GxP AUDITS
Need a GxP Audit?
Know where the gaps are before they become findings.
GCP Audit
Independent assessment of Phase 1–3 clinical trial activities, documentation and oversight to identify compliance gaps before they become findings.
Beyond GCP
A broader view. A stronger quality system.
GVP Audit
Review pharmacovigilance processes and systems to identify gaps in safety reporting, case management, oversight and compliance.
GLP Audit
Independent assessment of GLP processes, documentation, facilities and study conduct against applicable requirements.
GMP Audit
Assessment of manufacturing and quality systems to identify compliance risks across processes, documentation and quality controls.
System & Technology Audits
Independent assessment of clinical systems and technology platforms to evaluate compliance, data integrity, validation, security and operational controls across the clinical trial lifecycle.
eCOA / ePRO Audit
01Assessment of electronic clinical outcome assessment platforms and processes supporting patient-, clinician- and caregiver-reported data.
IRT / RTSM Audit
02Assessment of randomization, treatment assignment, trial supply and system controls to identify risks that could affect patient allocation, drug supply or trial integrity.
Safety System Audit
03Assessment of pharmacovigilance systems and technology supporting case processing, safety data management, reporting and oversight.
CTMS Audit
04Review of clinical trial management processes and system controls to assess data quality, study oversight, workflow management and traceability.
eTMF
05Assessment of electronic trial master file processes, document completeness, filing, metadata, access controls and oversight to support inspection readiness.
CSV Audit
06Independent assessment of computerized system validation practices, including validation planning, requirements, testing, documentation and change control.
Have a GxP audit requirement?
Let's discuss your needs and determine the right audit approach.