SAFETYEASY® SUITE

Medical Device Vigilance

Keep up with the changing regulations while optimising operational efficiency and user productivity

Align international medical device vigilance operations teams with an intuitive, unified, cloud-based system trusted by industry leaders. SafetyEasy® Suite is a multivigilance management solution which integrates automation with existing safety processes of life sciences organisations to manage adverse event reporting and stay compliant with the latest regulations. 

Growing medical device manufacturers and resellers trust individual vigilances provided by AB Cube for their safety regulatory processes.

Benefits

COST EFFECTIVE
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  • Improve collaboration among teams in real-time with deadline & reminder management systems. 
  • Edit reports in the blink of an eye without waiting for the system to load. 
  • Get automatic system updates to stay current with the latest regulations.
  • Enhance operational efficiency with a faster and agile safety solution.
SUBMISSION READINESS
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Spontaneously generate submission ready regulatory reports automatically populated with entered data.

  • CIOMS & MedWatch
  • Periodic Safety Update Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR)
  • Signal detection, line listings & summary tabulations

We’re ready

AI POWERED

AB Cube simplifies automation for your safety operations. SafetyEasy® Suite integrates seamlessly with your existing vigilance processes with minimal training. Leverage the power of automation with our 3-step process.

  1. Basic automation
  2. Robotic process automation
  3. Cognitive automation

Get ready to step into the world of pharmacovigilance powered by artificial intelligence.

Increased ROI on multivigilance operations with

SECURE AND COMPLIANT SAAS

HDS compliant server hosting for sensitive healthcare information, 2 hours Disaster Recovery Plan (DRP), HIPAA compliant, SSL web access, 99.99% SLA guaranteed, 21 CFR part 11 Audit Trail, ISO 27001 data center (Tiers III plus)

ONE-CLICK SUBMISSION

Smart E2B XML creator (R2, R3), multiple formats supported (MedWatch, CIOMS, Meddev, etc.) and email submission

2 WEEK IMPLEMENTATION

Digitise your excel-based and paper-trail regulatory reporting with SafetyEasy® Suite in less than 2 weeks

NO HIDDEN COST

Transparent terms and conditions since Day 1. Unlimited number of users, quarterly upgrades and support included in your licence. Your support tickets would not circle the world, our support team based in France is promptly resolves bugs and queries.

INTUITIVE USER INTERFACE

Automatically populated fields, narrative generation in just one click, smart MedDRA coding, integrated query module, fully customisable workflow

FULLY VALIDATED

GAMP 5 validation, online validation dossier available, validation dossier updated with each upgrade. Minimum validation effort required from the users.

« More than just a software vendor, AB Cube has been an important partner in our regulatory compliance. SafetyEasy® Suite is a secure, reliable, and user-friendly software which allows us to be compliant with safety requirements »

Global Head, Pharmacovigilance - EU QPPV -

Global Head, Pharmacovigilance - EU QPPV -

Air Liquide Santé International

« We especially appreciate the user-friendly interface and customisation capability, the ability of SafetyEasy® to evolve and adapt to the latest guidelines, the support offered by AB Cube and the responsiveness of their team »

EU QPPV & API Director

EU QPPV & API Director

Laboratoires SMB SA

ALWAYS COMPLIANT

We’re making medical device safety easy

Streamline safety operations with a system dedicated to the management of Adverse Events related to medical devices. SafetyEasy® Suite, cloud-based medical device vigilance is fully HL7 compliant and supports eMDR XML file creation.

Automatic recoding with new MedDRA versions enables easy data analysis. This system is equipped with completely customisable workflows to adapt to your organisation.

Integrated Business Intelligence tool in the medical device vigilance solution allows you to oversee and improve user productivity. 

Features

Gain efficiencies with industry’s trusted cosmetics safety solution fully dedicated to the management of Adverse Events, always aligned with the best practice and modern regulations.

DATA ENTRY

DATA ENTRY

  • User-friendly data entry
  • Inbuilt MedDRA coder, IMDRF coder
  • Duplicate check management
  • Generate narrative templates
  • Follow-up management
  • Attach documents

ADMINISTRATION

ADMINISTRATION

  • Full Workflow management
  • Users administration
  • User’s group rights management

TOOLS

TOOLS

  • MedDRA SMQ
  • Integrated query module
  • Calendar (submission & follow-up management)
  • Automatic mail generation
  • Schedule and assign tasks

INTEGRATION

INTEGRATION

  • Integrate with pharmacovigilance, cosmetovigilance or biovigilance for combination product reporting within SafetyEasy® Suite, multivigilance management solution

REPORT GENERATION

REPORT GENERATION

  • SAE Report table (MEDDEV 2.7/3), MedWatch, MIR…
  • Coming soon : Clinical Investigation Summary Safety Report Form (MDCG 2020 10-2)
  • eMDR XML HL7 Export
  • ANSM Form 5, Form 6,
  • DSUR tabulation & Line Listing

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Dicover other vigilances

Multivigilance

Harness the power of easy automation for all your global regulatory requirements

Multivigilance

Intuitive unified solution | Automation at your fingertips | Integrates with your processes

Pharmacovigilance

Efficient drug safety operations with the expertise of industry veterans begins here

Pharmacovigilance

Global compliance | User-friendly interface | Secure HDS compliant servers

Cosmetovigilance

Benefit from the world's first and only native cosmetics adverse events reporting system

Cosmetovigilance

Trusted by world leaders in cosmetics | Compliant with international regulations | Customisable workflows

Nutrivigilance

Ensure productive nutrient safety reporting with a native nutrivigilance solution

Nutrivigilance

Instinctive schema for smoother operations | Nutrient & protein regulatory adverse events reporting