Deviations Management Software

The TrackWise by Sparta Systems Deviations Management solution allows a broad range of deviations to be tracked and managed from initial inception, through investigation, root cause analysis through to the execution of corrective and preventative actions (CAPAs) and subsequent change controls.

TrackWise provides a fully configurable automated deviations process, allowing for the flexibility to fit the specific needs of corporate processes while providing a rigorous controlled environment to ensure compliance and regulatory conformance while mitigating risks of lost records or processes left incomplete or forgotten.

Benefits:

• Ensures regulatory and industry compliance through solution alignment and Sparta expertise in regulations including 21 CFR Part 11, 210, 211, 820, GMPs and ISO Standards
• Reduces risk of lost or incomplete data through closed-loop deviation management process
• Provides flexible yet controlled environments through fully configurable process workflows
• Decreases cycle time and production/operation costs by increasing quality and process efficiency
• Improves other quality and operating processes by integrating with other enterprise-level control systems such as EPRs and MESs, batch release systems, and regulatory reporting systems
• 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
• Decreases risks of repeat errors and issues by improving root cause analysis using built-in decision trees and drill-down selection lists