September 3, 2003

AssurX Releases CATSWeb Version 6 Enterprise Quality Tracking System with Powerful New Features

-- CATSWeb Version 6 enables simplification/enhancement of quality systems

-- Maintains 21 CFR Part 11 compliance for FDA regulated companies

-- Next-generation Web-based system is for intranet/Internet environment


MORGAN HILL CA USA -- AssurX today announced the release of CATSWeb Version 6 Enterprise Quality Tracking System. CATSWeb is a comprehensive, real-time collaborative workflow system that is designed to track and manage issues and actions, from identification through disposition and corrective action.

KEY ADVANTAGES OF CATSWEB VERSION 6 INCLUDE:

-- Field proven implementation and technology with thousands of users 24/7 worldwide.

-- Highly reliable -- engineered on true Internet architecture.

-- True 100% Zero-Client(TM) architecture scalable to hundreds or thousands of users, independent of client browser version or client operating system.

-- Fully customizable point-and-click graphical user interface (GUI). Change colors, images, layout, fonts, etc.

-- Point-and-click administration (forms design, signature workflow, escalation rules, etc.) eliminates the need for re-validation as the system is enhanced.

-- Includes out-of-the-box, ready to use forms that can be easily modified.

-- 100% 21 CFR Part 11 compliant

-- Effective analysis and decision-making capability provided through the unique ability to query all fields as named and configured across all forms.

-- Rapid deployment through easy point-and-click configuration of workflow, fields, forms, rules, lists, signatures, etc. No programming required.

-- Minimal training needed for users due to clean, intuitive interface with robust help files.

-- Fully query-able audit trail.

-- Integrates with any external system - ERP, MES, SCM, internally developed applications and databases, etc.

-- Flexible and all-inclusive handling of unlimited number of quality processes/forms as needed (does not require additional modules or databases to be purchased or added)

VARIETY OF QUALITY PROCESSES:

CATSWeb is an all-inclusive system that can handle a variety of quality processes. CATSWeb is so flexible it can be used for:

-- Customer complaints
-- CAPAs
-- Adverse Events
-- Nonconformances
-- Product Tracking
-- Supplier Quality
-- Audits and Findings
-- FDA Compliance
-- Safety Issues
-- Exception Reports
-- Change Requests
-- Manufacturing Defects
-- RMAs
-- Training Issues
-- Plus much more

ASSURX ALSO OFFERS VALIDATION PRODUCTS & SERVICES:

As FDA regulated companies move to paperless systems, a greater reliance has been placed on off-the-shelf products like CATSWeb. AssurX fully understands the requirements and concerns in meeting the stringent regulatory demands for software validation. A critical part of the product offering is providing superior validation support. AssurX offers an IQ/OQ Validation Package that provides a step-by-step procedure, including the description of the test and expected results.

Or, companies may also opt for full validation services from AssurX that include customizing the template IQ/OQ documents, developing a Process Qualification (PQ) document, as well as performing the validation.

About AssurX, Inc.
AssurX, Inc. provides CATSWeb, the field-proven leader as the industry's enterprise Quality Tracking System of choice -- accessed by thousands of users worldwide 24/7. CATSWeb is not just a static data repository; it's a collaborative, real-time dynamic workflow tool that assists in problem solving efforts. CATSWeb is a true Zero-Client(TM) application that can be accessed from any computer, running any operating system, with any Web browser, anywhere and anytime that an Internet or intranet connection is available.

CATSWeb is used at FDA regulated companies around the world, including Guidant Corporation, Alcon Labs, Boston Scientific/Target and Bausch & Lomb.