MasterControl Releases New Software Solutions for Regulated Companies

SALT LAKE CITY – January 4, 2006 – MasterControl Inc. recently introduced new software solutions especially designed to help companies comply with FDA regulations, ISO quality standards, and Sarbanes-Oxley Act (SOX) requirements. The company will showcase these innovative products at the Medical Design & Manufacturing (MD&M) West Exposition in California later this month.

The new solutions build on MasterControl's traditional strengths — ease of use, powerful functionality, and connectivity — and take them to the next level. They are meant to answer the needs of different departments throughout an enterprise and handle an organization's various compliance needs — FDA, ISO, SOX, or other regulatory requirements — under a single Web-based platform that provides access to all authorized users regardless of location. MasterControl solutions are designed not only to help companies attain compliance, but sustain it year after year by simplifying the compliance environment and reining in compliance costs.

A MasterControl team will demonstrate the new solutions at Booth 3548 in Anaheim Convention Center ( Anaheim, Calif. ) during the MD&M West Exposition to be held Jan. 31-Feb. 2. The solutions, all seamlessly integrated in the MasterControl™ quality management suite, are:

  • MasterControl Change Control™ helps sustain compliance by interconnecting quality subsystems, strengthening the change control procedure, and promoting efficiency. The solution can manage all types of changes, including product, equipment, facilities, and computer systems. It streamlines the entire change control process for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change implies great impact on the product and is likely to require regulatory filing. Customizable reports provide real-time status not only of change control tasks, but of the entire quality system.
  • MasterControl Audit™ integrates the different steps in the audit process and connects the audit process to the quality system. It provides the ability to launch a form directly from another form. For example, a CAPA form can be launched from the Audit Finding form, streamlining the process. Pertinent information from the Audit Finding form will be automatically entered into the CAPA form, reducing data entry. The form maintains the links so one can review a completed process and see what triggered it. The solution offers best-practice forms for tracking basic audit information and audit findings. It automates scheduling of all recurring audit-related activities and provides advanced analytics and reporting capability, so managers get a real-time view of the audit process.
  • MasterControl Customer Complaints™ integrates the complaint-handling process with the quality system to ensure compliance. It streamlines the complaint-handling process to help reduce the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to internal investigation, and culminating with a resolution of the issue. MasterControl integrates customer-complaint handling with its Corrective and Preventive Action (CAPA) solution to automatically escalate any serious quality problem The solution includes the FDA's MedWatch 3500A form for mandatory reporting of adverse events, allowing a seamless handover to an adverse events specialist.
  • The latest version of the MasterControl CAPA™ solution is designed to effectively manage the Corrective and Preventive Action process and link it with other processes critical to regulatory compliance, such as change control, audit, and customer complaints, for a holistic quality management strategy. It includes a best-practice “8D” process to guide the quality team through every step of CAPA implementation. A CAPA form can be launched directly from another form (e.g., a complaint form), automatically entering relevant data into the CAPA form, reducing data entry and eliminating errors from manual transfer of information. Through the Internet, customers, vendors, and others outside the company can submit customer complaint or other forms that could lead to CAPA.
  • For companies seeking compliance with the Sarbanes-Oxley Act (SOX), the MasterControl SOX™ solution package is a complete and easy-to-use solution that automates and effectively manages both the document-centric aspects as well as the voluminous data that must be collected to help ensure financial statement integrity. It includes a pre-configured form that addresses the most challenging part of SOX: Section 404. MasterControl documents and collects data pertaining to risks, controls, and tests. It links every risk with its control and test through pre-built workflows. It allows testing to be automatically scheduled and incorporates escalation to ensure that tests are completed.


About MasterControl
MasterControl Inc. has been at the forefront of providing innovative electronic quality management systems since 1993. The company offers comprehensive technical and customer support, including product training, installation, implementation, and validation services. Over 400 companies worldwide use MasterControl to comply with FDA regulations, ISO quality standards, and other regulatory requirements. For more information, visit, or call 800-825-9117.