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.