Change Control Software
TrackWise by Sparta Systems enables companies to improve efficiency, increase control and reduce defects as a result of implementing a cohesive enterprise change management program, which integrates with other components of the quality management system. TrackWise enables organizations to manage all related tasks and actions that are involved with the change, including impact assessments, implementation items, regulatory notifications or approvals, and post implementation actions, such as stability studies or effectiveness checks. TrackWise is the only solution designed to be flexible enough to manage all types of change using one centralized system, including:
- Equipment
- Process
- Batch/Material/Part
- Documents (SOPs, Protocols)
- Computer Systems
- Supplier
- Emergency Changes
- Labeling & Packaging
- EHS
- Utilities
- Validation
- And others...
TrackWise provides organizations with enforcement of standardized change control procedures, while allowing flexibility to meet specific workflow steps based on the type of change. In addition, TrackWise integrates with ERP, equipment inventory, MES systems and other systems to retrieve mater data and provides direct integration with document management systems enabling users to link content objects, check objects in or out, and review all relevant document history.
Benefits
- Ensures compliance with industry regulations and ISO standards
- Reduces risk by enforcing consistent and harmonized processes and procedures across the organization
- Eliminates the potential of lost information by electronically and securely managing all information in a centralized, scalable, and reliable system
- Improves the impact assessment process by automating required impact assessments based on the change type, impact, and other criteria
- Decreases cycle time and lower production costs by consolidating disparate systems, increasing efficiently, and improving quality
- Eliminates redundant systems and eliminate related costs by centralizing management of all change control items on to an enterprise quality management software platform
- Increases visibility and reduce product impact by notifying other departments and sites automatically when problems occur
- Increases accountability as well as collaboration by assigning investigations to responsible parties and monitoring due dates through interactive dashboards
- Improves efficiency and reduce change control closure time by automating workflow and implementing fully electronic and parallel review and approval processes
- Ensures an effective and closed-loop CAPA process by linking change controls to CAPAs
- Accelerates cycle time and batch release using integrated reporting and escalation to expedite emergency changes
- Enhances collaboration and improve productivity by integrating change control workflow with document management systems