Clarkston-Potomac Hires Leader for New FDA Validation Team.Business Editors/High Tech and Health Writers DURHAM, N.C.--(BW HealthWire)--Feb. 2, 2000 New hire will play critical role in enabling e-business consulting firm Noun 1. consulting firm - a firm of experts providing professional advice to an organization for a fee consulting company business firm, firm, house - the members of a business organization that owns or operates one or more establishments; "he worked for a to meet special needs of pharmaceutical, biological science industries Clarkston-Potomac, a full-service e-business and technology consulting firm, has hired Carol Brandt to lead a new team of consultants trained specifically in Food and Drug Administration (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. ) code validation requirements for computer systems of pharmaceutical and biological science companies. The firm's hiring of Brandt represents a continuation of its focus to meet the special needs of these companies. In her new position, Brandt will lead a strategic initiative that will concentrate on helping companies understand increasingly stringent and formalized for·mal·ize tr.v. for·mal·ized, for·mal·iz·ing, for·mal·iz·es 1. To give a definite form or shape to. 2. a. To make formal. b. FDA computer validation requirements and then help them design and implement fully compliant systems and processes that also meet their goals for conversion from traditional business models to e-business practices. &uot;Our FDA validation team's extensive knowledge of federal regulatory codes provides our clients with immediate access to critical information that enables them to deploy e-business solutions faster,&uot; said Monty (programming, abuse) monty - /mon'tee/ Any program with a ludicrously complex user interface that performs a trivial task. An example would be a menu-driven, button clicking, pulldown, pop-up windows program for listing directories. Hamilton, a managing partner who is responsible for leading Clarkston-Potomac's pharmaceutical initiative. &uot;This knowledge in turn provides our clients with the assurance that the information technology systems we design and implement for them will have built-in, full FDA compliance.&uot; The FDA published its first guidelines guidelines, n.pl a set of standards, criteria, or specifications to be used or followed in the performance of certain tasks. for computer software validation The certification that an information system has been implemented correctly and that it conforms to the functional specifications derived from the original requirements. Such validation is often performed by a third party consulting organization. approximately 10 years ago. In essence, these guidelines require documentation of the entire process of establishing a computer system to ensure that the system will do what it was designed for. These guidelines, which are much more stringent for the pharmaceutical and biological science industries than for others governed by the FDA, contain many &uot;gray&uot; areas not readily understood by all companies. This produces numerous challenges as companies attempt to bring their computer systems in line with the latest e-business strategy developments. &uot;A lot of misconception mis·con·cep·tion n. A mistaken thought, idea, or notion; a misunderstanding: had many misconceptions about the new tax program. exists about validation requirements, where they're needed and why companies will benefit from them,&uot; Brandt explained. &uot;But the bottom line is, if a company's systems are not properly validated, it can face severe penalties, including the ultimate risk of shutdown shut·down n. A cessation of operations or activity, as at a factory. shutdown Noun the closing of a factory, shop, or other business Verb shut down . &uot;While some companies have fully compliant systems in place, others are scrambling See scramble. to get on board, and in some cases, to even understand what is required of them,&uot; she continued. &uot;As experts in FDA validation, Clarkston-Potomac will work with these companies from the ground up to help them understand requirements as they relate to individual business practices and ultimately design and implement the appropriate systems and processes to ensure full compliance--in most cases, more cost-effectively than full-time, in-house staff whose knowledge of FDA regulations might be incomplete.&uot; Brandt brings to Clarkston-Potamac more than 20 years of experience in the bio-medical industry, much of it spent in research and development, quality assurance and FDA-related information technology validation roles for global pharmaceutical and biological sciences companies. Her global experience has provided her with expert knowledge as to the best practices for implementing global systems that allow international companies to use a single system to share documentation and meet FDA requirements. Clarkston-Potomac already has successfully worked with pharmaceutical companies on compliance issues. Mid-market and Fortune 500 companies alike have relied on Clarkston-Potomac to implement e-business and enterprise systems and processes that require regulatory compliance. The firm's experience includes customer and patient data tracking systems, customer relationship management (CRM (Customer Relationship Management) An integrated information system that is used to plan, schedule and control the presales and postsales activities in an organization. ) solutions, enterprise and product data management and online procurement The fancy word for "purchasing." The procurement department within an organization manages all the major purchases. and distribution for animal health, radio-pharmaceutical, agricultural sciences Agricultural science is a broad multidisciplinary field that encompasses the parts of exact, natural, economic and social sciences that are used in the practice and understanding of agriculture. (Veterinary science, but not animal science, is often excluded from the definition. and medical device manufacturers. Clarkston-Potomac is a middle-market leader in providing end-to-end, strategic business solutions powered by e-business. The company harnesses the power of the Internet to unleash business potential for mid-market firms by providing a full range of services including strategy, implementation and application support, or hosting. Through a client partnership approach, Clarkston-Potomac collaborates with its clients to articulate a competitive business vision and assemble a high-energy deployment team. Clarkston-Potomac serves clients in a diverse mix of industries, including automotive, chemical products, consumer package goods, healthcare, high technology, manufacturing, medical products and pharmaceuticals. The company, with headquarters in Durham, N.C., has locations in Detroit, Atlanta, Boston, San Francisco San Francisco (săn frănsĭs`kō), city (1990 pop. 723,959), coextensive with San Francisco co., W Calif., on the tip of a peninsula between the Pacific Ocean and San Francisco Bay, which are connected by the strait known as the Golden and Mumbai, India. For more information, visit Clarkston-Potomac's World Wide Web site at http://www.clarkstonpotomac.com . |
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