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SafetyEasy MD

 

The Medical Device Vigilance Software

Fully dedicated to the management of Adverse Events related to Medical Devices.

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HL7 eMDR XML

SafetyEasy MD is HL7 fully compliant and supports eMDR XML file creation.

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Smart MedDRA coding

MedDRA dictionnary coding, enabling easy data analysis. 

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Integrated BI solution

Business Intelligence tool integrated

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Integrated Workflow

A fully customizable workFlow is integrated with SafetyEasy. It adapts easily to your company’s organization.

Medical Device vigilance software’s Key Features
  •   User friendly Data Entry
  • Medical Device interface
  • MedDRA codder
  • Check duplicate management
  • Attach document
  • Narrative template generation
  • Follow Up Management

 

  •   MedDRA SMQ
  • Query module intergated
  • Calendar (Submission & Follow-up management)
  • Automatic Mail generation
  • Task Scheduler (Change MedDRA version for exemple)

 

  •  MEDDEV, MedWatch, MIR…
  • eMDR XML HL7 Import / Export
  • Form 5, Form 6
  • DSUR Summary tabulation & Line Listing

 

  •  Full WorkFlow management
  • Users administration
  • User’s group rights management
  •  Synchronization with SafetyEasy PV for vigilance on products combining PV and MD characteristics (such as injections)

SafetyEasy MD in Numbers

# of Database Installed worldwide

# of cases handled

# of countries

AB Cube safety database are integrated but also:

Compliant

Validated

  • GAMP 5 validation
  • On-line validation dossier available
  • Validation dossier updated with each upgrade
  • Minimum validation effort

Scalable & Flexible

  • Totally customizable by end users
  • Fully customizable Workflow
  • Full Query module integrated

Secured & Reliable

  • HIPAA compliant
  • SSL web access
  • BackUp & Restore
  • 99,99 % SLA guaranteed
  • 21 CFR part 11 Audit Trail
  • ISO 27001 data center (Tiers III plus)

Fast & User Friendly

  • Full web (pure HTML)
  • All web browsers compatibility
  • Customization available
  • Easy and fast data entry
  • Fully customizable WorkFlow

Fairly priced

  • No hidden costs
  • Clear and adaptative offer (From Basic to Professional)
  • Unlimited number of users
  • No additional cost for upgrades

SaaS & On-Premise

  • Pioneer of Hosted solutions
  • On-Premise option available
  • Extensive experience in data migration

With full services

  • Transparency (Access to online Document Management system)
  • eLearning
  • 24 / 7 hotline
  • Validation software
  • Ticketing software

Want more Information about our safety database ?

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AB Cube : The Safety Software Company

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