KLever eCTD              2La proposta KLever K-eCTD Solution                 Life Science                 Solutions
Agenda         Agenda         •   RA/eCTD Requirements         •   Proposed solution         •   Our key differentiators  ...
RA/eCTD Requirements             Life Science             Solutions
The starting point …                       Life Science                       Solutions
RA/eCTD System | Key Objectives• Provide a structured and secure repository  where submission’s documents can be created  ...
RA/eCTD System | Process Overview     Document Management      eCTD Dossier Management                                    ...
RA/eCTD System | eSubmission Process                                                         Publishing                   ...
Proposed solution           Life Science           Solutions
KeCTD | “Best of breed” Components 1. The EDMS leader – standard de facto in the Life Science     • EMC Documentum 2. The ...
KeCTD | Logical architecture    Input                                           Process Management     Extedo RLP Manager ...
KeCTD | Features   InputManagement             Document Capture               • Scan/Input CaptureTechnology              ...
KeCTD | Features  ProcessManagement   Documentum Repository               • Support for PDF content rendering, overlay,   ...
KeCTD | Features  ProcessManagement   KeCTD DataModel               • Reference implementation of RD Document             ...
KeCTD | Features  OutputManagement             eCTDManager               • CTD (PDF) and eCTDPublishing from the same     ...
KeCTD DataModel | Document TypesDocument Type                        DescriptionStudy Document                       Type ...
KeCTD DataModel | Metadata (common)All the Document Types have these common attributes Dossier Section       The CTD or ge...
KeCTD DataModel | Repository structure                  The documentation related to the specific function/department is s...
KeCTD DataModel | Document Lifecycles    Draft                         Final                          Invalid    Any new d...
KeCTD | Implementation Process           2 week           6 week   2 week   1 year      Estimated timeframe               ...
KeCTD Implementation Process   | Training TopicsGeneral• eCTD Specification• Authoring best practice for eCTD (MsWord, Ado...
KeCTD Implementation Process   | Application Support• Documentum eRoom based engagement model   • Service Ticket for help-...
Next: Extedo eCTDmanager                           Life Science                           Solutions
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keCTD

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keCTD

  1. 1. KLever eCTD 2La proposta KLever K-eCTD Solution Life Science Solutions
  2. 2. Agenda Agenda • RA/eCTD Requirements • Proposed solution • Our key differentiators • Next Steps & QA Life Science Solutions
  3. 3. RA/eCTD Requirements Life Science Solutions
  4. 4. The starting point … Life Science Solutions
  5. 5. RA/eCTD System | Key Objectives• Provide a structured and secure repository where submission’s documents can be created (or imported), reviewed, approved and retrieved, securing a controlled process and a complete control of the official and draft documentation.• Provide publishing functionalities for: • eCTD/Nees submission • Paper publishing Life Science Solutions
  6. 6. RA/eCTD System | Process Overview Document Management eCTD Dossier Management Life Science Solutions
  7. 7. RA/eCTD System | eSubmission Process Publishing Management Document Planning Life Science Solutions
  8. 8. Proposed solution Life Science Solutions
  9. 9. KeCTD | “Best of breed” Components 1. The EDMS leader – standard de facto in the Life Science • EMC Documentum 2. The eCTD Publishing leader – Extedo supply the import&review tool to EMEA • EXTEDO eCTDmanager 3. KLever is a strategic partner for EMC and Extedo in the LifeScience market • KeCTD “your klever eSubmission” Life Science Solutions
  10. 10. KeCTD | Logical architecture Input Process Management Extedo RLP Manager Extedo RLP Manager Management Study management Study management Output Management MS Office MS Office Document Document Extedo eCTDmanager Extedo eCTDmanager Documentum WebTop Documentum WebTop Authoring Authoring HL manager HL manager LifeCycle Mngt LifeCycle Mngt Teamworking Teamworking Validation Validation KeCTD Office KeCTD Office KeCTD configuration KeCTD configuration Documentum BPM Documentum BPM KeCTD Rules KeCTD Rules Kofax/ Kofax/ Extedo DocValidator Extedo DocValidator KeCTD Workflows KeCTD Workflows Extedo Captiva Captiva Extedo eCTDmanager eCTDmanager Document Document Capture Capture Documentum Repository Documentum Repository eCTD Output eCTD Output KeCTD KeCTD Batch Batch KeCTD Data Model KeCTD Data Model Paper Output Paper Output Life Science Solutions
  11. 11. KeCTD | Features InputManagement Document Capture • Scan/Input CaptureTechnology • Image enhancement, OCR KeCTD Batch • RA document classification and indexing Life Science Solutions
  12. 12. KeCTD | Features ProcessManagement Documentum Repository • Support for PDF content rendering, overlay, watermarking, and controlled printing. • Check-in/Check-out, version control, Cabinet/folder taxonomy • Role-based security and administration • 21 CFR Part 11 Compliant EUGMP Annex 11 Compliant Documentum BPM • Document and submission lifecycle management. • Document approval workflows including full-featured lifecycle document promotion Life Science Solutions
  13. 13. KeCTD | Features ProcessManagement KeCTD DataModel • Reference implementation of RD Document Lifecycles • Preconfigured Registration Dossier Templates for CTD. Localized Document Templates eCTDManager • Assembly & Submission Publishing in PDF and eCTDFormat • Comprehensive Submission Lifecycle Management • Built in Support for National, Centralized, Decentralized and Mutual Recognition Procedures Life Science Solutions
  14. 14. KeCTD | Features OutputManagement eCTDManager • CTD (PDF) and eCTDPublishing from the same Structure • Preconfigured Registration Dossier Templates for CTD/eCTD Structure Life Science Solutions
  15. 15. KeCTD DataModel | Document TypesDocument Type DescriptionStudy Document Type denoting all kinds of study documents, e.g., • final reports, • interim reports, • amendments, • protocols, • case report forms, • patient information sheets …PublicationCMC Document Type denoting documentation from CMC, such as the Quality Module of the registration dossier.Overview/Summary Document Type denoting all types of expert overviews, written, or tabulated summaries.Investigator’s BrochureRegulatory Administrative DocumentGeneral Used for documents not classifiable under any of the above types. Life Science Solutions
  16. 16. KeCTD DataModel | Metadata (common)All the Document Types have these common attributes Dossier Section The CTD or generic dossier section number Number Date Date of the document in format DD/MM/YYYY Drug Substance(s) Drug substance used in the study. This field is optional and must not be filled in Drug Product Pharmaceutical Form Dosage Manufacturer Life Science Solutions
  17. 17. KeCTD DataModel | Repository structure The documentation related to the specific function/department is stored into the corresponding folder. Under each departmental folder, an “Active Substance Folder” for each AS to which the documentation is related is available. The structure under the Active Substance Folder may be decided by each department according to their needs/rules. When the documents are promoted as final, they become visible also in the Submission area. In the Submissions folder and subfolders the documentation related to a specific submission will be collected. Life Science Solutions
  18. 18. KeCTD DataModel | Document Lifecycles Draft Final Invalid Any new document or new Function/Department Function/Department version is created or responsible and RA responsible: Can declare imported in the system as SuperUser: Can create that the document is no Draft and the access to initial and subsequent longer to be used. this document is limited to versions. Once a The document is visible users belonging to the document has been only to RA & Function Function/Department created it can only be responsible. responsible modified through a new version. Others: Can View/Download Word or PDF versions (if available). Life Science Solutions
  19. 19. KeCTD | Implementation Process 2 week 6 week 2 week 1 year Estimated timeframe Life Science Solutions
  20. 20. KeCTD Implementation Process | Training TopicsGeneral• eCTD Specification• Authoring best practice for eCTD (MsWord, Adobe Acrobat)Product oriented• Documentum Administration for IT• Documentum User Training• eCTDManager Fundamentals for RAOptional: Workshop – simulate the eCTD process Life Science Solutions
  21. 21. KeCTD Implementation Process | Application Support• Documentum eRoom based engagement model • Service Ticket for help-desk and feature request • Ticket approval lifecycle and reporting• Pre-defined SLA • Next business day ticket management • 8hh x 5 dd dedicated support team• Remote support via Bomgar appliance (www.bomgar.com) • It works transparently through corporate firewalls, and enables remote desktop connection to attended or unattended computers. Life Science Solutions
  22. 22. Next: Extedo eCTDmanager Life Science Solutions

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