How to build and implement an eQMS: efficiency, compliance and data integrity – Replay

Risk Analysis

Controlling your risk analysis in full compliance with relevant regulations and standards.

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Your needs
  • Capitalizing on your risk analysis (identifying hazards…)
  • Drawing up rules for scaling and controlling your risks
  • Assessing efficiency of  risk control measures
  • Monitoring KPIs to help you with decision making
  • Reducing time spent on document management (technical files…)
Our solutions
  • Centralizing and sharing data (check-lists, hazards, risk control measures, rules…)
  • Automated process for scaling and controlling hazards (scales, aversion matrix, level and type of risk)
  • Real time reporting (dashboards, KPI monitoring….)
  • The risk management file is automatically published

This application is suited to risk analysis procedures within the medical & pharmaceutical industry (AMDEC/FMEA/FMECA, Criticality, ISO…).

All our applications are based on a range of powerful features that are compliance oriented (21 CFR Part 11, traceability matrices, reporting and automatic publishing,…) and can be easily connected to our regulatory database monitoring platform (fragmented regulatory texts available in the regulatory database, and regulatory watch ).

Why choose a customizable application

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100% secure

Servers located in France.
ISO27001:2013 Certified Data Centers

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Tailored

We build your application with you

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Customizable

Unlimited adaptation possibilities

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Compliant

Ensure regulatory compliance and data security

Request a presentation

Benefit from a free discussion about your digitalization needs.