• TrackWise - GLP Audit Software Solution

    You realize you need greater control over and improved visibility into your quality and compliance processes.  Your company’s QA Unit is working hard to keep GLP audit programs organized with many different manual processes and spreadsheets.  Your auditors are in need of a tool to drive a more efficient auditing process.  Management is requesting a comprehensive snapshot of key audit program metrics.  Whether your role is part of the QAU, study director, principal investigator, sponsor, auditor or a stakeholder in the process, the TrackWise Preclinical GLP Audit Sotware Solution can help your organization streamline the GLP auditing process.

    The TrackWise Preclinical GLP Auditing Solution

    The TrackWise Preclinical GLP Audit Software Solution, featuring the Audit Execution Package, is designed to facilitate the processes involved with GLP auditing in addition to providing the standard quality, compliance and workflow management capabilities of TrackWise.  And for organizations looking to consolidate their auditing processes, the TrackWise platform has the ability to support all audit programs using an enterprise system. 

    A Fully-Integrated System

    The need to measure and ensure quality is vital throughout the preclinical study process.  Enterprise quality management software provides a flexible and configurable platform for tracking and managing quality and compliance events to ensure that preclinical research activities are continually measured, monitored and improved upon.

    Key Features and Benefits of GLP Software:

    • Maintain the master schedule sheet in a controlled environment.
    • Design structured audit templates that simplify the process of auditing against regulations such as 21 CFR Part 58, 40 CFR Part 792, ICH S7A, and ICH S7B.
    • Simplify the process of preparing for and supporting the QA statement.
    • Organize study records in an intuitive and hierarchical format such that they can be easily located while preparing for audits.
    • Maintain copies of study protocols within TrackWise’s seamless environment so they can be quickly and easily referenced.
    • Document findings and observations and draft audit reports in real time, on location, without online connectivity using the offline audit feature of the Audit Execution Package.  This feature eliminates the time-consuming and redundant process of inputting notes into a word processor and then publishing to an electronic system.
    • Track and manage audit scheduling, audit templates, audit execution, and the resulting follow-up activities, with all relevant parties working within one environment.
    • Generate reports to monitor and review auditor resource allocation and scheduling, draft and formal audit reports, and reports to track and trend on findings and corrective actions to drive continuous improvement. 

    TrackWise GLP Audit Software Can Help You Achieve the Business Outcomes You Are Striving For:

    • Securely manage all information in a centralized, scalable and reliable enterprise system. 
    • Increase productivity and efficiency and reduce non-value add activity and the potential for errors by eliminating the process of duplicating data entry. 
    • Reduce risk by enforcing consistent and harmonized processes and procedures across the organization while allowing auditors the appropriate level of flexibility to do their job. 
    • Increase accountability and collaboration by assigning activities to responsible parties and monitoring due dates through interactive dashboards. 
    • Facilitate compliance with 21 CFR Part 58, 40 CFR Part 792, ICH S7A, and ICH S7B 
    • Lower costs by consolidating redundant systems and enhancing collaboration, fueling cost-savings and increasing ROI. 

    For information about Good Clinical Practice software, visit the GCP audit page. 

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