Corrective and Preventive Action (CAPA)

In today’s increasingly regulated business environment, medical device companies need to investigate and track quality related events in the day-to-day manufacturing operations. Sparta Systems corrective action and preventive action (CAPA) software solution automates CAPAs generated independently or through other medical device quality processes. It also tracks and manages the process of generating and carrying out CAPA process plans, verifies completion, automates follow-up effectiveness tasks, and, when applicable, closes the loop with the incident record for which the CAPA was created.  
 
Sparta Systems' enterprise quality management software (EQMS) solution makes it possible to implement a holistic approach to CAPA management software activities. The flexible architecture grants organizations the power to log and manage CAPA quality assurance issues originating from any source, while its automated workflow engine routes records through the appropriate investigation, root cause analysis, planning, verification and effectiveness steps. With Sparta Systems' CAPA solution, organization are assured a repeatable, compliant, and 100% closed-loop corrective action and preventive action process. 

Medical Device Manufacturing and the Journey from Better to Best

Benefits of Sparta Systems' CAPA Solution:

  • Decreases cycle time and production/operation costs by increasing quality and process efficiency  
  • Escalates the issues of highest risk to the change control process ultimately leading to next-generation CAPA software design changes 
  • Reduces risks of repeated issues and problems by ensuring CAPA management processes are followed-up as defined by SOPs  
  • Incorporates the use of CAPA review boards as appropriate in organizations  
  • Reduces risk of lost or incomplete data through closed-loop CAPA management process  
  • Provides flexible yet controlled environments through fully configurable process workflows  
  • Improves other quality and operating processes by integrating with other enterprise-level control systems such as ERPs and MESs, batch release systems and regulatory reporting systems  
  • Increases operational transparency through automated alerts, overview views using dashboard functionality, and extensive reporting capabilities  
  • Increases accountability through assignments, CAPA process step sign-offs, and automated audit trails  
  • Facilitate compliance with medical device industry regulations including 21 CFR Part 11, 21 CFR Part 803 and 21 CFR Part 820; ISO 9001, 13485, 13488, 14001, 14791; EN 46001 and 46002; GMP #40 and #63 ordinances and other international standards
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