ArisGlobal continues to support its customers on XEVMPD guidelines in preparation for IDMP
STAMFORD, CT— 22 September, 2014—ArisGlobal, a leading provider of solutions to the life sciences industry, has announced the release of RegisterTM 5.4.2. This milestone marks the availability and continuity of the company’s fully XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) compliant solutions – RegisterTM 5.4.2 and agXchange RSM 5.5.2.
With this release ArisGlobal not only shows its commitment to ensuring compliance for its current and future customers but this also brings enhancements including improved security/privilege defining capabilities, readiness for UDI (Unique Device Identification) submissions to the FDA (The Food and Drug Administration) and enhanced configuration capabilities.
ArisGlobal was the first to enable XEVMPD compliance for its customers in 2012 and now continues to help forward-thinking companies prepare for the upcoming Identification of Medicinal Products (IDMP) mandate in 2016. In addition, the solution provides a complete regulatory information management (RIM) and tracking platform to centrally manage and seamlessly disseminate accurate and up-to-date regulatory information to all stakeholders.
Improvements available with the 5.4.2 release include:
• XEVMPD enhancements – ArisGlobal was the first company to enable compliance with the XEVMPD guidelines in 2012 and with the RegisterTM 5.4.2 release, enhancements have been made in line with the latest guidelines to further support customers in their regulatory journey.
• Custom configuration – Register enables custom configuration of modules which are critical to life science companies. The installation is available for the entire organization within a company and is available for all customers, regardless of size.
• Improved user privilege set up – With the improvements in user experience, functional security administrators can configure the required level of security for users much more easily.
AstraZeneca who has been working with ArisGlobal since 2012 using Register™ welcomes the updated version. “We see considerable benefits to our business including getting ready for the evolving XEVMPD requirements.” Said David Bergland Director, Implementation at AstraZeneca. “We are delighted that ArisGlobal has released the updated version which we plan to upgrade to later this year, in the longer term it will also help AstraZeneca considerably in preparing for the forthcoming IDMP mandate in 2016”.
Wim Cypers Vice President, Regulatory Affairs at ArisGlobal said “we were the first solution provider to enable fully automated XEVMPD submissions for our customers in 2012, with the 5.4.2 release we wanted to reaffirm our commitment to XEVMPD and prepare customers for IDMP implementation in 2016”
Register 5.4.2 and agXchange RSM 5.5.2 are available to customers immediately as a licensed on-premise offering or as a hosted Cloud solution via agOnDemand™, ArisGlobal’s comprehensive Software-as-a-Service (SaaS) delivery platform.
For over 25 years ArisGlobal (www.arisglobal.com) has been a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and quality & compliance for medical inquiries. Solutions are available on premise or on a regulated cloud platform. 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.
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