Accenture and QUMAS partner to provide enterprise compliance management solution
Regulatory authorities require pharmaceutical, biotechnology and medical device companies to establish and maintain extensive records and documents related to drug development and manufacturing activities. Under the terms of their new agreement, Accenture and QUMAS will work together to offer companies the ability to streamline and enhance the management of electronic records, to enable enterprise-wide compliance and reduce the amount of time spent on administration.
The QUMAS solution is designed to support the management of the full lifecycle of regulatory-controlled documents. According to its developers the solution enables companies to manage a number of documents, including policies, procedures, clinical trial documents, regulatory submissions, forms, drawings and specifications and some manufacturing documents.
Under the terms of the agreement, Accenture will become QUMAS's preferred business integration provider for the QUMAS DocCompliance, CAPACompliance and other software tools.
"The significance of compliance in the pharmaceutical industry is critical," said Ken Lacey, Accenture Global Managing Partner Pharmaceuticals & Medical Products. "In fact, pharmaceutical industry executives have projected that the new FDA regulations addressing electronic records and electronic signatures could be more significant than Y2K. By joining forces with QUMAS, Accenture will be able to help our clients manage compliance more efficiently, which in turn should impact their bottom line and enable
a clearer focus on more strategic initiatives," he added.
"Accenture's industry experience and corporate reach will enable QUMAS to capture executive mindshare, and lead the industry to embrace our solution as a critical part of their complete compliance management program," said Paul Hands of QUMAS. "We have a strong, industry-proven track record in enterprise compliance management, and our relationship with Accenture will help us to rapidly bring this solution to a wider market."