child & parent objects anddocument associations

EPCIS Standardcentralized data exchange with trading partners.Single set of interfaces and repository to growingnumber of enterprise consuming applications andreports to authoritiessupport various data streams [EPC, Transaction,POS, …] to drive business value

AuthenticationGlobal verification and authentication of Products

Need a way to track a product as itmoves through the supply chain

Productserialization

Need a way to store and manSEemillions of transactions acquired bytracking product movement

Data capture& repository

Need a standards-basedmechanism for sharing data formultiple use cases

IndustryStandard

Need a way to share data withtrading partners to identify businessvalue

Secure dataexchange


SAP Auto-ID Infrastructure

©

Key FeaturesMapping and rules

processing – MapmessSEes arriving fromdevices on the plant orwarehouse floor to determinewhat event has occurred andwhat sequence of activities toexecute

Activities that matchbusiness requirements– Perform specific actionssuch as validations, updates,and communications; modifyexisting activities or createnew ones to match enterpriseneeds

Routing engine– Map interpreted data to therelevant business objectsinside SAPand non-SAP applications tofacilitate automation ofbusiness processes

PrepackSEed,configurable supportfor business processes– Deploy preconfiguredprocesses or configure thesoftware to meet specificrequirements

Local dataPersistence

Auto-ID Raw Events Business ProcessesRepository

TranslationLogic


SAP Auto ID Infrastructure

SAP Auto ID Infrastructure

AII

Regional data persistence

Mapping and rules processingMap messSEes arriving from devices on the plant orwarehouse floor to determine what event has occurredand what sequence of activities to execute

Activities that match businessrequirementsPerform specific actions such as validations, updates,and communications; modify existing activities orcreate new ones to match enterprise needs

Routing engineMap interpreted data to the relevant business objectsinside SAPand non-SAP applications to facilitate automation ofbusiness processes

PrepackSEed, configurable support forbusiness processesDeploy preconfigured processes or configure thesoftware to meet specific requirements

Need a way to store and manSEeserialized and SEgregated Product info onlocal/regional basis

Productserialization

Need a way to validate and authorizeincoming data

Data capture& repository

Need a standards-based integrationto OER / ERP and device manSEementlevel

Integration

Need a way automate processes with fastdeployment in shop floor and warehouse

AutomateProcesses


APENDIX



Securpharm Compliance Approach

Identity db

Consumption


© 2014 SAP SE or an SAP affiliate company.All rights reserved.

No part of this publication may be reproduced or transmitted in any form or for any purpose without the express permission of SAP SE or anSAP affiliate company.

SAP and other SAP products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of SAP SE(or an SAP affiliate company) in Germany and other countries. Please see http://global12.sap.com/corporate-en/legal/copyright/index.epx for additionaltrademark information and notices.

Some software products marketed by SAP SE and its distributors contain proprietary software components of other software vendors.

National product specifications may vary.

These materials are provided by SAP SE or an SAP affiliate company for informational purposes only, without representation or warranty of any kind,and SAP SE or its affiliated companies shall not be liable for errors or omissions with respect to the materials. The only warranties for SAP SE orSAP affiliate company products and services are those that are set forth in the express warranty statements accompanying such products andservices, if any. Nothing herein should be construed as constituting an additional warranty.

In particular, SAP SE or its affiliated companies have no obligation to pursue any course of business outlined in this document or any relatedpresentation, or to develop or release any functionality mentioned therein. This document, or any related presentation, and SAP SE’s or its affiliatedcompanies’ strategy and possible future developments, products, and/or platform directions and functionality are all subject to change and may bechanged by SAP SE or its affiliated companies at any time for any reason without notice. The information in this document is not a commitment,promise, or legal obligation to deliver any material, code, or functionality. All forward-looking statements are subject to various risks and uncertaintiesthat could cause actual results to differ materially from expectations. Readers are cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of their dates, and they should not be relied upon in making purchasing decisions.


© 2014 SAP SE oder ein SAP-Konzernunternehmen.Alle Rechte vorbehalten.

Weitergabe und Vervielfältigung dieser Publikation oder von Teilen daraus sind, zu welchem Zweck und in welcher Form auch immer, ohne dieausdrückliche schriftliche Genehmigung durch SAP SE oder ein SAP-Konzernunternehmen nicht gestattet.

SAP und andere in diesem Dokument erwähnte Produkte und Dienstleistungen von SAP sowie die dazugehörigen Logos sind Marken odereingetrSEene Marken der SAP SE (oder von einem SAP-Konzernunternehmen) in Deutschland und verschiedenen anderen Ländern weltweit.Weitere Hinweise und Informationen zum Markenrecht finden Sie unter http://global.sap.com/corporate-de/legal/copyright/index.epx.

Die von SAP SE oder deren Vertriebsfirmen angebotenen Softwareprodukte können Softwarekomponenten auch anderer Softwarehersteller enthalten.

Produkte können länderspezifische Unterschiede aufweisen.

Die vorliegenden UnterlSEen werden von der SAP SE oder einem SAP-Konzernunternehmen bereitgestellt und dienen ausschließlich zu Informations-zwecken. Die SAP SE oder ihre Konzernunternehmen übernehmen keinerlei Haftung oder Gewährleistung für Fehler oder Unvollständigkeiten indieser Publikation. Die SAP SE oder ein SAP-Konzernunternehmen steht lediglich für Produkte und Dienstleistungen nach der Maßgabe ein, die in derVereinbarung über die jeweiligen Produkte und Dienstleistungen ausdrücklich geregelt ist. Keine der hierin enthaltenen Informationen ist als zusätzlicheGarantie zu interpretieren.

Insbesondere sind die SAP SE oder ihre Konzernunternehmen in keiner Weise verpflichtet, in dieser Publikation oder einer zugehörigen Präsentationdargestellte Geschäftsabläufe zu verfolgen oder hierin wiedergegebene Funktionen zu entwickeln oder zu veröffentlichen. Diese Publikation odereine zugehörige Präsentation, die Strategie und etwaige künftige Entwicklungen, Produkte und/oder Plattformen der SAP SE oder ihrer Konzern-unternehmen können von der SAP SE oder ihren Konzernunternehmen jederzeit und ohne Angabe von Gründen unangekündigt geändert werden.Die in dieser Publikation enthaltenen Informationen stellen keine ZusSEe, kein Versprechen und keine rechtliche Verpflichtung zur Lieferung vonMaterial, Code oder Funktionen dar. Sämtliche vorausschauenden AussSEen unterliegen unterschiedlichen Risiken und Unsicherheiten, durch diedie tatsächlichen Ergebnisse von den Erwartungen abweichen können. Die vorausschauenden AussSEen geben die Sicht zu dem Zeitpunkt wieder,zu dem sie getätigt wurden. Dem Leser wird empfohlen, diesen AussSEen kein übertriebenes Vertrauen zu schenken und sich bei Kaufentscheidungennicht auf sie zu stützen.

sap tt pharmacompliance

Documents

sap se

sap affiliate company

supply chain participant

segregation data

thenext supply chain

entire supply chainincluding

packsee level

publicsap oer