Tampa, FL – May 20, 2009 -- Pilgrim Software, Inc., a world-leading provider of Enterprise Compliance and Quality Management (ECQM) software solutions, today announced that Nikki Willett, vice president of Regulatory Affairs for Pilgrim, recently addressed an audience of pharmaceutical and regulatory experts at the 2009 Parenteral Drug Association (PDA) Annual Meeting.  Willett presented a roadmap for implementing a “Lean Quality” program that enables pharmaceutical companies to increase productivity, maintain regulatory compliance, and boost customer satisfaction and profit through automation.

The 2009 PDA Annual Meeting, held in Red Rocks, NV last month, explored some of the most influential factors impacting the current state and future development of the pharmaceutical and biopharmaceutical industry. Built on the theme, The Impact of the Microchip – Application of Modern Technologies in the Development, Manufacture and Testing of Bio/pharmaceutical Products, the conference examined the systems and tools that can help companies maximize efficiency and productivity, while consistently delivering safe, pure and reliable drugs to patients.

“The concept of Lean is all about getting the right things to the right place at right time -- the first time, and always looking for continuous improvement,” Willett said. “Implementing lean, simple and intuitive procedures, and robust process architecture, results in quick navigation and a focus on problem solving, not navigating a maze of inefficiencies.”

Willett spoke of eliminating “process efficiency villains” including manual, paper-based data management processes that result in constraints, bottlenecks and human error.  “To ensure quality through lean change, a company must have processes in place that are capable and predictable.”

The presentation outlined the benefits of automation for pharmaceutical manufacturers, including data improvement and process improvement, and the resulting positive impacts on bottom-line costs and quality. “In the end, less is more,” Willett advised the audience.  “A lean, clear, concise, simple, intuitive, well-architected, integrated, high-throughput automated process management system will solve operational problems, not just the symptoms, and lead to outstanding results.”

Nikki Willett is vice president of marketing and regulatory affairs for Tampa, FL-based Pilgrim Software, Inc.  She is responsible for managing all aspects of Pilgrim’s worldwide product, vertical, telemarketing and corporate marketing strategic initiatives. She is a seasoned product and marketing professional with an extensive background in the high tech marketing, technology and regulatory industries. With over twenty-five years in software, Ms. Willett has focused on advancing technology through the constant evaluation of business trends to help organizations progress and succeed through the use of automation. She has participated in standard committees for the creation of digital standards with the FDA for new drug application (NDA) submissions and for the Air Transport Association (ATA). She is an active member of leading trade and industry associations such as Advamed, as well as RAPS, IVT, ISPE, PDA, ISBT and AABB representing the industries Pilgrim services.

About Pilgrim Software, Inc.   
Pilgrim Software, Inc. is a world-leading provider of Enterprise Compliance and Quality Management solutions for global organizations. Named 2007 & 2008 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 ww.pilgrimsoftware.com.