This Government Contract opportunity from Department Of Health And Human Services was posted on April 29, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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21 CFR Part 11 Compliance Module Integration & Validation

Closed

Federal

Submission Closed05/10/2026, 03:00:00 AM UTC

Contract Overview

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

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NAICS: 541380

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Tennessee Department of Transportation

POSTED

DEADLINE

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Tennessee Department of Transportation

POSTED

in 10 days

DEADLINE

in 10 days

AI Contract Overview

The contract involves the integration, configuration, validation, and documentation of a compliance module designed to meet the requirements of 21 CFR Part 11. This module is intended to ensure data integrity, maintain comprehensive audit trails, enable electronic signatures, and provide secure access controls for clinical data environments. The goal is to support regulatory compliance in clinical data management by implementing robust technological solutions that align with federal standards. Issued by the National Institutes of Health under the Department of Health and Human Services, the subcontract focuses on services classified under NAICS code 541380. The work is to be performed in Bethesda, with a clear deadline for proposal submission set for May 10, 2026. This project underscores the importance of adhering to stringent regulatory frameworks in clinical research and seeks specialized expertise to validate and document compliance processes effectively.

General Info

Integration and validation of 21 CFR Part 11 compliance module for secure clinical data management.

Agency

Department Of Health And Human Services → National Institutes Of Health Olao

NAICS

541380 - Testing Laboratories and ServicesView NAICS

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PhaseClosed

PostedApr 29

subcontract

Response DeadlineMay 10

Deadline has passed

Submission Closed

05/10/2026, 03:00:00 AM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → National Institutes Of Health Olao

Office AddressN/A

ContactsNo contact information available

Full Description

Configuration, validation, and documentation of the 21 CFR Part 11 compliance module to ensure data integrity, audit trails, electronic signatures, and secure access for clinical data.