Regulatory Information Management (RIM)

ViSU is a Cloud based Centralized Regulatory Information Management (RIM) solution to efficiently manage your regulatory data, activities, processes, submissions and commitments.

Modules:

  • Products
  • Registrations
  • Documents Management System
  • Commitments, HA & NB Interactions
  • UDI
  • eIFU

visu-regulatory-information-management

KEY BENEFITS

  • Increase global coordination and collaboration between departments and affiliates by sharing a common authoritative information source.
  • Track and Control the registration, renewal and re-registration process.
  • 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 submission Standards Compatible.
  • Manage global IFU distribution electronically to distributors, physicians & HCPs.

Solution Features



COMPLIANCE
  • European & Worldwide Regulations compliance
  • FDA 21 CFR part 11 compliant

VALIDATION
  • Minimum validation effort

FULL SERVICES
  • eLearning
  • 24/7 hotline
  • Validation software

SECURED & RELIABLE
  • HIPAA compliant
  • SSL web access
  • Backup & Restore
  • 99.99% SLA guaranteed
  • 21 CFR part 11 Full Audit Trail

FAST & USER FRIENDLY
  • Full web (pure HTML)
  • All web browser compatibility
  • Customization available
  • Easy & fast Data Entry

FAIR PRICING
  • No hidden costs
  • Clear and adaptive offer (From Basic to Professional)
  • Unlimited number of users

SAAS & ON-PREMISE
  • Hosted solutions
  • On-Premise solution
  • Great experience in data migration

SCALABLE & FLEXIBLE
  • Full Query module integrate
  • Totally customizable by end users
  • Fully customizable Work Flow

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