If your organization must comply with FDA "Quality Audit" regulations, you need quality systems that are controlled through audits.  What's more, under the Current Good Manufacturing Practice (cGMP) principles, quality audits are considered necessary in the management of quality systems.

Integware's FastTrak™ Quality Audit helps you meet the management challenges that accompany audits.  Built using powerful PLM technology, FastTrak™ Quality Audit arms your company with a solution designed specifically for the medical device industry.  This easy-to-use solution allows you to manage both internal and external audits to dramatically enhance accountability, quality and regulatory compliance.

Key capabilities in FastTrak™ Quality Audit include:

• Perform both internal and external audits
• Track audit details such as date, audit lead, audit participants, description, risk management, type, areas of investigation and findings
• Implement bill-of-audit investigations to consolidate efforts and alert different internal audit officials of findings from related yet different audits (e.g. ISO and FDA)
• Automatically generate audit reports showing investigations and findings
• Avoid conflicts of interest by ensuring audit personnel are appropriately suited based on process ownership
• Track findings and resolution (can be enhanced by implementing FastTrak™ CAPA, FastTrak™ Change and FastTrak™ NCR
• Manage audit and re-audit schedules and automate notifications to people involved in the audit process
• Provide automatic escalation when audit resolution is not completed in a timely manner
• Provide management and trending reports of audit results and findings

To learn more about FastTrak™ Quality Audit and other FastTrak™ solutions, visit our News and Events page to sign up for one of our Thursday afternoon webinars.