Quality Assurance

The quality assurance (QA) group in medical device companies are required to manage the compliance of government regulations and maintain production costs to ensure product quality and patient safety.QA professionals provide quality oversight of operations so products meet current Good Manufacturing Practices (cGMP) and company quality standards.They are also responsible for training, audits, documentation creation and communication to leadership.
Sparta Systems’ enterprise quality management software (EQMS) enables organizations to ensure compliance, increase efficiencies, improve quality and reduce costs by centralizing and integrating key quality processes globally, including management and reporting of deviations, complaint handlingsupplier qualityinternal and external audits, change control , corrective and preventive actions (CAPA) and others.  

Benefits of Sparta Systems' EQMS for Quality Assurance:

  • Ensures compliance with 21 CFR Part 11, as well as other government regulations and ISO standards 
  • Implements best-of-breed quality management integrated with other data management systems, such as Enterprise Resource Planning (ERP) and Manufacturing Execution Systems (MES)  
  • Reduces risk of adverse events and other customer incidents  
  • Maintains high quality levels across the supply chain  
  • Reduces costs incurred by inefficient operations, re-works, scrap  and process down times  
  • Decreases product approval and time-to-market cycles

Addressing Internal and External Risks through EQMS Implementation

A Guide for Medical Device Manufacturers

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