NetRegulus to Release Powerful New AlertExpert™ Software Utility
CHICAGO – NetRegulus, a leading producer of software solutions for FDA-regulated businesses in the life sciences industry, today released details of a new addition to the NetRegulus v6 product line. Due for release in Q4 2003, AlertExpert™ will provide users with even greater flexibility in examining their data and defining appropriate actions, depending on these findings. The core of the new technology is the ability to monitor and delimit data results gathered by ad-hoc queries to the v6 database at predefined intervals. With AlertExpert, the user needs no special programming tools to quickly and intuitively:
- Establish thresholds for any situation or set of conditions
- Add user-definable actions – including sending e-mails, creating automatic issues, triggering alerts, generating trending records, and producing site data-clarification requests – that will automatically occur when triggered by a predefined event or threshold
- Preserve and attach various types of data to be used for documentation
Designed to work across all business-process solutions encompassed by NetRegulus v6, users will find AlertExpert invaluable for managing and monitoring product quality, a key issue in the regulated products industry. AlertExpert enables the user to:
- Establish Corrective and Preventive Action (CAPA) checks
- Generate new quality issues, tasks, and/or investigations associated with predefined conditions
- Identify and analyze quality trends
- When special conditions exist, automatically alert key personnel in the complaints, nonconformance, or audit areas
- Monitor the performance of suppliers and vendors with regard to incoming materials
NetRegulus v6 users whose primary application is study data management will find AlertExpert particularly useful as they manage their business processes. AlertExpert will automatically scan data for study-specific conditions and take appropriate user-defined actions if and when a given condition occurs. AlertExpert utility will quickly and automatically identify a variety of critical data conditions, including:
- Missing data values
- Possible extreme data points (outliers)
- Event occurrences in excess of specified threshold values
“AlertExpert is aptly named because it automatically keeps track of – and takes action on – so many details and potential problem events that manual methods could overlook. We anticipate a very positive reception for this release,” says NetRegulus CEO Mark Schaub. “NetRegulus v6 is already a robust product, but AlertExpert gives customers an added margin of safety, automates a problem-prone business process, and adds enriching detail to the database.”
About NetRegulus
Oakbrook Terrace, Illinois-based NetRegulus is a privately held firm that has pioneered software solutions for clinical, quality, and regulatory data management for the life sciences industry since 1998. The company has gained an international reputation for best-in-class Web- and Windows-based software that is fully compliant with the FDA’s 21 CFR Part 11 requirement. The firm offers software solutions for complaint handling, CAPA management, clinical study data management, adverse event tracking, nonconformance handling, and other critical business needs. At the hub of the whole suite is the NetRegulus v6 database, which provides a central repository for all data. It all adds up to an enterprise-wide, always accessible system for tracking and managing regulatory data.
###
For additional information, contact:
Jim Grosspietsch
Director of Marketing, NetRegulus
(888) 707-6900
jim.grosspietsch@NetRegulus
