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News

ICON selects Sparta’s TrackWise to achieve global quality assurance

Sparta Systems : 13 June, 2008  (Application Story)
ICON, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has selected Sparta Systems’ TrackWise software to streamline and enhance the quality assurance processes across its drug development practices.
“We are excited at the prospect of greatly enhancing our efficiency as a global QA group within ICON, and as a result, bringing increased benefit to ICON through the provision of a better global oversight of compliance to client needs and regulatory requirements,” said Margaret McKee, director of quality assurance, ICON. “Implementation of TrackWise will provide us with the opportunity to improve and harmonize our internal QA processes.”

“In the drug development services industry, quality is the name of the game,” said Sahaf Flam, managing director, Sparta Systems Europe. “We are thrilled that a global leader such as ICON has selected TrackWise to help standardise its quality and compliance processes across its global quality assurance teams. In turn, TrackWise will help ICON improve compliance with both regulatory and sponsor requirements.”

ICON plans to utilise TrackWise to manage all internal and external audits and inspections including system/process audits, internal project audits, supplier audits and contracted audits. It also intends to track and manage corrective and preventive actions (CAPAs) and other quality issues as well as monitor the production of global trends and metrics for improvement, management and readiness for external audits and inspections.

The drug development services provider seeks to derive a number of key benefits from its use of TrackWise including:

- A central repository for quality information;

- Increased QA efficiency and more proactive use of QA resource;

- Enhanced compliance with regulatory and sponsor requirements;

- Harmonization within the global QA teams;

-Improved quality of QA reporting providing management with valuable, real time information;

- Tools to allow QA teams to expand proportionally in order to meet the future needs of ICON.

Following the launch of TrackWise, the company intends to evaluate other parts of the organization outside of the QA function where the enterprise quality and compliance management software could be applied.
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