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HemoSense Names Pilgrim Software as CAPA & Complaints Management Provider
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Jul 27, 2007, 15:30

Tampa, FL – July 27, 2007 --  Pilgrim Software, Inc., a world-leading provider of Enterprise Compliance and Quality Management (ECQM) software solutions, today announced that HemoSense, Inc., a growing medical device manufacturing firm, has selected Pilgrim’s SmartCAPA™ and SmartComplaints™ products to manage its CAPA and complaints handling processes. Pilgrim’s scalable, electronic solutions will facilitate HemoSense’s quality system enhancements to meet its anticipated growth and further support its regulatory compliance risk management efforts.

SmartSolve® solutions provide HemoSense users with automated, streamlined and integrated solutions to manage business processes throughout the organization. SmartCAPA and SmartComplaints form a closed-loop CAPA and complaint management system that allows users to report, react to, and resolve issues as well as prevent recurrence through appropriate actions.

Electronic records management of these key processes with SmartCAPA and SmartComplaints, will help HemoSense meet FDA requirements for quality records, while enhancing communication with customers.

“Partnering with Pilgrim enhances our quality efforts at both the process and product level,” said Doug Rundle, Vice President of Quality Assurance and Regulatory Affairs for HemoSense.  “With increased quality focus throughout our organization, we are taking a proactive approach to risk management to ensure that customer complaints and other regulatory processes continue to be effectively managed.”

“HemoSense reviewed several options and selected Pilgrim because of our out-of-the-box system that is tried and proven in accordance with industry best practices,” said Prashanth Rajendran, Pilgrim Software’s Chief Operating Officer.  “In addition to providing HemoSense with automated processes that will support their manufacturing and sales operations, our solutions also provide them with the scalability to easily integrate additional modules and multiply the number of users as they increase their personnel and product portfolio.”


About HemoSense, Inc.

HemoSense is a point-of-care diagnostic healthcare company that initially has developed, manufactures and commercializes easy-to-use, handheld blood coagulation systems for monitoring patients taking warfarin. The HemoSense INRatio® system, used by healthcare professionals and patients themselves, consists of a small monitor and disposable test strips. It provides accurate and convenient measurement of blood clotting time, or PT/INR values. Routine measurements of PT/INR are necessary for the safe and effective management of the patient’s warfarin dosing. INRatio is sold in the United States and internationally. For more information, visit www.hemosense.com. www.hemosense.com


About Pilgrim Software, Inc. 
  
Pilgrim Software, Inc. is a world-leading provider of Enterprise Compliance and Quality Management solutions for global organizations. Named 2007 North American Enterprise Compliance & Quality Management Company of the Year by Frost & Sullivan, Pilgrim helps organizations manage industry and regulatory compliance, reduce manufacturing costs and improve customer satisfaction. For more information, visit Pilgrim Software’s website at www.pilgrimsoftware.com.



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