News - FDA Regulated

MasterControl to Showcase Complete Software Solution for FDA-Regulated Companies at Interphex 2007

SALT LAKE CITY – Mar. 13, 2007 – MasterControl Inc. will showcase MasterControl™ Version 6, a complete software solution for FDA-regulated companies, at the Interphex 2007 exhibition on April 24-26 in New York City.

MasterControl™ Version 6 greatly expands the company's offerings for the FDA-regulated sector with the introduction of five new modules. The release is consistent with MasterControl's commitment to help pharmaceutical and other life science companies achieve greater efficiency and higher product quality and at the same time maintain FDA compliance.

A MasterControl team will demonstrate the solution at Booth 2847 in Jacob K. Javits Convention Center in New York City during the Interphex exhibition.

Version 6 builds on MasterControl's traditional strengths ? ease of use, compliance, and connectivity. It introduces the following compliance management software applications:

• MasterControl Document Connections? enables FDA-regulated 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.
• MasterControl Enterprise? provides enterprise-wide connectivity for diverse organizations without sacrificing the flexibility of individual business units to manage their own processes. This innovative software offers advanced filtering capability that enables individual business units to participate in the overall corporate quality system while streamlining and optimizing their processes independently.
• MasterControl Rules? allows customers to monitor 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.
• MasterControl Toolkit? is an application programming interface (API) module that gives FDA-regulated companies 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 FDA compliance management.
• MasterControl 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 validation strategy.

The MasterControl™ integrated software solution helps companies meet stringent FDA requirements. It facilitates compliance management by automating and managing document control, change control, training management, audits, corrective/preventive action (CAPA), customer complaints, nonconformance disposition, deviation handling, electronic batch record management, and other processes critical to regulatory compliance.

MasterControl considers validation an integral part of software solutions for FDA-regulated customers. The company's ?continuous validation? approach dramatically cuts the time, pain, and cost involved in validation, making it easier to re-validate future upgrades.

Register for your free Interphex Hall Pass. Visit MasterControl Booth 2847 and pick up a thumb drive containing complimentary industry white papers. https://www1.compusystems.com/servlet/AttendeeRegLoginServlet?evt_uid=304&CampaignCode=PS546

About MasterControl
MasterControl Inc. has been at the forefront of providing software solutions for regulated companies since 1993. Hundreds of life science companies worldwide use MasterControl to help ensure compliance with FDA regulations such as 21 CFR Parts 11, 210-211, 820, 1270-1271, and 606 . In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support, including product training, implementation, and validation services. For more information about MasterControl compliance software, visit www.mastercontrol.com, or call 800-825-9117.