How document templates can facilitate or prohibit multipurpose documents


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How document templates can facilitate or prohibit multipurpose documents that can be reused throughout a product's and document's life cycle

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How document templates can facilitate or prohibit multipurpose documents

  1. 1. How Document Templates canFacilitate or ProhibitMultipurpose of DocumentsMichiel Stam – Manager Regulatory OperationsQdossier B.V.
  2. 2. AgendaMultipurpose & TemplatesContent and Context of useMetadata and subject definitionFacilitating multipurpose documentsTemplate granularity, naming and numberingSubmission content planHarmonised namingControl of templatesLocation of contents6/24/2013 - proprietary 2
  3. 3. MultipurposeAvoid duplication of workSingle authoritative sourceKnow “where used”Product life cycle managementRegulatory compliance6/24/2013 - proprietary 3Reuse of document contents in a differentcontext across products, regions andformats
  4. 4. About document templatesCapture predefined contentsDefine styles, headers and headingsProvides guidance and example textCaptures descriptive information about contentsPart of system for organizing documents by subjectFocus on word-processed format (electronic media)6/24/2013 - proprietary 4
  5. 5. Content and Context – Carrot and potato recipes6/24/2013 - proprietary 5ManufacturersCompetentauthoritiesProductionprocess(active)substancesDrugProducts
  6. 6. Content and Context – Every item documented6/24/2013 - proprietary 6ManufacturersCompetentauthoritiesProductionprocess(active)substances
  7. 7. Content and Context – Cross references6/24/2013 - proprietary 7ManufacturersCompetentauthoritiesProductionprocess(active)substances
  8. 8. Content and Context – Branding6/24/2013 - proprietary 8ManufacturersCompetentauthoritiesProductionprocess(active)substances
  9. 9. Context of useContent carrier (e.g.document)Locationofdocumentin dossieror DMSCross references toother documentsBrandingwithin acontentcarrier6/24/2013 - proprietary 9Contextof use
  10. 10. Template metadata selectionNo out-of-the box system availableRoles and responsibilitiesStorage, retrieval and permission controlUsage across toolsTo describe content only (subject)Contextual metadata in eDMS doc properties only6/24/2013 - proprietary 10
  11. 11. Definition of subjectDiscrete piece of contentSpecific topicIdentifiable purposeStand-aloneReuseable in various context6/24/2013 - proprietary 11
  12. 12. Facilitating multipurpose documents (I)Templates:Well defined template granularityStrong document namingGeneric cross-references (exchangeable destination)Standardized document contentsGuidance, training and standardization:MetadataLean authoringVersioningSupported by submission content plan:Document namingOutline and granularityMetadata and context of useRelations between documents in context of use6/24/2013 - proprietary 12
  13. 13. Facilitate multipurpose documents (II)Supported by document management processStore and locate templates and documentsCapture and define document naming and propertiesVersion control of templates and documentsManage document locationsMaintain relationships between documentsSupported by training and monitoring6/24/2013 - proprietary 13
  14. 14. Template granularitySeparation of reusable and submission-specific contentsMultiple granularity options:Single or multiple docs per CTD sectionSpecific or non-specific to the <subject> (e.g. drug product)P.1 Description <container name>P.7 <container name>P.7 <free text> <container name>P.7 <free text>6/24/2013 - proprietaryOption for single document, specific to the containerOption for multiple documents, specific and non-specific to the container(preferred)
  15. 15. Document numberingExclude (sub)section numbering from eCTD namesFacilitate reuse across CTD module 3 and Asean CTD part IIOmit redundant numbering in eCTDConsider cross-references!6/24/2013 - proprietary 15
  16. 16. Document namingStrong namingMinimize contextual informationSpecific enough to specify contents (future proof!)Standardized naming variablesAccording to internal and external conventionsHarmonized namingAcross eDMSContent plansDocument templatesPublished output (e.g. electronic submissions or SharePoint)Multiple document name typeseDMS name(e)CTD nameOutput file name6/24/2013 - proprietary 16
  17. 17. Multipurpose namingContainer part fit for multiple container closuresystems, across multiple products and regions:3.2.P.7 Cap 3ml Vial Qdrug3.2.P.7 Cap 3ml Vial QdrugP.7 Cap 3ml Vial QdrugP.7 Cap 3ml VialP.7 Cap VialP.7 Vial Cap 13mm6/24/2013 - proprietary 17
  18. 18. Submission content plan6/24/2013 - proprietary 18
  19. 19. Harmonized naming6/24/2013 - proprietary 19
  20. 20. Control of templates and documentsHow to manage template versions?Existing document is current, finalized and approvedKeep track of changesOwnership of multipurpose templates• Authorization and approval of draft documentsReview procedure not limited to contents onlyContents in context of multipurposeMetadata6/24/2013 - proprietary 20
  21. 21. Facilitating Lean AuthoringTrained AuthorsContents according to defined locationAvoid contextual informationProper use of Word featuresCross references, headers, headings, captions etc.Template guiding information and examplesAuthoring styleGranularityHeader informationDocument namingCross-reference styleContents expected6/24/2013 - proprietary 21
  22. 22. Location of contents (I)Defined by template, however..Stability data intermediates appears in:Intermediates sectionStability sectionArt 46 Statement appears as:- Addendum to the Cover Letter?- Addendum to M.2.5 Clinical Overview?6/24/2013 - proprietary 22
  23. 23. Location of contents (II)Batch numbering in 3.2.P.3.3 and not together with batchanalyses in 3.2.P.5.4Stability conclusions only in 3.2.S.7.1 and 3.2.P.8.1 (notin other stability sections)Process validation on intermediates:Included in S.2.4 Intermediates?Or in S.2.5 Process validation?Or S.2.6 Manufacturing process development?6/24/2013 - proprietary 23
  24. 24. Templates as part of RIM process6/24/2013 - proprietary 24Global trackingsystemSubmission contentplanSearch eDMS docsand templatesCTD documenttemplateDocumentauthoringDocumentstorageElectronicsubmissionsHealthAuthoritySharepointCloningArchive eCTDviewer
  25. 25. Thank you !Questions?