The importance of firmware validation

As Vosfox Medical, a CDMO specialising in low-volume production of medical devices and components, we have different packaging machines. I was working on validating a new machine, a blister former-sealer.
As part of my equipment validation, I have to challenge the software by testing all the values that can be entered and the response. These values can be actual values or values that are normally out of range.
In this case, I tried to enter negative values for the time, temperature and number of blisters per run. The machine did not return with an error message but just did something. For example, a negative blister forming time resulted in indefinite forming.
You would expect that the supplier is testing these bugs, but not all equipment suppliers follow design qualification steps, including their verification and validation.

The challenge of the system resulted in my case completely crashing the software, which had to be re-installed. The supplier repaired most of the bugs, and now we will re-test the machine.

Software validation testing is also important for all firmware-related software. In this case, it resulted in an improved product.

If you want to learn more about validation or any other operation-related question, I now offer a free hour of consulting to start-up companies to answer most of their questions.
You can book a meeting with me through this link or contact us.