Global Biomedical Company Successfully Deploys SmartCAPA
Tampa, FL – September 12, 2006 – Pilgrim Software, Inc., a leading provider of Enterprise Compliance and Quality Management (ECQM) software solutions, today announced that Biosite® Incorporated (NASDAQ: BSTE), a global biomedical company, has gone live with Pilgrim’s SmartCAPA module. With SmartCAPA implemented, Biosite employs a collaborative approach to tracing and resolving deviations as well as preventing recurrences to ensure constant compliance with FDA and industry regulations.
SmartCAPA is an automated, closed-loop system that allows users to initiate corrective and preventive actions to quickly address and resolve issues. With SmartCAPA’s control over signatures, escalations and standard processes, Biosite encourages cooperation among responsible individuals and allows access to real-time data through trending and analytical reports.
“Due to Biosite’s rapid growth over the past five years, the company has outgrown its previous CAPA system. Biosite now requires an automated system that can help it improve the efficiencies and reduce costs associated with disconnected and labor intensive systems,” said Prashanth Rajendran, Chief Operating Officer of Pilgrim Software. “Biosite selected Pilgrim’s SmartCAPA because it provides industry best practice workflows that create a cost-effective model for meeting both compliance requirements and operational excellence initiatives. Additionally with SmartCAPA, Biosite gains an automated and scalable application that can be tailored to adapt with the company as it grows to alleviate future growing pains.”
SmartCAPA was implemented successfully by Biosite’s staff due to Pilgrim’s out-of-the-box solution and the strong domain expertise of Biosite’s internal implementation team. The self-sufficient implementation approach Biosite took resulted in minimal added support from Pilgrim consultants.
Biosite currently is using SmartCAPA within its Regulatory Affairs and Quality Assurance departments at its San Diego, CA headquarters. Over time, the company intends to broaden SmartCAPA’s scope within the organization. The deployment of SmartCAPA represents the first milestone in the process of deploying Pilgrim’s entire SmartSolve suite at Biosite. The next implementation is SmartAudit, Pilgrim’s audit management solution.
About Biosite Incorporated
Biosite Incorporated is a leading bio-medical company commercializing proteomics discoveries for the advancement of medical diagnosis. The Company's products contribute to improvements in medical care by aiding physicians in the diagnosis of critical diseases and health conditions. Biosite's Triage(R) rapid diagnostics are used in approximately 50 percent of U.S. hospitals and in more than 50 international markets. Information on Biosite can be found at www.biosite.com.
About Pilgrim Software, Inc.
Pilgrim Software, Inc. is the leading provider of Enterprise Compliance and Quality Management solutions for global organizations. Pilgrim helps organizations manage industry and regulatory compliance, reduce manufacturing costs and improve customer satisfaction. For more information, visit Pilgrim Software’s Web site at www.pilgrimsoftware.com.







