Would an FDA Audit catch you with non-compliant Tools?

Will the FDA agree that your Intended Use Validations are Valid?

Are you the Head of Quality Control, Quality Engineering or Quality Systems for a Bio-pharmaceutical company – and your team has built or purchased tools to support the design & development of your market facing (drug) product?

Are those tools, which will never be sold to a customer, fully implemented into your GMP Work Flow?

Do you have everything properly documented, so when the FDA decides to audit your company there won’t be any surprises?

Is your Intended Use Validation (IUV) Program fully implemented, thoroughly documented, and completely current – so you can simply hand the program manual to the FDA when they ask?

Here are examples of what I mean:

  • You’re developing a new drug and your engineers created a user-friendly application, for internal use only, to document all the drug trials and their results – so you can report them to management for progress status reports
  • Your company produces XYZ life-saving drug, and they built a machine for lab technicians to create test samples on their benchtop – so they can test viability of the drug
  • Your engineering team has built a Research Use Only (RUO) machine, which supports the work your scientists are performing to create the next lifesaving drug

Do you have compliant process in place for the items on the list above – that proves you’ve conducted intended use validation properly, including the project plan, approved intended use requirements, validation protocol (including test cases and expected results), test execution and test report – and the documentation for all of which was correctly reviewed and approved by the required parties?

Have you adhered to good documentation practices, so the controlled results can be traced – and therefore, trusted?

When you utilize any tool to design, develop, build, test, manufacture, release or support an FDA Regulated Product – that tool needs to be properly documented & validated for the GMP work flow.

Keep in mind, the IUV process is a standalone project – which can be rather time consuming and is unavoidable.

For Most projects, when IUV is necessary – the time & effort required is almost never provided for in the schedule – it’s simply expected to be planned & executed by the existing team…and not impact the timeline.

If you are concerned you haven’t properly documented and validated the tools you’re using now, or plan to use in the future, or you are lacking experienced resources for this required task – please contact us for a review.

We will let you know what’s needed, and we can provide the short-term targeted support necessary to perform the work, not only in accordance with the letter of FDA regulations, but to the intent of FDA regulations – so your project can be completed on time without any surprises, later.


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