First Consulting Group and CDC Solutions Offer Comprehensive Content Management for Life Sciences.Business Editors/Hi-Tech Writers LONG BEACH, Calif. & PHILADELPHIA--(BUSINESS WIRE)-- Oct. 30, 2002 Alliance will provide single-source solutions for regulatory compliance in pharmaceutical R&D, good manufacturing practices Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. and marketing & sales First Consulting Group (FCG FCG First Consulting Group FCG Foreign Clearance Guide FCG Fatigue Crack Growth FCG Flux Compression Generator FCG Guinean Civic Forum (Guinea-Bissau) FCG Fisheries Consultative Group (ASEAN-SEAFDEC) ), (Nasdaq:FCGI FCGI Fast Common Gateway Interface FCGI Fellow of the City and Guilds Institute (UK) ) and CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation Solutions (CDC), today announced an alliance to offer life sciences firms comprehensive solutions for publishing, managing and tracking the content of new drug applications to the Food and Drug Administration. Those solutions address both present and future regulatory demands around the globe, including the requirements of the Common Technical Document (CTD CTD 1 Connective tissue disease, see there 2 Cumulative trauma disorder, see there ) and electronic Common Technical Document The Electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format. (eCTD). By packaging CDC's software with its own leading document-management suite, FCG is able to provide pharmaceutical and life sciences companies with the most complete and effective content-management system in the industry, resulting in even better value to FCG's clients. FCG has signed an Original Equipment Manufacturer's (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 ) agreement to embed em·bed also im·bed v. em·bed·ded, em·bed·ding, em·beds v.tr. 1. To fix firmly in a surrounding mass: embed a post in concrete; fossils embedded in shale. CDC's leading regulatory publishing solution, EZsubs(TM) Enterprise, into its FirstDoc(TM) Turnkey offering. FirstDoc is the industry's only comprehensive and pre-packaged electronic content-management solution supporting R&D and the regulatory submissions process. It is specifically designed to meet the needs of small and mid-size life sciences organizations. As the leading technology for streamlining the electronic regulatory publishing process, EZsubs Enterprise now enhances FirstDoc by supplying powerful, advanced electronic publishing An umbrella term for non-paper publishing, which includes publishing online or on media such as CDs and DVDs. , which meets the CTD and eCTD guidelines. The complete FirstDoc package is delivered and supported by FCG. This solution integrates the many best-of-breed components required to comply with regulatory guidelines, resulting in both reduced lifetime cost of ownership and a clearly defined upgrade path. The packaged approach also enables a FirstDoc solution to be operational in as little as eight weeks. With the requirements of the CTD and eCTD from the global regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. , life sciences companies must be ready to meet the strict standards that come with the new guidelines. "Life sciences companies demand solutions that are flexible enough to keep up with the evolving requirements of global regulatory agencies, and sophisticated enough to meet the internal mission-critical needs of the product research and development process," said Jeff Klein, Vice President, FCG Software Development. "EZsubs Enterprise completes FirstDoc by providing the advanced regulatory publishing that is well proven in small biotechnology organizations as well as the world's top pharmaceutical companies." FCG and CDC have also joined forces to offer a solution for the management of controlled documents, such as for Good Manufacturing Practices (GMP GMP (guanosine monophosphate): see guanine. ). To meet these needs, FCG's FirstDoc incorporates CDC's PDFaqua and Print Services Manager which reduces the risk of non-compliance by providing defined processes There are two major approaches to controlling any process:
It ensures compliance with all GMPs and 21 CFR CFR See: Cost and Freight Part 11. "After evaluating other solutions on the market, FCG determined that PDFaqua provides `best in class' watermarking and print and view control to help ensure the highest level of security within GMP environments," added Klein. The entire FirstDoc(TM) product suite, comprised of FirstDoc(TM) R&D, FirstDoc(TM) CRFs, FirstDoc(TM) GMP, and FirstDoc(TM) Marketing and Sales, now includes an advanced e-signature capability powered by CDC's PDFfusion. Philip Padfield, Chief Executive Officer of CDC Solutions, said, "We are delighted that FCG chose EZsubs and PDFaqua to enhance their regulatory solutions and services. Our long-standing partnership with FCG proves that EZsubs and PDFaqua are well supported by FCG's extensive experience in designing, developing and deploying systems that help life sciences companies meet their GMP, submissions management and publishing challenges." About First Consulting Group First Consulting Group is a leading provider of consulting, technology, outsourcing and applied research services for healthcare, pharmaceutical and other life sciences organizations throughout 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. , Europe and Japan. The firm's services are designed to increase its clients' operations effectiveness, resulting in reduced costs, improved customer service, enhanced quality of patient care and the more rapid introduction of new pharmaceutical compounds. More information about FCG is available through the World Wide Web site at www.fcg.com or by calling the toll free number 800-345-0957. About CDC Solutions Ltd. Founded in 1994, CDC Solutions is the leader in high performance document-based solutions to the Life Sciences industries. The open, flexible technologies developed by CDC Solutions enable Life Sciences companies to meet the strict standards of regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities across the world, helping them achieve quality, accuracy, and data integrity to deliver reports and submissions reliably on time. CDC Solutions helps compress the regulatory submissions and approval process, improving speed to market, cost control, and productivity: all of which contribute to ensuring patients' and physicians' timely access to new drugs. CDC Solutions develops products in-house, employing a team of developers and regulatory specialists who actively pilot new initiatives with clients and partners. Through its strategic business partners, CDC Solutions' technology is used to address the needs of other document intensive industries such as engineering, utilities, and finance. For more information, call +44 1249 705300 (United Kingdom) or +1 610.834.9021 (CDC Solutions Inc., North America), or visit the CDC Solutions website at www.cdcsolutions.com. CDC Solutions, EZsubs, PDFfusion, PDFrender, PDFaqua, PDFcontrol, Xtensia, Xssembler, and Xport are trademarks or registered trademarks, service marks or registered service marks of CDC Solutions Ltd. All other product and company names mentioned herein may be trademarks of their respective holders. |
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