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. Laboratory Information Management System (LIMS) Request for Proposals (RFP)

2. Statement of Work for LIMS Indefinite-Delivery Indefinite-Quantity Base Contract (same as attachment 1)

3. Statement of Work for Task Order 1 - LIMS Laboratory Assessment and Laboratory Pilots 1 and 2

4. Statement of Work for Task Order 2 - LIMS Project Management and Technical Coordination and Operations and Maintenance (O&M)

5. Glossary/Acronym Use 6. Attachments (On CD)

The Attachments, in which all are on a Government-provided CD, comprise the following:

Number File name Summary

1 LIMS IDIQ SOW Statement of Work for the LIMS base contract 2 Pricing Spreadsheet Spreadsheet for pricing proposal submission 3 Past Performance Questionnaire Relevant experience questionnaire 4 Labor Category Descriptions Descriptions of notional requirements for each

LIMS labor category 5 Offerors Questionnaire.doc A questionnaire that Offerors shall fill out and

include with their proposals. 6 Task Mapping Matrix.pdf A sample task mapping matrix 7 LIMS Project Charter ver

1.0.Redacted.pdf The LIMS project charter

8 EPLC Overview for Contracts_v1.1.pdf Overview of the FDA’s Enterprise Performance Lifecycle (EPLC) framework.

9 LIMS Solution Conceptual Architecture, Products, SOA v0.4.pdf

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.

10 Attachment MARCS Framework 1_0 SystemDesign.pdf

The MARCS framework system design

11 Attachment MARCS Framework 2.1.pdf Description of the MARCS framework 12 ALM - LIMS Requirements Repository

Version 1.0.3 - 01.18.2011.xls A list of the LIMS requirements (.xls version)

13 Attachment MARCS Interface Control Document for SERS.pdf

Technical information on the interface with SERS

14 Attachment MARCS Addendum to MARCS Framework 2.1.pdf

Additional information on the current status of the MARCS framework

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LIMS RFP Documentation Package

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15 Attachment MARCS Roadmap-1.1.pdf The planned MARCS rollout. 16 Attachment MARCS Interface Control

Document for DSS.pdf Technical information on the interface with DCC

17 ALM - LIMS BRD.pdf LIMS Business Requirements 18 ALM - LIMS CONOPS Version 1.0 -

09.22.2010.pdf LIMS Concept of Operations

19 ALM - LIMS Glossary Version 1.0 - 09.23.2010.pdf

LIMS Glossary

20 ALM - LIMS SRS Version 1.0.3 - 01.18.2011.pdf

LIMS System Requirements Specification

21 ALM - LIMS To-Be Process Model Version 1.0 - 09.15.2010.pdf

Desired process model of a LIMS

22 ALM LIMS Boundary Document to IT BrB-Redacted.pdf

The formal LIMS boundary document

23 ALM LIMS PPA.v1.0.xls The LIMS Project Process Agreement (.xls version)

24 RBIS current and future architecture.pdf The IT architecture of RBIS 25 HHS Contractor Oversight Guide -

Section 2.pdf Security requirements pertaining to Contractor-developed systems

26 Current MARCS Web Services.pdf Descriptions of MARCS services and their interlinkages

27 ALM-LIMS_Configuration_Mgmt_Plan_v1.0.pdf

The LIMS configuration management plan

28 ALM-LIMS_Project_Mgmt_Plan_LIMS v1.1-redacted.pdf

The LIMS project management plan

29 ALM-LIMS_Requirements_Mgmt_Plan.v1.0.pdf

The LIMS Requirements Management Plan

30 ALM-LIMS_Risk_Mgmt_Plan_v1.0.pdf The LIMS risk management plan 31 Security Authorization Toolkit.pdf The FDA security authorization instructions 32 Severity and Priority Code

Descriptions.pdf Descriptions of the priority and severity codes for the help desk

33 FDA SDE.pdf The Developer’s Guide to the FDA Standard Development Environment

34 DEN Instruments Instruments at the Denver laboratory 35 NRL Instrument Survey.pdf Instruments at the Northeast Regional Lab 36 Labs - Global Instrument List v1.0

Redacted.pdf Global list of instruments at ORA laboratories

37 Laboratory Staff Size.pdf The number of employees at all ORA laboratories

38 ORA Lab Locations and Capabilities.pdf A listing of the ORA labs and their purviews 39 WRS_Dev_Test_Zones.pdf Comprehensive infrastructure implementation

specifications for using the White Oak Development Center

40 FDA 3398 Contractor's Commitment to Protect Non-Public Information Agreement form

41 LIMS Mandatory Requirements Checklist Offerors are to complete this checklist and submit with proposal.

42 Demonstration Instructions Description of the LIMS Demonstration Requirement