JERSEY CITY, NJ — October 8, 2008 - QUMAS, a leading provider of Compliance Solutions, announced that PharmaZell, a newly established company that has taken over Noveon's business of active pharmaceutical ingredients, has selected QUMAS for Compliance and Quality Management. PharmaZell will implement QUMAS DocCompliance™ as its enterprise regulatory content management system across its global locations. In phase two, PharmaZell will implement QUMAS ProcessCompliance as its enterprise quality assurance system, combining deviation, complaint and CAPA management.
"Pharmazell will leverage QUMAS' compliance solutions and expertise to meet our regulatory requirements", said Dr. Hans-Christian Müller (Manager Quality Control & Assurance). "The QUMAS solution meets our needs because it is scalable, and can be implemented in defined phases, enabling us to get the entire enterprise on board in a planned way."
Deployed at major pharmaceutical companies across the globe, QUMAS DocCompliance provides an off-the-shelf content management system with a controlled repository that ensures enterprise-wide consistency and compliance. QUMAS ProcessCompliance provides configurable workflow management that ensures the enterprise can react in real time to deviations and issues.
"The integration of document and process management is key to PharmaZell", said Caoimhe Kiely, Global Head of Marketing at QUMAS. "This integration provides them with certainty that global users commit (through electronic signatures) to adhere to the policies laid out by the company, and that any issues that occur are dealt with in an auditable process. Ultimately the corrective action is linked to an update of the document or SOP, which needs to be changed because of an issue and the lessons learned during the resolution".
QUMAS is the leader in Compliance Solutions with more than 250 customer deployments and over a decade of experience helping companies in highly regulated industries provide a proactive regulatory defense. QUMAS solutions for life sciences are designed to achieve compliance with industry and government standards for 21 CFR Part 11, cGxP, Quality, R&D, Regulatory Affairs and Clinical Operations.
For more information visit www.qumas.com
PharmaZell's mission is to provide high quality ingredients and services at competitive prices to its customers. This is achieved by combining manufacturing and development bases in Europe and India. PharmaZell operates cGMP sites in Chennai/India, Copenhagen/ Denmark and Raubling/Germany with a total of about 330 employees. An additional site is currently being developed in Vizag/India. PharmaZell's quality assurance and regulatory departments ensure full regulatory and GMP compliance.
For more information visit www.pharmazell.com
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