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Regulatory Compliance & Validation Documentation

Active

Federal

Response Deadline07/31/2026, 11:00:00 AM 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 contract requires the preparation of comprehensive system validation packages, audit trails, and compliance documentation tailored to support FDA inspections and internal audits, with specific emphasis on meeting the requirements of 21 CFR Part 11 for electronic records and signatures. The deliverables must ensure full regulatory alignment and provide traceable, reliable evidence of system integrity and control throughout the validation lifecycle, covering all aspects necessary to withstand rigorous scrutiny from federal regulators and internal compliance teams. The work is classified as a subcontract under NAICS code 541611, with performance based in Bethesda, Maryland, 20892, and is managed by the Program Support Center Acquisition Management Service under the Department of Health and Human Services. Responses are due by July 31, 2026, at 11:00 AM, with the opportunity posted on July 28, 2026. No set-aside designation is specified, and the contract is accessible through the SAM.gov platform for eligible subcontractors seeking to support federal compliance initiatives in regulated industries.

General Info

Prepare FDA-compliant validation packages and 21 CFR Part 11 documentation for Bethesda-based federal audit support.

Agency

Department Of Health And Human Services → Program Support Center Acq Management SvcView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedJul 28

subcontract

Response DeadlineJul 31

Submission deadline

Response Deadline

07/31/2026, 11:00:00 AM UTCin 1 day

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Program Support Center Acq Management Svc

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → Program Support Center Acq Management Svc

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Office AddressN/A

ContactsNo contact information available

Full Description

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Preparation of system validation packages, audit trails, and compliance documentation to support FDA inspections and internal audits, including 21 CFR Part 11 validation reports.

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