Categories
Quality & Compliance — GxP Audits & Gap Analyses
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Response Time3 Hours
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Delivery Time3 Weeks
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Location
Service Description
Service Description
Lumanity performs GxP audits and gap analyses to assess clinical, manufacturing, and vendor compliance. Their assessments help identify issues early, reduce regulatory risk, and ensure all partners meet GCP, GMP, and GLP requirements.
What This Service Includes
GCP, GMP, and GLP audit
Vendor and CRO qualification audits
Documentation and data integrity verification
Compliance risk scoring
Corrective and preventive action (CAPA) planning
Frequently Asked Questions
Can audits be conducted remotely?
Yes — both remote and onsite options are available.
Do they perform vendor qualification audits?
Absolutely — CROs, CDMOs, labs, and more.
What deliverables are provided?
A full audit report, findings, risk classification, and CAPA recommendations.
Can Lumanity re-audit after CAPA implementation?
Yes — we verify remediation effectiveness.
