GxP Audit Services
Engage our team of industry-veteran auditors for rigorous vendor audits that meet the demands of today’s regulatory environment.
Diligent Results
Countries with Diligent Auditor coverage
GxP Vendor Categories
OUR FOCUS
Our expertise
Leverage industry-leading auditor expertise
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Audit Capabilities
Expert-led audits for every need
Rely on a consistent audit methodology across all Vendor and site types, with confidence that reports reflect current global regulatory standards.
Audit types
Diligent supports comprehensive GxP-aligned audits across the clinical development lifecycle—so you can manage all your qualification needs with a single partner.
GCP / GCLP – CROs, clinical labs, and clinical service providers .
GLP – Nonclinical research and laboratory operations.
GMP – Manufacturing, packaging, and production support.
GVP – Pharmacovigilance and safety operations.
Investigator Site Audits – Sites, site networks, and site management organizations.
In-Study / Requalification Audits – Trial-specific Vendor and site oversight.
Technology & Digital Systems Audits – Regulated systems such as eCOA, eTMF, eConsent, and related platforms.
Audit standards informed by global regulations
We apply updated global regulations to our audit standards in real time:
21 CFR 312
21 CFR 320
21 CFR 50
21 CFR 54
21 CFR 56
21 CFR Part 11
China HGRAC
EU Annex 11
EU 536/2014
Eudralex Volume 10
ICH E21
ICH E2A
ICH E6 (R3)
ICH E8
ICH E9
ICH E17
MHRA GCP Guide
And more
Core capabilities in our standard audit scope
At a minimum, every audit assesses the following core capabilities:
Organization
Financial Stability
Insurance Standards
Ethics/Anti-Bribery/Anti-Corruption
Privacy & Personal Data Protection
Computer Systems/ 21 CFR Part 11 Compliance
GDPR
HIPAA
Quality Management Systems
Risk-Based Quality Management Systems
Third-Party Quality Management & Oversight
Document Management & Control
Operations & Project Management
Data Management & Transfer
Staffing, HR Management & Training
Facilities Management
Audit Library and Custom Audits
Diligent offers a robust database of already-completed, up-to-date GxP qualification audit reports to enable clients to qualify new Vendors in a fraction of the time and cost. Clients can also engage our team of expert auditors for new audits tailored to specific studies or Vendors
About our auditors
Our clients rely on Diligent's network of industry veteran auditors to satisfy their unique quality and regulatory requirements. With 50+ specialists across the globe—each with deep expertise in specific vendor types and current regulatory guidelines—you can be confident the right expert is assigned to your work.
Customer stories
Lilly's 50% Increase in Vendor Qualification Capacity
"Lilly has leveraged Diligent’s platform capabilities to quickly access completed qualification questionnaires and Vendor Qualification Assessment reports for vendors of interest.”
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