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This Subcontract opportunity from Department Of Defense was posted on November 5, 2025. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

21 CFR Part 11 Compliance and Software Validation

Closed
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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AI Contract Overview

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This subcontract, issued by the Naval Surface Warfare Center under the Department of Defense, requires the software and firmware in mass comparators to be brought into compliance with 21 CFR Part 11 standards for electronic records and signatures. The primary objective is to ensure that all digital documentation and signatures meet specific regulatory requirements for authenticity and reliability. The selected contractor must provide critical deliverables, including the Software Version Description identified as CDRL A003 and comprehensive validation documentation. This project is categorized under NAICS code 541511 and will be performed in Beaufort, South Carolina. Responses to this opportunity are due by November 21, 2025.

General Info

Agency

Department Of Defense → Naval Surface Warfare Center

NAICS

541511 - Custom Computer Programming Services

Place of Performance

Beaufort, SC, 29904, USA

Set-Aside

NONE

Documents

This scope was carved out of N6426726R1000.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Defense → Naval Surface Warfare Center
ContactsNo contacts available
OfficeN/A
Organization / AgencyDepartment Of Defense → Naval Surface Warfare Center
Office AddressN/A
ContactsNo contact information available

Full Description

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Ensure software/firmware in mass comparators complies with 21 CFR Part 11 for electronic records and signatures. Deliver Software Version Description (CDRL A003) and validation documentation.

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