Hi there,
I am after some advice. We have a plastic moulding operation and part of this requires maintaining run charts of certain dimensions on the parts made.
The plastic parts are components that we then assemble into Class 1 and 2 medical devices and sell.

We are investigating a PC based system data capture system which interfaces with various dial test indicators. This has the ability to perform the statistical functions we require and print the chart out. It is a software package that accepts and processes the data. This would interface with hardware that we supply.

We intend on keeping the paper copy as the quality record. We are still quite some time away from having a part 11 compliant system to keep the electronic copies.

What questions should I ask of the software vendor?
Ideally they could supply all the software validation documents to show the software does what we will use it for.
What does the FDA look for in OTS software?
What have other people found in similar situations?

Unfortunately this is not my field, though I am learning fast:)

Thanks in advance for any information you might have.

Tim Sharp

Hi Tim, welcome to the Cove. I think that the amount of work will depend upon how much the software vendor has done. You can find more about this in the FDA guidance documents, General Principles of Software Validation (http://elsmar.com/Forums/attachment.php?attachmentid=2402) and Off-The-Shelf Software Use in Medical Devices (attached below).

Our company is currently going through some procedural updates in response to FDA requirements regarding validation of the use of OTS software (OTSS). Their concerns are primarily: (1) That you have invesigated and approved of the processes that the supplier has in place to validate their software, and (2) that you validate the use of that software in your environment by your own, defined methods. Both of these must be documented to provide evidence that you did the investigation and validation.

My company contracts to design and test medical devices for other companies. When we use LABVIEW, MATLAB or SIMULINK during the design verification phases, we enter data into the program that will give us an expected result to verify/validate the program. Is this sufficient?

My company contracts to design and test medical devices for other companies. When we use LABVIEW, MATLAB or SIMULINK during the design verification phases, we enter data into the program that will give us an expected result to verify/validate the program. Is this sufficient?

I'm not sure I understand the context of your question or situation. Are you saying that you are providing simulated data as input to your program and then looking for a result to fall within expected parameters?

In any case, there is much that needs to be done in order to validate a program if it is used within the quality system of your company, and really can't be answered simply. It is also dependent on whether or not the program is used as part of the design process or the manufacturing process; the design process is being held to much more rigid controls than manufacturing processes at this time, although recent FDA audits seem to be beginning to focus more and more on manufacturing metrics as indicators of quality. The General Principles of Software Validation from the FDA mentioned earlier is the place to start.