Software as a NON-medical device

Thank you all, very useful insights from everyone as is always the case in this forum!

It is one thing to highlight potential gaps in GAMP-5 guidelines, quite another to completely dismiss the entire guidance.
I am a Biomedical Engineer and I worked for quite few major medical device manufacturers who depend on GAMP-5 guidance to adhere to good manufacturing practices (GxP)

Typically, the software system validation should always align with 21 CFR Part 11 and GAMP-5 guidance

The question is about a software product, not a software used in a manufacturing process.

21 CFR part 11 only applies to electronic systems used (for electronic records and/or electronic signatures) to support the predicate Quality System regulations, which for medical devices would be part 820.

I am not passing any judgement on ISPE's GAMP 5, or on issues of compliance with part 11; but I question what relevance either has to the specific questions in this thread.

Correct
Just to expand,
Predicate rules, according to FDA definition:

"The underlying requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act, and FDA regulations (other than part 11) are referred to in this guidance as predicate rules"

Download the guidance from this page.
(Since I am new to the forum, I was not allowed to include the 'Link')

You can google it.

@Gemayel12 , I am not sure what point you are trying to make. I did not get the impression that @bill.Kal is trying to market either:

• Software for use in (an FDA regulated industry's) manufacturing process, or
• Software for use in (an FDA regulated industry's) quality system

You are referring to things that don't apply.

I am clarifying the disinformation you inadvertently posted in this forum.

Gemayel12 said:

I am clarifying the disinformation you inadvertently posted in this forum.

Click to expand...

Please quote the disinformation, and state the nature of the inaccuracy.

@Tidge and @Gemayel12 , just a clarification to help move this discussion forward.
Indeed, it is NOT our intention to market

• Software for use in (an FDA regulated industry's) manufacturing process, or
• Software for use in (an FDA regulated industry's) quality system

Our intention is to understand what are the labeling requirements In EU (NOT USA) for a software that will be used in a clinical setting BUT IS NOT a medical device, i.e. which regulation governs these types of software since MDR 2017/745 or IVDR 2017/746 do NOT apply.

Hey Bill
Google this title
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Good luck

(I was not allowed to post the link since I am still new to the forum)

Gemayel12 said:

Hey Bill
Google this title
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Good luck

(I was not allowed to post the link since I am still new to the forum)

Click to expand...

Again this is NOT my case. I am dealing with a NON medical device. What you are sending is MDCG 2019-11 (software for medical purposes).
Thank you!!