Center for Veterinary Medicine: Document Management Now and Future

Jerome J. McDonald, Ph.D.
Center for Veterinary Medicine

presented at:
DIA Document Management Conference
FDA Panel Discussion
February 13, 2003

Slide 2

Strategy for Document Management

• Integrated environment for conducting reviews
  
• Unite the various repositories for files and documents
  
• Unified searches for subject matter
  
• Leverage previous development
  
• Communicate between applications

  Result: Application environment combining both presentation and storage of reviews

Slide 3

Submission Tracking and Reporting System (STARS)

• Implemented in Oracle and is part of the Corporate Database Portal (CDP).
  
• Recording, tracking, and disposing submissions received from the regulated industry in support of (A)NADAs
  
• Implements the CVM pre-marketing review and approval process by maintaining detailed information on the status of a submission, personnel assigned to the review, location, due dates and time spent in review.
  
• Provides reviewers with a prioritized list of review assignments based on due date
  
• Provides managers with status information on any submission under review,
  
• Provides an expanding capability for reviewers to summarize their findings as part of the STARS database.
  
• Active link to an electronic submission stored in a secure area of the CVM LAN.
  
• Contains the history of submission reviews leading to the approval of a New Animal Drug Application (NADA).
  
• Repository of information about marketing conditions.
  
• Extensive capability for consulting reviews.
  
• Extensive suite of production reports.
  
• Input by DCU, reviewers, and information specialists.
  
• Tracks consulting reviews from DERS.

Slide 4

Electronic Submission System (ESS)

• Submission received as PDF attachment to formatted e-mail message
  
• Automated processing of PDF
  
  • Information extracted and submission created in STARS
    
  • Decrypted attachment filed on LAN
    
• Submitter receives confirmation of submission registration by e-mail
  
• Submission file is recorded and is viewable in STARS

Slide 5

Image - Screenshot of Corporate Database Portal

List of all Submissions for Document

Slide 6

Image - Screenshot of STARS 2000

Pending Submission Location/Status

Slide 7

ESS Update

• Protocol submission in pilot process 9/19/02
  
• Guidance to be published in 3 weeks
  
• Available for 60-day comment period
  
• Process opened to all participants
  
• Go to CVM's Home Page for details
  
• Electronic Submissions link
   

Slide 8

Corporate Document Management System (CDMS)

• Based on Documentum
  
• Knowledge management
  
• Interface for reviewer processes
  
• Workflow modeling and automation
  
• Electronic records
  
• Electronic signatures
  
• Connection to data applications

Slide 9

Integrated Environment

Image of a chart

Slide 10

Migration Pathway

• Stage 1 - Documents available on LAN (Baseline)
  
• Stage 2 - Improve search ability of documents
  
• Stage 3 - Adapt archiving processes to CDMS
  
• Stage 4 - Processes automated for document lifecycle
  
• Stage 5 - Documents related to submission encapsulated by index

Slide 11

Stage 1 - Baseline

Documents stored on LAN by 4 processes:

• Manual
  
• Labeling supplement letters
  
• Drug Experience Report letters
  
• Electronic Submission System

Slide 12

Manual Storage Process

• Review documents, files, and action letters produced via Office suite
  
• Stored in read-only area of LAN by gatekeeper
  
• Collected in folder designated by completed submission document
  
• LAN filename denotes submission and action type

Slide 13

Labeling Supplement Letter

• Interface allows entry of information into STARS by reviewer
  
• Draft action letter generated as Oracle Report
  
• Draft may be edited
  
• Reviewer archives letter in interface
  
• DCU operator closes the review
  
• Review generated in STARS as Oracle Report

Slide 14

Drug Experience Report Letter

• Interface allows entry of information into DERS by reviewer
  
• Draft action letter generated as Oracle Report
  
• Draft may be edited
  
• Reviewer archives letter in interface
  
• Reviewer closes review in interface
  
• Review generated from DERS as Oracle Report

Slide 15

Stage 2 - Migration to CDMS

A four step process:

• Document selection
  
• Obtaining information about document
  
• Loading coordination tables in database
  
• Move documents into CDMS and update coordination tables with object link
  
• Implemented with Visual Basic and Java with embedded Oracle stored procedures
  
  Slide 16

Stage 2 - Results

• Documents and files archived on LAN now incorporated into CDMS and available there
  
• Stage 1 processes still in effect
  
• Electronic submissions remain stored on LAN but accessible in CDMS
  
• Review documents and letters made visible in the STARS/DERS interface via LAN
  
• Periodic update program migrates new Stage 1 documents

Slide 17

Stage 3 - Processes target CDMS

• STARS labeling supplement letter process updates coordination tables and inserts directly into CDMS instead of LAN
  
• DERS letter process updates coordination tables and inserts directly into CDMS instead of LAN
  
• Gatekeeper for manual process operates in CDMS with update of coordination tables
  
• ESS modified to update coordination tables

Slide 18

Stage 3 - Results

• STARS/DERS interface will display review documents via pointer to CDMS rather than to LAN
  
• Stage 1 process CVM documents no longer stored on LAN
  
• Electronic submissions continue to be stored on LAN

Slide 19

Stage 4 - Automate Manual Processes

• Implement manual review processes in Documentum workflows
  
• Access electronic submissions directly from workflow
  
• Archive review products directly in CDMS
  
• Update transactions in STARS automatically
  
• Update coordination tables

Processes unrelated to transactional database may be implemented directly at this stage

Slide 20

Stage 5 - Encapsulation

• Construct link map of submissions related to a review activity as they are received
  
• Integrate review work products with the link map of the submissions reviewed
  
• Update transactional database
  
• Update coordination tables
  

Processes unrelated to transactional database may be updated also at this stage

Slide 21

A View into the Future

Totally integrated CVM process

• Data available for review
  
• Historical data available online
  
• Electronic review
  
• Automated workflow
  
• Storage and retrieval of information
  
• Web-based communication
  
• Pre and post-marketing information
  
• Data submitted electronically