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Software Validation & Regulatory Compliance Support

Active

Federal

Response Deadline08/20/2026, 02:00:00 PM UTC

Contract Overview

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

AI Contract Overview

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The Department of Veterans Affairs is seeking a subcontractor to provide comprehensive software validation and regulatory compliance support for the FCS Express Clinical Edition. The primary objective of this engagement is to deliver Installation Qualification, Operational Qualification, and Performance Qualification services to ensure the software is fully validated in accordance with FDA requirements and 21 CFR Part 11 standards. This opportunity is categorized under NAICS code 541690 and is managed by the Network Contract Office 8. Interested parties must submit their responses by the deadline of August 20, 2026, following the posting date of August 14, 2026.

General Info

VA seeks subcontractor for FCS Express software validation and FDA regulatory compliance support.

Agency

Department Of Veterans Affairs → 248-NETWORK Contract Office 8 (36C248)View Agency

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

FL

Set-Aside

NONE

Documents

This scope was carved out of 36C24826Q1122.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

7A21--FCS Express Clinical Edition

AI Contract Breakdown

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Timeline

PostedAug 14

subcontract

Response DeadlineAug 20

Submission deadline

Response Deadline

08/20/2026, 02:00:00 PM UTCin 5 days

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 248-NETWORK Contract Office 8 (36C248)

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Veterans Affairs → 248-NETWORK Contract Office 8 (36C248)

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Office AddressN/A

ContactsNo contact information available

Full Description

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Provide Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) services to validate FCS Express Clinical Edition in compliance with 21 CFR Part 11 and FDA requirements.

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