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Software Validation and Regulatory Compliance Services

Active

State & Local

Response Deadline11/17/2026, 09:00:00 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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This subcontract for Software Validation and Regulatory Compliance Services supports prime contractors on UT Health San Antonio projects. The scope of work focuses on providing validation and quality assurance for regulated cellular therapy software, specifically executing user acceptance testing and validation scripts for CAR-T and TIL workflows. Key technical responsibilities include the configuration of Chain-of-Identity and Chain-of-Custody processes to ensure strict adherence to 21 CFR Part 11 and HIPAA compliance standards. The selected provider is responsible for delivering critical documentation, including Validation Summary Reports and UAT sign-off. This opportunity falls under NAICS code 541690 and is associated with UT Health San Antonio. Interested parties must submit their responses by the deadline of November 17, 2026.

General Info

Software validation and regulatory compliance services for UT Health San Antonio by November 2026.

Agency

Texas → Ut Health San Antonio

NAICS

541690 - Other Scientific and Technical Consulting Services

Place of Performance

TX, USA

Set-Aside

NONE

Documents

This scope was carved out of 745-27-P07.

The full solicitation package (15 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Cellular Therapy Lab Software

AI Contract Breakdown

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Timeline

PostedOct 9

subcontract

Response DeadlineNov 17

Submission deadline

Response Deadline

11/17/2026, 09:00:00 PM UTCin 24 days

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Organization & Contact Information

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AgencyTexas → Ut Health San Antonio

ContactsNo contacts available

OfficeN/A

Organization / AgencyTexas → Ut Health San Antonio

Office AddressN/A

ContactsNo contact information available

Full Description

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Performs validation and quality assurance for regulated cellular therapy software for prime contractors on UT Health San Antonio projects. Executes UAT and validation scripts for CAR-T and TIL workflows, configures Chain-of-Identity (COI) and Chain-of-Custody (COC) processes, and ensures 21 CFR Part 11 and HIPAA compliance. Delivers Validation Summary Reports and UAT sign-off documentation.

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