CAPA for Clinical Auditing

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.

The Five Building Blocks of a Corrective and Preventive Solution

Benefits of Sparta Systems' Clinical CAPA Solution:

Sparta Systems enables your organization to manage simple to complex investigations and improve root cause analysis by: 

  • Assigning investigation “tasks” to investigation team members and automating workflow steps 
  • Providing a collaborative environment where manufacturing, investigators, CAPA owners and quality assurance share investigation results and monitor status 
  • Improving root cause classification and sub-classifications through drill-down root cause trees and online reporting tools 
  • Increasing resource utilization and collaboration by automating workflow processes and providing secure access to related information across multiple audit groups and trials
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© 1995-2016 Sparta Systems, Inc. All Rights Reserved.Sparta Systems Logo