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. RA/eCTD System | Process Overview
Document Management eCTD Dossier Management
Life Science
Solutions
7. RA/eCTD System | eSubmission Process
Publishing
Management
Document
Planning
Life Science
Solutions
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. 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. KeCTD | Features
Input
Management
Document Capture
• Scan/Input CaptureTechnology
• Image enhancement, OCR
KeCTD Batch
• RA document classification and indexing
Life Science
Solutions
12. KeCTD | Features
Process
Management 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. KeCTD | Features
Process
Management 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. KeCTD | Features
Output
Management
eCTDManager
• CTD (PDF) and eCTDPublishing from the same
Structure
• Preconfigured Registration Dossier Templates for
CTD/eCTD Structure
Life Science
Solutions
15. KeCTD DataModel | Document Types
Document Type Description
Study Document Type denoting all kinds of study documents, e.g.,
• final reports,
• interim reports,
• amendments,
• protocols,
• case report forms,
• patient information sheets …
Publication
CMC 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 Brochure
Regulatory Administrative Document
General Used for documents not classifiable under any of the above types.
Life Science
Solutions
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. 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. 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. KeCTD | Implementation Process
2 week 6 week 2 week 1 year
Estimated timeframe
Life Science
Solutions
20. KeCTD Implementation Process | Training Topics
General
• eCTD Specification
• Authoring best practice for eCTD (MsWord, Adobe Acrobat)
Product oriented
• Documentum Administration for IT
• Documentum User Training
• eCTDManager Fundamentals for RA
Optional: Workshop – simulate the eCTD process
Life Science
Solutions
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
