Medical Device Link.

Originally Published EMDM September 2002

WEB WATCH

The software provides manufacturers with a mechanism to implement and verify the effectiveness of CAPA-related changes

SmartCAPA from Pilgrim Software allows users to manage all issues and tasks related to corrective and preventive action. (click to enlarge)

Web-based management of corrective and preventive action (CAPA) from any location and from any Internet-enabled device is built into a company's suite of software. SmartSolve, developed by Pilgrim Software Inc. (Tampa, FL, USA), incorporates SmartCAPA, a tool that provides strict control over the life cycle of corrective and preventive actions, in compliance with US FDA regulations.

"CAPA issues account for 30 to 50% of US FDA citations," notes director of marketing Chris Parsons. The Web-based solution, says Parsons, gives manufacturers a closed-loop mechanism to initiate, implement, and verify the effectiveness of changes prompted by an exception experience. SmartCAPA is compliant with US 21 CFR Part 11 requirements for electronic signatures and electronic records, he adds.

Because CAPA implementation produces organizational change that must be effectively managed, coordinated change management capabilities are built into the program. Configurable work-flow management functions ensure that CAPA processes are handled accurately and efficiently. A library of workflow templates allows the application of established procedures across the entire CAPA process.

The goal of a good CAPA system, adds Parsons, is to ensure a top-down approach to compliance. SmartCAPA is designed to support this methodology. Because the software extends "corporate visibility into the CAPA process, corrective action can be initiated at the highest levels of the company and driven down throughout the organization," says Parsons.

For more information, contact Pilgrim Software Inc., 2807 W. Busch Blvd., Ste. 200, Tampa, FL 33618, USA; phone: +1 813 9151663; fax: +1 813 9151948; e-mail: mitchelle@pilgrim-software.com; Internet: www.pilgrimsoftware.com.

Copyright ©2002 European Medical Device Manufacturer