# Presentation: 301153

## Center for Veterinary Medicine:Document Management Now and Future

- Jerome J. McDonald, Ph.D.Center for Veterinary Medicine
- presented at:
- DIA Document Management ConferenceFDA Panel Discussion
- February 13, 2003

## 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

## 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.

## 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

## Slide 6

## 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 WWW.FDA.GOV/CVM for details
- Electronic Submissions link:
- www.fda.gov/cvm/index/esubs/esubstoc.html

## 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

## Integrated Environment

- _STARS_

- _CDMS_

- _Mediator_

- ESS

- CD

- Scanned file

- Assignment
- Tracking
- Performance
- Completion time
- Appl. Summary
- Reviewer access
- Mgt. reports

- Recognition
- Process

- Build
- Process

- Communication
- Process

- Repository
- Indexed docs.
- File cabinets
- Workflows
- Publication
- Archiving

## 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

## Stage 1 - Baseline

- Documents stored on LAN by 4 processes:
- Manual
- Labeling supplement letters
- Drug Experience Report letters
- Electronic Submission System

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## 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