A Compliance and Traceability Toolkit

Master Control, Inc., Salt Lake City, Utah
Tel: (801) 942-4000; Web: www.mastercontrol.com

Closed Loop CAPA Management

This closed-loop CAPA management system has been designed to allow users in any department to initiate a corrective and preventive action to address and resolve an issue. The CAPA Management System can help you identify the occurrence of non-conformances, customer complaints, incidents, discrepancies, out-of-specification events or other quality issues, according to Pilgrim Software. It has also been designed to facilitate communication and improve workflow, offering e-mail and project management tools.

Meanwhile, an investigation process allows users to map preventive actions to their root causes to eliminate problems at their source and prevent recurrence. A “review verification” mode can be set up to ensure that a CAPA has been effective. The software integrates with MES, ERP and LIMS systems, and can be integrated with Pilgrim’s document management system. It is part of Pilgrim’s SmartSolve and Q&MIS solutions, which include the SmartComplaints enterprise-wide complaints management solution.

Pilgrim Software, Inc., Tampa, Fla.
Tel: (813) 915-1663; Web: www.pilgrimsoftware.com

Enterprise Process Management

TrackWise is a centralized Web-based system for managing, tracking and reporting all quality and compliance-related issues and actions. The software has been developed to help ensure compliance, improve control, reduce risk, and lower costs by consolidating the management of issues and actions, automating workflow, and facilitating trending and reporting. It has been implemented for applications that include quality management systems (QMS), environmental health and safety (EHS), internal audits and observations, governance risk and compliance, change control, IT service management, and action-item tracking.

The program features a patented continuous “business rules engine” that can help organizations automate rules enforcement. It features personalized and interactive dashboards and integrated reporting, according to its developer, Sparta Systems. The company also claims that the software reduces license, maintenance and training costs, while offering network functions that can facilitate safe remote access for employees and business partners.

Sparta Systems, Inc., Holmdel, N.J.
Tel: (732) 203-0400; www.sparta-systems.com

Process Compliance

ProcessCompliance features pre-configured, built-in best practices for the management of a wide range of processes, including; CAPA, planned and unplanned deviations, audits, validation, customer complaints, and Sarbanes-Oxley compliance processes, Market Timing Incidents, AML processes and multi-site change control.

Designed to be a flexible, scaleable and secure solution, ProcessCompliance is said to provide reliable workflow management and control, allowing each organization to map the system to its own specific processes and enhance both regulatory compliance and overall operational efficiency. Its developer, Qumas, says that the system can be easily and seamlessly integrated with its sister product DocCompliance, leveraging the latest relational database and web technologies to improve access to documents during all phases of process management.

Qumas, Inc., Florham Park, N.J.
Tel: (973) 377-8750; www.qumas.com