CFSAN Situational Awareness View (CFSAV)
CFSAN Situational Awareness View (CFSAV) From Prototype to Production in the Federal Environment
Kathleen Cheeseman Simmy Yau February 27, 2013
What is CFSAV? CFSAN + SAV
Center for Food Safety and Applied Nutrition Situational Awareness Viewer
CFSAV • View CFSAN activities • Current focus is on CFSAN data • Accessible by and limited to all of FDA • Allowing future expansion and collaboration across the agency • Allowing display of trade secret information
Context • • • •
FDA Organization CFSAN Culture Drivers and Framework Policies and Procedures
FDA Organization Food and Drug Administration
Office of Operations
Office of Foods and Veterinary Medicine
Information Technology
Center for Food Safety and Applied Nutrition
Office of Medical Products and Tobacco
Office of Global Regulatory Operations and Policy
CFSAN Culture • The scrappy underdog working on a shoestring budget with a long history of using IT to support the scientific work of the center. • No user fees – MUCH lower budget than other parts of FDA. • PhD and MS scientists with research backgrounds. • Leads to LOTS of low-budget experiments outside of formal channels. • CFSAV was one low-budget experiment.
Drivers and Framework • The current FDA IT Strategic Plan lists 37 statutes, regulations, OMB Circulars, and directives that govern our IT development.
OMB OMB Circular OMB Circular A-16 Circular A-16 A-16 ClingerClingerCohen ClingerCohen Act Cohen Act Act
HIPAA HIPAA FSMA FSMA FSMA
How the Process is Supposed to Work
IT, Data, Security and Infrastructure Standards
System Implemented
IT Development
Project Initiated
Procurement
Investment Board Review
Business Need
Enterprise Performance Lifecycle
What Happened • CFSAV was built as a prototype by one guy on a “server” (aka PC). • He showed off the prototype to management. • He left the agency. • Management liked it – wanted to make it more widely available and add more data. • The remaining group members called OIM to help. • Then the fun begins.
How the Process Worked
IT, Data, Security and Infrastructure Standards
System Implemented
IT Development
Project Initiated
Procurement
Investment Board Review
Business Need
Enterprise Performance Lifecycle
Filling in the Missing Pieces
Organization and Staffing • Within CFSAN – A SMALL, multi-disciplinary, Geospatial Information Team. • Providing infrastructure and support to incorporate geospatial information into existing or new business processes.
CFSAN GIS Roles Program Lead and CFSAN Liaison to Agency Coordinates CFSAN GIS efforts Communicates with CFSAN and FDA Management
Business Stakeholders and Critical Partners Per Schedule: • Define Business Requirements • Participate in the drafting of EPLC docs • Participate in User Acceptance Testing • Accept final work product
OAO GIS Analysts Project Manager • Provide Project Support • Perform complex geospatial and statistical analyses • Provide hands on support
COR IT Project Manager • Manage IT Investment • Manage Procurements • Support IT standards Contracting Officer
Partnerships • CFSAN partnered with FDA’s Office of Crisis Management (OCM) via formal MOU providing for shared resources and responsibilities. • CFSAV integrates with OCM ArcGIS Server – providing additional capabilities • OCM manages a consolidated ESRI license package – reducing overhead costs
Business Need and ITIRB • Becomes the responsibility of the new CFSAN Geospatial Information Team in partnership with the supported programs to: – Define the Business Needs – Provide all the documentation for ITIRB review and approval.
• We’re building on our success - have seen year over year increases from FY11, FY12, and planned FY13.
Procurements • IT Development and support generally performed under contract. • IT PM serves as Contracting Officer’s Representative (COR). • We have consolidated some contracts and in FY13 will be consolidating additional contracts.
Hardware Upgrades • From old desktop-turned-server in the basement of the building • To meeting FDA IT Network and Hardware standards
– Including multiple server environments (dev/test/preprod/prod) in high availability data centers. – Including connecting to and utilizing the existing OCM ArcGIS Server – Including EPLC documentation and configuration management – Security Assessments
Software Upgrades (The CFSAV Application Grows) • The CFSAV Application Grows – Initial prototype was the ESRI Out of the Box Viewer – Enhanced prototype added FDA Firm data and Reportable Food Report (RFR) data – The production system adds: • • •
CFSAN Adverse Event Data (CAERS) The HSPD-12 login “module” – securing both the User Interface (UI) and the ArcGIS Server (in progress) Additional data layers
• Upgrade to ArcServer 10.1 to interface with FDA’s LDAP (in progress). • Upgrade to Flexviewer 3.1 to solve some 508 issues (in progress).
And Grows and Grows (the future) • CFSAV will continue to grow and require care and feeding – Additional widgets will be added as new data sources are available – Implement a Configuration Control Board – Hardware and Software upgrades – Additional procurements? – Transition to FTE maintenance?
Questions?
Kathleen Cheeseman Simmy Yau February 27, 2013
What is CFSAV? CFSAN + SAV
Center for Food Safety and Applied Nutrition Situational Awareness Viewer
CFSAV • View CFSAN activities • Current focus is on CFSAN data • Accessible by and limited to all of FDA • Allowing future expansion and collaboration across the agency • Allowing display of trade secret information
Context • • • •
FDA Organization CFSAN Culture Drivers and Framework Policies and Procedures
FDA Organization Food and Drug Administration
Office of Operations
Office of Foods and Veterinary Medicine
Information Technology
Center for Food Safety and Applied Nutrition
Office of Medical Products and Tobacco
Office of Global Regulatory Operations and Policy
CFSAN Culture • The scrappy underdog working on a shoestring budget with a long history of using IT to support the scientific work of the center. • No user fees – MUCH lower budget than other parts of FDA. • PhD and MS scientists with research backgrounds. • Leads to LOTS of low-budget experiments outside of formal channels. • CFSAV was one low-budget experiment.
Drivers and Framework • The current FDA IT Strategic Plan lists 37 statutes, regulations, OMB Circulars, and directives that govern our IT development.
OMB OMB Circular OMB Circular A-16 Circular A-16 A-16 ClingerClingerCohen ClingerCohen Act Cohen Act Act
HIPAA HIPAA FSMA FSMA FSMA
How the Process is Supposed to Work
IT, Data, Security and Infrastructure Standards
System Implemented
IT Development
Project Initiated
Procurement
Investment Board Review
Business Need
Enterprise Performance Lifecycle
What Happened • CFSAV was built as a prototype by one guy on a “server” (aka PC). • He showed off the prototype to management. • He left the agency. • Management liked it – wanted to make it more widely available and add more data. • The remaining group members called OIM to help. • Then the fun begins.
How the Process Worked
IT, Data, Security and Infrastructure Standards
System Implemented
IT Development
Project Initiated
Procurement
Investment Board Review
Business Need
Enterprise Performance Lifecycle
Filling in the Missing Pieces
Organization and Staffing • Within CFSAN – A SMALL, multi-disciplinary, Geospatial Information Team. • Providing infrastructure and support to incorporate geospatial information into existing or new business processes.
CFSAN GIS Roles Program Lead and CFSAN Liaison to Agency Coordinates CFSAN GIS efforts Communicates with CFSAN and FDA Management
Business Stakeholders and Critical Partners Per Schedule: • Define Business Requirements • Participate in the drafting of EPLC docs • Participate in User Acceptance Testing • Accept final work product
OAO GIS Analysts Project Manager • Provide Project Support • Perform complex geospatial and statistical analyses • Provide hands on support
COR IT Project Manager • Manage IT Investment • Manage Procurements • Support IT standards Contracting Officer
Partnerships • CFSAN partnered with FDA’s Office of Crisis Management (OCM) via formal MOU providing for shared resources and responsibilities. • CFSAV integrates with OCM ArcGIS Server – providing additional capabilities • OCM manages a consolidated ESRI license package – reducing overhead costs
Business Need and ITIRB • Becomes the responsibility of the new CFSAN Geospatial Information Team in partnership with the supported programs to: – Define the Business Needs – Provide all the documentation for ITIRB review and approval.
• We’re building on our success - have seen year over year increases from FY11, FY12, and planned FY13.
Procurements • IT Development and support generally performed under contract. • IT PM serves as Contracting Officer’s Representative (COR). • We have consolidated some contracts and in FY13 will be consolidating additional contracts.
Hardware Upgrades • From old desktop-turned-server in the basement of the building • To meeting FDA IT Network and Hardware standards
– Including multiple server environments (dev/test/preprod/prod) in high availability data centers. – Including connecting to and utilizing the existing OCM ArcGIS Server – Including EPLC documentation and configuration management – Security Assessments
Software Upgrades (The CFSAV Application Grows) • The CFSAV Application Grows – Initial prototype was the ESRI Out of the Box Viewer – Enhanced prototype added FDA Firm data and Reportable Food Report (RFR) data – The production system adds: • • •
CFSAN Adverse Event Data (CAERS) The HSPD-12 login “module” – securing both the User Interface (UI) and the ArcGIS Server (in progress) Additional data layers
• Upgrade to ArcServer 10.1 to interface with FDA’s LDAP (in progress). • Upgrade to Flexviewer 3.1 to solve some 508 issues (in progress).
And Grows and Grows (the future) • CFSAV will continue to grow and require care and feeding – Additional widgets will be added as new data sources are available – Implement a Configuration Control Board – Hardware and Software upgrades – Additional procurements? – Transition to FTE maintenance?
Questions?
