Computer System Validation

Our Risk Assessments are powered by iRISK™

They will be CSA (Computer Software Assurance) transition ready.

Faster than anyone else due to our exclusive methodology based on automated processes and knowledge base.


Talk to our experts

Computer System Validation

Our Risk Assessments are powered by iRISK™

They will be CSA (Computer Software Assurance) transition ready.

Faster than anyone else due to our exclusive methodology based on automated processes and knowledge base.


Talk to our experts

Reduce up to 70% the time spent in Risk Assessments

Increase adherence of the system output to the regulated process

Reduce up to 50% the time spent in testing

FDA, ICH Q9, GAMP® Regulatory and ISPE guidelines based

Computer System Validation based on science

The upcoming Computer Software Assurance model reduces the cost of validation and provides a more risk and science based approach. Instead of creating a huge amount of documents and aligned with agile methodologies, it introduces unscripted testing and makes the validation a more flexible process whilst increasing the focus on product quality, patient safety and data integrity.

This is why we have already started using this approach, powered by the extensive knowledge base of risks of our iRISK™ solution.

Validation that goes way beyond documentation is our belief.

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How does it work

The time spent on generating validation documents and during scripted testing is enormous, delaying projects and increasing its costs. Besides that, the documentation itself does not add value to the company and is used only during regulatory inspections.

Not anymore.

Our risk and science based methodology powered by iRISK™ is FDA 21 CFR Part 11, ICH Q9 and GAMP® based.

It speeds up the risk assessment process and allows us to use the CSA approachs, where most of the tests are unscripted. It also introduces the usage of automated testing tools.

And the automated testing adds value since all scripts can be reused during the operation and maintenance phases of the system lifecycle for change management testing.

Our validation reporting is inspection-ready as we are experts on Quality Risk Management and accustomed to provide a detailed justification for the decisions taken during the validation.

...

This is what you'll get from working with us:

  • You will have access to our computer system risk knowledge base and speed up the risk assessment
  • You will have a clear understanding of the computer system impact on product quality, patient safety and data integrity
  • Your computer system will have an increased adherence to product quality atributes and regulatory requirements
  • The TCO (Total Cost of Ownership) of your computer system will be reduced because it will be fit for its intended use since day one, requiring less changes and having less deviations during its lifecycle
  • You can save time and money because we can be faster than anyone else due to our exclusive methodology

The stages of product lifecycle that we impact

4TuneEngineering 4TuneEngineering lifecycle

The solutions we work with

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What can you expect when you work with us

  • We will guide you through the initial phase of the project using our set of questionnaires that will serve as the basis for our proposal.
  • Once we agree on scope and comercial aspects, we move into the contract phase.
  • 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 create an instance of iRISK™ for the project
  • We will create all documentation required and execute tests among with key-users
  • 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.
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Let's save time and money with your Computer System