Process and Quality


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