Attachment 5 - Offerors Questionnaire.doc

Offerors Questionnaire

Attachment 5 - Offerors Questionnaire for

Laboratory Information Management System (LIMS) Integration and Development Contract

1.

LIMS Vendor Information

Vendor responses to this request shall contain the following points. Responses shall not exceed 5 total pages using the same submission criteria listed in the “Instructions for Proposal Submission” section of the solicitation document. Responses to this questionnaire are not part of the 50 page limit for the technical proposal.

1. LIMS Vendor’s Organization History

1.1. Year company was founded

1.2. Number of years in the LIMS business

1.3. Number of staff in the organization

1.4. Number of staff assigned to LIMS-related operations

1.5. Number of staff in LIMS development

1.6. Describe vendor’s certifications (e.g. CMMI, ISO)

1.7. Describe history of vendor’s LIMS development efforts

1.8. Date of original version, if applicable

1.9. Date of current version, if applicable

2. Current Installation Base

2.1. Total number of unique customer installations

2.2. Total number of LIMS customers on latest version

2.3. References for two LIMS customers on latest version with LIMS needs similar those stated in this RFP

2.4. References for two additional customers

2.5. Total number of concurrent user licenses or workstations on which LIMS software is installed

2.6. Number of LIMS tailored installations per lab

3. Product Marketing

3.1. Describe primary LIMS market

3.2. Market presence – vendor’s established market share/customer base in the LIMS business

3.3. Is product marketed as (indicate all that apply):

· Part of a “bundled” product,

· Part of multi-vendor suite, or

· A stand alone product offering.

3.4. Describe any warranty provided (length, coverage).

3.5. New version and release strategy (how often and to whom available).

3.6. R&D Investment – vendor’s level of R&D investment and their focus on overall future direction of product

4. Implementation Support (installation, training, database conversion)

4.1.

Describe application and database installation procedure.

4.2.

Describe the administrative and user training provided as a part of the implementation process.

4.3.

Describe legacy data migration and conversion to LIMS

4.4.

Describe database conversion tools/programs used for converting a legacy database.

5. LIMS Technical Support

5.1.

Describe Help Desk support and problem investigation including:

· Hours of operation,

· Access method(s) (800 numbers, Internet, on site, on-line remote, etc.),

· Help desk operator training and LIMS experience,

· Issue-logging mechanism,

· Documentation of complaint history and resolution.

5.2.

Describe strategy for system patches and fixes including:

· Application method: individually or in groups

· Mode of deployment to user site (remote, by user, etc.)

· Recipients of systems patches and fixes (entire customer base, version specific users only, etc.)

· Describe bug-fix priority and average timeframe between report and installed fix.

5.3.

Describe continuing training opportunities (if any)

5.4.

Describe how new versions and releases are deployed.

6. User Groups and Other Services

6.1.

Name of user group and contact information (name, phone number, address and/or e-mail address).

6.2.

Group organizational structure and membership requirements.

6.3.

Describe group purpose and objectives.

6.4.

Frequency of meetings and location(s).

6.5.

Number of members (organizations and average attendance at last two meetings).

6.6.

Describe other customer services and benefits.

7. Vendor Risk Assessment

7.1.

Provide Dunn & Bradstreet rating if available.

7.2.

Percent personnel turn over last year.

7.3.

Provide financial statement (balance sheet, income statement for last full year).

8. Documentation

8.1.

Describe the level of detail addressed by the documentation (e.g., general operation, low level configuration, report design, Application Programmatic Interface access, etc.).

8.2.

Describe on-line documentation that can be accessed by the user directly from the application screens.

8.3.

Describe the organization of the documentation and provide a hard copy version for evaluation.

2.

LIMS Characteristics

Vendor responses to this request shall contain the following:

1. General Characteristics of the LIMS

1.1.

Describe the basic system architecture (web based, client server, multi-tiered, etc.) and operating architecture (server location, etc.).

1.2.

Describe the operating systems supported on the client (if applicable) and the server.

1.3.

Describe any database back-ends supported and do they use native drivers, ODBC, JDBC, or another access technology.

1.4.

Describe whether a customer has direct read and write access to the underlying data within the COTS and if so, through what tools, mechanisms, and/or designs.

1.5.

Describe user interfaces supported (thin client, thick client, Web, Portable Digital Assistant, Application Programmatic Interface, any form of ActiveX Data Objects, Dynamic Data Exchange, .NET, ADF, Spring, etc.)

1.5.

Describe user interfaces supported (thin client, thick client, Web, Portable Digital Assistant, Application Programmatic Interface, any form of ActiveX Data Objects, Dynamic Data Exchange, .NET, ADF, Spring, etc.)

1.6 Describe Application Programming Interfaces (APIs) and its applicability for LIMS configurations

1.7.

Describe how site synchronization is achieved in the event of network failure in multi-site implementations if separate site servers are utilized.

1.8.

Describe other products with which the LIMS is designed to integrate.

1.9.

Describe the user interfaces supported by the product that are used by two or more customers (include PDA, Web, GUI, etc.)

1.10.

Describe whether a customer can install multiple non-interacting instances of the LIMS in order to support development, pre-production (or integration), training, and testing. If so, describe the most common approach used by customers and give two supporting customer references.

1.11.

Describe the system audit trail capability.

1.12.

Describe the minimum requirements for workstations and associated peripherals such as printers and bar code readers.

1.13.

Describe methods of user authentication used in the system.

1.14.

Describe the degree of user customization of the system, including configuration tools and user management.

1.15.

Discuss the strategy for deploying any product at multiple sites.

1.16.

Discuss, present, and weigh options for using MARCS components or other ORA systems instead of or complementary to components of various LIMS COTS.

1.17. Discuss the data back-up and recovery strategies and features.

1.18. Discuss the configuration and management tool.

1.19. Describe performance requirements.

1.20. Describe instrument integration strategy/protocol for their product to some standard instrument (and give a few examples of these lab instruments)

1.21 Discuss standard based mechanisms such as OLE for Process Control (OPC) and AnIML (XML based standard) for instrument integration.

2. Database

2.1.

Specify the name of database management product if one is used. FDA requires compatibility with the ORACLE 11g suite.

2.2.

Describe the data model (flat file, relational, object-oriented, proprietary, etc.).

2.3.

Specify the size of largest customer installed LIMS database (GigaBytes/PetaBytes and number of test records).

2.4.

Describe relationship of server size to database size and impact of server memory (all in relationship to system response time).

2.5.

Describe impact of workstation sizing on response time (if any).

2.6.

Describe relationship of response time to number of concurrent users.

2.7.

Provide the maximum number of concurrent users who can be efficiently supported.

2.8.

Specify the application development languages supported.

2.10.

Describe the database tools supplied along with the application.

2.11.

Describe the archiving capability and approach utilized in the LIMS application.

2.12.

Describe the audit trail capability and approach utilized to address HIPAA requirements.

2.13.

Describe method and frequency of and requirements for data backup and recovery.

3. SOA

3.1.

Specify the Web Service Standards supported. FDA is seeking compatibility with the ORACLE SOA 11g suite.

3.2.

Specify the Portal Standards supported (WSRP, JSR 168, JSR 268, Portlet, etc.).

3.3.

Specify the BPM Engine used. FDA is seeking integration compatibility between LIMS BPM and ORACLE BPMS.

3.4.

Specify Messaging Support (JMS, FILE/FTP, MQSeries, and Web Service).

3.5.

Specify JCA Adaptor Support.

3.6.

Specify SOA Security Standards supported.

3.7.

Specify B2B Support.

3.8.

Specify SOA Service Discovery Support.

3.9.

Describe SOA Service Life Cycle Management Process.

3.10.

Describe SOA Governance Process using SOA Repository.

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