Change Control
Best practices and industry standards, as well as regulations imposed by regulatory bodies, require companies to demonstrate control over change management. Change control systems must ensure consistent procedures and informed decision-making by qualified individuals as well as assure traceability back to the justifications behind the change process.
Despite the economic benefits, the vast and complex nature of change control procedures has caused many companies to struggle with implementing a global change management system. As a result, many companies use a collection of disconnected manual systems, spreadsheets and databases, which results in duplicate data, data errors, and delays.
TrackWise Change Control Solutions
TrackWise software enables companies to improve efficiency, increase control, and reduce defects as a result of implementing a cohesive enterprise change control program, which integrates with other components of the quality management system. TrackWise is the only solution designed to be flexible enough to manage all types of change using one centralized system.
- Equipment
- Process
- Batch/Material/Part
- Documents (SOPs, Protocols)
- Computer Systems
- Supplier changes
- Emergency Changes
- Labeling & Packaging
- EH&S Changes
- Utilities
- Validation
- And others...
TrackWise provides your organization with enforcement of standardized change control procedures, while also allowing flexibility to meet specific workflow steps based on the type of change. TrackWise's fully automated workflow engine routes change control records through the applicable impact assessment, review, approval, and implementation stages based on specific details of the change. The patented 24/7 business rules engine ensures appropriate parties are notified of proposed changes, assigns necessary tasks, and automatically schedules approvals based on change type, impact, priority, and any other criteria.
TrackWise integrates with ERP, equipment inventory, MES systems, and other systems to retrieve mater data. It also provides direct integration with document management systems enabling users to link content objects, check objects in or out, and review all relevant document history.
In addition to managing the change control process, TrackWise enables your organization 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.
Benefits
- Ensure compliance with industry regulations and ISO standards.
- Reduce risk by enforcing consistent and harmonized processes and procedures across the organization.
- Eliminate the potential of lost information by electronically and securely managing all information in a centralized, scalable, and reliable system.
- Improve the impact assessment process by automating required impact assessments based on the change type, impact, and other criteria.
- Decrease cycle time and lower production costs by consolidating disparate systems, increasing efficiently, and improving quality.
- Eliminate redundant systems and eliminate related costs by centralizing management of all change control items on to an enterprise quality management software platform.
- Increase visibility and reduce product impact by notifying other departments and sites automatically when problems occur.
- 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 workflow and implementing fully electronic and parallel review and approval processes.
- Ensure an effective and closed-loop CAPA process by linking change controls to CAPAs.
- Accelerate cycle time and batch release using integrated reporting and escalation to expedite emergency changes.
- Enhance collaboration and improve productivity by integrating change control workflow with document management systems.
