Part 11 Requirements - Medical Devices vs. Pharmaceuticals

[mlabardi]

I recently switched from a Pharmaceutical Company to a Medical Device company. I think I already know the answer but since I am not 100% familiar with what is acceptable in the medical device industry I thought I would post here for some additional input.

Background. My current company is a virtual company. We contract everything out to other manufacturers. One of our products (plastic molding and assembly) is contracted out to a firm in China. I have been presented with a paperless system for tracking pieces and parts using excel that would substitute as a Device History Record (DHR). I know that excel is not a part 11 compliant system because there is no security, no ability to track any changes or really to know who made any additions/changes etc. In my past experience in pharma this would never fly all our primary data records were paper and got archived. Does the FDA look upon the medical device industry different than the pharma industry? We don't have the $$ to invest in part 11 complaint software at this point. I just need some confirmation that I am going to have to be the bad guy and have them implement a paper system as a primary original data record. I'm ok with them entering the information into a database as long as there are compliant records.

In addition, the topic has come up about a visual imaging system. The system is set up so that a balloon part is inflated and then the profile of the balloon is examined by the imaging system. The computer then either accepts or rejects parts. These parts on not serialized so after the fact the parts cannot be matched to the pictures on the imaging system. I have told them that they need to save and archive the digital images as part of that device history record. I am getting a little bit of resistance on this issue due to the large volume of data being obtained. My rational is that the DHR is part of the predicate rule of 820 so then part 11 would apply. I think I am getting a headache (and I have not even got into computer validation with them yet).

I am struggling because I am new to the company and product and still not 100% sure what everyone is doing and how they are operating. I am still trying to get up to speed.

Thank in advance.

[Ajit Basrur]

I am not sure of the rest of the organizations, but we adopt paper based DHRs in China. In the past, one of the customer requested for an electronic DHR but since our organization globally does not have one, the issue died out.

As such, there is no such regulation that the DHR should be electronic.

[mlabardi]

Let me clarify. They (China) want to use MS excel as a DHR. My argument is that this violates part 11 requirements. I think they need a paper based DHR. Are there any device manufacturers who use ms excel as part of a DHR?

I think I am going to have to make sure they set up a paper based DHR.

[Al Rosen]

Originally Posted by mlabardi

Let me clarify. They (China) want to use MS excel as a DHR. My argument is that this violates part 11 requirements. I think they need a paper based DHR. Are there any device manufacturers who use ms excel as part of a DHR?

I think I am going to have to make sure they set up a paper based DHR.

Bottom line? They need to be compliant with part 11 if they are electronic records.

[mlabardi]

Originally Posted by Al Rosen

Bottom line? They need to be compliant with part 11 if they are electronic records.

Thank you so much for reiterating that. I knew it, but I feel so much better to get confirmation from someone else.

I guess I keep thinking that these firms should know the regulations too because they are in the business. I keep wondering how they survive the FDA? I know the rules about part 11 but I am frustrated that no body else seems to. I have had to babysit all my contractors who don't seem to know any of the regulations (either 11 or 820). I had one contractor say to me "What is a Device Master Record?" followed by "I don't see why we need Device History Records?" OK, I'll stop venting. I guess I am just going to keep looking for better contractors and continue to try and straighten them out.

[Al Rosen]

Originally Posted by mlabardi

Thank you so much for reiterating that. I knew it, but I feel so much better to get confirmation from someone else.

I guess I keep thinking that these firms should know the regulations too because they are in the business. I keep wondering how they survive the FDA? I know the rules about part 11 but I am frustrated that no body else seems to. I have had to babysit all my contractors who don't seem to know any of the regulations (either 11 or 820). I had one contractor say to me "What is a Device Master Record?" followed by "I don't see why we need Device History Records?" OK, I'll stop venting. I guess I am just going to keep looking for better contractors and continue to try and straighten them out.

They should also know that lead is toxic.

[Ajit Basrur]

Originally Posted by mlabardi

Thank you so much for reiterating that. I knew it, but I feel so much better to get confirmation from someone else.

I guess I keep thinking that these firms should know the regulations too because they are in the business. I keep wondering how they survive the FDA? I know the rules about part 11 but I am frustrated that no body else seems to. I have had to babysit all my contractors who don't seem to know any of the regulations (either 11 or 820). I had one contractor say to me "What is a Device Master Record?" followed by "I don't see why we need Device History Records?" OK, I'll stop venting. I guess I am just going to keep looking for better contractors and continue to try and straighten them out.

21 CFR Part 11 provided ONLY if the records are electronic.

[Ajit Basrur]

Originally Posted by mlabardi

Thank you so much for reiterating that. I knew it, but I feel so much better to get confirmation from someone else.

I guess I keep thinking that these firms should know the regulations too because they are in the business. I keep wondering how they survive the FDA? I know the rules about part 11 but I am frustrated that no body else seems to. I have had to babysit all my contractors who don't seem to know any of the regulations (either 11 or 820). I had one contractor say to me "What is a Device Master Record?" followed by "I don't see why we need Device History Records?" OK, I'll stop venting. I guess I am just going to keep looking for better contractors and continue to try and straighten them out.

Come to us ........ we know all these things very well