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  • Change Control Software

    TrackWise can be used as change control software that enables your organization to improve efficiency, increase control and reduce risk as part of a cohesive enterprise change management program that is integrated with other enterprise-level systems. TrackWise change control software enables organizations to manage all tasks and actions related to change management, including impact assessments, implementation plans, regulatory notifications or approvals, and post-implementation actions, such as stability studies and effectiveness checks.

    TrackWise is the only centralized change control software solution designed to be flexible enough to manage all types of change, including:

    • Equipment
    • Processes
    • Batches/materials/parts
    • Documents (SOPs, protocols)
    • Computer systems
    • Suppliers
    • Emergency changes
    • Labeling & packaging
    • Environmental health & safety (EHS)
    • Utilities
    • Validation
    • And others

    TrackWise enables you to standardize change control procedures while giving you the flexibility to meet specific workflow steps based on the type of change. In addition, TrackWise integrates with enterprise resource planning (ERP), equipment inventory, manufacturing execution (MES), document management and other enterprise systems, making it possible to access master data, link content objects, check objects in or out, and review all relevant document history. Just as importantly, TrackWise provides the closed loop from initial incident to the CAPA, change control and regulatory fillings needed to ensure compliance.

    TrackWise change control functionality can be seamlessly integrated with other enterprise applications such as ERP or CRM to ensure impact assessments are conducted for every country the product is sold in. Click here to learn more about integration using TrackWise web services. [http://www.spartasystems.com/trackwise-eqms/integration-technology/]

    Benefits of TrackWise Change Control Software:

    • Reduce risk by enforcing consistent and harmonized change control procedures across the organization
    • Ensure an effective and closed-loop CAPA process by linking change control to CAPA management
    • Eliminate redundant systems and related costs by centralizing management of all change control programs
    • Improve the impact assessment process by automating workflows based on the change type, impact and other criteria
    • Increase visibility of issues when they occur by using automatic notifications that can reduce product impact
    • Increase accountability as well as collaboration by assigning investigations to responsible parties and monitoring due dates through interactive dashboards
    • Improve efficiency and reduce change control closure time by automating workflows and implementing fully electronic and parallel review and approval processes
    • Accelerate cycle time and batch release using integrated reporting and automated escalation to expedite emergency changes
    • Improve transparency and productivity by integrating change control workflow with other enterprise systems