Deviations, Out of Specifications (OOS) & Investigations

An effective and compliant quality management system requires that deviations, out of specifications (OOS), errors, and other events are recorded, assessed for product impact, and investigated to determine root cause. ISO, GMP, and other quality standards present strict guidelines that require organizations to follow procedures and establish controls surrounding the deviation management and corrective and preventive action processes.

Key challenges for many companies using paper based processes, disconnected databases, or modules of an ERP system have been to ensure that events are accounted for and processed efficiently and consistently. Stagnated deviations, lab investigations, and other errors delay product release and cost the organization time, as well as money, by interrupting production and distracting resources. Lack of consistency around investigation and root cause analysis processes, leave room for error, and increase the likelihood of repeat problems.

Implementing robust systems to manage deviations, investigations, and resulting corrective action processes reduces the cost of quality, improves productivity, and decreases time to market. Deviation and investigation management is an important component of the overall quality management system, and therefore requires an integrated and closed-loop approach.

TrackWise Deviation, OOS, and Investigation Management Solutions

TrackWise addresses these challenges and enables your organization to manage all deviations, out of specifications, and other events in a consolidated repository as part of your organization's enterprise Quality Management System (QMS). With TrackWise, your organization will ensure compliance while your employees become more productive as they access records from a user friendly, web-based interface, completely eliminating paper based forms.

TrackWise ensures zero "missing in action" deviations, improves impact assessment, and automates workflow, enabling your organization to reduce deviation cycle time and improve quality. Integration to your existing EPR and MES systems streamlines the production process to improve batch release without requiring any software customization.

Benefits

• Ensure compliance with industry regulations, including 21 CFR Part 210, 211, 820, GMPs, ISO standards, and others.
• 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 batch release process by integrating to Enterprise Resource Planning (ERP) systems such as SAP, Oracle/JD Edwards, Baan, BPCS, and others.
• Decrease cycle time and lower production costs by consolidating disparate systems, increasing efficiently, and improving quality.
• Increase visibility and reduce product impact by automatically notifying other departments and sites 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 record closure time by automating your workflow and implementing fully electronic review and approval processes.
• Take proactive steps to eradicate repeat errors by improving root cause analysis with built-in decision trees and drill-down selection lists.
• Ensure an effective and closed-loop CAPA process by relating problem analysis and root cause to CAPA planning, implementation, and verification, as well as to effectiveness measurement.
• Improve decision-making and increase control by accessing critical information through TrackWise's built-in enterprise reporting system and management dashboards.
• Accelerate cycle time and batch release using integrated reporting and escalation to expedite high priority items.