udi platform - sap cloud based life sciences solutions · 6 reasons for a managed udi cloud...

Untertitel, ggf. Kunde,

Ort

UDI Platform

Managed Service on SAP Cloud Platform

Seite 2© projektraum36 GmbH & Co. KG

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About Unique Device Identification (UDI)UDI is already mandatory in USA and is part of

EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR)

• UDI helps identifying products (via Label) and publishing product master-data in public databases

Goals

• Improve patient safety

• Improve recall processes

• Improve Market surveillance

Mandatory for all Medical Device Manufacturers

FDA

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mp

le


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5

The global UDI Challenge

Many more UDI

Regulations are in

works

Few Years

Which Authority

demands what

and when?

A Puzzle

Different Data

Models, different

UDI Databases

Different…


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EU MDR / IVDR Transition Periods

05/2017

EU MDR Effective

EU IVDR Effective

05/2022

EU IVDR

Date of application

05/2020

EU MDR

Date of application

Today


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What does that mean for you?

When will new

implementation guides be

published?

Unclear Timelines

Stay compliant and keep the

deadlines of all authorities

Close Deadlines

Always stay tuned to not miss

any information / requirements

Market Monitoring

New authorities have different

requirements capture them and

plan the implementation

New Requirements

Supply all authorities in

different ways

New Interfaces

Ensure that pending changes

are implemented during

operation

More Updates

Have enough developers ready

for the upcoming

implementations

More Development

Be aware that the support effort will

increase with each additional authority

More Support


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6 reasons for a managed UDI Cloud Solution

Concentrate on your Core Business

The requirements affecting your UDI Processes are driven by external Authorities. A

managed Cloud Solution is close to the market and implements all requirements timely.

Less Support effort

An externally managed Cloud solution includes Support and relieves the burden on your

Support Organization.

Simplified Ressource Planning

A managed Cloud Solution scales for you with every regulatory Authority. You neither need

new hardware nor Software Development Ressources.

1

2

3


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6 reasons for a managed UDI Cloud Solution

Calculable Costs

A Cloud Provider offers transparent licensing metrics for the Service Subscription. You

achieve Planning security on your whole UDI Lifecycle.

Clear Test and Change Management

A managed Solution ensures the majority of tests during Changes of the UDI Process. A

clear Change Request Handling and traceability ease to estimate the Regression Test

efforts for you.

Compliance

A managed Solution covers all requirements on the submission handling to UDI Databases

worldwide you can concentrate on the data preparation.

4

5

6


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One UDI Platform for all Regulatory Authorities

The specific requirements

of the different authorities

will always be timely

implemented

New Regulatory Authorities

Your data will stay your

data. You will be

supported in transforming

the data into the

Your Data

Forced changes by the

authorities will be covered

and you will be informed

proactively

Changes

Link your existing

master-data

processes to the

Cloud-Service

Your Processes

Will be implemented

without affecting your

interface to the service

New Interfaces to Authorities


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We care - our Managed Service approach

MarketMonitoring

Change Implemen-

tation

New Authority Interfaces

Validation Package

ActiveCustomer Support

ContinuousCompliance

Support

UDI Platform (as a Service)

SAP Cloud Platform


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Landscape Integration

SAP PDSM

SAP ERPSAP S/4 HANA

SAP S/4 HANA Cloud

3rd Party (e.g. RIMS)

Data Maintenance

Load data from Source

Enrich data

Add authority specifics

Flexible ApprovalProcess

Data Validation

Check data consistency

Check specificauthority rules

Respect Grace Periodhandling

Data Submission

Transform data intotarget format

Submit data toauthority

Handle authorityresponses

Reporting

Trace maintenancestatus

Monitor submissionstatus

Multi-agencyReporting

UDI Platform at a glance

UDI Platform Core

Generic Data Models

Flexible Workflows

Staging Area

Sub

missio

n A

dap

ters

Flexible User Interfaces

Pre-configured Content Packages (FDA, EUDAMED)

Un

ified Su

bm

ission

Han

dlin

g

Validation Rules Audit Trail (Part 11)


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SAP

Cloud

Platform

Hybrid SAP Landscape

SAP ERP

SAP S/4 HANA (Cloud)

3rd Party

SAP PDSM FDA GUDID

EUDAMED

Upcoming

AgenciesSAP ERP

RIMS


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Get a first impression!

Submission Status at a glance

Data Validation

Data Maintenance

Flexible Data Models


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UDI Platform - Adaptable to suit your needs

You already have maintained most of

your UDI-Data in your ERP?

Validation of your data

Simplified Release-Workflow

Submission Management

You have your device data ready but

no agency specific data?


Customized Release-Workflow


You want to manage most of your UDI-

data in the Platform?

Data enrichment


Customized Release-Workflow


Data enrichment

Create new maintenance flows


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Integration Options

SAP ERP S/4 HANA

On-Premise

S/4 HANA

Cloud

Other

systems

REST

ODATA / CDS

ODATA

SAP SLT *

SAP SDI *

SAP PI *

SAP CPI *

* SLT = SAP Landscape Transformation | SDI = Smart Data Integration | PI = Process Integration | CPI = Cloud Process Integration | Separate licenses needed


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Visit us in the SAP App Center!

https://www.sapappcenter.com/apps/29728/udi-platform#!overview

Thank you for your Attention!

07.05.2018

Please contact us:

Patrick Pfau, Managing Director

E: [email protected]

udi platform - sap cloud based life sciences solutions · 6 reasons for a managed udi cloud...

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