Medical Device 

Quality Management Software for Medical Devices

In the medical device industry safety and quality is characterized by stringent FDA regulations and standards as follows:

• cGxP: Good Manufacturing/Laboratory Practices
• QSR: Quality Systems Regulation / 21 CFR Part 820,
• ISO13485: International Standard Medical Device Quality Management System
• 21 CFR Part 11: Electronic Record; Electronic Signatures
• ISO14971 Risk Management System
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff

IQS's Quality Management software exceeds compliance by carefully examining the smallest details. The scrutiny applied by IQS connects missed data to provide unsurpassed traceability. This provides FDA regulated companies with greater efficiencies and unsurpassed cost containment.

• IQS enterprise and global architecture dramatically reduces the time to resolve complaint investigations and CAPA.
• IQS provides easy access to detailed information from engineering and manufacturing to quickly deliver resolution of issues.

Features

• Centralizes and categorizes all types of issues
  • Customer complaints
  • Internal incidents
  • Supplier issues
• Detailed data for investigations and determination of root cause the first time
  • Engineering drawings and specifications
  • SOP and documents revisions
  • Product/part characteristic information
  • Control plans and process flows
  • Customer, supplier and internal communications
  • Inspection plans and data
  • Equipment, calibration, maintenance and SPC data
  • Employee skills and training information
  • And more
• Traceability with above information
• Determines scheduled audits / delivers findings
• Tracks, routes and escalates complaints as required by QSR
• Automatically generates CAPAs when required
• A full closed-loop CAPA system
• Works across sites and suppliers for optimum efficiency re-occurrence prevention
• Effectively verifies remediation tasks
• Web-based quiz capabilities to assure training and compliance
• Supplier web portal allows real-time teaming with suppliers to resolve issues
• 21CFR Part11 compliance
• Audit trails, security and other compliance tools
• Complete supplier performance history including
  • Ratings
  • Inspection histories
  • CAPA tracking and corrective actions

Benefits

• Decreases complaint response time and effort
• Increases product and process efficiency
• Systematizes complaint handling process
• Provides proactive problem elimination
  • Within sites
  • Across sites
  • Across suppliers
• Dramatically reduces and / or lowers
  • Risk of warning, recall, and customer issues
  • Product production costs
  • Audits preparation and execution time
  • Costs to enhance and improve quality