CHICAGO, February 6, 2017 /PRNewswire/ --
Next-Generation, Cloud-Based Regulatory Information Management System Features Integrated Industry Standard Practices and Advanced IDMP Compliance
ArisGlobal, a leading provider of integrated, cloud-based software solutions for life sciences, announces LifeSphere™ RIMS, a multi-tenant cloud-based Regulatory Information Management System (RIMS) that heralds the era of RIMS modernization and innovation with a process and workflow-driven approach for handling all regulatory affairs business processes, using a fully IDMP-compliant data structure. Configurable, role-based workflows, security and other configuration options enable the intuitive user interface to be easily tailored for global, regional and affiliate participation, ensuring a successful enterprise-wide rollout. The Industry Standard Practices-based solution will enable clients to enjoy more frequent upgrades that are implemented faster, with minimal business impact, and reduced costly outlays, achieving global roll-outs in mere weeks.
"LifeSphere™ RIMS comes with built-in Industry Standard Practices based on our 20 years of regulatory experience and the active participation and feedback from a well-established users community to solve real-life problems," said Wim Cypers, Senior Vice President, Regulatory. "It's a uniquely rich and flexible solution that handles all regulatory affairs processes and their variations."
LifeSphere™ RIMS capabilities:
- The core Regulatory Affairs (RA) tracking modules: Product Registrations, Submission Processes and Agency Interactions provide a single solution for tracking all RA business processes and providing real-time visibility of ongoing submissions, authorizations, commitments, open agency correspondence and upcoming renewals for ensured compliance. Additional modules for Clinical Trial Application Tracking, Global Change Management and Dossier Planning and preparation are planned.
- Compliance module with ISO IDMP and EU extensions coverage provides end-to-end solution for not just submissions compliance but also business benefits of a central product dictionary.
- Comprehensive business process workflow automation enables demand forecasting, submission planning and performance tracking for improved decision making.
- Out-of-the-box interfaces with document management systems and configurable data exchange mechanisms result in improved cross-functional process efficiencies, collaboration, control and visibility of the single source of truth.
- SaaS-based, multi-tenant cloud platform shortens deployment cycle for functional upgrades for constantly evolving regulations, improving agility and responsiveness to changes and minimizing technology risks. On-premise deployment is available, if required.
ArisGlobal's cloud-based solutions facilitate global drug development and regulatory compliance within the life sciences and healthcare industries. Its cloud platform supports the entire product life cycle including clinical development, regulatory affairs, safety and pharmacovigilance and medical communications. Hundreds of drug and device manufacturers, CROs and regulatory agencies leverage ArisGlobal's advanced technology solutions spanning regulatory information management, risk evaluation and mitigation strategies, medical information and clinical trial management software to make better and more informed decisions, facilitate compliance, reduce risk, and improve operational efficiency. Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.
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