Quality Risk Management Process Optimization

It's time to make your risk assessments easier, streamline your operations and improve your reporting.

And most importantly, you will use your resources better.

What are you waiting for?


Talk to our experts

Quality Risk Management Process Optimization

It's time to make your risk assessments easier, streamline your operations and improve your reporting.

And most importantly, you will use your resources better.

What are you waiting for?


Talk to our experts

Simplify you Quality Risk Management process 

Automatize and Optimize your Framework

Digitally integrated process means Less documentation and administration

ICH Q9, EMA and FDA Guidelines Compliance

An Essential element

Every product or process has associated risks. Because of that, Quality Risk Management gives you the ability to maintain compliance while also identifying inconsistencies that could be harmful to your customers.

Often, your process can be time and resource consuming for you and the rest of your team.

Therefore, an optimized Quality Risk Management Process in the Pharmaceutical and Biopharmaceutical industries is essential. 

But more than that, your QualityRisk Management process should support your decision-making by providing you an understanding of the consequences of your choices. 

...

If you need to have it, you should have the best

Quality and Risk Management processes can be complex and involve a significant effort around documentation and administration, allocating the time of your resources on these aspects rather than on what matters: a critical and thorough risk evaluation on your processes.

We have almost two decades of experience on the subject. We can help.

Our solutions will help you identify, quantify and prioritize risks. You will be able to build risk mitigation strategies for both new and existing assets over the lifecycle of products, equipment, facilities, suppliers, and analytical methods.

...

We'll work alongside you to help you analyze, manage or implement processes like: 

  • Quality System improvements – gap assessments against industry state-of-the-art, revision of procedures and training on recommended practices.
  • Root Cause Analysis (RCA) and investigations for specific problem statements
  • Specific process and product assessments:
    • Critical Quality Attributes (CQA) Assessment
    • Critical Process Parameters (CPP) Assessment
    • Critical Material Attributes (CMA) Assessment
  • Development of Process Control Strategies, from the start of the development phase.
  • Risk ID & Control tools (PHA, FMEA, FMECA, FTA, HAZOP, HACCP).
  • Development of risk-based custom-made digital solutions
  • Establishment of Risk-Based Supplier Qualification programs
  • Establishment of CQV Risk-Based programs
  • Establishment of CSV Risk-Based programs

The parts of product lifecycle that we impact

4TuneEngineering 4TuneEngineering lifecycle

The solutions we work with

consulting irisk riskregister isee
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What can you expect when you work with us

  • We will have a Pre-project meeting so that we can understand your expectations in the short and medium-term.
  • When everything is lined-up, and if you are happy, we will enter into contract.
  • Our teams will meet to formalize the project kick-off, covering the project scope, schedule, milestones, deliverables, and anything else that is necessary.
  • We will install the necessary software with any customizations that we may have agreed before.
  • We will define Software training dates for your team in order to make sure you can make the most out of Risk Management Digitalization.
  • We will provide you support and follow-up during our partnership.
software-print

Let's bring your Quality Risk Management Process to the top.

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