Cork, Ireland and New York, New York, April 11, 2001– Accenture and QUMAS, Ltd., today announced a global alliance aimed at enhancing the pharmaceutical and medical device industries’ ability to comply with the Food and Drug Administration’s requirements for electronic records and electronic signatures (21 CFR Part 11).
The alliance combines Accenture’s industry experience and deep technology skills with QUMAS’s application software tools such as DocCompliance and CAPACompliance. Over time, Accenture, a leading global management and technology consultancy, and QUMAS, a leading provider of Enterprise Compliance Management software solutions, are planning to expand this solution to other regulated industries with similar needs.
Regulatory authorities require the pharmaceutical, biotechnology and medical device companies to establish and maintain extensive records and documents related to drug development and manufacturing activities. Together, Accenture and QUMAS will offer these companies the ability to significantly streamline and enhance their management of electronic records, which will ultimately enable enterprise-wide compliance and reduce the amount of time spent on administration.
The QUMAS solution supports management of the full lifecycle of regulatory-controlled documents, addressing the FDA’s recently published mandate defining requirements for electronic records and electronic signatures. Additionally, the solution helps companies manage a diverse mix of documents, including policies, procedures, clinical trial documents, regulatory submissions, forms, drawings and specifications and some manufacturing documents.
Accenture will become QUMAS’s preferred business integration provider for the QUMAS DocCompliance®, CAPACompliance and other software tools, as well as for the services of professionals trained in these applications.
“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.
QUMAS’s CEO Paul Hands noted, “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. 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.”
Accenture is a $10.3 billion global management and technology consulting organization. The firm is reinventing itself to become the market-maker, architect and builder of the new marketplace, bringing innovations to improve the way the world works and lives. More than 70,000 people in 46 countries deliver a wide range of specialized capabilities and solutions to clients across all industries. Under its strategy, the firm is building a network of businesses to meet the full range of client needs -- consulting, technology, outsourcing, alliances and venture capital. Accenture’s home page address is http://www.accenture.com.
QUMAS, Ltd., is the leading developer of Enterprise Compliance Management Solutions designed to help regulated industries ensure regulatory compliance. For over a decade, QUMAS has been providing industry-proven Enterprise Compliance Management solutions to market leaders in the pharmaceutical, medical device, biotechnology and contract research industry sectors. Using advanced technology and regulatory domain intelligence, QUMAS’ pre-packaged compliance management solutions automate critical document processes and dramatically reduce document cycle times. QUMAS solutions deploy rapidly to deliver FDA (including 21 CFR Part 11 electronic signature and records), EMEA and ISO-related best practices for the automation of controlled documentation and electronic regulatory submissions. QUMAS services include validation, user training, migration services and technical support as part of a total software and services offering. QUMAS, Ltd. Is based in Cork, Ireland, with US headquarters in Florham Park, NJ, with additional offices throughout the United States. For more information, please visit our Web site http://www.QUMAS.com or contact QUMAS at +353 21 4320050 (Europe) or (973) 377-8750 (North America).