Date post: | 06-Feb-2018 |
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May 11, 2017
INCREASED TRANSPARENCY ANDCOMPLIANCE BY ESTABLISHING A SINGLE SOURCE OF PRODUCTINFORMATIONAndres Snoeckx
4May 12, 2017 Work in progress – not all products commercially available
TECHNICAL SEGMENTS*
Diverse range of core competencies
7May 12, 2017
ONCE UPON A TIME…
PreservationRetrievalReusabilityTransparency
GMPDataanalysisUpdatesSubmissions
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
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…
21May 12, 2017
OUTLOOK
DHF
SAPInterface
DHF SalesForceInterface
DHFGUDIDInterface
Workflowbased submission to GUDID