MasterControl Inc.

Feb. 1, 2007
Software Modules Facilitate FDA Compliance

MasterControl Inc. has released MasterControl Version 6, which vastly expands the company’s offerings with the introduction of five new modules:

  • Document Connections enables companies to integrate their existing electronic repositories with MasterControl applications for effective management of specific quality processes critical to compliance such as training, CAPA, and nonconformance disposition. This module enables easy and immediate integration without expensive custom coding.

  • Enterprise provides enterprise-wide connectivity for diverse organizations without sacrificing the flexibility of individual business units to manage their own processes, offering advanced filtering capability that enables individual business units to participate in the overall corporate quality system while streamlining and optimizing their processes independently.

  • Rules allows the monitoring of quality events and tasks on a real-time basis, which is crucial in ensuring FDA compliance. Users will be able to monitor the process through user-defined rules that trigger automatic notification when user-specified thresholds are surpassed.

  • Toolkit is an application programming interface (API) module that provides the capability to integrate MasterControl’s robust quality management solutions with their existing enterprise resource planning (ERP), customer resource management (CRM), and other systems for a more connected suite of applications and a holistic approach to compliance management.

  • Transfer OQ is an ideal tool for customers with risk-based policies that allow assimilation or “transfer” of OQ documentation as part of their overall validation effort, saving both time and money. TOQ provides completed validation and support documentation of IQ/OQ tests performed at MasterControl, as part of an overall continuous validation strategy.

The MasterControl integrated compliance software solution helps meet stringent FDA requirements, but can also help with compliance with ISO standards, Sarbanes-Oxley Act, and other regulations. MasterControl facilitates compliance management by automating and managing document and change control, training management, audits, corrective/preventive action (CAPA), customer complaints, nonconformance disposition, deviation handling, electronic batch record management, and other quality processes critical to regulatory compliance.