good data governance is good regulatory compliance

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Good Data Governance is Good Regulatory Compliance An Ounce of Prevention is Worth a Pound of Cure Web Briefing 20 September 2017 1

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Page 1: Good Data Governance is Good Regulatory Compliance

Good Data Governance is Good Regulatory ComplianceAn Ounce of Prevention is Worth a Pound of Cure

Web Briefing20 September 2017

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Page 2: Good Data Governance is Good Regulatory Compliance

Intelligent MDM™

© 2017 Semarchy

Good Data Governance is Good Regulatory ComplianceAgenda

Information Governance & xDMFoundation for Compliance

Crossing the Data DeltaThe Path to Excellence

Intelligent MDM™Get there faster

Page 3: Good Data Governance is Good Regulatory Compliance

Intelligent MDM™

© 2017 Semarchy

Today’s speakers

Cliff Gibson

Senior Enterprise Architect at

Guy Bradshaw

Strategic EIM Consultant at

Michael Hiskey

Chief Marketing Officer at

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Information Governance & xDMFoundations for Compliance

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Cliff GibsonSenior Enterprise Architect

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Borderless problems require unconstrained solutions

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Intelligent MDM™

© 2017 Semarchy

About

Cliff GibsonSenior Enterprise Architect at

Life Sciences(9 years)

Pivotal in the transformation towards an MDM first environment and data driven cultureImplementation of key in systems across Manufacturing, Supply Chain, Research, Finance, Sales & Market Access

Electronics Manufacturing & Automotive (12 years)

IT Consultant implementing ERP systems, and developing value-add applications

Experience in TOGAF, COBIT, GDPR, ITIL, PRINCE II

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Intelligent MDM™

© 2017 Semarchy

I love data!

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Mundipharma IT Services delivers IT expertise and solutions to a network of independent associated companies (IACs) working in the global pharmaceutical industry.

Based in Switzerland, with subsidiaries in the UK, Germany and Singapore, we support customers in Europe, Canada, Asia, Australia, the Middle East, Africa and Latin America.

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The Conceptual Bits…Part 1

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Intelligent MDM™

© 2017 Semarchy

The same problem many times over

What is a Product or PersonDefinitions, Attributes , Data Quality, Business Rules

Who owns informationAccountability (owners), Responsibility (stewards)

Where to get information fromSource Systems, Integration, Timing

External ConnectionsData Exchange, Portals, EDI, Contracts

Page 12: Good Data Governance is Good Regulatory Compliance

Intelligent MDM™

© 2017 Semarchy

Beyond the “big ticket items” for regulatory compliance…

New Product Introduction

Product Discovery & Launch Planning

Serialisation(Track-n-Trace)

Where has it been

Labelling*

Safety & Presentation

*Potentially saving 70% vs budget due to work done in MDM platform

Page 13: Good Data Governance is Good Regulatory Compliance

Intelligent MDM™

© 2017 Semarchy

FLUTIFORM 125 UG 5 UG PRESSURISED INHALATION SUSPENSION Q12H

The data quality challenge

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AFFERA pMDI 125/ 5µG 1 ST

flutiform 125 mcg/ 5 mcg

FLUTIFORM 125/5

Flutiform 125/5 *120

Flutiform 125/5 1s

Flutiform 125/5mcg 1s

FLUTIFORM 125/5uG

FLUTIFORM 125µG/5µG B/1 HP

Flutiform 125mcg/ 5mcg pro

FLUTIFORM 125MCG/5MCG 120 DOSE/INHALATOR

FLUTIFORM MDI (SUSPENSION) 125/5 MCG

FLUTIFORM MDI 125/5 (SG)

Flutiform MDI 125/5 (SK)

FLUTIFORM MDI 125/5 MCG

FLUTIFORM pMDI 125/ 5µG 1 ST

FLUTIFORM pMDI 125/ 5µG MU 1 ST

FLUTIFORM® 125/5MCG 1s

FLUTIFORM® 125/5MCG 1s (AU)

FlutiFormo 125/5

HK FLUTIFORM MDI 125/5 MCG

Fluticason nullFluticasone & FormoterolFluticasone& FormoterolFormoterol & FluticasoneFluticasone - FormoterolFluticasone/Formoterol

InhalerLiquidsMDIN/AINHALER

Page 14: Good Data Governance is Good Regulatory Compliance

Intelligent MDM™

© 2017 Semarchy

Single View Integration

One integration channel

Benefits of a single xDM solution

Mentality

Challenges“NIH” mentality

Governance

One governance structure

One true single view of Product

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Intelligent MDM™

© 2017 Semarchy

Applying the same process beyond IDMP, and the product domain

Compliance

General Data Protection Regulation and other compliance

rules

Transparency

Ready for transparency rules and disclosure codes

Talent Management

Enable Human Resources management

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@ MundipharmaPart 2

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𝓍

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Intelligent MDM™

© 2017 Semarchy

Discovery & initiation2015

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Initial stagesQ3 - 2014

Market scan

Scanned the market and ran a Proof of Value with Semarchy

Getting seriousQ1-Q2 2015

RFP

Ran full RFP with 5 MDM vendors.Resulted in purchasing MDM system at end of Q2

Learning to flyQ3-Q4 2015

First pilots

With Entity, ran a pilot within Mundipharma Research.

Ran a pilot within Supply Chain & Manufacturing

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Intelligent MDM™

© 2017 Semarchy

Project kickoff2016

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Let’s get it doneQ2 2016

IDMP Iteration 1

Began designing MDM implementation for IDMP.

First iteration of Medicinal Product went live in 8 weeks.

Up and runningQ4 2016

Go-live+ Experimentation

Completed all PoC’s and extraction of large amount of data for IDMP from Research systems

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Intelligent MDM™

© 2017 Semarchy

Continual improvement2017

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Make it betterQ1 2017

Connect more sources

Connected data from Supply Chain & Manufacturing.

Connected to Oracle, SAP, & 2 instances of Infor Demand Planning.

Create momentumQ2 2017

Governance

Governance group established and operational. Glossaries, Attributes, Lifecycle, Flow, Data Quality

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Intelligent MDM™

© 2017 Semarchy

What’s next?2017 - 2018

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Better & betterTODAY

Even more sources and domains

More Supply Chain, SAP * 2 & JDE.

Built the Person/Org model to connect 2 instances of Workday, SAP Success Factors & Service Now

Create momentumCOMING SOON…

Exchange

Build a data exchange for over 100 contract manufacturers (CMOs), 30 3rd Party Warehouses and contract research organisations (CROs).

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Intelligent MDM™

© 2017 Semarchy

Conceptual Product data flows

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Regulatory

ISO

Country, Currency, Dose Forms…

Substances, Licences, Active Ingredient, Medicinal Product, Indications, Brands

Supply Chain

Data Warehouse

References

Transactions

References

Source

Golden & Xrefs

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The Technology & PeoplePart 3

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Intelligent MDM™

© 2017 Semarchy

Our systems environment

R&D

Commercial

Supply Chain

IT

22 Warehouses

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Intelligent MDM™

© 2017 Semarchy

Our partners

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Intelligent MDM™

Smart | Agile | MeasurableIterative true Multi Domain MDMAdvanced connectivity capability

Information Management Experts

Fast Time to ValuePragmatic and iterative methodology

Deep MDM knowledge

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Intelligent MDM™

© 2017 Semarchy

IDMP Product

Research Project

Clinical Trials

HCP Manufacturing Product

The data model

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TakeawaysConclusion

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Intelligent MDM™

© 2017 Semarchy

Governance + xDM = Compliance

Be a Data GeekDon't get bogged down in IDMP or GDPR. It's just DATA !

And most importantly, take the first step!

Right TechnologyUse xDM as tools to solve the Information Management problem. Fail Fast, Learn, Iterate.

StakeholdersGet them onboard and communicate at every opportunity.

Beyond RegulationLook beyond the regulations for your Business Case (Minimisation, Analytics, Track and Trace, …)

MethodologyData Delta methodology fits with xDM. Progressive & Pragmatic.

GovernanceGet it established. The sooner, the better.

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Borderless problems require unconstrained solutions

Page 29: Good Data Governance is Good Regulatory Compliance

Crossing the Data DeltaThe path to excellence

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Guy BradshawStrategic EIM Consultant

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Intelligent MDM™

© 2017 Semarchy

What prevents good data management?

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THE DATAYOU HAVE

BUSINESS PEOPLE WHONEED INFORMATION

The gap between the

Data you haveand the

Information you need.

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Intelligent MDM™

© 2017 Semarchy

The Data Delta

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THE DATAYOU HAVE

BUSINESS PEOPLE WHONEED INFORMATION

We call the gap the

“Data Delta”

6 Principles & 14 Domains

to help you cross it

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Intelligent MDM™

© 2017 Semarchy

ORGANISATIONAL STRATEGY AND GOVERNANCE

Data must be Controlled throughbusiness application implementation

How data is Used, Sharedand Integrated must be agreed

Principles of Access must be established: data lifecycle, storage, privacy & security

Data Quality must be defined, measured & managed

Data must be Described accurately and consensually

Data must be Governed and Owned

MDMRDM

Integration & Interop.Open Data

Data StorageInformation Security & Privay

Data Quality Management & Remediation

Data ArchitectureData Modeling & DesignMetadata ManagementData Catalogue

Data Governance

EDW, BI, AnalyticsDocument & Content Mgt

OWNER

DESCRIPTION

QUALITY

ACCESS

USAGE & SHARING

IMPLEMENTATION & CONTROL

Crossing the Data Delta

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Intelligent MDM™

© 2017 Semarchy

The perfect opportunity to be different

ExpertiseMundipharma’s supply chain and research systems with

Intelligent MDM from Semarchy were

implemented with expertise from Entity Group

Readiness

Mundipharma were prepared for the requirements that ISO

Protocols for the IDMP demand

Governance

Strong data management principles are the foundation for IDMP, GDPR compliance

and other regulatory obligations

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Entity Group are specialists in Enterprise Information Management

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Intelligent MDM™Get there faster.

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Michael HiskeyEvangelist, CMO

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Intelligent MDM™

© 2017 Semarchy

Why the World Needs Intelligent MDM™ Now

SmartAlgorithms empower stewardship

and advance matching, survivorship, curation and classification.

A native, semantically complete data model facilitates transparent lineage,

auditability and governance.

AgileAgile methodologies applied to

MDM are materialized via an intuitive, integrated design,

development and user interface.

Adaptive modeling enables business flexibility.

MeasurableMDM is an initiative, not a

technology. xDM is evolved into a business

with minimal disruption, to optimize adoption and show

measurable enterprise ROI almost immediately.

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80% of Semarchy clients have a fully-functioning solution in less than 10 weeks.

60% have implemented more than one domain

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IntelligentSmart algorithms

serve business users

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Transforming consumers into producers.

ProductiveMaterial design

drives unparalleled performance and

productivity

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Intelligent MDM™

© 2017 Semarchy

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Intelligent MDM™

© 2017 Semarchy

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Intelligent MDM™

© 2017 Semarchy

: data stewards champions

Intelligent stewardshipInbox prioritization, dynamic classification

Smart data certificationMatch/merge, enrichments, data quality

Guided authoringLinked to governance standards

Graph NavigationDemystify relationships complexity

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Page 41: Good Data Governance is Good Regulatory Compliance

Intelligent MDM™

© 2017 Semarchy

Where do we go from here?

Get Educated

Download the Book …and more resources on GDPR from our

websites

Get Started

Arrange a Semarchy Proof of Value combined with an Entity

Data Strategy Session

Get Efficient

Leverage Semarchy xDM and Entity’s data management as a

service

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Thank yousemarchy.com/mundipharma

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semarchy.com/entity