good data governance is good regulatory compliance
TRANSCRIPT
Good Data Governance is Good Regulatory ComplianceAn Ounce of Prevention is Worth a Pound of Cure
Web Briefing20 September 2017
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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
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
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
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.
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
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
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
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™
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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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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
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
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
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).
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
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
Intelligent MDM™
© 2017 Semarchy
IDMP Product
Research Project
Clinical Trials
HCP Manufacturing Product
The data model
TakeawaysConclusion
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Intelligent MDM™
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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
Crossing the Data DeltaThe path to excellence
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Guy BradshawStrategic EIM Consultant
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.
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
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
Intelligent MDM™Get there faster.
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Michael HiskeyEvangelist, CMO
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
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
Intelligent MDM™
© 2017 Semarchy
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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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