GxP Auditing

Harbor Clinical’s team of GxP auditors is available to help you plan, schedule, manage, and conduct your site/vendor audits.

Whether you need initial qualification, routine surveillance, a for-cause investigation, CAPA follow-up, or pre-inspection readiness; Harbor Clinical provides independent GxP auditing services. The result is a practical audit that goes beyond findings: clear expectations, actionable remediation, and stronger sponsor control. Audits are conducted across the clinical development lifecycle, including site, vendor, system, and process audits conducted for:

qualification,
routine oversight,
for-cause investigations,
regulatory readiness.

Our global network of experienced auditors delivers consistent, inspection-ready assessments aligned with international regulatory expectations, while focusing on actionable findings that strengthen compliance, quality systems, and sponsor oversight, wherever your program operates.

Audit Types include:

Extensive GxP Experience

With an extensive, skilled, and geographically-dispersed audit team, we can accommodate your audit in any location against an array of Good Practices including:

GCP - Good Clinical Practice

Led by senior auditors with hands-on site, CRO, and sponsor oversight experience, our GCP audits focus on real-world trial execution, risk signals, and inspection defensibility—whether qualifying partners, supporting oversight, or preparing for regulatory inspection.

GMP – Good Manufacturing Practice

Our GMP audits are conducted by auditors with deep manufacturing and quality system backgrounds, supporting CMO/CDMO qualification, ongoing oversight, and QP release readiness. We focus on practical GMP risk, documentation integrity, and supply chain impact.

GDP – Good Distribution Practice

We audit global depots and logistics providers with a strong understanding of temperature-controlled supply chains and international distribution models, helping sponsors maintain product integrity and regulatory compliance across regions.

GLP – Good Laboratory Practice

Our GLP audits are performed by auditors experienced in nonclinical and preclinical environments, with emphasis on data integrity, study traceability, and regulatory expectations for submissions and inspections.

GVP – Good Pharmacovigilance Practice

Harbor Clinical’s GVP audits leverage deep pharmacovigilance and safety operations expertise, assessing global safety systems, vendor performance, and sponsor oversight to support compliance, inspection readiness, and risk management.

GxP Computerized Systems / CSV

Our auditors bring combined quality and system validation expertise, enabling meaningful assessments of GxP computerized systems beyond checklists—focusing on data integrity, system lifecycle control, and inspection-ready documentation.

GCLP – Good Clinical Laboratory Practice (where applicable)

We audit central and specialty laboratories with direct experience in clinical sample workflows, ensuring alignment with protocol requirements, data integrity expectations, and regulatory scrutiny.

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Discover how Harbor Clinical can assist your company. Committed to quality. Committed to you.

Functional Service Provision

Functional, Flexible, and Fractional. Harbor Clinical provides a broad portfolio of services across the clinical development lifecycle.

GxP Auditing

Audit Types include:

Extensive GxP Experience

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Functional Service Provision

Quality Assurance Services