Appendix 2-CSC Future State.ppt

PPT presentation 2 MB Posted Jul 17, 2012

Attached to: Regulatory Review Support
Solicitation number: RFP-12-223-SOL-00161
Issued by: Department of Health and Human Services Food and Drug Administration

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Appendix 2 - Future State

File	Type	Posted
RFP FDA-SOL-12-1100474 IDIQ Regulatory Review Support - Amendment 1 JGF.pdf	PDF	Aug 16, 2012
Revised RFP-12-223-SOL-00161.pdf	PDF	Jul 26, 2012
Amendment 1 - RFP-12-223-SOL-00161.pdf	PDF	Jul 26, 2012
Attachment 5 IDIQ Pricing Worksheet.xls	XLS spreadsheet	Jul 17, 2012
Appendix 1-CDER Process for Adoption of Standard.pdf	PDF	Jul 17, 2012
Appendix 4-CSC Process Configuration.pdf	PDF	Jul 17, 2012
Appendix 5- CSC Process Configuration Map.pdf	PDF	Jul 17, 2012
Appendix 3-CSC_Tools Timeline.ppt	PPT presentation	Jul 17, 2012
Appendix 7-Application Review Process Model.ppt	PPT presentation	Jul 17, 2012
RFP-12-223-SOL-00161.pdf	PDF	Jul 17, 2012
Appendix 6-CDER CS Technical and Functional Capability Phases.pdf	PDF	Jul 17, 2012

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Future State

Support for: Analysis, Data Prep, Training

Reviewer Portal Business Process Modeler Toolbox/ Depot Search Technology

Interaction with Sponsor (Phase 1, 2, 3) CSC runs data quality checks and loads into Janus Data and analysis are accessed through technology

Sponsor submits standardized data to CDER

File details come from the government source that posted it. Updated Nov 14, 2017.