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Aris Global, LLC Launches Register™ 5.4 for Comprehensive Regulatory Information Management


9/30/2013 11:06:28 AM

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STAMFORD, CT— September 30, 2013— ArisGlobal, a leading provider of solutions to the life science industry, today announced that it has launched the significantly improved new version of its Regulatory Information Management System (RIMS). Register 5.4 is available for immediate deployment. It is offered on-premise or as Software-as-a-Service (SaaS) on ArisGlobal's proven platform – agOnDemand™.

"The move towards adoption of the Identification of the Medicinal Products (IDMP) standards published by the International Organisation for Standardization (ISO) and use of these identifiers in the processes for Individual Case Safety Reports (ICSRs) will significantly extend the requirements of data submissions to regulatory agencies. Reporting will need to be comprehensive and consistent between regulatory and pharmacovigilance channels so the ability to share common dictionaries of products and substances will be critical to the efficient and accurate management of information," said Andrew Marr, PhD, a recognized thought-leader on the creation, management and exchange of electronic information between industry and regulators and a 28-year industry veteran.

“We are excited to announce the availability of the new version of Register. It will be the perfect choice for companies that want a future ready RIMS to prepare for the next big regulatory change – ISO IDMP. We believe that Register 5.4 is a significant step forward for us as well as the industry,” said Wim Cypers, vice president of Regulatory Affairs at ArisGlobal.

“Register 5.4 incorporates all the feedback gathered carefully from several life sciences and medical devices companies of varying size and scale. Smart enhancements such as centralized management of dossier related documents for all types of regulatory submissions, an improved user-defined home screen for information at a glance, improved pricing and regulatory intelligence modules and much more make it a comprehensive RIMS. It has the best-in-class SAP® integration features, a new module to fully support medical devices registration submissions management and tracking.”

Why should you consider Register 5.4?

- Be a fully compliant life sciences or medical devices company with a strategic, centralized, automated approach to regulatory information management of global product portfolio.

- Improve efficiency and save time by integrating Register with other systems to ensure easy flow of information by supporting integration with eCTD publishing applications, SAP and Document Management Systems (DMS) e.g. Documentum, SharePoint.

- Meet all needs of scale and scope of regulatory information management by easily integrating processes and systems with Register.

- Ensure smooth flow of information, collaboration, knowledge management and work distribution between Headquarters and Affiliates

- Easily define and access all relevant product, registration and authority interaction information via user-defined home pages with graphical iViews.

- Enhance end user’s experience while ensuring data security using Register’s user role-based access.

About ArisGlobal

ArisGlobal (www.arisglobal.com) is the leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and quality & compliance for medical inquiries. Life science companies using ArisGlobal’s solutions can better build and maintain the trust they need with their customers, medical practitioners and regulatory bodies around the world.

Contact

Kathy Capper

ArisGlobal

Tel + 44 (0)1908 506075

kcapper@arisglobal.com

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