Medical Device Corrective and Preventative Actions
Medical device companies need to investigate and track quality related events throughout day-to-day manufacturing operations. Sparta offers corrective and preventive action (CAPA) solutions that automate the process. They help to initiate and execute CAPAs, verify completion, check effectiveness, and close the loop with on the incident record for which the CAPA was created.
CAPA quality assurance issues that originate from any source can be logged, while the automated workflow engine routes records through the appropriate investigation, root cause analysis, planning, verification and effectiveness steps. With Sparta, companies are assured a repeatable, compliant, and 100% closed-loop corrective action and preventive action process.
Benefits of Sparta CAPA Management
- Decreases cycle time and production/operation costs by increasing quality and efficiency.
- Escalates the issues of highest risk to the change control process.
- Reduces risks of repeat issues and problems.
- 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 your ERP, MES, batch release, and regulatory reporting systems.
- Increases operational transparency through automated alerts, dashboards, and reporting.
- Increases accountability through assignments, sign-offs, and automated audit trails.
- Facilitates compliance with 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.