ACUTA, ARIM, Software Release

ACUTA Ships ARIM 3.1, ARIM 2.3.3 and Validator

As you can see in the photo above, we have been putting tremendous effort toward shipment of the latest releases of the ARIM (ACUTA Regulatory Information Management) system. Shy Kumar, Founder and CEO of ACUTA, said this of the new releases:

The ACUTA team continues to innovate with a focus on bringing new capabilities and technologies to our customers with the 3.1 release of ARIM. Thanks to the hard work, new ideas, dedication and determination of our team of professionals, our customers are receiving a more intuitive and stable Regulatory experience, both in our 2.x and 3.x platforms.

The following new releases shipped during the week of August 21:

  • ARIM version 3.1, our flagship edition that runs completely in HTML 5 without the need for Java
  • ARIM version 2.3.3 HF 10, an update to the older platform
  • ARIM Validator 2.3.3 HF 8, the standalone regulatory submission validator

ARIM 3.1

Version 3.1 builds on the technology shipped in ARIM 3.0 to deliver a pure browser-based experience, without requiring platform plug-ins such as Java or Silverlight. The Version 3 platform also includes the Registrations Tracking Module, a master repository for product and registration data, to plan and track the global marketing status of products; Paper Publishing; and Side-by-side PDF document viewing. Don Palmer, Director of Product Strategy, had this to say: “With this release, ARIM reaches a new level – adding more functionality and making the system simpler to implement and use.”

Enhancements in version 3.1 include

  • The addition of printing and downloading for Read-Only user licenses in the Viewer module
  • Control of metadata values in 3.2.A sections, based on ICH Q&A on section 3.2.A
  • Selection of multiple documents in the Publisher module to streamline deletions
  • An option to set the status of all documents in a submission when publishing
  • Usability enhancements when creating and editing EU and GCC submissions with multiple member states
  • Veeva Vault integration including access to documents via folder structure, and assignment of documents using Binders
  • Content search has been extended to the Correspondence & Commitment module
  • The addition of Master Commitments
  • User customization of the default landing page to select the most frequently-used module

ARIM 2.3.3 HF 10 and ARIM Validator 2.3.3 HF 8

These are “Hot Fix” releases, focusing on requested updates from clients. Among other changes and improvements, HF 10 increases the number of submission sequence description choices.

The Validator module adjusts the behavior of PDF file validation, and includes improvements relating to nested Module 1 node extensions, and how new indications are handled in submissions to SwissMedic.

Upgrade Paths

The ARIM v2.3.3 platform will continue to be supported in parallel with ARIM v3.1 until further notice. Our current policy is to provide support for the current release plus two prior releases. Customers using our Multi-Tenant environment will be upgraded automatically in early September. Plans for migration from the 2.3 platform to the 3.1 platform will be presented to customers in the coming weeks.

Contact ACUTA to plan your implementation of Regulatory Information Management with ARIM.

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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