About FDA
Enhanced Regulatory Workflow through Project Management System
Description: Implement enhanced Project Management System to monitor and improve regulatory workflow and milestone completion for licensing actions in the Office of Vaccines Research and Review
Accomplishment: TBD
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
A. Evaluate system requirements |
1/13/2010 |
Completed | 1/13/2010 |
|
B. Identify system resource requirements |
1/31/2010 |
Completed | 1/31/2010 |
|
C. Define pilot program |
3/21/2010 |
Completed | 3/21/2010 |
|
D. Develop project management templates |
4/14/2010 |
Completed | 4/14/2010 |
|
E. Install software on Regulatory Project Manager (RPM) computers |
4/14/2010 (12/31/2010) |
Completed | 10/27/2010 |
|
F. Train staff for managing the review of active submissions |
4/14/2010 |
Completed | 4/14/2010 |
|
G. Complete first Monthly Action Update using new system |
4/14/2010 |
Completed | 4/14/2010 |
|
H. Conduct review of system after first monthly update with staff |
4/30/2010 |
Completed | 4/30/2010 |
|
I. Conduct assessment after 3 months of deployment |
7/15/2010 |
Completed | 7/15/2010 |
|
J. Conduct assessment after 6 months of deployment |
10/15/2010 |
Completed | 10/15/2010 |
|
K. Conduct assessment after 12 months of deployment |
4/30/2011 |
Completed | 3/25/2011 |
|
L. Refine project system before full deployment |
4/30/2011 |
Completed | 4/30/2011 |
|
M. Go/No Go decision for full deployment |
5/7/2011 |
Completed | 5/7/2011 |
|
N. Implement system Office-wide |
5/14/2011 |
Completed | 5/14/2011 |
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |
Glossary
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.







