Appendix 3-CSC_Tools Timeline.ppt

PPT presentation 75 KB 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 3 - CSC Tools/Analytics Timeline

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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 2-CSC Future State.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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LEGEND:

JREV: JReview CDV: CDER Data Validation MAED: MedDRA-based Adverse Events Diagnostics CSCP: CSC Portal CSCP/SL: CSC Script Launcher NIMS: Non-Clinical Information Mgmt System CSC Timeline for UAT / Go-Live

CSCP - UAT on Test Env Fri 6/15/12 NIMS - Production UAT Fri 6/22/12

CDV - R2.0 UAT

Wed 7/25/12 JREV - Production Release Mon 3/12/12 CDV - R1 Go Live Wed 2/29/12 JREV - R9.2.3 UAT (line 342) Wed 2/22/12

Finish Sat 10/27/12 Apr 15, '12

May 27, '12

Aug 19, '12

Sep 30, '12

MAED - UAT (line 25) Thu 3/1/12

MAED - Go Live Fri 3/30/12

CDV - R1.5 UAT

Tue 4/24/12

NIMS - Pre-Prod UAT Fri 5/4/12

CDV - R1.5 Go Live Mon 5/7/12

CSCP - UAT on DEV (line 282) Wed 5/9/12

NIMS - Go Live Mon 7/16/12

CSCP - Go Live Fri 7/20/12

CDV - R2 Go Live Wed 8/15/12

CSCP/SL - UAT on TEST Wed 10/10/12

CSCP/SL - Integration with Reviewer Portal Thu 10/11/12

CSCP/SL - Go Live Thu 10/18/12 Today

Jul 8, '12

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