from DSSResources.comPfizer implements Pilgrim Software's SmartAudit to facilitate quality and regulatory auditsTAMPA, Fla., Oct. 27, 2006 -- Pilgrim Software, Inc., a world-leading provider of Enterprise Compliance and Quality Management software solutions, announced that Pfizer Inc. has deployed Pilgrim's SmartAudit solution in record-breaking time at its New York City headquarters. The fully automated solution, implemented in just four months, will be used across the Pfizer Corporate Regulatory Compliance (CRC) function, enabling Pfizer to manage regulatory and quality audits, improve visibility into client processes, and attain long-term strategic goals and objectives. Pfizer CRC is a harmonization of four separate compliance groups that includes Pfizer's Research Quality Assurance, Corporate Quality Assurance, Research Development Oversight, and Environmental Health and Safety Compliance Assurance. These groups, all within Pfizer's Legal Division, will now employ SmartAudit to facilitate legal audits impacting clinical studies, manufacturing operations, environment, health and safety, regulatory and quality assurance, and other key processes. With SmartAudit in operation, hundreds of Pfizer auditors across five countries can track their actions in a structured and verifiable manner, and receive notifications and subsequent approvals, thereby increasing their accountability. Furthermore, management is able to monitor audit processes and access data and reports on the company's compliance standing which can be leveraged to take quick, effective and appropriate actions to prevent or correct problems. "As the provider of many of the world's best-known medicines and consumer brands, it is critical that Pfizer constantly ensure it is offering its patients and consumers the highest quality and most advanced products, while remaining fully compliant with internal standards and external regulatory requirements," said Ciaran Schoenauer, Pfizer's Senior Director of Strategic Operations, Corporate Regulatory Compliance. "By automating the audit process, Pfizer will further enhance its global reputation for quality and its distinction as the most trusted and reliable pharmaceutical company in the world." "SmartAudit provides Pfizer with a 21 CFR Part 11 compliant solution, creating electronic records and employing electronic signatures," said Pilgrim Software's CEO Prashanth Rajendran. "We believe that Pfizer now not only has a robust system to monitor compliance, but also has a competitive advantage because audits will be rapid, cost-effective and result in sustained product reliability and consumer trust." Pfizer has undertaken a three-phased approach to implementing SmartAudit to avoid overwhelming end-users with a single monolithic release. With Phase One completed, Pfizer will continue to rollout SmartAudit to all its organizations throughout the remainder of 2006 and into 2007. Contact: Sandy Carson, carsons@pilgrimsoftware.com Pilgrim Software, Inc. Ph: (813) 915-1663 Fax: (813) 915-1948 http://www.pilgrimsoftware.com |