CAPA Management Software

CAPA for FDA Compliance

A corrective action is the activity or activities performed to correct a quality incident that happened and keeps it from recurring.  A preventive action is put in place as a continuous improvement to prevent the same or similar problem from happening at any location within the organization that may have the same or similar processes in place. Quality incidents can be identified from complaints, audits, adverse events and must be evaluated and addressed through a company’s CAPA process. 

Conquer Corrective Action and Shift to Preventive Active

An automated CAPA system is crucial to ensure organizations are addressing quality events and solutions in an efficient manner throughout the supply chain. Employees must be able to identify events and issues, investigate why those events occurred, implement a plan that effectively solves the root cause, and be able to track and manage any tasks and workflows to ensure the problem is solved.

Easily Demonstrate CAPAs to the FDA and Other Regulators

Additionally, having CAPA processes in place as part of your quality management system is required by a number of regulations and industry standards, including GMP, ISO 9001 and 14001,TSCA, REACH, and other international standards. Failure to comply with these regulations and standards could have far-reaching consequences that could include anything from fines and penalties, to loss of business from customers looking for organizations with a proven quality management system.

Sparta offers quality and compliance solutions that make it possible for your company to take a holistic approach to your corrective and preventive activities. The flexible corrective action system architecture gives your organization the power to log and manage quality issues originating from any source while an automated workflow engine routes records through the appropriate investigation, root cause analysis, planning, verification and effectiveness steps.

Benefits of Sparta CAPA Software Solutions

  • Reduce the risk of lost or incomplete data with a closed-loop system.
  • Facilitate compliance with industry regulations including GMP, ISO 9001 and 14001, TSCA, REACH, and other international standards.
  • Provide a flexible yet controlled environment through fully configurable workflows.
  • Reduce the risk of repeat issues by ensuring that defined processes are followed.
  • Decrease cycle time and production/operation costs by increasing efficiency.
  • Improve the efficiency of quality and operating processes by integrating with other enterprise-level control systems such enterprise resource planning (ERP) and manufacturing execution systems (MES) and other enterprise IT systems.   

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