Out Of Spec/Out Of Trend (OOS/OOT) Software Solutions

TrackWise by Sparta Systems solution for Out of Spec/Out of Trend (OOS/OOT) ensures potential product non-conformances are properly and efficiently investigated and handled through the tracking and managing of the initial report, phased investigation, root cause analysis and any resulting Corrective Action and Preventative Actions (CAPAs) and change controls.

Trackwise's OOS/OOT solution is compatible with the two phase FDA OOS guidelines with fully configurable workflows. The solution also integrates with other TrackWise quality management systems, giving companies the flexibility to initiate CAPAs based off of OOS investigations, manage supporting documentation through a document management solution, and trigger personnel training through training manager.

Benefits:

• Ensures compliance with industry and government regulations and ISO standards
• Decreases cycle time and production/operation costs by increasing quality and process efficiency
• Lowers customer complaints while protecting product and corporate brand by decreasing risk of non-conformed products being released to market
• Reduces risks of repeated OOS non conformances by ensuring follow-up actions such as CAPA processes are completed
• Reduces risk of lost or incomplete data through closed-loop OOS process
• 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 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