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Gilead Sciences Goes Live with Pilgrim’s SmartCAPA to Facilitate FDA and cGxP Compliance


Tampa, FL – November 28, 2005 –
  Pilgrim Software, Inc., the leading provider of Enterprise Compliance and Quality Management Solutions, announces that Gilead Sciences has gone live throughout their organization with SmartCAPA to facilitate compliance with FDA’s 21 CFR part 11 and cGxP requirements.

“Gilead was able to successfully expedite and implement its existing business processes across its global sites in seven months because of our validated off-the-shelf solutions,” said Prashanth Rajendran, Chief Operating Officer of Pilgrim Software. “With SmartCAPA live throughout the organization, Gilead has a fully automated CAPA system that has streamlined processes as well as brought together previously disparate information into a centralized location reducing the cost from the previous paper based administration.  This provided management with real-time visibility and enhanced reporting, tracking and trending capabilities to identify the occurrence of nonconformances, incidents, discrepancies and other product and process quality concerns.”

In addition, SmartCAPA has provided global collaboration allowing each Gilead site to leverage lessons learned and successes into best practices, resulting in an increased level of continuous improvement throughout the organization.  By providing immediate notifications and best practice workflows, SmartCAPA allows responsible parties on tasks and investigations to quickly resolve issues ensuring that Gilead is continually in compliance with all FDA and cGxP regulations. Currently, Gilead is in the process of implementing the SmartDoc and SmartTrain modules, which will go live in Spring 2006.


About Gilead Sciences
As a leading biopharmaceutical company, Gilead Sciences has been discovering, developing and commercializing small molecule therapeutics for more than a decade to advance the care of patients suffering from life-threatening infectious diseases. In addition to their marketed products, Gilead has a clinical, preclinical and research pipeline focused on developing anti-infectives. Gilead’s marketed products include unique therapeutics and a number of category firsts and market leaders. Headquartered in Foster City, CA, Gilead maintains research, development or manufacturing facilities in the United States and Europe. In the United States, operations are based in Foster City and San Dimas, CA, and Durham, NC. European operations are based in Cambridge, UK; Dublin, Ireland and Paris, France. Additionally, sales and marketing organizations are located in the following cities: Athens, Greece; Cambridge, UK; Lisbon, Portugal; Madrid, Spain; Melbourne, Australia; Milan, Italy; Munich, Germany and Paris, France. NASDAQ stock symbol: GILD. For more information about Gilead Sciences, visit their web site at www.gilead.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.