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 like 21 CFR Part 820, as well 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 (CAPA) tracking. In addition, the audit management software delivers audit reports that can be generated as needed, thereby eliminating time consuming paper-based processes. TrackWise can also be utilized to manage the responses of audits conducted of your facility, such as regulatory or customer audits, to ensure audit findings are resolved in a timely fashion.
The TrackWise Audit Execution Package is an additional offering that can be utilized to generate even higher levels of efficiency and consistency in your audit programs. This package changes the audit paradigm by enabling auditors to document results in real time and eliminating the error-prone and time-consuming copy/paste steps found in most audit programs. A new offline tool gives auditors the ability to conduct the audit and document results, including any associated observations, whether signed into TrackWise or not. The TrackWise Audit Execution Package bridges the gap between the needs of your management team and your auditors, providing management the consistent data needed to evaluate audit program effectiveness while providing auditors the flexibility and authoring tools they need to be successful in the field.
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