Can we consider Operating System as OTS (Off The Shelf) Software?

K

kingkobra

#1
Hello Folks ,

Here is a link of the OTS software guidance doc ,
http://www.fda.gov/medicaldevices/d...guidancedocuments/ucm073778.htm#_Toc458569098

in which OTS software defined as a generally available software component, used by a medical device manufacturer for which the manufacturer can not claim complete software life cycle control(I consider OS can be classified as OTS software as per this definition).

And here is the link of Premarket submission of the software . On the page no. 11 , OTS and OS are mentioned as different components (As per this point they are different).
http://www.fda.gov/downloads/medica...onandguidance/guidancedocuments/ucm089593.pdf

so should I consider OS as an OTS software ?

Thanks in advance .
 
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yodon

Staff member
Super Moderator
#2
Re: Can we consider Operating System as OTS?

Definitely a difficult question. We have tended to soft-shoe it.

For embedded systems (w/ OSs), we capture as much info as we can on the OS for the documentation but really consider system-level testing sufficient to assert claims of "working."

For desktop systems where it may be used under a mix of OSs (e.g., Windows XP, Windows 7, ...), we test on all "supported" systems (as documented in the IFU) and, again, this is what we use to claim working. The problem here is ongoing patches that the OS vendor distributes. Ideally, you would have some post-market surveillance system set up to assess potential impact from each patch / upgrade. This may result in some level of re-test (or documented justification why not).

For server-based systems (where the manufacturer controls the server), we generally tend to look the other way. ;-) Well, maybe not totally. We do try to document the configuration and control changes but probably not to the extent as above.

When you get to hosted systems, it's even more challenging.

I think your Configuration Management Plan can address how you approach control of the OS. If you document what you're doing and the rationale for why the approach is sound (and safe), it seems to be fairly well accepted. If your system is heavily dependent on system services (provided by the OS), then maybe you need to step up the controls / management a bit more.
 

joemar

Involved In Discussions
#3
Re: Can we consider Operating System as OTS?

I know this is an old thread that I am reviving. sorry for that...

but would we have to validate an OTS software: (1) the Microsoft Windows OS that we use to run the following softwares, (2) software used to make product labels that are then printed out and placed on pouches (and physically reviewed), or (3) software used record invoices that contain information on where specific lots of finished goods were sold (for recall purposes, and this is not recorded elsewhere)? Even though we print a hard copy of each invoice and are on a paper system overall (basically quickbooks).

would the supplier of these software products need to be included on an approved supplier list if we purchase a hard copy of the software but they provide periodic updates?

Im completely confused about where the line is for both validation and what needs to be on an approved supplier list.
 

Mark Meer

Trusted Information Resource
#4
Re: Can we consider Operating System as OTS?

Im completely confused about where the line is for both validation and what needs to be on an approved supplier list.
The "line" will be fuzzy, but is ultimately drawn by you. Likewise, the scope of any validation plans and supplier evaluations is your call...

Good place to start is with some basic risk assessment: What is the worst-case of failure/degradation of the OTS software or supplier?

As far as OTS software for quality system management purposes, data integrity and system reliability are good examples of risks to consider. These, however, can largely be mitigated by back-up procedures and choosing well-established software with good history of use and user base.

Another approach is to consider: if you were to re-build the company from scratch how important are these things in terms of ensuring you have the same quality of product and confidence in your system as before?
If you restarted with everyone on Mac OS instead of Windows would it really make that big a difference? Probably not.
 
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