Supplier Quality Management

For medical device manufacturers, having visibility into the critical supply chain processes, starting with the raw material suppliers and vendors through point-of-sale is a major factor to success.  Producing poor products or wrong products that require repair or replacement erodes customer sentiment and impacts customer satisfaction levels negatively.

Sparta Systems' TrackWise Supplier Quality Management

TrackWise supplier quality management software offers features such as supplier scorecards, supplier qualification best practices, manage the approved supplier list (ASL), and tracking systems for supplier non-conformances and resulting CAPA.  
The supplier qualification and vendor tracking software for medical device manufacturers increases the efficiency of supplier and vendor selection by both tracking and managing the qualification and approval process for new potential vendors and parts while avoiding redundant evaluations.  Sparta Systems software enables complete maintenance and transparency of all previous vendor records, making them available for reference across the enterprise. Supplier qualification is further enhanced by our advanced auditing capabilities, allowing the offline execution of audits,  generation of audit reports and seamless integration into the corporate quality

Sparta Systems’ Stratas Supplier Collaboration Solution

Stratas Supplier Collaboration software is a cloud-based portal that extends quality processes beyond a corporation’s four walls out to suppliers, contract manufacturers and other partners in the external supply network. This allows them to participate directly in quality interactions that historically have been handled using inefficient, manual methods. When combined with the rich capabilities of TrackWise, Stratas creates a fully featured, end-to-end supplier quality management solution.

A Quality Medical Device Begins with Supplier Quality Management

Addressing Nonconformance and Risk in Real-time

Sparta Systems’ supplier nonconformance process ensures all supplier non conformances are addressed and appropriate actions are taken by tracking and managing all reported non-conformances, their subsequent investigations, and any resulting CAPA in a timely and harmonized manner. Efficiency gains are achieved through effective workflow progression and appropriate risk management. 
Supplier scorecards are the real-time view into the health ofa supply chain. These scorecards pull information from the enterprise quality management software (EQMS) processes and activities such as new supplier qualification, incoming inspections, non-conformance , SCARs, supplier actions and audit results, as well as ERP data such as quantity delivered and on-time delivery statistics. This truly holistic view helps highlight areas of greatest risk in your supply chain to make appropriate supplier development, supply usage and spend decisions. 

Benefits of Supplier Quality Management System for Medical Device Manufacturers:

  • Facilitates compliance with medical device industry regulations including 21 CFR parts 11, 803 and 820; EN 46001 and 46002; GMP #40 and #63 ordinances and other international standards, including EU GMP Annex 11
  • Ensures compliance with medical industry and government regulations and ISO standards, ISO 9001, 13485, 13488, 14001, 14791
  • Reduces risks of medical device and healthcare product deviations and other quality incidents by ensuring supplier and vendor non-conformances are addressed before using materials in product  
  • Increases supplier selection efficiency by eliminating redundant supplier evaluations across departments using a standardized, centralized supplier evaluation process

Click here to learn more about Sparta Systems TrackWise SQM Solution

Click here to learn more about Sparta Systems Stratas Supplier Collaboration Solution

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