News

MasterControl Launches Business Rules Solution for Regulated Industries

SALT LAKE CITY – Nov. 3, 2006 – MasterControl Inc. today introduced MasterControl Rules?, a new software solution that utilizes business rules to monitor quality events and tasks on a real-time basis and help managers solve issues in a more proactive way.

MasterControl Rules is an ideal solution to help FDA-regulated and ISO-certified companies monitor product or service issues on a real-time basis. A prompt discovery of serious quality problems helps prevent product recalls and rework, and ultimately helps reduce possible consumer injuries, or even death, due to defective products.

Through MasterControl Rules, a manager can set thresholds for quality events, such as customer complaints or material nonconformances, which will trigger notification and alert the manager to take appropriate action (e.g., launch a corrective/preventive action investigation) as soon as possible.

Below are some of the key features of MasterControl Rules.

• Configurable Rules: Rules can be configured based on a company's needs, but the most common type is notification rule, which triggers an alert to affected users, so they can take an appropriate action. The notification rule provides a high degree of customization, including frequency, subject line, e-mail text, recipients, etc.
• Criteria Functionality: Depending on source data selected by a user, triggers may be based on when criteria are met (e.g., every time there's a task past its due date), or based on a number of records (e.g., every time the system finds an accumulation of 15 CAPAs for a specific product). This will alert the user to act accordingly as soon as possible.
• Rights-Based Capability: The extent of a user's rules capability is based on his/her system rights. The two types of rights are rules administration and ?My Rules.? The latter is available on basic and advanced levels. B y giving users the capability to manage their own tasks with the help of rules, they become more accountable for monitoring and completing their tasks.
• Rules Administration: Users with rules administration rights have the ability to:
  • Create, copy, edit, and delete rules;
  • Suspend a rule without deleting it;
  • Mark notification rules as mandatory to prevent basic and advanced users from disabling them in their ?My Rules™ access page; and
  • Create notification rules that involve other users.
• My Rules ? Basic Users: Access includes setting notification rules for themselves, and setting frequency of notification for other, non-mandatory rules that affect them.
• My Rules ? Advanced Users: Access includes all of basic users' capabilities plus the ability to create rules notifying others. 

As a part of the MasterControl™ quality management suite, MasterControl Rules can be integrated with other MasterControl applications designed to manage quality processes that are critical to regulatory compliance, such as document control, change control, training, CAPA, audit, customer complaints, and nonconformance disposition.

In addition, MasterControl offers FDA-regulated companies a continuum of validation products and services that address different levels of software validation needs based on individual risk assessment. This line of products and services make ?continuous validation? possible by dramatically cutting the time, pain, and cost involved in validating a system, reducing the risks of project implementation, and making it easier to validate software upgrades.

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.