Medical Device Audit Management

Automate Your Audit Management Processes

Medical device manufacturers must comply with 21 CFR Part 820, medical device reporting (MDR), premarket notification 510-(k), investigational device exemption, and quality system (QS) regulations.  Audits help manufacturers to improve quality, lower costs, and increase compliance. But, managing them manually can become a time and resource intensive process. 

Sparta Audit Management for Medical Device Companies

Sparta helps auditors plan and execute audits more efficiently by providing an integrated tracking and workflow engine that automates all steps in the audit lifecycle. It helps auditors with scheduling, preparation, auditing, report approval, report issuance, response, and corrective action (CAPA) tracking.  Companies can standardize on best practice approaches throughout the company to better manage compliance and risk. You can even extend those best practices out to suppliers and to improve quality, compliance, and uniformity throughout your supply chain. 

Benefits of Audit Management Software

  • Reduces risk and increases audit efficiency and visibility by enforcing consistent and harmonized processes and procedures across the organization.  
  • Securely manages all information in a centralized, scalable and reliable closed-loop CAPA system.   
  • 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. 
  • Reduces risk of lost or incomplete data through a centralized, scalable auditing system.  
  • Provides flexible, yet controlled functionality to allow the co-location of multiple diverse auditing groups and processes.   
  • Increases operational transparency through automated alerts, overview views using dashboard functionality, and extensive reporting capabilities. 
  • Increases accountability through assignments, process step sign-offs, and automated audit trails. 
  • Feeds information to supplier oversight processes to enable truly integrated supplier oversight. 

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