Change Control Software

The TrackWise Change Management solution ensures all documented changes are properly coordinated while increasing transparency by managing the change control process across all relevant departments from initial request, through pre- approvals, change execution, follow up approvals and implementation. All tasks and activities are tracked including actions needed to complete the change, regulatory approvals and updates as well as the appropriate linkages to other quality and regulatory processes including CAPA and Product Registration Tracking.

Trackwise's Change Control solution enforces a standardized change control process across the enterprise while allowing the flexibility to meet specific workflow steps, making it the only solution designed to be flexible enough to manage all types of changes using one centralized system. Change management applications include areas such as equipment, process, batch/materials, documents, computer systems, suppliers, emergency, labeling and packaging, EH&S changes, utilities and validation.

Benefits Include:

• Ensures compliance with industry and government regulations and standards
• Ensures proper coordination across stakeholders though automated workflows and alerts
• Decreases cycle time and production/operation costs by enforcing consistent and harmonized processes across the organization
• Provides seamless integration to QMS functionality such as CAPAs, and other quality activities.
• Reduces risk of lost or incomplete data through an automated closed-loop change control process
• Reduces costs of change control driven by multiple redundant, siloed systems
• Provides flexible yet controlled environments through fully configurable process workflows
• Improves other quality and operating processes by integrating with other enterprise-level control systems such as EDMSs, EPRs, and MESs
• Increases operational transparency through automated alerts, overview views using dashboard functionality, and extensive reporting capabilities
• Increases accountability though assignments, process step sign-offs, and automated audit trails