In a rapidly growing and highly competitive landscape, medical device and diagnostic manufacturers face countless unique industry challenges, including shorter product lifecycles, increased legal and regulatory scrutiny, and the need to manage strategic partnerships across the value chain.
Sparta Systems’ regulatory compliance software helps organizations mitigate risks and reduce the complexity of regulated business processes while reducing costs associated with the production, sales, and service of medical devices and diagnostic products.
Sparta’s best practices and domain expertise can enable your organization to effectively comply with regulations that include 21 CFR Part 11, 21 CFR 820, GMP, ISO13485, ISO9000, and other industry standards.
Since 1994, TrackWise software has 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 TrackWise 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, 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 your 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.