Medical Molding Audit for ISO13485 / Injection Machine Software validation

Are there any medical molders in this group? We are currently going through an audit in our Dominican Republic factory to get our Certification for ISO13485. I have worked in Medical Molding for many years producing drug delivery systems, but the auditors are now asking for Validation of the Software of the Injection Molding Machine. So my question is how do we validate the software? I have several friends that work for a very large Molding Molding Company and they tell be that they do not do any validation of the software. The auditor has told me that this is a new requirement.

Hi Tim,
I have heard of this for the first time also. Software validation is a must but not sure how you would do that with the machine. You can use calibration records. I would also argue that the software is not rally doing any calculations (other than the graphs and the SPC) and so not sure what needs to get validated.
Suhas

Per FDA regulations, the key considerations are:

Does the equipment create files/records that are stored?
Are machine outputs used to make product quality decisions?
Can the software be modified by the user?

You will need a software section in the press IQ that assesses these criteria. Essentially, you want to demonstrate that the machine software is not within the scope of 21CFR part 11, which deals with electronic records. If your machine software is not accessible to control by anyone within your company, and if you are making quality decisions based on inspection rather than cycle data, then you can justify not validating the software beyond calibrating the outputs (temperatures, positions, and pressures).

My best advice is to become familiar with the FDA regulations, particularly 21CFR part 820 (which deals with validation & verification), so that if your auditors get uppity you can demand chapter and verse of the regulations and then explain how you comply or why it doesn’t apply.