• GMP Auditing Compliance Software

    Auditing is a critical component of following FDA GMP (Good Manufacturing Practice).  Many companies’ Quality Assurance groups are working hard to keep GMP audit programs organized using various manual processes and spreadsheets.   Management is requesting a comprehensive snapshot of key audit program metrics.  Auditors are in need of a tool to drive a more efficient auditing process with greater control over and improved visibility into quality and compliance processes.  Whether your role is internal or external, auditor or a stakeholder in the process, the TrackWise GMP Auditing Solution can help your organization streamline GMP audits.

    The TrackWise GMP Auditing Solution

    The web-based TrackWise GMP Auditing Solution features the Audit Execution Package which now provides an FDA compliant method for auditors to draft audit reports offline while out in the field. The solution also provides organizational management consistent data to evaluate audit program effectiveness.  Since the solution includes the standard TrackWise software, customers receive the quality, compliance, and workflow management capabilities inherent to TrackWise.  For organizations looking to consolidate their auditing processes, the TrackWise platform also can support all types of audit programs in one enterprise system.

    Whitepaper: Automated Audit Management - Download Now 

    A Fully-Integrated System

    The need to measure and ensure quality is vital throughout all aspects of the manufacturing process.  TrackWise enterprise quality management software provides a flexible and configurable platform for tracking and managing quality and compliance events to ensure that manufacturing activities are continually measured, monitored and improved upon.  In addition to managing all aspects of the audit process, the TrackWise GMP software solution manages the associated findings or observations, corrective and preventive actions (CAPAs), risk assessments, risk management and the analysis and approvals of changes.  TrackWise also tracks and manages deviations, process validation, complaint handling, manufacturing incidents, training records and more.

    Key Features and Benefits:

    • Design structured audit templates that simplify the process of auditing against regulations such as 21 CFR Part 11, Part 210, Part 211, and Part 812, as well as ICH requirements and other regulatory authority regulations and guidance
    • 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 schedule, audit plans, 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 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 activities and the potential for errors by eliminating redundant 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
    • Lower costs by consolidating redundant systems and enhancing collaboration, fueling cost-savings and increasing ROI
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