SAM #FDA-75F40126Q00115

FDA Solicitation for SciNote ELN Software License Renewal, Support, and Expansion

The U.S. Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), is seeking renewal and expansion of SciNote Electronic Laboratory Notebook (ELN) software licenses and related support for its laboratories in Silver Spring, MD and Saint Louis, MO. - Government Buyer: - U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), and Office of Translational Sciences (OTS) Division of Applied Regulatory Science (DARS) - OEMs and Vendors: - SciNote (OEM) - Products/Services Requested: - Renewal of 270 SciNote ELN software licenses (base year), with an option for up to 150 additional licenses - Technical support for all licenses, including software updates, bug fixes, and helpdesk support (Monday–Friday, 8AM–8PM EST) - Project management, configuration, and implementation support for on-premises installations - Training for up to 270 users, including at least one in-person session per location and online sessions as needed - Professional services for post-implementation customization and improvements (up to 400 hours) - Integration with ItemAware inventory system, ChemDoodle software, and Microsoft Office Online - Unique/Notable Requirements: - Brand name or equivalent solutions permitted if all technical requirements are met - ELN must support on-premises installation and integration with specified third-party systems - Compliance with ISO 17025 and Section 508 accessibility standards - Documentation, validation protocols, reports, and user guides required as deliverables - Two 12-month option periods for renewal and expansion - Place of Performance/Delivery: - FDA White Oak Campus, Silver Spring, MD - FDA Saint Louis Facility, Saint Louis, MO

Description

This request is to renew SciNote Electronic Laboratory Notebook (ELN) software (licenses and support) for the FDA/CDER labs. Brand name equivalent products shall meet all technical requirements, and the contractor must provide configuration, professional services, training, and implementation services to transition existing ELN into equivalent ELN. SciNote ELN software is within lifecycle of approved software and satisfies all security and technology requirements from FDA. SciNote ELN software is installed on premises and actively used by FDA labs. Contractor must provide renewal for licenses, support for current on-premises installations, support for current integration with inventory system (ItemAware), ChemDoodle software, and Microsoft Office Online. Contractor must provide training and professional services.

The Contractor shall provide FDA/CDER labs with consultation and integration assistance including documentation and training deliverables. The required documentation from the contractor will include all executed validation protocols, reports and User Guide/manual for reference.

The Government will award a contract resulting from this solicitation to the responsible quoter as a fixedprice contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the noncost factor (technical conformance to the requirements of the solicitation). The Quoter's initial quotation shall contain the Quoter's best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not beconsidered for award.

The following factors shall be used to evaluate quotes:

- Total price.

- Technical features meeting/exceedingrequirements specified in Section 4, 5 and 6.

In addition, "or Equal" quotes will be evaluated in accordance with FAR provision52.211-6: Brand Name or Equal, paragraph (c). Each "or Equal" solution proposed shall demonstrate:

- A technical volume withdetailed point-by-point description of how the equal to product meets all the salient characteristics of this solicitation, specialized inSections 4, 5, and 6.

- Completed Section 508 Product Accessibility Templates (PAT) in full text.

For further details, please review the attached RFQ FDA-75F40126Q00115_ document.

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