Transcript Astellas Pharma US, Inc.

MWDUG
August 30, 2006
Integrating Document Management &
Submissions Management
Table of Contents
 Introduction
 Scenario / History
 Approach
 Solution
 Outcome
 Part II
 Future
 Conclusion
Introduction
Astellas Pharma US, Inc. (formerly Fujisawa in the
Chicago area & Yamanouchi in the New Jersey area)
is in the top 20 pharmaceutical companies in the
world.
World headquarters are in Tokyo, Japan. US
headquarters are in Deerfield, IL.
Marketed Products:
Scenario / History
Systems pre 2005:
Electronic Submissions
Local File Share
Local File Share
(authored documents)
(electronically
processed documents)
Hard Copy Output
Scenario / History
Systems pre 2005:
 Software development in a development environment &
validation in the production environment (no QA and/or
Validation Environment)
 Not 21 Code of Federal Regulations (CFR) compliant
 No Electronic Signatures
 No Version Control
 No SOPs describing the document management process
 No defined workflows
 No defined document lifecycle
Scenario / History
2005
Scenario / History
Scenario / History
January 2005
Departmental initiative to upgrade/implement electronic
systems:
1. Implementation of an electronic submissions
management system (software = docuBridge)
2. Implementation of a structured product labeling (SPL)
system (software = i4i Alice)
3. Implementation of an electronic document management
system (software = Documentum)
Scenario / History
December 2005:
1. Implementation of an electronic submissions management system
(docuBridge 3.6 SP2)
2. Implementation of a structured product labeling (SPL) system (i4i Alice)
3. Implementation of an electronic document management system
(Documentum)
Scenario / History
December 2005:
Paper Format
(IND, Annual
Reports)
Paper Format
DocuBridge
Local File Share
Local File Share
Electronic
Format
(eCTD, eIND,
eNDA, etc.)
Electronic
Format
Approach
User Requirements for the Documentum System
 User Friendly
 Bulk Import
 Bulk Assignment of document attributes upon import
 21 CFR Part 11 Compliant
 Maintain internal hyperlinks when documents are rendered to PDF
 Provide a repository for archival of regulatory submissions
 Interface with the docuBridge submissions management software
 Minimize customizations for the first release
 And have it all done in 4 months…
Approach
Hardware / Software
 Our approach was to use out-of-box options as possible to minimize rework and revalidation when we upgrade in the future.
 Out-of-the-box options were left enabled in most cases to allow for
system flexibility and process improvement.
 Use configurations rather than customizations in order to minimize
development time and potential rework in future releases and
upgrades.
 ADTS was selected to allow for hyperlinks to render correctly in the
system. We wanted to minimize rework in this area and used this
technology to create and maintain hyperlinks automatically rather
than manually.
 Due to the inexperience of using a document management system
in our area, this approach was effective since user requirements /
expectations were reasonable.
Approach
Hardware / Software
 WebTop (5.3 SP2)
 PDF Annotation Services (5.3 SP2)
 Apache Tomcat J2EE (5.0.28)
 Documentum Administrator (5.3 SP2)
 Oracle 10g
 Solaris 10i
 Red Hat Linux ES 4
 Microsoft Windows 2003 Server
 Content Server Full Text Indexing (5.3
SP2)
 docuBridge 3.6 SP2
 Adobe Acrobat 6.0
 Advanced Documentum Transformation Services (5.3 SP2)
Approach
Hardware / Software
 Develop a controlled code promotion and testing strategy –
including development, QA and production environments and
code promotion strategy.
Development
Check In / Promotion
Criteria (Complete
Unit Test & Code
Review)
QA
Production
Check In / Promotion
Criteria (Complete
Validation Test & Sign of
Validation Summary
Report)
Approach
Project Team
 Assemble a focused project team including subject matter experts
from Regulatory Affairs and Medical Writing, full time QA resource and
dedicated IT Manager and resources.
 Define the business process
 Create user requirements
 Create functional requirements
 Build design and define configurations
 Build out IT infrastructure to support the system
 Develop training and roll-out plan
 Manage project scope
Approach
Project Team
 Assemble
a focused project team including subject matter experts
Project Team:
from Regulatory Affairs and Medical Writing, full time QA resource and
1 System Owner
dedicated IT Manager and resources.
1 Technical Project Manager
 Define the business process
1 Business Analyst
 Create user requirements
1 QA Resource
 Create functional requirements
1 IT Analyst
 Build design and define configurations
3 Consultants
 Build out IT infrastructure to support the system
 Develop training and roll-out plan
 Manage project scope
Approach
Target System at the conclusion of the project
Paper Format
ADMS
DocuBridge
Electronic
Format
Solution
ADMS:
ADMS
ADMS Working
ADMS Archive
 Creation / Import
 Archive submissions &
correspondence
 Workflows
 Electronic signatures
 docuBridge Connection
 Limited access
Solution
ADMS:
ADMS
The folder structure for the working cabinet
ADMS resembles
Working the CTD submission
ADMSstructure.
Archive This
enables
the submissions personnel
entering the &
 Creation
/ Import
 Archive submissions
documents to place the documents
in the same
correspondence
 Workflows
location as they will appear in the submission.
 Limited access
 Electronic
signatures
The folder
structure for the archive cabinet will
be buildConnection
by the submissions personnel as
 docuBridge
submissions are made to the regulatory
authorities.
Solution
Solution
Solution
ADMS:
 Major Configuration Items:
 Document Types
 Document Attributes
 Document Lifecycle
 Workflows
Solution
ADMS:
 Major Configuration Items:
 Document Types
 Created 20 document types for the working cabinet
 Created 1 document type for the archive cabinet
 Document Attributes
 Document Lifecycle
 Workflows
Solution
ADMS:
 Major Configuration Items:
 Document Types
 Document Attributes
 Created corresponding attributes for each document
type.
 The astellas_doc type held common attributes
 Subsequent document_types held specific attributes
 Document Lifecycle
 Workflows
Solution
ADMS:
 Major Configuration Items:
 Document Types
 Document Attributes
 Document Lifecycle
 Defined a document lifecycle for all documents in ADMS
Draft
Route for Review
Route for
Submissions
Ready
Submissions
Ready
 Workflows
Superceded
Solution
ADMS:
 Major Configuration Items:
 Document Types
 Document Attributes
 Document Lifecycle
 Workflows
Three Workflows for ADMS documents
 Route for Review w/ PDF annotations
 Route for Submissions Ready w/ eSig
 Route for Submissions Ready w/o eSig
Solution
ADMS – docuBridge connector:
Connector functionality:
 Automatically move submissions ready documents from
ADMS to docuBridge
 Automatically move document attributes from ADMS to
docuBridge
 Allow for users to manually select documents to move to
docuBridge
Solution
ADMS – docuBridge connector:
Connector functionality:
 Automatically move submissions ready documents from
ADMS to docuBridge
 When a document is promoted to the “Submissions
Ready” lifecycle state, the document is moved to
docuBridge
 Automatically move document attributes from ADMS to
docuBridge
 Allow for users to manually select documents to move to
docuBridge
Solution
ADMS – docuBridge connector:
Connector functionality:
 Automatically move submissions ready documents from
ADMS to docuBridge
 Automatically move document attributes from ADMS to
docuBridge
 When a document is moved to docuBridge, its attributes
are also moved into docuBridge
 Allow for users to manually select documents to move to
docuBridge
Solution
ADMS – docuBridge connector:
Connector functionality:
 Automatically move submissions ready documents from
ADMS to docuBridge
 Automatically move document attributes from ADMS to
docuBridge
 Allow for users to manually select documents to move to
docuBridge
 Provide a manual interface to move Draft documents
from ADMS to docuBridge
Solution
Solution
ADMS – docuBridge connector:
ADMS Lifecycle
Paper Format
Doc A
Draft
Submissions
Ready
DocuBridge
Attribute A
Attribute B
Attribute C
Electronic
Format
Solution
ADMS – docuBridge connector:
ADMS Lifecycle
Paper Format
Doc A
Draft
Submissions
Ready
DocuBridge
Attribute A
Attribute B
Attribute C
Electronic
Format
Part II
ADMS v.1.2
 Update the ADMS and docuBridge document types and
attributes to be consistent
 Validate docuBridge against Adobe 6.0 and 7.0
Part II
ADMS v.1.2
 Update the ADMS and docuBridge document types and
attributes to be consistent
 The first phase solely focused on developing the ADMS
document types and attributes. This phase requires the
document types and attributes to be synchronized between
systems.
 Addition of document types and properties to both
systems to ensure data consistency.
 Validate docuBridge against Adobe 6.0 and 7.0
Part II
ADMS v.1.2
 Update the ADMS and docuBridge document types and
attributes to be consistent
 Validate docuBridge against Adobe 6.x and 7.x
 Our corporate standard for Adobe will change to 7.x in
August. We validated Adobe 6.x to include users of the
SPL application that will not upgrade. We were validated
against Adobe 5.x, 6.x and 7.x.
Future
ADMS
 Creating an interface for the management of Standard
Operating Procedures (SOPs) within ADMS
 Creating an interface for Validation documents within ADMS
 Integration with the SPL system
 Integration/replacement of the global document exchange
into ADMS
 Integration with the global document management system
Future
Conclusion
ADMS
 Implementing a system in 4 months takes a dedicated team
and strict management of scope.
 Good requirements (both User and Functional) are the basis to
managing scope.
 Build an IT infrastructure for developing and promoting code
for a validated application.
 Using primarily out-of-the-box functionality allowed for a fast,
flexible and cost-effective solution for our user base.
 The new system enhanced the current business process and
reduced manual steps (ADMS – docuBridge integration).
Questions
?