Pfizer Rolls Out Pilgrim Software's Smartaudit to Facilitate Quality & Regulatory Audits
TAMPA FL USA -- OCT 30 2006 -- Pilgrim Software, Inc., a world-leading provider of Enterprise Compliance and Quality Management (ECQM) software solutions, today announced that Pfizer Inc. (NYSE: PFE) has successfully deployed Pilgrim's SmartAudit solution in record-breaking time at its New York City headquarters.
The fully-automated solution, implemented in just 4 months, will be used across the Pfizer Corporate Regulatory Compliance (CRC) function. This enables Pfizer to manage regulatory and quality audits, improve the visibility into client processes, and attain long-term strategic goals and objectives.
Pfizer CRC is a harmonization of 4 separate compliance groups that includes Pfizer's Research Quality Assurance, Corporate Quality Assurance, Research Development Oversight, and Environmental Health & Safety Compliance Assurance. These groups, all within Pfizer's Legal Div, 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, a global team of hundreds of Pfizer auditors across 5 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 Sr 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."
"Our SmartAudit solution provides Pfizer with a 21 CFR Part 11-compliant solution, creating electronic records and employing electronic signatures," said Prashanth Rajendran, Pilgrim Software's Chief Operating Officer. "We believe that Pfizer now not only has a robust system to monitor compliance, but also has an advantage over competition. Performing audits will be rapid, cost-effective, and result in a sustained product reliability and consumer trust."
Pfizer has undertaken a 3-phased approach to implementing SmartAudit, so as to avoid overwhelming end-users with a single monolithic release. With Phase One completed, Pfizer will continue to rollout SmartAudit to all of its organizations, throughout the remainder of this year and into early 2007.
ABOUT PFIZER:
Pfizer Inc, founded in 1849, is dedicated to better health and greater access to healthcare for people and their valued animals. Our purpose is helping people live longer, healthier, happier lives. Our route to that purpose is through discovering and developing breakthrough medicines; providing information on prevention, wellness and treatment; consistent high-quality manufacturing of medicines, consumer products; and global leadership in corporate responsibility. Every day we help 38 mln patients, employ more than 100,000 colleagues, utilize the skills of more than 12,000 medical researchers, and work in partnership with governments, individuals, and other payers for healthcare to treat and prevent illnesses-adding both years to life and life to years. For more information, please visit:
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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 FURTHER INFORMATION, PLEASE CONTACT:
Jennifer Holtvluwer
Pilgrim Software, Inc.
2807 W Busch Blvd Ste 200
Tampa FL USA 33618
813-915-1663 ext 289 phone
813-915-1948 fax
holtvluwerj@pilgrimsoftware.com
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