SAP Info Hub Overview v1.7
SAP Info Hub Overview v1.7
SAP Info Hub Overview v1.7
Date – 24-Feb-2022
Overview
SAP Information Collaboration Hub for Life Sciences
Document History
PUBLIC Overview
2 © 2022 SAP SE or an SAP affiliate company. All rights reserved. Document History
Contents
2 Introduction ................................................................................................................................... 6
2.1 Supported Supply Chain Partners ....................................................................................................... 6
2.2 Service Options ...................................................................................................................................... 6
2.3 Release Strategy .................................................................................................................................... 7
8 Support ......................................................................................................................................... 21
8.1 Global Support and Maintenance Mode ............................................................................................ 21
8.1.1 Monitoring ............................................................................................................................ 21
8.2 Support Process ..................................................................................................................................22
8.2.1 Project Mode........................................................................................................................22
8.2.2 Production Live Mode .........................................................................................................23
8.3 Customer Contact ...............................................................................................................................23
8.3.1 Onboarding Phase ...............................................................................................................23
8.3.2 Production Live Phase ........................................................................................................23
8.4 Downtime Notifications .......................................................................................................................24
8.5 SAP ONE Support Launchpad ............................................................................................................24
Overview PUBLIC
Contents © 2022 SAP SE or an SAP affiliate company. All rights reserved. 3
8.6 Incident Handling Process .................................................................................................................. 25
8.7 Support FAQs....................................................................................................................................... 26
Legal Disclaimer
The information in this document is confidential and proprietary to SAP and may not be disclosed without the
permission of SAP.
PUBLIC Overview
4 © 2022 SAP SE or an SAP affiliate company. All rights reserved. Contents
1 About this Document
This document provides an overview of the SAP Information Collaboration Hub for Life Sciences including the
various options and services available.
Related Information
Overview PUBLIC
About this Document © 2022 SAP SE or an SAP affiliate company. All rights reserved. 5
2 Introduction
The SAP Information Collaboration Hub for Life Sciences is an on-demand solution that connects pharmaceutical
organizations and their supply chain partners on a secure network that is owned and managed by SAP. Connected
partners can exchange serialization and related messages across a secure and reliable network.
The Hub supports various integration capabilities such as content-based routing and mapping, as well as a
number of connectivity options, providing standardized integration between partners.
The SAP Information Collaboration Hub for Life Sciences allows for the interconnection of pharmaceutical supply
chain partners, including:
• Marketing Authorization Holder (MAH)
• Wholesaler
• Contract manufacturing organization (CMO)
• Third-Party Logistics service provider (3PL)
• Dispenser
• Regulatory Body
Access to the SAP Information Collaboration Hub for Life Sciences is through a subscription. The following
subscription options are available:
• Supply Chain Partner Collaboration with partners such as MAHs, CMOs, 3PLs, Wholesalers, and so on
• Regulatory Reporting
• Regulatory Collaboration
• U.S. Drug Supply Chain Security for Sales Return Verification and regulatory collaboration (DSCSA)
The following figure shows the various scenarios.
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6 © 2022 SAP SE or an SAP affiliate company. All rights reserved. Introduction
1
Hospitals &
SAP Advanced Track and Trace for Pharmacies
Pharmaceuticals Wholesaler
The SAP Information Collaboration Hub for Life Sciences release strategy includes four quarterly shipments.
There is a deployment to a Staging environment followed two weeks later by a deployment to Production.
Customers have access to the Staging environment to test a new release prior to deployment to Production.
SAP gives advance notice of dates and service updates for each deployment.
The sections which follow outline the service, onboarding and support options.
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Introduction © 2022 SAP SE or an SAP affiliate company. All rights reserved. 7
3 Supply Chain Partner Collaboration
The option for Supply Chain Partner Collaboration supports the following:
• CMOs can request serial numbers from a Marketing Authorization Holder (MAH). The MAH responds to the
request by providing serial numbers to the requester.
• CMOs and 3PLs can send a Serialization Event Message (SEM) to an MAH.
• MAHs can send a Serialization Event Message (SEM) to 3PLs and wholesale distribution customers.
More Information
PUBLIC Overview
8 © 2022 SAP SE or an SAP affiliate company. All rights reserved. Supply Chain Partner Collaboration
4 Regulatory Reporting
The SAP Information Collaboration Hub for Life Sciences service for Regulatory Reporting requirements offers:
• Reporting to Regulatory Reporting systems around the world
• Collaborate with business partners to share and report regulatory information
This section outlines options for regulatory reporting to authorities in various regions. For information on
Regulatory Collaboration, see section 5.
The regulatory reporting option supports the following processes connecting to the European Hub (EU Hub) for
compliance to the Falsified Medicines Directive (FMD):
• Submission to EU Hub of Product Master Data and Product Pack Data
• Execution of Product Pack Verification, Batch Recall and Product Pack State Update
• Web App for Report Service and Alerting
Overview PUBLIC
Regulatory Reporting © 2022 SAP SE or an SAP affiliate company. All rights reserved. 9
Customer
Reports
EU Hub
Customer
Non SAP Backend
Reports
The SAP Information Collaboration Hub for Life Sciences can route messages to the EU-Hub received from
various backend systems including:
• Encryption and signing of messages
• Token handling
• Error handling
• Routing responses from EU-Hub back to the message sender
A Regulatory Reporting Option for Bahrain is available to customers under specific license. The service is based
on the Generic Reporting Framework introduced with SAP ATTP 3.0 for customers who wish to connect:
• An SAP Advanced Track and Trace for Pharmaceuticals backend system with the minimum release version
3.0
•
The SAP Information Collaboration Hub for Life Sciences transforms Generic Reporting Notifications which are
sent according to the configuration guide including the following features:
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10 © 2022 SAP SE or an SAP affiliate company. All rights reserved. Regulatory Reporting
SAP ATTP
backend
system, Generic Reporting EPCIS 1.2 according to Technical
Version 3.0 or according to specification Onboarding Guide
higher Manufacturer
A Regulatory Reporting Option for Brazil is available to customers under specific license. The service is based on
the Generic Reporting Framework introduced with SAP ATTP 3.0 for customers who wish to connect:
• An SAP Advanced Track and Trace for Pharmaceuticals backend system with the minimum release version
3.0
SAP ATTP
backend Generic Reporting
system, Version according to specification Custom XML-based format defined in
3.0 or higher SNCM Interface Manual
Manufacturer
The SAP Information Collaboration Hub for Life Sciences transforms Generic Reporting Notifications which are
sent according to the configuration guide including the following features:
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Regulatory Reporting © 2022 SAP SE or an SAP affiliate company. All rights reserved. 11
• Error handling and monitoring on technical message level
A Regulatory Reporting Option for Indonesia is available to customers under specific license. The service is based
on the Generic Reporting Framework introduced with SAP ATTP 3.0 for customers who wish to connect:
• An SAP Advanced Track and Trace for Pharmaceuticals backend system with minimum release version 3.0
SAP ATTP
backend
Generic Reporting
system, Version Custom JSON-based format
according to specification
3.0 or higher defined in BPOM API V 3.0
Manufacturer
The SAP Information Collaboration Hub for Life Sciences transforms Generic Reporting Notifications which are
sent according to the configuration guide including the following features:
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12 © 2022 SAP SE or an SAP affiliate company. All rights reserved. Regulatory Reporting
4.5 Regulatory Reporting for Russia
The RU-OMS Regulatory Reporting service of the SAP Information Collaboration Hub for Life Sciences is available
to customers who wish to connect:
• An SAP backend system such as SAP Advanced Track and Trace for Pharmaceuticals
• A non-SAP backend system
Cus tomer
Reports
OMS
Cus tomer
Reports
The SAP Information Collaboration Hub for Life Sciences routes messages to Russian OMS devices hosted by
CRPT.
Overview PUBLIC
Regulatory Reporting © 2022 SAP SE or an SAP affiliate company. All rights reserved. 13
4.5.2 MDLP Regulatory Reporting
The MDLP Regulatory Reporting service of the SAP Information Collaboration Hub for Life Sciences is available to
customers who wish to connect:
• An SAP backend system such as SAP Advanced Track and Trace for Pharmaceuticals
• A non-SAP backend system
Customer
Reports MDLP
Customer
Reports
The SAP Information Collaboration Hub for Life Sciences routes reporting messages to MDLP including the
following features:
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14 © 2022 SAP SE or an SAP affiliate company. All rights reserved. Regulatory Reporting
4.6 Regulatory Reporting for Saudi Food & Drug Authority
(SFDA)
Customer
Reports
DTTS
Customer
Non SAP Backend
Reports
The SAP Information Collaboration Hub for Life Sciences routes messages to the DTTS from SFDA received from
various backend systems and includes the following features:
• Mapping to the requested message format
• Error handling
• Show overview of responses from SFDA DTTS
More Information
Overview PUBLIC
Regulatory Reporting © 2022 SAP SE or an SAP affiliate company. All rights reserved. 15
5 Partner Collaboration for Regulatory
Reporting
The SAP Information Collaboration Hub for Life Sciences service for Regulatory Reporting requirements offers:
• Reporting to Regulatory Reporting systems around the world
• Collaboration with business partners to share and report regulatory information
This section outlines options for Regulatory Collaboration. For information on Reporting to Regulatory Authorities,
see section 4.
5.1 Overview
The Regulatory Collaboration service is based on the generic reporting framework for SAP Advanced Track and
Trace for Pharmaceuticals.
SAP ATTP
backend Generic Reporting
system, Version according to specification
3.0 or higher
Manufacturer Regulatory
Reporting
System
Information Collaboration Hub
Sends Generic Reporting Defined local
For Life Sciences
notification according to notification format
specification
3PLs
Wholesalers
Dispensers
The service is scalable to high volumes of business partner connections for each customer due to automation and
a self-onboarding approach.
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16 © 2022 SAP SE or an SAP affiliate company. All rights reserved. Partner Collaboration for Regulatory Reporting
• Allows pharmaceutical manufacturers to report serialization data to business partners, so that the business
partners can report to the regulatory body
• Converts generic reporting messages from SAP Advanced Track and Trace for Pharmaceuticals (ATTP) into
the defined local notification format
• Enables self-onboarding and automated technical certification of business partners to minimize onboarding
efforts
• Allows business partners to manage own company data and users
• Supports Web App and B2B data exchange with connected business partners
• Supports simplified connectivity to business partners who use third-party solution providers
• Supports technical and functional response handling using the ATTP generic reporting framework
SAP ATTP
backend Generic Reporting
system, Version according to specification
3.0 or higher
Manufacturer
specification
3PLs
Wholesalers
Dispensers
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Partner Collaboration for Regulatory Reporting © 2022 SAP SE or an SAP affiliate company. All rights reserved. 17
6 U.S. Drug Supply Chain Security Service
SAP offers a dedicated service to support the requirements for the U.S. market according to the U.S. Drug Supply
Chain Security Act (DSCSA). The service supports verification of saleable returns as well as supply chain
notification, also known as Transaction Information and Transaction Statement Exchange (TI/TS Exchange).
Saleable returns verification can be made against an SAP blockchain or a customer's backend such as SAP ATTP.
The verification router service (VRS) offers the following:
• MAHs can connect their own EPCIS repository to the service or send product pack data to a blockchain
repository.
• Manufacturers can define the endpoint for verification based on GTIN in a Lookup Directory.
• Wholesale Distributors can verify returns. The verification request is routed based on the content of the
Lookup Directory
• Web App to review blockchain content, write logs and view verification logs
• Web App to configure verification responses
• Web app to configure alert options and manage alerts
Wholesaler
EPCIS To
Blockchain VR
Repository
Manufacturer VRR
Wholesaler
Verification Inf ormation Collaboration Hub
against own For Lif e Sciences
EPCIS
Repository
Sends Verification Requests
BC-based and receives Verification
Repository
Request Response
Customer
EPCIS to Blockchain
EPCIS
Node
VR Verification Request
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18 © 2022 SAP SE or an SAP affiliate company. All rights reserved. U.S. Drug Supply Chain Security Service
6.2 Supply Chain Notification - Transaction Information
Exchange
The service allows MAHs to send product pack data to their wholesale distribution customers to fulfill the
requirements for exchange of transaction information (TI) and transaction statement (TS) according to DSCA
requirements. MAHs can exchange TI/TS messages B2B with U.S. Wholesalers using GS1 EPCIS 1.2 U.S.
Healthcare Implementation Guideline as a standard (EPCIS 1.2 USHC). TI/TS Messages must be sent for every
shipment and require full serialization aggregation.
• Manufacturers can push traceability data to their wholesale distribution business partners. SAP onboards a
manufacturer's wholesale distribution business partners.
• Wholesale Distributor and Dispensers can receive traceability data from their suppliers. SAP onboards the
wholesale distributor's or dispenser's suppliers.
ATTP Repository
Manufacturer
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U.S. Drug Supply Chain Security Service © 2022 SAP SE or an SAP affiliate company. All rights reserved. 19
7 Onboarding Options
There are different options to onboard to the SAP Information Collaboration Hub for Life Sciences.
Connected partners can exchange messages through:
• B2B connection
• Third-party solution provider connection
• Web App
This section describes SAP’s fair usage policy with regards to offboarding and onboarding partners.
SAP is aware that customers sometimes work with partners intermittently or on a seasonal basis. For this reason,
it may be appropriate to offboard a partner and onboard another partner.
SAP operates a fair usage policy of 10% per year when it comes to offboarding and onboarding partners. For
example, if a customer has subscribed to thirty connections, that customer can offboard and onboard three
partners during the course of one year.
If you need to exceed the 10% fair usage, please contact SAP.
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20 © 2022 SAP SE or an SAP affiliate company. All rights reserved. Onboarding Options
8 Support
Support for the SAP Information Collaboration Hub for Life Sciences is provided by SAP teams in complimentary
times zones, who are available 24x7 for Very High and High priority incidents.
8.1.1 Monitoring
At frequent intervals, message failures are collected and include the following information:
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Support © 2022 SAP SE or an SAP affiliate company. All rights reserved. 21
8.2 Support Process
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22 © 2022 SAP SE or an SAP affiliate company. All rights reserved. Support
8.2.2 Production Live Mode
The Customer Success Manager (CSM) is the primary contact person during the onboarding and production
phases.
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Support © 2022 SAP SE or an SAP affiliate company. All rights reserved. 23
8.4 Downtime Notifications
The SAP team sends regular notifications to customers and partners to inform of:
• Planned maintenance and unexpected outages to SAP Information Collaboration Hub for Life Sciences and
relevant platform components
• Outages of regulatory reporting systems
Customers and partners can sign up directly with Regulatory Organizations to receive notifications for planned
downtime of regulatory reporting systems.
The SAP ONE Support Launchpad is a one-stop for all support and service related needs, to access software,
request license keys, get technical support and find documentation.
Access to the SAP ONE Support Launchpad is through the SAP Support Portal.
There are SAP Notes, Knowledge Based Articles (KBA) and SAP Community tips to help solve issues. If these do
not provide the necessary information, there is the option to Report an Incident.
The SAP ONE Support Launchpad allows customers to report and track incident reports.
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24 © 2022 SAP SE or an SAP affiliate company. All rights reserved. Support
A First Level Support hotline is available for help reporting an incident.
The Support component for SAP Information Collaboration Hub for Life Sciences is LOD-PHN-SUP.
SAP
Customer CSM SAP Support Onboarding QA Development
Team (OBT)
Reacts on
Reacts on
Report Incoming
Incoming
Incident Incident
Incident
Point of Contact
Facilitate
Communication Incident Analysis
Implement in Provide
Between QA Test
Staging Solution
Customer &
Support
Can
Issue
Yes be
Solved? OBT Contact
Customer to
Confirm Fix
No
Confirm Fix
Internal Ticket
Created
Move to
Close Incident
Production
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Support © 2022 SAP SE or an SAP affiliate company. All rights reserved. 25
8.7 Support FAQs
Q: What is an incident?
A: An Incident is a software issue in the application, a platform problem or any other service disruption with
respect to SAP Information collaboration Hub for Life Science.
Q: What if the issue is not in the application, but in the platform or related to a service?
A: You can report an incident using the same component LOD-PHN-SUP. The support team will assess if
the issue is in the application or the platform. If it is in the platform, the incident will be routed to the
standard component according to the issue category.
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26 © 2022 SAP SE or an SAP affiliate company. All rights reserved. Support
9 Important Disclaimers and Legal
Information
Any software coding and/or code lines/strings ("Code") included in this documentation are only examples and
are not intended to be used in a productive system environment. The Code is only intended to better explain and
visualize the syntax and phrasing rules of certain coding. SAP does not warrant the correctness and completeness
of the Code given herein, and SAP shall not be liable for errors or damages caused by the usage of the Code,
unless damages were caused by SAP intentionally or by SAP's gross negligence.
9.2 Accessibility
The information contained in the SAP documentation represents SAP's current view of accessibility criteria as of
the date of publication; it is in no way intended to be a binding guideline on how to ensure accessibility of software
products. SAP in particular disclaims any liability in relation to this document. This disclaimer, however, does not
apply in cases of willful misconduct or gross negligence of SAP. Furthermore, this document does not result in any
direct or indirect contractual obligations of SAP.
As far as possible, SAP documentation is gender neutral. Depending on the context, the reader is addressed
directly with "you", or a gender-neutral noun (such as "sales person" or "working days") is used. If when referring
to members of both sexes, however, the third-person singular cannot be avoided or a gender-neutral noun does
not exist, SAP reserves the right to use the masculine form of the noun and pronoun. This is to ensure that the
documentation remains comprehensible.
The SAP documentation may contain hyperlinks to the Internet. These hyperlinks are intended to serve as a hint
about where to find related information. SAP does not warrant the availability and correctness of this related
information or the ability of this information to serve a particular purpose. SAP shall not be liable for any damages
caused by the use of related information unless damages have been caused by SAP's gross negligence or willful
misconduct. All links are categorized for transparency (see: http://help.sap.com/disclaimer).
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