PROCESS AND QUALITY
• Apply the necessary processes to ensure the safety, quality and efficiency of clinical operations
• Define the appropriate Quality Management System (QMS)
• Write Quality Manual and Policies
STANDARD OPERATING PROCEDURES (SOPs)
• Determine which SOPs are needed and document this in SOPs plans
• SOP review and assessment
• Process assessment and gap anaysis
• Process mapping
• Write clear and understandable SOPs
• Train to ensure SOPs are implemented
PROCESS IMPROVEMENTS
• GCP self-inspections to improve quality and inspection readiness
• Identify process improvement opportunities through metrics
• Review of observations and issues that have affected past projects