The services we provide

Quality Management System

• Development and Implementation of Quality Management System
• Development/revision of SOPs, Work Instructions, Forms, Manuals, Study Plans
• Corrective and Preventative Action Plan systems (CAPA) - development and improvement
• Development of Audit Plans, Audit Metrics.

Interim QA placement

• Act as internal QA lead
• Provide quality and compliance consulting support

Inspection Readiness

• Gap analysis to identify areas for improvements
• Regulatory inspection preparation
• Inspection Readiness Training

Clinical Compliance Project Management

• Project management across quality and functional units
• Vendor management and oversight

Auditing

• Vendor risk-assessment, vendor qualification audit (remote, on-site)
• CAPA plan development and maintenance for audits, support with audit follow-up and corrective actions