Quality Audit

ComplianceLogix offers complete audit management services, including site selection, standardized audit reporting, metrics and documentation via our secure compliance portal.

• Clinical investigator site audit
• Contract Manufacturing Organization audit
• Contract Research Organization audit
• Contract Service Provider audit
• Laboratory audit
• Vendor qualification

Auditor Selection

ComplianceLogix auditors are selected based upon their expertise, prior client experience, professionalism and location to find the right person for your project. CVs of potential auditors are provided for client review and an initial interview is conducted to ensure that the consultant is the right fit for your project and company culture. ComplianceLogix consultants work as an extension of your team.

Audit Management

Auditors may follow ComplianceLogix procedures or operate under client Standard Operating Procedures to ensure consistency of practice and standardized audit reporting. Consultants work directly with client project teams on all project deliverables.

Auditors are assessed on the quality and consistency of deliverables by ComplianceLogix with regular client feedback to ensure a successful ongoing relationship. Timelines for audit reports and other deliverables are monitored to ensure ongoing transparency of project status. All audit documentation may be maintained on our secure network portal for client access. Summary audit metrics are provided to review progress, identify any potential systemic issues and ensure ongoing compliance.