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Mobile Medical Device App Validation Guidance vs. GPSV?

J

Joemj

#1
Hello, I am new to this forum and I am looking for a thread specifically on mobile app validation but I don?t see one. My questions are related to low-risk Mobile Apps and NOT Mobile Medical Apps as defined by the FDA. The FDA has indicated they intend to exercise enforcement discretion for these types of apps. (Not quite sure I understand what that really means).
Most of our apps in this category are used by sales and marketing personnel. Many render or contain promotional, sales support, and training (PSST) material that have been approved within our internal systems. As such, the material being rendered by the apps are classified as Labeling materials, and therefore are determined to be part of our Quality System requiring computer system/software validation. We also consider, perhaps conservatively, these records within the app as Part11 electronic records even though the app has absolutely no provision or function that allow a user to change or alter the material. When information is changed, or a new OS is deployed, the app is versioned by the developer and its functions re-verified.
We have a standard protocol for non-device quality system validation but it is truly for large complex IS systems. We are trying to better scope it or tailor it for these types of applications for our eMarketing team who really have limited knowledge with software validation, if any. They do not understand terms such as ?risk-based validation? or to ?scope the validation accordingly?. Getting these apps out to the sales & marketing force quickly and expeditiously is imperative.
My questions are:
1. The release of the Mobile Medical App Guidance states that FDA will not or does not intend to enforce the FD&C Act on these types of non-medical apps. Does that mean that 21CFR820 would not apply since it?s not considered a device, therefore negating the requirement for validation?
2. We definitely want to do some verification but what is appropriate or expected?
3. Are we too conservative in calling these types of apps quality system apps, and or electronic records?
4. Has anyone had similar situations or can lend advice say with generating templates?
Thanks,
Joe
 
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Marc

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#2
A quick "Bump". My Thanks in advance to anyone who can help with this one.
 
I

isoalchemist

#3
A few more details would be helpful and may change the advice but from my current understanding it sounds like your app is training materials for internal use.

If it does not fall under the definition of a Mobile Medical App or an MSDS the FDA really won't care about it from a validation perspective.

If the training is discussing a medical device/drug they you may want approval(s) of the content to ensure you are not stating an unintended or off label use of the product.

Again these sound more like training materials so putting them into the same box as what would be required of a quality systems application seems to be a bit harsh, but they should fall under the same revision guidelines and control mechanism to ensure they provide the correct information at any given time.

As for validation, any SW product should undergo a validation. What else do you base the decision that it is ready to be released. The protocol may be relatively simple but conceptually it is the same as a bigger system, does it do what it was intended to do, does it met the design requirements, and does it perform as expected. The complexity of the validation will be linked to the complexity of the system and if any risk.:2cents:
 
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