ViSU

Regulatory Information & Submission Management software centralizes data and documents for effective control and minimizes compliance risks.

ViSU is a cloud based RIM Software for global users to access and manage regulatory data (Regulatory Product Information), documents (Submissions, EDMS), Submissions planning, HA/NB correspondence, Reg Intel and many more.

MODULES

  • Products
    Products
    Detailed information of Products captured and acts as a Central Repository for global access as System of Truth
  • Registrations
    Registrations
    Capture and Track Life cycle information of Products in several Countries
  • Submissions
    Submissions
    Streamline end-to-end Submission Management. In built submission plans by Country and solid project management allows tracking down to the document/function level for on time global submissions
  • Commitments
    Commitments
    Initiate and Track information related to Regulatory and Compliance activities across Agencies and Notified Bodies
  • Correspondence
    Correspondence
    Create and track HA Correspondence management with built in Response Compilation module and auto-match responses from previous Submissions
  • EDMS
    EDMS
    A modern Document Management System with all features
  • UDI
    UDI
    Prepare, Validate, Submit and Track UDI Submissions of a product (initial & lifecycle)
  • Standards
    Standards
    Subscribe for Medical Device Standards and get alerts or updates on subscribed standards
  • eIFU
    eIFU/Labeling
    Portal linked to Products with internal and public web pages with several languages included

KEY BENEFITS

  • Increase global coordination and communication between functions and affiliates by sharing a common authoritative regulatory┬áinformation source
  • Built-in Reg intel to help plan for new products or new countries with regulations and checklists
  • Track and Control the Registrations, Renewals and Re-registration milestones
  • Maintain traceability at all times from Master Documents (DHF) to individual Country dossiers
  • Proactive alerts on Commitments that are due and Track/manage effectively
  • Build and submit UDI submissions directly from ViSU
  • Manage global IFU/Labels distribution electronically. Control which version is active in what country
  • Leverage Electronic notifications to alert users of critical updates
  • Robust querying, dashboards and reports
  • Eliminate Spreadsheets, tedious data-entry and manual cross-checking / reconciliation of data
  • Improve data control and consistency

ViSU TECHNICAL FEATURES

Compliance

COMPLIANCE

  • EU & Worldwide Regulations compliance
  • FDA 21 CFR part 11 Compliant
Full Services

FULL SERVICES

  • Super-fast Implementation
  • Cloud-based so no IT burden for you
Fair Pricing

FAIR PRICING

  • No hidden Costs
  • Clear and Adaptive offer (From Basic to Professional)
Scalable & Flexible

SCALABLE & FLEXIBLE

  • 1 or 1000 users, ViSU is for you
  • Totally Customizable by end users
  • Fully Customizable Work Flows

Ready to improve your efficiency and lead the regulatory functions "better"?

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