Laboratory Information Management System (LIMS) RFP Documentation Package This Laboratory Information Management System (LIMS) Request
for a Proposal (RFP) is documented in the attached sections that describe the U.S. Food and Drug Administration, Office of Regulatory Affairs (ORA) service needs. This documentation is supplemented with attachments that provide in-depth background information that relates to each described system and need described in the RFP documentation. The RFP consists of the following documents: 1. 2. 3. 4. 5. 6. Laboratory Information Management System (LIMS) Request for Proposals (RFP) Statement of Work for LIMS Indefinite-Delivery Indefinite-Quantity Base Contract (same as attachment 1) Statement of Work for Task Order 1 - LIMS Laboratory Assessment and Laboratory Pilots 1 and 2 Statement of Work for Task Order 2 - LIMS Project Management and Technical Coordination and Operations and Maintenance (O&M) Glossary/Acronym Use Attachments (On CD)
The Attachments, in which all are on a Government-provided CD, comprise the following:
Number 1 2 3 4 5 6 7 8 9 File name LIMS IDIQ SOW Pricing Spreadsheet Past Performance Questionnaire Labor Category Descriptions Offerors Questionnaire.doc Task Mapping Matrix.pdf LIMS Project Charter ver 1.0.Redacted.pdf EPLC Overview for Contracts_v1.1.pdf LIMS Solution Conceptual Architecture, Products, SOA v0.4.pdf Summary Statement of Work for the LIMS base contract Spreadsheet for pricing proposal submission Relevant experience questionnaire Descriptions of notional requirements for each LIMS labor category A questionnaire that Offerors shall fill out and include with their proposals. A sample task mapping matrix The LIMS project charter Overview of the FDAs Enterprise Performance Lifecycle (EPLC) framework. A high-level view of a conceptual architecture for a LIMS solution; Existing enterprise wide license agreements that can be used for a LIMS solution; and Considerations regarding the SOA maturity of proposed LIMS solutions. The MARCS framework system design Description of the MARCS framework A list of the LIMS requirements (.xls version) Technical information on the interface with SERS Additional information on the current status of the MARCS framework
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Attachment MARCS Framework 1_0 SystemDesign.pdf Attachment MARCS Framework 2.1.pdf ALM - LIMS Requirements Repository Version 1.0.3 - 01.18.2011.xls Attachment MARCS Interface Control Document for SERS.pdf Attachment MARCS Addendum to MARCS Framework 2.1.pdf
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LIMS RFP Documentation Package
15 16 17 18 19 20 21 22 23 24 25 26 27 Attachment MARCS Roadmap-1.1.pdf Attachment MARCS Interface Control Document for DSS.pdf ALM - LIMS BRD.pdf ALM - LIMS CONOPS Version 1.0 09.22.2010.pdf ALM - LIMS Glossary Version 1.0 09.23.2010.pdf ALM - LIMS SRS Version 1.0.3 01.18.2011.pdf ALM - LIMS To-Be Process Model Version 1.0 - 09.15.2010.pdf ALM LIMS Boundary Document to IT BrB-Redacted.pdf ALM LIMS PPA.v1.0.xls RBIS current and future architecture.pdf HHS Contractor Oversight Guide Section 2.pdf Current MARCS Web Services.pdf ALMLIMS_Configuration_Mgmt_Plan_v1.0.pd f ALM-LIMS_Project_Mgmt_Plan_LIMS v1.1-redacted.pdf ALMLIMS_Requirements_Mgmt_Plan.v1.0.pd f ALM-LIMS_Risk_Mgmt_Plan_v1.0.pdf Security Authorization Toolkit.pdf Severity and Priority Code Descriptions.pdf FDA SDE.pdf DEN Instruments NRL Instrument Survey.pdf Labs - Global Instrument List v1.0 Redacted.pdf Laboratory Staff Size.pdf ORA Lab Locations and Capabilities.pdf WRS_Dev_Test_Zones.pdf The planned MARCS rollout. Technical information on the interface with DCC LIMS Business Requirements LIMS Concept of Operations LIMS Glossary LIMS System Requirements Specification Desired process model of a LIMS The formal LIMS boundary document The LIMS Project Process Agreement (.xls version) The IT architecture of RBIS Security requirements pertaining to Contractordeveloped systems Descriptions of MARCS services and their interlinkages The LIMS configuration management plan
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The LIMS project management plan The LIMS Requirements Management Plan
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The LIMS risk management plan The FDA security authorization instructions Descriptions of the priority and severity codes for the help desk The Developers Guide to the FDA Standard Development Environment Instruments at the Denver laboratory Instruments at the Northeast Regional Lab Global list of instruments at ORA laboratories The number of employees at all ORA laboratories A listing of the ORA labs and their purviews Comprehensive infrastructure implementation specifications for using the White Oak Development Center Contractor's Commitment to Protect Non-Public Information Agreement form Offerors are to complete this checklist and submit with proposal. Description of the LIMS Demonstration Requirement
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FDA 3398 LIMS Mandatory Requirements Checklist Demonstration Instructions
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