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cGMP Compliance Remediation & Gap Closure

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Federal

Contract Overview

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

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The contract involves identifying and addressing compliance deficiencies within the Laboratory Information Management System (LIMS) to ensure adherence to current Good Manufacturing Practices (cGMP). Key activities include process validation, updating documentation, and making necessary system adjustments informed by a Site Process Analysis. The objective is to remediate gaps and enhance the system’s compliance posture. Issued by the National Institutes of Health under the Department of Health and Human Services, this subcontract focuses on services aligned with the NAICS code 541611, which pertains to administrative management and general management consulting services. The work is to be performed in Bethesda, Maryland, and the contract emphasizes thorough evaluation and adjustment of the LIMS system to meet strict regulatory standards, supporting the overall integrity and reliability of laboratory processes.

General Info

Address LIMS compliance gaps through validation, documentation updates, and system adjustments per cGMP standards.

Agency

Department Of Health And Human Services → National Institutes Of Health - CcView 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

PostedJan 7

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → National Institutes Of Health - Cc

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Office AddressN/A

ContactsNo contact information available

Full Description

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Identification and resolution of compliance deficiencies in the LIMS system to meet cGMP standards, including process validation, documentation updates, and system adjustments based on Site Process Analysis findings.

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