Servicing for SaMD

[nbonds007]

Hello. I've been reading over and over again the definition of product (3.15) and especially Note 2 to entry: Service is the result of at least one activity necessarily performed at the interface between the customer and the supplier and is generally intangible. Here is the reason why. We provide a web/cloud base software that customers can download onto their computers. We currently have an electronic QMS that holds Customer Feedback/Complaints. The company is a startup, and they are looking at a customer support service such as Zendesk to help customers with troubleshooting/feedback/complaints.

Right now, we listed Clause 7.5.4 Servicing Activities as being excluded because no product will physically come back to us. However, if a customer calls and they are having trouble uploading an image to the software. We walk them through it, and it determines the user didn't read the user manual. Is that considered "servicing"? And if the troubleshooting was down in Zendesk, then we would need to have that system validated prior to use, correct?

Is there a difference between troubleshooting and servicing?

Thanks in advance.

 

[yodon]

You're not physically changing anything in troubleshooting. You may find bugs but fixing those aren't servicing for software (you're not going to fix a bug for just 1 customer). Presuming something like you are correcting a configuration that they didn't do correctly or walking them through proper operation (the user didn't read the manual?), I would treat those as complaints and trend to see if your instructions need to be improved OR your setup needs to be improved. It may well be a leading indicator of usability issues.

I'm not familiar with Zendesk so I'm not sure about your validation question.

 

[indubioush]

Agree. It doesn't seem like you are servicing your medical device by these activities. In my opinion, the activities you describe fall under section 7.2.3 of the standard.

 

[nbonds007]

You're not physically changing anything in troubleshooting. You may find bugs but fixing those aren't servicing for software (you're not going to fix a bug for just 1 customer). Presuming something like you are correcting a configuration that they didn't do correctly or walking them through proper operation (the user didn't read the manual?), I would treat those as complaints and trend to see if your instructions need to be improved OR your setup needs to be improved. It may well be a leading indicator of usability issues.

I'm not familiar with Zendesk so I'm not sure about your validation question.

Your sentence "You're not physically changing anything in troubleshooting" completely made everything make sense now. Thank you for that. I do agree that any assistance with correcting a configuration that they didn't do correctly or walking them through something would be treated as a complaint to trend.

Zendesk is a customer support ticket system and support software. Since we currently do not have enough employees to dedicate someone to answer the phone (we don't even have an office, we all work remotely) then support will be used with Zendesk. Customers will use that to notify us of any questions, inquiries, complaints, etc.

 

[nbonds007]

Agree. It doesn't seem like you are servicing your medical device by these activities. In my opinion, the activities you describe fall under section 7.2.3 of the standard.

Thank you for your response. Looking at 7.2.3 - if we move forward using Zendesk, which is a customer support ticket system & support platform, then my gut is telling me that we would need to have that system validated prior to using it because it will be the main system for customers to communicate with us about our products. Would you agree?

However, we do have an electronic QMS, so any complaints that would come from Zendesk would be put into our eQMS, which is already validated. But because Zendesk will be our communication tool and hold other information regarding our product, I'm leaning towards the requirements under 4.1.6. Any feedback would be greatly appreciated.

 

[yodon]

I'm still not completely clear on what Zendesk does. Does it have some logic (do you configure?) for routing inquiries, complaints, issues? Is it maintaining any records? What's the risk if Zendesk fails to meet its requirements (have you defined them?)?

If you do go forward with validation, bear in mind that validating cloud-based applications has some land mines. You are not in control over when changes are made so you'll have to monitor and do your due diligence in assessing re-validation needs.

 

[nbonds007]

I'm still not completely clear on what Zendesk does. Does it have some logic (do you configure?) for routing inquiries, complaints, issues? Is it maintaining any records? What's the risk if Zendesk fails to meet its requirements (have you defined them?)?

If you do go forward with validation, bear in mind that validating cloud-based applications has some land mines. You are not in control over when changes are made so you'll have to monitor and do your due diligence in assessing re-validation needs.

It's basically a virtual help desk. If you have any issues/questions, you would click on the support link and provide the information that you are trying to find. Let me wait until I get more information on how my company wants to utilize it. Thank you for your quick responses!