Root-Cause Analysis and Corrective and Preventive Plan of Actions

Process Deviations are intricate.

When your process is not yielding what you expected, when you have tried different ways to solve it and the process deviation remains, you probably need a different approach.

We can help.


Talk to our experts

Root-Cause Analysis and Corrective and Preventive Plan of Actions

Process Deviations are intricate.

When your process is not yielding what you expected, when you have tried different ways to solve it and the process deviation remains, you probably need a different approach.

We can help.


Talk to our experts

Fresh eyes

from an External Team

Solid expertise

in Pharma Root-Cause Analysis

Allows your team

to remain focused

Full ICH Q9 and FDA

Guidelines Compliance

...

Alice is a freelance web designer and developer based in London. She is specialized in HTML5, CSS3, JavaScript, Bootstrap, etc.

...

Alice is a freelance web designer and developer based in London. She is specialized in HTML5, CSS3, JavaScript, Bootstrap, etc.

...

Alice is a freelance web designer and developer based in London. She is specialized in HTML5, CSS3, JavaScript, Bootstrap, etc.

Why you should be taking a different approach

When we talk Pharma and Biopharma industries, process deviations can present themselves as a major liability in terms of compliance if they are not properly and timely addressed.

Cutting your losses becomes then a function of how quickly you manage to overcome the non-conformances in your process.

That is our focus: to provide you with a highly specialized Root-Cause Analysis and subsequent Corrective and Preventive Plan of Actions (CAPA) that will not only stop your resource-bleeding, but also make your process more robust.

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How will we help you

You've been fighting a process deviation, and the results haven’t been what you expected. That is costing you time, money and energy. If you choose to work with us it will be our mission to stop that as fast as it is humanly possible.

For that, our almost two decades of experience and proprietary technology come together to look at your process data, perform the analysis, discover the problem and then propose the solution.

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What can you expect by working with us

  • You will have your problem solved within the timeframe needed
  • We will use state-of-the-art Root-Cause Analysis tools and processes such as 5 Whys, Fishbone/Ishikawa Diagram, Cause-Effect Matrix and Failure Mode and Effects analysis (FMEA)
  • You will get a full understanding of your process
  • Your losses will be minimized, and your process performance improved
  • We'll guarantee your process will be ICH Q9 compliant
  • We will leave you with process control strategies that increase its long-term robustness
  • We will most likely discover new improvement opportunities for your process

The stages of product lifecycle that we impact

4TuneEngineering 4TuneEngineering lifecycle

The solutions we work with

consulting irisk riskregister isee

What happens 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

Don't waste anymore time fighting that Process Deviation