Nonconformance & Investigations

An effective and compliant quality management system requires that material, supplier and product nonconformance records are recorded, assessed for 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 nonconformance, root cause analysis, and corrective and preventive action processes.

Key challenges for many companies using paper based processes, disconnected databases, or modules of their ERP system, have been to ensure that nonconformance records are accounted for and are processed efficiently and consistently. In addition to creating a risk of non-compliance with industry regulations, stagnant nonconformance investigations also have a monetary impact to the organization. They delay product release and cost the organization time and money by interrupting production and distracting resources.

TrackWise Nonconformance Management Solutions

TrackWise quality management software enables companies to achieve compliance while reducing the cost of quality by implementing a closed-loop nonconformance, investigation and CAPA system. TrackWise improves productivity and reduces cycle time by empowering your employees to be more productive as they perform nonconformance workflow processes from a user friendly, web-based interface, completely eliminating paper based forms.

Whether supplier related or internal, TrackWise ensures proper management of the nonconformance process by assigning accountability and managing the workflow process from investigation through Material Review Board (MRB).

TrackWise ensures zero "missing in action" nonconformance records, improves impact assessment, and automates workflow, enabling your organization to reduce investigation 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 product disposition and 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.
• Reduce product impact by notifying other departments and sites automatically when problems occur.
• Increase accountability and enhance 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.
• Eradicate repeat errors by proactively driving 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.