QMS and Computerized Software Compliance with Standards

[aisaev]

Hi,

I'm very new to this forum and sorry if my posted question is not in correct thread.

Anyway,
The question I cannot find the answer is: what FDA, ICH or other acts, guides should my company's QMS comply with?

The company I work for, is an ISO9001:2008 certified and thus has the QMS that is fully aligned with this standard requirements. Starting from this year marketing decision is made to design and implement software product for Pharmaceutical industry. Basically, we would like to produce clinical trials software for electronic data capture (EDC) and clinical data management (CDM). Future plans may lead us to medical imaging software.

The task I'm facing now is to adopt existing QMS to any regulations that may be applied to such software. I did a long research through FDA, GxP and other acts, but I could not find the answer to my question. The guides and regulations are too high level to make a decision.

E.g., It clear that designed software and QMS must follow CFR 21 Part 11 act. However still cannot understand if we need to comply with CFR 21 Part 820 in terms of QMS. The same is with various GxP e.g. GAMP 5, GCP.

Any help or advice here will be much appreciated.

 

[yodon]

If the software is considered a medical device, then yes, you would be obliged to have a quality system compliant with 21 CFR 820.

If you are getting into medical device (software) you may also want to consider adding ISO 13485 registration. Not a big leap from 9001.

 

[sridharafep]

small error in this thread - it should be

ISO 9001:2008

and ISO 9000: 2005

 

[aisaev]

TO: sridharafep
Yes, you're right. mistyped a bit.

TO: yodon
I think my main problem is to determine if software will be considered a medical device software. I do feel that when we will come to Medical Imaging stuff, it would be easy to say yes, it is a medical device software. But currently when we talk about clinical trial management software with EDC and CDM only it is quite hard to make a decision.

 

[yodon]

Frankly, if you have a well-defined, state-of-the-art process, you're going to be doing pretty much everything that's required by the regulation. There's a bit of additional overhead in compiling things like the DHF and the DMR but it's pretty minimal effort. You're right in that the imaging software will no doubt be considered a device so why not bite the bullet and have a single process that is compliant. Probably easier than trying to run multiple processes.

Do you have particular reservations about adopting the requirements of 820? If so, maybe articulate them and the forum can offer advise on best practices and minimizing overhead.

 

[aisaev]

It is hard to say that what we've got is the state-of-the-art process. Still it is quite good.
Anyway, I got your point. Was thinking in the same way.

As for 820, it is in discussion now. Let see if there will be some.

 

[jkuil]

Please read FDA's Guidance for Industry Computerized Systems Used in
Clinical Investigations