FDAnews Device Daily Bulletin


Nov. 23, 2005

AssurX, a provider of enterprise quality and compliance systems, has launched a new system to help device and drug manufacturers comply with multiple regulatory requirements and manage documents relating to safety issues, customer complaints and supplier quality.

Users can access the system, the CATSWeb Process for Document Control, from any computer and through any web browser, AssurX said. It is available as a hosted service or as an onsite enterprise application.

CATSWeb allows users to manage the controlled content life cycle, from change orders through release approval, dissemination and training, AssurX said. For example, the system includes a workflow system for managing content, such as procedures, specifications and drawings, through integrated change orders, version control and training tasks.

"The training component of CATSWeb is especially valuable, because federal inspectors often examine an organization's training programs -- and evidence that the training actually occurred -- to get a feel for the level of control and discipline," said Sal Lucido, vice president of enterprise solutions at AssurX. Among other things, the system: Manages and distributes content, including standard operating procedures, drawings and datasheets; and helps users comply with current good manufacturing practices, 21 CFR Part 11, the Sarbanes-Oxley Act and the Health Insurance Portability and Accountability Act.

CATSWeb customers include Guidant, Alcon and Fischer Imaging, AssurX said.