ICON plc Selects TrackWise For Audit And Corrective And Preventive Action Management
Sparta Systems, Inc., (Sparta) the maker of TrackWise® and the market leader in enterprise Quality Management System (QMS) software for the life sciences industries, today announced that ICON plc (NASDAQ:ICLR), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has selected TrackWise as its enterprise tool for managing global quality requirements, with initial implementation of the system focused on internal, external, and supplier audits, as well as Corrective and Preventive Action (CAPA) management.
TrackWise is a 21 CFR Part 11 compliant, web-based tracking software tool for electronically managing, tracking, and trending quality and regulatory issues and action items across the enterprise. The ability of TrackWise to centralize unlimited quality processes into a single, integrated system helps organizations increase efficiencies and achieve compliance by linking and consolidating related events and actions, automating workflow, and facilitating trending and reporting across quality systems and organizational areas.
"ICON utilized a formal evaluation process, which initially included sending out detailed requests for proposals to several vendors," commented Josephine Coyle, Vice President of Corporate Quality Assurance at ICON. "The selection team chose TrackWise, based on the system's flexibility and Sparta's proven experience in the life sciences industry. We felt that Sparta and TrackWise provided the best long term solution to meet our needs."
Coyle added that in addition to the RFP process, vendors were asked to provide product demonstrations. "Out of the systems we evaluated, the end users rated TrackWise the highest in terms of user-friendliness and overall functionality."
"The TrackWise system will act as a central repository for quality information and will enhance efficiency by enabling more proactive use of company resources," stated Graeme Pluves, Account Executive, for Sparta Systems Europe, Ltd. "The system is designed to facilitate process harmonization, providing users with valuable, real time information to support business objectives."
ICON will leverage Sparta's best practices and industry experience to facilitate its implementation of TrackWise.
About Sparta Systems
Sparta Systems, Inc. is the industry leader for global quality and compliance management systems. Its TrackWise product is a web-based software application used by quality, manufacturing, and regulatory affairs professionals to manage quality and compliance issues across the enterprise. The company has more than 12 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. More information about Sparta Systems and TrackWise can be found at www.sparta-systems.com.
About ICON plc
ICON plc is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. They specialize in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. ICON teams have successfully conducted over 1900 development projects and over 2300 consultancy engagements across all major therapeutic areas. ICON currently has over 4000 employees, operating from 48 locations in 30 countries. Further information is available at www.iconclinical.com.
Source: Sparta Systems, Inc.