Transcript Electronic Submissions @ Abbott Laboratories

Abbott e-Submissions
Program
Documentum Migration Utility
& Third Party Access Application
02/18/2005
v1.0
Agenda
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Background
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Migration Utility
•
–
Project Background
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System Overview
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Solution Screen Shots
Third Party Access (Extranet)
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Project Background
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System Assumptions
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System Overview
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Solution Screen Shots
Abbott Confidential
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Background
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e-Submissions (e-Subs) Program
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Manages process and procedures followed to submit documentation to the
FDA
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Uses Documentum to manage all submission documents
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WebTop 5.1 (with customizations), AnnoDocs, CoreDossier
e-Subs 2004 Pain Points
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Need the ability to efficiently “bulk load” documents into e-Subs
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Need more control over documents that are shared externally
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e-Submissions Migration Utility
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Problem Statement
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Need to move and/or copy documents and attributes:
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into Documentum from an external file source
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between Documentum Docbases
Need to enforce complex processes including:
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Ensuring specific business rules are applied to the target data in
Documentum.
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Reducing complexity and support expense by having a common tool for
each different data source that contains documents to be moved or
copied into Documentum.
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Simplifying user interfaces for initiation and tracking of migration efforts.
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Minimizing time and management effort to set up large migration tasks.
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Reducing effort involved in recovering from a failed migration.
Abbott Confidential
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Use Case – Statistical Datasets
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Stats Group creates and manages datasets to support drug studies
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Hundreds of datasets could be included in one submission
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Currently a manual process to import each dataset into Documentum
using the Webtop interface, and set property values one-by-one
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After import, must then proceed to route each dataset on workflow for
acceptance
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Migration Utility – Vision
1. Accept input from multiple sources and formats (Data Staging)
2. Import data into Documentum in a batch approach
3. Allow for configurable business rules to be applied to the imported
batch
export
Content
&
XML index
file
Validate
& import
e-Subs
Docbase
Staging Area
Migration Utility
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1. Data Staging
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Prior to importing into Documentum, stage the data from the various
sources in a common area.
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Staging area is a designated file share on the web server
Leverage XML to capture indexing information to be used for import
into the target Documentum object:
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Document type
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Destination location
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Attribute name and value mappings
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Content pointer
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Rendition pointer
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Version tree structure
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Audit trail values
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Lifecycle state
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Workflow template
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Benefits of Staging
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Allows for re-use of import processing code
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Do not want to develop and maintain separate code modules for file-share
import versus Docbase import, etc.
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Content is just content in the staging area
Allows for consistent application of business rules
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All content from the various sources is staged for import according to
standard business rules
export
Content
&
XML index
file
validate
& import
Staging Area
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2. Batch Processing
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Bundling a logical set of data and processing it as a batch results in a
more efficient and manageable migration effort including:
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Reduced set up time by allowing certain properties to be defined at a batch
level rather than the document level.
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Decreased preparation time by providing the ability to copy a document’s
setup to other documents within the batch.
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Improved monitoring by allowing large migration efforts to be broken down
into phases to help meet various load and timing constraints.
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Addressing failed imports by automatically isolating failed documents so they
can easily be identified, corrected, and re-run.
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3. Configurable Business Rules
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A set of business rules is associated with each e-Subs document type
in the target Docbase. The business rules define what criteria must be
met in order for migrated content to be imported as a particular
document type.
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XML schemas are used to define and enforce the business rules
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The schemas validate things such as…
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Lifecycle States
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Lifecycle
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Required
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Lookup Values
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Data Type
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String Lengths
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Special Characters
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Phased Approach
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Phase 1.0
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Enabled migration via Excel batch files
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Export = none
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Data Staging = manual
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Validate and Import = Migration Utility Import module
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Deployed September 2004
Phase 2.0
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Enabled migration from a File Share source
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Export and Data Staging = Migration Utility Interface
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Validate and Import = Migration Utility Import module
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Deployed January 2005
Phase 3.0
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Under development now – target deploy June 2005
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Will enable Docbase to Docbase migration
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Solution Screen Shots
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File Share Source:
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Create New batch
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Upload Documents
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Batch Details
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Document Setup
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Document Details
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Available Batches
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Error Processing
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Available Batches
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The available batches screen is the first screen presented upon login. It lists all the
batches that have been created, and provides the option to create a new one.
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Create New Batch
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A user can set batch level properties
and select local files and directories
from the file system to include in the
batch by clicking the add files button.
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Upload Documents
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After selecting one or more files,
the user clicks the upload button
to transfer the files from the
local file system to the staging
area.
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Batch Details
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Once a batch is created, the batch detail screen is displayed listing each document in the
batch. Users may click on a document name to set up Documentum properties specific to
that document type in the target Docbase.
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Document Setup
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The document setup screen is
the first screen that is displayed
when a user selects a document
in order to specify its properties.
The document setup screen is
used to specify general
properties for the target
document in Documentum such
as its document type and
location within the Docbase. A
user may click the next button to
continue to add additional details
for the document.
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Document Details
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Abbott Confidential
This document details screen shows how a user is able to specify attribute values for
the target document. The Justification for Change and Reason for Change attributes
listed on this screen are examples of how suggested values can be pulled from
Documentum and listed to help ensure data integrity.
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Document Details (cont.)
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This document details screen shows how a workflow template and workflow performers
can be associated with a document. Upon import, the workflow will be initiated
automatically.
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Back to Batch Details
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When a user returns to the batch detail screen, the properties are displayed along with the
document name. Users may also click the copy doc setup button to copy properties from
one document to any other documents in the batch.
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Back to Available Batches
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Once all the documents have been set up for a batch, a user may begin the verification and
import process from the available batches screen. A user may click on a batch name to
add or setup additional documents. A user may click the Verify link to verify that all
documents in the batch have been set up to meet the defined business rules. After a batch
has been successfully verified, a user may click the Import link to import the batch into
Documentum. If an error occurs in the verification or import process, an error link will be
displayed in the status column directing the user to a detailed error screen.
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Validation Error Processing
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The detailed verify error screen lists all documents that failed to meet
a business requirement with a detailed description of the failure. From
this screen, a user may click on any of the documents to remove it
from the batch or correct any of its setup properties. After making
corrections, the user can run the verification process again from the
available batches screen.
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Import Error Processing
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The detailed import error screen lists all documents that failed to
import into Documentum. From this screen, a user may click on any of
the documents to remove it from the batch or correct any of its setup
properties. Documents that imported successfully are automatically
removed from the batch, making it easy for a user to run the import
process again for only the documents that failed. After making
corrections, the user can run the verification and import process again
from the available batches screen.
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Lessons Learned
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Import processing is not difficult
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Bulk of the challenge lies in…
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Providing flexible architecture for business rule enforcement
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Providing a robust user interface for users to easily define index information
and to be confident of correct import
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Batch details
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Defining attribute mappings
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Validation and Import Error processing
Allowing users to re-use defined document setups is high value
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e-Submissions Third Party Access
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Problem Statement
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e-Submissions leverages third-party medical writers and medical
investigators (CRO)
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Current issues being faced when dealing with third party authors:
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Lack of an audit trail of third party activity and actions
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Confidential documents residing in third party email accounts and local hard
drives
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Third party authors not utilizing the latest e-Submission document templates
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The need to email documents to third party authors
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The need to send hard copies of documents
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The need to scan-in hard copy signature pages
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Third Party Access - Vision
Abbott Standards, Templates, Processes
Abbott Site 1
Abbott Site 2
Repository
Publishing COE
Extranet Application
CRO
Data Import
To Regulatory Agencies
Abbott Standards, Templates, Processes
Abbott Confidential
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Project Approach
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2004
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Perform analysis and user requirements gathering
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Develop a prototype of the interface
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Identify and explore technical architecture alternatives
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Pilot a solution with subset of CRO’s by end of year
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Compile a post-pilot summary report
2005
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Abbott Confidential
Implement a Validated system
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System Requirements
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3rd Parties will not have access to the e-Sub System directly
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An Abbott owner will make documents available to the 3rd Parties
3rd Parties will have the ability to author, review and approve
documents
3rd Party audit trails will be maintained
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This poses too much of a security risk
Same audit trails for external and internal users
3rd Parties will see internal Abbott reviewer comments/annotations
The 3rd Party System will allow local export and printing
3rd Party access will be via the web
3rd Parties will access the application through a Citrix environment
The 3rd Party System will provide reasonable response time and
performance
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System Overview – Process Flow
1 – Abbott Author
-Logs into the internal Abbott
e-Submissions application
-Initiates workflow to make
document(s) available to
external users
4 – Extranet Application
-Serves up the document in
Microsoft Word 2000 or
Adobe Acrobat
2 – e-Sub System
-Notifies the external coauthors
-Routes the workflow to
the external users inbox
5 – 3rd Party Author
-Edits/accepts/approves
the document
-Finishes the workflow task
3 – 3rd Party Author
-Logs into the 3rd Party
Extranet application
-Accesses inbox
-Selects workflow task and
requests document for
edit/acceptance/approval
6 – Extranet Application
-Routes the document(s)
back to the e-Submissions
system
7 – e-Sub System
-Notifies the Abbott author,
and delivers the workflow
back to Abbott author, or
ends the workflow
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System Architecture Alternatives
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e-Sub Direct
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Allow 3rd party users to access the e-Sub System directly
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Would publish the e-Sub application to a Citrix host in Abbott network DMZ
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Would require heavy customizations to the e-Sub (Webtop) application to
ensure the proper interface is shown to external users
Extranet Application
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Build a new 3rd party extranet application, complete with a separate interface
and repository from the e-Sub System
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Would require some type of communication mechanism between e-Sub and
the new extranet application
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Data consistency could become an issue with this alternative
Extranet Interface with e-Sub Repository
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Build a new 3rd party extranet interface, but have it connect directly to the eSub docbase
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Would still require minimal changes to the e-Sub System to support new
interface
Abbott Confidential
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System Architecture Decision
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Extranet Interface with e-Sub Repository
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Decision was made to follow this architecture, because it provides all
the advantages of a secure streamlined interface for third party users,
while minimizing data consistency issues.
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Other advantages of this architecture
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Less moving parts
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Makes use of existing eSub architecture
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Follows an approved Abbott network security model
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Strikes the best balance in terms of validation requirements
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Will require the least amount of validated changes to eSub
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The Extranet Interface will be a new self-contained code base and can be validated
on its own, separate from eSubs
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System Overview – Pilot Architecture
Abbott Firewall
Extranet Application
e-Submissions
Abbott
Author
External
3rd Party
User
DMZ Citrix
Internal Citrix
Abbott Confidential
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Web Server
&
Docbase
Internal Citrix
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Solution Screen Shots
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Extranet Interface Only
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Login for external users
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Processing Authoring Tasks
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Processing Approval Tasks
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Logging In
1.
Abbott Confidential
Login…login again…and login one more time…
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Inbox
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Authoring Task View
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Delegate
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Checkin
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Approval Task View
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Approve All
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Reject All
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Selective Approve/Reject
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Questions
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