Originally Published MPMNSeptember 2003

INDUSTRY NEWS

System Integrates Manufacturing and Regulatory Controls

LauraAngela Bagnetto

A system that integrates corrective action programs and manufacturing controls has been developed for companies in regulated industries. The fruit of an alliance between Camstar Systems Inc. (Campbell, CA; www.camstar.com) and Pilgrim Software Inc. (Tampa, FL; www.pilgrimsoftware.com), the product seeks to speed reaction times.

Marketed under the Camstar name, the system addresses manufacturing, quality control, and regulatory issues in compliance with 21 CFR Part 11. One of its key features is the integration of real-time detection and response, notably in respect to the handling of corrective and preventive action (CAPA) procedures.

"The system will register a nonconforming event and open up a CAPA report," says Rob Rudder, vice president of business development at Camstar. Everything comes to a halt until the problem is resolved. A role-defined alarm alerts the appropriate person, whether it is the machine operator, quality assurance manager, or someone at the corporate level. "That is what this system is all about," says Rudder. "It delivers information to the right person so that he or she can react quickly."

Alerts can be sent via e-mail or to a pager or PDA. Most companies opt for e-mail, according to Rudder. The alerts can be viewed on the company's intranet to foster "collaboration in working out a solution," says Rudder. Managers are also able to monitor progress and response times.

Camstar and Pilgrim both embed .net and xml Web services in their applications. This made it easy to blend the functionality of both systems while providing a common user experience. The resulting product reportedly can help device OEMs improve quality, increase yields, and speed new products' time to market while achieving regulatory compliance.


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