Since 1994, Sparta Systems enterprise quality management software (EQMS) solutions have been successfully enabling companies of all sizes to achieve unprecedented gains in efficiency by consolidating redundant systems, reducing manual operations, and implementing operational best practices. Leading device manufacturers worldwide rely on Sparta’s EQMS to manage, track, and report on incidents to help ensure compliance with regulatory requirements, manage the supply chain, and reduce cycle time and time-to-market.
Implement a global and consolidated approach to managing customer complaints and medical device reporting, including eMDR and eMDV.
Track and manage all phases of the product nonconformance process with Sparta Systems' nonconformance software, from the initial report to the investigation and root cause analysis to any resulting actions and follow-up verification.
Develop a repeatable, compliant, and closed-loop CAPA process that logs and manages quality issues originating from any source to help drive next generation design changes.
Manage the process of qualifying, selecting, and monitoring suppliers and supply chain partners using features such as supplier scorecards, supplier qualification workflows and tracking systems for supplier nonconformances.
Identify and mitigate operational and compliance risks by efficiently managing the full audit lifecycle, including the resolution of findings in a timely and effective manner for internal, regulatory and supplier audits.
Integrate risk management processes across a company’s entire quality management system, ensuring that nonconformities, regardless of source, are evaluated using consistent criteria to determine risk prior to escalation to CAPA.
Contact Sparta Systems today for more information on our enterprise quality management software solution for medical device organizations.
Click here to learn more about Sparta Systems' enterprise quality management system TrackWise.
Click here to learn more about Sparta Systems' cloud enterprise quality management solution 123Compliance.