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    ARIM is your one stop solution for Publishing, Validation, Viewing of eCTD and NeeS submissions along with managing Regulatory Interactions and Registrations Tracking!

Image ACUTA Regulatory Information Management

Preface

Competitive Life Science business strategies require a company to be able to coordinate operations across dispersed and often outsourced research, manufacturing, marketing, and regulatory functions. For Regulatory Affairs to meet this challenge, amidst constantly changing regulations, it must be collaborative, efficient and compliant. Yet many departments struggle with unifying critical data and processes to form a sustainable whole.

An effective RIM strategy is one that enables you to develop, store and access electronic information with confidence. Combined with a knowledgeable workforce, RIM can satisfy the drive to launch quickly in global markets, meet regulatory filing requirements, monitor products and product approvals, plan resources, and continuously adapt to the demands of health authorities.

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Solution

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ACUTA Regulatory Information Management (ARIM) system is a cloud based system developed using the latest web interactivity to facilitate business processes to ensure effective management of regulatory information. ARIM is designed to assist companies manage their regulatory information more efficiently and cost effectively. It covers all aspects of the RIM process and offers a cost effective solution for companies of all sizes.

ARIM has five core modules that are essential to the regulatory information management life cycle.

  • Correspondence and Commitments
  • Publishing & Validation
  • Submission Planning
  • e-Submission Viewer
  • Registration and Tracking

ACUTA’s goal is to offer software and services that enable you to adhere to strict standards set by regulatory authorities around the world, and help you launch and manage your products with compliance and reliability. We guarantee your ability to maintain data and information quality, accuracy and integrity.

ARIM Module Overview

Correspondence and Commitments

ImageThe ARIM Correspondence and Commitments module provides a rapid and efficient method for electronically archiving, tracking and responding to health authority communications. With it you can upload internal and external correspondence, link them to each other and to submissions, assign metadata, create follow-up actions and bring actions to a close.

Benefits
  • Keeps track of all health authority activities
  • Eliminates spreadsheets and tedious manual data-entry and linking processes
  • Reduces operation costs by eliminating redundant systems
  • Creates comprehensive status reports
  • Increases accuracy of commitment responses
  • Improves data control and data consistency
  • Supports operations from on-site and remote locations
  • Can be used on mobile devices


Submission Planning

ImageThe ARIM Submission Planning module provides preparation, workflow and management tools of key importance to regulatory operations. With it you can add efficiency and cost effectiveness to the process of planning, creating and tracking agency submissions. The Submission Planning module addresses regional and global-dossier planning, as well as resource and time management. When integrated with the Correspondence and Commitments module and the Publishing and Validation module, it enables you to keep track of internal submission deadlines and monitor your entire submission-building process.

Benefits
  • Eliminates spreadsheet reliance and manual tracking
  • Eliminate multiple, redundant systems and significantly increases project efficiency
  • Provides real-time access to relevant submissions and associated commitment information
  • Decreases submission time-lines
  • Increases speed and accuracy of commitment responses
  • Streamlines regulatory-operation work-flows through a single, accessible tool
  • Includes submission start-to-end work-flow management and resource allocation capabilities

Registration and Tracking

ImageThe ARIM Registration and Tracking module provides universal, multi-level tracking and reporting capabilities across your product portfolio. When combined with process-oriented planning, it gives instant access to vital clinical and CMC product information, such as approved labeling, indications, dosages, manufacturing sites, distribution paths and other user-defined product attributes. As xEVMPD and IDMP use expand, easily convert your data to standard values and stay compliant. This module catalogs and retrieves data on all of the following:

Benefits
  • Record Active Ingredient & excipient details such as strength, pharmacopoeia, raw materials, biological sources, and suppliers
  • Tie together Manufacturers and functions, such as API production, stability testing, and pre-dosage processing
  • Search and Report on indications including both full label indications along with brief indication keywords for quick searches
  • Labeling details such as package insert, carton label, and hospital inserts
  • Standardize Packaging details such as primary, secondary, packaging types and descriptions
  • Keep track of Country-specific details such as storage conditions and shelf life
  • IDMP, xEVMPD and upcoming SPL7 standards compatible

Publishing & Validation

ImageThe ARIM Publishing and Validation module is used to create, edit and validate eCTD and NeeS submissions. With it you can seamlessly import existing applications from legacy systems into ARIM. The module supports all DTD versions required by agencies around the world, including the FDA Regional DTD v3.3 and EU DTD 3.0.

Benefits
  • Simple and easy-to-use interface
  • Built-in PDF Viewer and basic Editor (internal and external hyper-linking and bookmarking)
  • Study Autoloader
  • Creates and validates submissions with a single tool
  • Scales to user volume
  • Integrates with EDMS systems such as SharePoint, Documentum and Veeva Vault
  • Optimizes and integrates with all other modules
  • Paper publishing from eCTD and NeeS to support rest of the world submission requirements

e-Submission Viewer

ImageThe ARIM e-Submission Viewer module enables you to read and navigate through eCTD and NeeS submissions in a variety of views. It is compatible with national and regional submission formats, particularly those developed by the FDA, EMA, Health Canada, Swiss Medic, Japanese Health Ministry and Australia's TGA. The e-Submission Viewer includes features and functionalities based on recommendations from Options for the Presentation of eCTD Messages, as developed by the IRISS Life Cycle Topic Group.

Benefits
  • Simple, easy-to-use interface
  • Read submissions in folder view, sequential view, cumulative view and current view
  • Navigates through lifecycles and cross-references easily and intuitively
  • Auto-registers new submissions
  • Searches across documents in accordance with user-defined parameters
  • Has granular security to manage access to submission content
  • Integrates with all other ARIM modules
  • Includes a Global Dossier, to view submission documents across the globe, plus a Core Dossier


Key Benefits

Image ARIM is designed for both cloud-based and on-premise deployment. It supports Regulatory Affairs and Operations processes regardless of their complexity or geographic location, and it offers global access 24 x 7 x 365. With the cloud model, there is no need to purchase hardware or software, and no installation or maintenance is required. Now for the first time, with ARIM, you can have a fully compliant system up and ready to use in a matter of hours.

  • Provide a link between agency communications and regulatory submissions
  • Manage and track correspondences with health authorities along with the resulting commitments and status
  • Manage and track regulatory reporting processes including product safety update reports (PSURs)
  • Ensure faster response time
  • Provide real-time access to relevant health authority correspondence and commitment information to all the individuals involved in the process
  • Increase speed and accuracy of commitment responses
  • Eliminate redundant systems and reduce repetitive and manual data entry