SOURCE: QUMAS

QUMAS

August 25, 2009 11:32 ET

Wockhardt Reduces the Number of CAPAs Using QUMAS ProcessCompliance

CORK, IRELAND--(Marketwire - August 25, 2009) - QUMAS, a leading provider of regulatory compliance solutions, today announced that Wockhardt UK, a diverse pharmaceutical business, has gone live with QUMAS ProcessCompliance as its Quality Management Solution for deviation management. Already using QUMAS DocCompliance for the management of all regulatory and GMP documents, Wockhardt is now using ProcessCompliance to manage all deviations, incidents and CAPAs.

"Prior to the deployment of ProcessCompliance, we relied on an old Access database that was not user-friendly," said Mr. Milind Korgaonkar, PM and IT Lead at Wockhardt. "During the implementation of ProcessCompliance, we remodeled our processes significantly to assign thresholds with scores, and combined with the ease of use of the system (leading to swift user acceptance), we have seen a dramatic drop in the number of CAPAs being raised on deviations."

Wockhardt has implemented and validated ProcessCompliance for deviations, incidents and CAPAs, and has also trained its production group on 'Root cause analysis.' The company next plans to roll out ProcessCompliance to Audit, and to bring other deviations under control in the system. By implementing the full Quality Management Solution from QUMAS, organizations can leverage 'round-tripping' between DocCompliance and ProcessCompliance, ensuring any related documents or SOPs are updated as part of Corrective Actions, providing irrefutable evidence to regulators of lessons learned through deviations.

"By adding process improvements during the implementation of their new ProcessCompliance system, Wockhardt leveraged a prime opportunity to remodel outdated procedures, and improve them dramatically while implementing electronic process management," said Ken Hayward, CTO for QUMAS. "We encourage all of our clients to review existing practices when configuring their new systems, to ensure they truly are implementing the best process possible in their new best of breed system."

About QUMAS

QUMAS is the leader in Regulatory Compliance Solutions with more than 250 customer deployments and over 15 years' experience in highly regulated industries. For more information visit www.qumas.com.

About Wockhardt

Wockhardt UK is a diverse pharmaceutical business, created from the merger of CP Pharmaceuticals and The Wallis Laboratory. They are a major supplier of healthcare products to the Retail Pharmacy, Hospital and Grocery sectors, with thriving Export and Contract Manufacturing Divisions also in place. For more information visit www.wockhardt.co.uk

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