Effective risk management and compliance with government regulations drive the need for ongoing auditing in organizations. For companies that are regulated by the FDA or are following quality standards such as ISO 9000/14000, regular audits are also essential to reduce the risk of noncompliance. With increasing business complexity and the rising number and types of audits that companies need to conduct, companies are realizing that point-solutions and spreadsheet-based systems are no more suitable for managing internal audit programs. 

TrackWise audit management software empowers medical device manufacturers with the tools to improve quality, reduce costs and identify operational and compliance risks by managing the full audit lifecycle and helping to ensure that findings are resolved in a timely and effective manner. Medical device manufacturers must comply with a wide range of regulations, such as medical device reporting, premarket notification 510 (k), investigational device exemption and quality system (QS) regulations. TrackWise audit management software allows manufacturers to take a best practices approach to compliance and risk management and support all audit programs using an enterprise system.

TrackWise assists auditors to plan and execute audits more efficiently by providing an integrated  tracking system and a powerful workflow engine that automates all steps in the audit lifecycle, including scheduling, preparation, auditing, report approval, report issuance, response and corrective-action tracking. In addition, the audit management software delivers audit reports that can be generated on-the-fly, thereby eliminating time consuming paper-based processes. 

Benefits of Audit Management Software

• Reduce risk and increase audit efficiency and visibility by enforcing consistent and harmonized processes and procedures across the organization 
• Securely manage all information in a centralized, scalable and reliable system 
• Facilitate compliance with industry regulations including ISO standards 
• Reduces risk of lost or incomplete data through a centralized, scalable auditing system 
• Provide flexible, yet controlled functionality to allow the co-location of multiple diverse auditing groups and processes 
• Increase operational transparency through automated alerts, overview views using dashboard functionality, and extensive reporting capabilities 
• Increase accountability though assignments, process step sign-offs, and automated audit trails