What is your Top 10 List for Passing an FDA Audit?

Is your team preparing for an audit…possibly caused by excessive CAPA’s?

I know (we) engineering types don’t always appreciate guidance the quality folks share with us – particularly regarding compliance best practices – but experience has shown (over the long haul) that following their advice ‘proactively’ provides giant benefits to the R&D team.

In other words, by following the “Intent” of FDA guidelines (before, during and after a product is built and released) we will experience reduced time-to-market and higher quality products…that are routinely delivered on time.

Advantu has put together a whitepaper, describing the Top 10 Things You Need to Ace an FDA Audit – which teams continually ask us to send to them. 

But it’s not the complete story.

This list provides (more than) Quality best practices, it also contributes to higher quality products being built & delivered…because it’s complementary with software development best practices.


The FDA requires medical device manufacturers to follow their guidance, in order for them to implement processes designed to build/release products which are safe for patients and easier to operate/manage for the entire hospital staff, including nurses, doctors and their IT department.

Implementing and executing the intent of FDA guidance ensures you’ll utilize best practices throughout the entire product development and delivery lifecycle, with nothing left to chance.  Pretty much everything has been planned for, so all you have to do is execute (and document the execution of your plans) and you’ll end up being able to repeatedly design/build/deliver high quality products…on a consistent basis…without experiencing any ugly surprises.

Here are the First 5 Top ‘Things’ from our Whitepaper:

1 – Perform a Compliance Gap Assessment and follow-on Mock FDA Audit

  • Define the starting point before beginning the journey

2 – Prioritize Gap Assessment and Mock Audit remediation recommendations

  • Risk identification, with corrective action correlation is key

Imagine how much this feedback would aid your SDLC; the whole point of FDA/ISO compliance is to ensure you’re following FDA and SDLC best practices throughout the life of the project – those benefits are measurable & help make sure your entire organization is on the same page.

3 – Make Process Improvement a Priority

  • Be proactive, versus reactive – and enjoy the benefits of ‘best practices’

If your entire organization is continually measuring their individual/collective processes, your chances of success continue to increase (year over year) on a consistent basis. No guessing and no stress with a new product release because…you’re hoping you didn’t miss anything critical.

4 – Close Training Gaps

  • You are only as good as your team – make sure they’re fully up to speed

How often do we all say, ‘man we really need to get trained on that process…’, and then it’s forgotten until the next release?  Or how about this: “If those people had been properly trained, they wouldn’t have missed that key step in the process…and that failed audit could’ve been prevented…”

5 – Enhance Validation and Process Controls

  • Without reliable guardrails, the essence of ‘quality’ is an illusion

Face it, if you don’t measure your validation and process controls, you won’t know if you’re up to ‘best practice’ standards – and without proper validation and/or process controls, you’re going to be constantly reacting to bad news, big challenges and very unhappy customers.  It’s just so much easier when you are fully compliant…because you dramatically reduce costly rework, and you eliminate product release fears entirely. 

Half our business as a company, is providing QMS support for our medical device/biotech/biopharma clients; and it’s quite evident that a lot of mistakes are made in this area…due to either a lack of training or loss of domain knowledge when someone leaves their quality department.

And we’ve noticed, the gaps we find in an organization’s quality management system, directly impact their R&D/manufacturing capabilities on a regular basis.  During the process of implementing quality ‘best practices’, our clients always have an epiphany regarding their software development lifecycle – those ‘aha’ moments when it all starts to make sense to them. 

We’ve also observed that doing things right can be a huge confidence boost for the entire team…and an awesome stress reducer for upper management at time of release.

Do you have questions regarding QMS or SDLC ‘best practices’ – please send us a note:


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