QAU:

Flexible Quality Assurance Unit Staffing and Program Support 

• Hands-on assistance with completing projects to meet deadlines
• Auditing and inspecting of in-process activities
• Reviewing and auditing of draft reports
• Auditing of study records and raw data
• Guidance in regulatory strategy

Quality Assurance Unit Support

• Master Schedule development and maintenance
• In-process auditing and inspecting
• Data auditing and assessment
• Draft report auditing and evaluation
• Auditing of supplemental reports by project scientists
• Review and evaluation of reports for contract studies
• Corrective actions and responses to audit findings
• Quality Assurance statements

Preparation for Regulatory Audits

• Mock audits of in-house GLP operations
• Staff training in regulations and compliance
• Facilitation and coordination of regulatory audits
• Audit summaries and corrective actions
• Responses and resolution of audit findings
• Audit tracking and trend analysis