News

MasterControl Introduces Nonconformance Solution for Companies in FDA and ISO Environments

SALT LAKE CITY – Aug 2, 2006 – MasterControl Inc., the leading software provider for companies in FDA and ISO environments, today introduced a solution that automates and effectively manages the process for controlling and handling nonconforming materials.

For regulated companies, conformance to approved materials and components is key to ensuring product quality and safety. The FDA's Current Good Manufacturing Practice (CGMP) regulations, ISO 9001, ISO 13485, and ISO 14001 all require manufacturers to establish and maintain procedures for the disposition of products that don't conform to specified requirements. Under these regulations and standards, the nonconformance disposition process is an integral part of the quality management system ? and an essential part of compliance.

MasterControl Nonconformance™ is a configurable and easy-to-use solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconformance incidents. As part of the MasterControl™ integrated quality management suite, this application connects the nonconformance procedure to other quality processes (corrective/preventive action, training, change control) under a single Web-based platform.

Here are the key features of MasterControl Nonconformance™:

•  Best-Practice Form ? A pre-configured, multi-page form simplifies the process and accelerates evaluation and disposition of nonconforming materials by prompting the appropriate departments to collect and track all relevant data. The form is automatically routed to responsible personnel and escalates accordingly if the case is not processed promptly.

•  Best-Practice Process ? This solution incorporates a five-step process that will help the quality unit make timely and appropriate decisions. The process will guide the team from initiation through investigation, recommendation, disposition, and management approval.

•  Flexible Process ? MasterControl can be used as a stand-alone process for the purpose of small-scale, localized disposition of nonconforming materials. But its flexibility allows for integration with the corrective/preventive action (CAPA) process if the situation warrants a separate CAPA case while the initial nonconformance is independently processed and closed.

•  Form-to-Form Launching ? A CAPA form can be launched directly from a nonconformance form, connecting one process to the next. Not only does MasterControl streamline this process, but it also maintains the links so one can review a completed process and easily see what triggered the CAPA. Relevant information from the nonconformance form will be automatically entered into the CAPA form, reducing data entry and increasing accuracy.

•  Analytics Reporting Tool ? The Nonconformance solution includes a standard set of pre-configured reports that can be customized by end users. Nonconformances can be trended, and incidents analyzed by material, shift, machine, supplier, etc. These "data-mining" capabilities can give important insight into systemic quality issues and serve as another starting point for CAPA.

•  Compliant System ? MasterControl provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA's 21 CFR Part 11 requirements.

For FDA-regulated companies, MasterControl offers a continuum of products and services that address different levels of validation needs based on individual risk assessment. MasterControl makes continuous validation possible by dramatically cutting the time involved in validating a system, reducing the risks of project implementation, and making it easier to validate software upgrades, all of which help lower validation cost.

About MasterControl
MasterControl Inc. has been at the forefront of providing innovative electronic quality management systems since 1993. Hundreds of companies worldwide use MasterControl to help ensure compliance with FDA regulations such as 21 CFR Parts 11, 210-211, 820, 606; ISO 9000, ISO 13485, ISO 14000, and other ISO standards; and Sarbanes-Oxley Act requirements. 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, visit www.mastercontrol.com, or call 800-825-9117.