AlfaNordics Quality Risk Management

Introduce risk management - to have the overview to do things right - the first time

Be able to make the best business decisions in mitigating risks in your organization

Take AlfaNordics advice

AlfaNordic has in-depth knowledge of the authorities' quality requirements for the life science industry. We are experts in Good Manufacturing Practice and have +10 years of experience as consultants on national and international GMP interpretations and implementation.

AlfaNordic's team of consultants is trained in facilitating change processes. Based on the strong foundation of knowledge and skills that already exist in your company, we can help you create an overview of your problems – and give an indication of how to get in compliance and what resources it will require.


Risk management advice can be structured through workshops or project management. Quality Risk Management activities can be anchored eg. in projects, in business, in GMP or in Environment Health & safety systems.

AlfaNordic has expertise in these areas:

  • Quality risk analyzes of products, e.g. Design Validation for Medical Devices
  • Quality risk analyzes of critical processes and system designs
  • Quality risk analyzes during qualification, scale up and validation
  • Risk Ranking and establishing limits 
  • Project Risk Management eg. by due diligence
  • Priority / screening tool for suppliers and contractors
  • Training in ICH Q9 and training in methods / tools
  • Establishment of tactical and operational documents for the description of Quality Risk Management (QRM) in the quality management system (QMS)
  • Optimization of Quality processes, evaluation of relevant in-process controls and design control strategy 

Contact us

Do you want to know more about the above topic? Do you have a competency inquiry or a specific assignment that you need help with? You are always welcome to contact us directly. 

Ole Markersen
Forretningschef / Vice President
+45 3144 7511