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INCREASEDTRANSPARENCYAND · PDF fileDHF SAP Interface Transfer ofarticles Transfer...

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May 11, 2017 INCREASED TRANSPARENCY AND COMPLIANCE BY ESTABLISHING A SINGLE SOURCE OF PRODUCT INFORMATION Andres Snoeckx
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May 11, 2017

INCREASED TRANSPARENCY ANDCOMPLIANCE BY ESTABLISHING A SINGLE SOURCE OF PRODUCTINFORMATIONAndres Snoeckx

2May 12, 2017

3May 12, 2017

CLINICAL SEGMENTSSubspecialties with high volumes of digital medical data

4May 12, 2017 Work in progress – not all products commercially available

TECHNICAL SEGMENTS*

Diverse range of core competencies

5May 12, 2017

HISTORY OF INNOVATIONContinuous flow of wide range of products

6May 12, 2017

PATIENT DATA MANAGEMENTPre-fetching and data organisation through central gateway

7May 12, 2017

ONCE UPON A TIME…

PreservationRetrievalReusabilityTransparency

GMPDataanalysisUpdatesSubmissions

Brainlab tools

8May 12, 2017

VISION

ElectronicTechnicalFile(ETF)

Brainlab tools

9May 12, 2017

IMPLEMENTATION PROJECT

Definitions• Document types

• DMR• DHR

• Part types• Software• Hardware

• Lifecycles & workflows• DHF Document review• DHF Document approval• Purchasing release• Production release• Market release

• Team roles• Attributes• Product <> documentation relationship

Migration of 2 pilot products2 QM team membersDuration: 1 year

10May 12, 2017

WINDCHILL @ BRAINLAB

2006Introductionof Windchill40-50users

2014Introductionof ETF120users

2017

400+users Features,content

Prod

ucts

11May 12, 2017

LINKING PRODUCT & DOCUMENTATION

DHF

DMR

12May 12, 2017

21 CFR PART 11 COMPLIANT APPROVAL

13May 12, 2017

MIGRATION

14May 12, 2017

DHF

DesignHistory File(DHF)

DHF

CURRENT STATUS

PlanningDesignInputRisk management fileUsabilityengineering fileVerificationValidationDesignReviewChanges

15May 12, 2017

CURRENT STATUS

DHF

DesignHistory File(DHF)

DHFDeviceMasterRecord(DMR)

ArticlesTechnicaldrawingsTestprotocolsLabelspecsUDIspecsDatasheetsServiceManuals

16May 12, 2017

CURRENT STATUS

DHF

DesignHistory File(DHF)

DHFDeviceMasterRecord(DMR)

DHFLicense

Management

Licenses (e.g.FDAdevice listing)Managementof license to article relationshipSubmissionworkflowsLicense specific file compilation

17May 12, 2017

CURRENT STATUS

DHF

DesignHistory File(DHF)

DHFDeviceMasterRecord(DMR)

DHFLicense

ManagementDHFProduct

labeling

LabelsInstructions for Use

18May 12, 2017

CURRENT STATUS

DHF

DesignHistory File(DHF)

DHFDeviceMasterRecord(DMR)

DHFLicense

Management

DHFPatents

DHFProductlabeling

19May 12, 2017

OUTLOOK

DHF

SAPInterface

Transferof articlesTransferof attributesTransferof statusTransferof configurations…

20May 12, 2017

OUTLOOK

DHF

SAPInterface

DHF SalesForceInterface

ComplaintsServiceinformation…

21May 12, 2017

OUTLOOK

DHF

SAPInterface

DHF SalesForceInterface

DHFGUDIDInterface

Workflowbased submission to GUDID

22May 12, 2017

LESSONS LEARNED

Manage the change – real change hurtsUser acceptance (particularly acceptance of ergonomics) is hard work, but pays offUse pilotsFocus on the process - across team and tool boundariesBig vision – small stepsMake sure everyone talks about the same thing


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