ViSU

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

ViSU is cloud based for your global users to access that manages your 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 collaboration between functions and affiliates by sharing a common authoritative information source
  • Track and Control the Registration, Renewal and Re-registration milestones
  • Create once and system will create other Countries Submissions (Dossiers/TFs) for you
  • Detailed Submission planning to Country Specific Regulations (plans) inbuilt to ensure accurate TOCs at all times
  • Maintain traceability at all times from Master Documents (DHF) to individual Country dossiers
  • Track the status of Regulatory Commitments and Correspondence required to keep Products on the market
  • Leverage Electronic notifications to alert users of critical information updates
  • Gain visibility into Registration activities and Product Information through robust querying and dash board reporting
  • Quickly and accurately answer questions regarding all Regulatory activities
  • Eliminates Spread sheets, tedious manual data-entry and linking processes
  • Improve data control and consistency
  • Reduces operation costs by eliminating redundant systems
  • UDI submissions directly from the tool
  • Manage global IFU/Labels distribution electronically to distributors, physicians & HCPs

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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