Multi-Tenant Cloud Platform Transforms the Regulatory Department with End-to-End Approach that Closes the Information Gaps
Chicago, Illinois, June 9, 2017 – ArisGlobal, a leading provider of integrated, cloud-based software solutions for life sciences announces LifeSphere Regulatory, a multi-tenant, cloud-based solution with out-of-the-box, pre-validated industry standard practices that offers regulatory departments of life sciences companies a global, end-to-end approach for regulatory business processes covering the complete product life cycle. The solution also ensures compliance with global regulations like XEVMPD and IDMP, while enabling other departments to share regulatory information to improve overall organizational compliance. Cognitive computing functionality, including machine learning, streamline and automate core processes to improve efficiency and productivity.
“Today’s life sciences companies are painfully aware of the increasing information gaps between the regulatory department and other parts of the company. They are tired of having to deal with a piecemeal approach to managing regulatory affairs processes,” said Wim Cypers, ArisGlobal Senior Vice President, Regulatory. “With LifeSphere Regulatory, these companies now have a best practices-based regulatory platform that connects all the cogs in the machine: product and clinical trial registrations, dossier planning and compiling, submission planning and tracking, agency interactions, commitments tracking, global change management and data standards compliance.”
LifeSphere Regulatory solution suite includes two products:
- LifeSphere® RIMS: An Industry Standard Practices (ISP) based Regulatory Information Management System (RIMS) with advanced IDMP compliance (first announced February 6, 2016), LifeSphere RIMS utilizes a process and workflow-driven approach for intuitive and comprehensive handling of all global regulatory business processes covering the complete product lifecycle. The application also ensures compliance with global regulations like XEVMPD, IDMP and others and enables sharing of regulatory information with other departments to improve their overall compliance.
- LifeSphere® IDMP: LifeSphere IDMP enables companies to not just become compliant with standards like IDMP and XEVMPD across the globe but also enables them to leverage compliance-related investments for realizing multiple business benefits. Using its flexible integration layer and NLP capabilities, companies can collect information from different system and document sources into an IDMP and XEVMPD compliant central data hub. Users can then review and enrich the data before extracting standard specific data sets, validating against specific business rules and electronically submitting to the regulatory authorities.
Learn more: LifeSphere Regulatory Overview Data Sheet
ArisGlobal is the visionary technology company that’s transforming the way today’s most successful Life Sciences companies develop breakthroughs, and bring new products to market. Our cognitive technology platform, LifeSphere®, integrates machine learning capabilities to automate all core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy. Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.