An aging population and high prevalence of chronic disease has put clinical trials in high demand. Even though patients volunteer to participate in clinical programs to gain early access to medication, treatment and medical care, their safety should never be compromised. Quality management plays a pivotal role in evaluating the benefits and risks of a medial product or procedure to ensure patient safety.
Corrective action and preventive action (CAPA) is an important process to help manage quality. An effectively implemented CAPA program will improve clinical trial process data integrity while protecting patients. Once a problem is identified, an investigation takes place to determine how widespread it is by conducting a root cause analysis and investigation. Finally, the prevention requirements are defined so the problem does not happen in the future.