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Regulation and manufacturing come together

By Staff Reporter , 28-Jun-2007

A US software solutions provider has signed up Merck & Co for the global installation of a system which will bring together regulations and manufacturing.

ArisGlobal's comprehensive web-based solution called Register allows for the tracking of all product information and management of all product registrations and renewal activities on a global basis. Speaking to US-PharmaTechnologist.com, ArisGlobal director of regulatory compliance Mark Loudon said in today's pharmaceutical industry so many products had so many varieties and formulations with different registrations in different countries that it made sense to combine all the information into one system.


Often information was scattered around, he said, with different areas looking after current registrations, future registrations, patents and what clinical trials were ongoing in what countries. "The information used to be in a spread sheet or a data base but it's impossible now with the number of registrations."


For example, some companies might have up to 30 versions of aspirin and all would be needed to be registered individually, he said. Register also helped to maintain product data, such as formulations, indications, packaging, release specifications, manufacturing procedures, and other detailed product information required for global regulatory and QA compliance.


Bringing together what product has what registrations would increase efficiency and streamline the manufacturing process when changes, such as reformulations, were implemented, Loudon said. Merck joins Sanofi-Aventis, Novo Nordisk and Schering-Plough in the use of the technology.


While there were other systems on the market, Loudon believed Register had a more "comprehensive coverage" and focused on bolstering the safety and quality of products much more.


ArisGlobal vice president of global sales and marketing Simon Sparkes said in a statement: "The role of regulatory affairs is critical in ensuring successful product registrations and renewals in each market. However, as the number of products, product variations and potential markets increase, regulatory affairs often rely on manual, disconnected or semi-automated IT systems to support. This often leads to compliance issues and inconsistencies between regulatory and manufacturing."

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