Atairgin Technologies Taps QUMAS Enterprise Compliance Management Solution to Meet FDA Guidelines on Electronic Signature.Business Editors/Hi-Tech Writers FLORHAM PARK, N.J.--(BUSINESS WIRE)--Nov. 28, 2000 Biotechnology company creates paperless document management environment to cut circulation, review, and validation time QUMAS Inc., the leading provider of Enterprise Compliance Management Solutions for regulated industries, today announced that Atairgin Technologies, a biotechnology company with headquarters in Irvine, CA, has chosen to implement QUMAS DocCompliance(R) to manage regulatory compliance for all documentation. DocCompliance is a complete, out-of-the-box solution designed to exclusively manage the full lifecycle of regulatory controlled documentation throughout the enterprise. Atairgin selected the QUMAS system to create an automated, paperless environment and ensure that documentation is compliant with all Federal Drug Administration regulations, including 21 CFR CFR See: Cost and Freight Part 11, regarding electronic signature. Kiu Leung, director of product development for Atairgin said, "We looked at three different regulatory compliance software solutions but chose QUMAS for two critical reasons. First, the QUMAS system is totally compliant with the FDA's 21 CFR Part 11 ruling on electronic signature. Second, we felt secure in the knowledge that QUMAS is totally focused on the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. regulated industry which is essential in ensuring compliance with FDA regulations." Atairgin is an emerging healthcare technology company dedicated to improving the quality of care in women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. by developing reliable early detection tests to significantly reduce breast and ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast mortality, and creating breakthrough applications in women's healthcare. The company is currently engaged in clinical trials for its first product, a blood test to detect ovarian cancer. QUMAS President Kevin O'Leary Kevin O'Leary is the name of:
Leung expects that automating compliance processes with DocCompliance will save substantial resources for the company. He said, "By going paperless, Atairgin will be able to update and circulate documents for approval and training far more quickly and efficiently than if we were managing our documents manually. Qumas DocCompliance securely circulates documents to designated recipients via email, noting that they need to read and approve the material. The sender has a record that the document was delivered to each recipient. They can easily track responses, and then follow-up with those who haven't, ensuring rapid review and approval." Once Atairgin products receive FDA approval for manufacture, master device records and other critical documentation must be transferred to the designated OEM (Original Equipment Manufacturer) The rebranding of equipment and selling it. The term initially referred to the company that made the products (the "original" manufacturer), but eventually became widely used to refer to the organization that buys the products and vendor in a controlled environment. DocCompliance will facilitate the process by enabling an automated transfer quickly and securely, in full compliance with all FDA guidelines. About QUMAS QUMAS, Inc. 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 ruling on electronic signature and records), EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. 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, Inc. is based in Cork, Ireland Cork, Ireland is a term which may refer to the following places in southern Ireland, depending on context.
For more information, please visit our Web site www.qumas.com or contact QUMAS at 973/377-8750 (North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. ) or + 353 21 4320050 (Europe). |
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