Document Controls - Input and Ideas - Small medical devices company

[DeviceMaker]

Chris - this sounds good. With periodic reviews and the data backed up, you could fix an error that cropped up through an accidental overwite. I have been at my small medical device compnay for a year now, and I am still trying to get the system straight!

Mike

 

[Chris Ford]

Chris - this sounds good. With periodic reviews and the data backed up, you could fix an error that cropped up through an accidental overwite. I have been at my small medical device compnay for a year now, and I am still trying to get the system straight!

Mike

How are you guys managing the change system? Do you use Excel for an index or do you have a database?

At the end of the day, I'm just basically perplexed by this challenge, because of the level of concern and Class III environment. I want to make it really easy for them to use (so they actually use it) without forgetting it's a Class III device (and all the controls FDA will expect to see).

I'm probably over-analyzing this. Even though they've requested a large manual-style document, I think I'm going to take a step back up to the 30,000 foot level, and create a high-level SOP for their PMA. All the rest of this detail, I can include in a work instruction. Then I can hope that there won't be a pre-approval inspection since this is a "virtual company", and they may never actually look at these details. I just hate hedging bets that way and I'd really hate to put a system in place there that the FDA finds inadequate. They may need to bite the bullet and hire someone to deal with document control if it came to that.

 

[DeviceMaker]

Chris,

We are a Class I exempt device manufacturer and we currently use Excel. We would like to get into Canada which classifies out product as Class II which requires ISO 13485 certification. Since I am new to that, I have been mainly perusing the 13485 forum here and it has been extremely helpful. I happened to stumble upon your question searching for a document related question. We are looking into software systems that can help us manage document control among other things.

I think your approach of a simple, high-level SOP along with a detailed work instruction will help this company. I knew someone a couple of lifetimes ago that used to tell me he was not interested in getting zero 483s, just zero warning letters. I have always taken this to heart when thinking of things like this. It is usually better to have something simple that the FDA may find fault with, than something that takes a committee a year to work on to try for perfection. In that year you had nothing, plus when something this big goes into effect, habits are already in place so people will continue doing hat they have been doing despite the SOP.

The FDA would probably appreciate the growth of a system from a simple high-level SOP to more detailed as needs arise. Hope this helps and good luck.

Mike

 

[Chris Ford]

Chris,

We are a Class I exempt device manufacturer and we currently use Excel. We would like to get into Canada which classifies out product as Class II which requires ISO 13485 certification. Since I am new to that, I have been mainly perusing the 13485 forum here and it has been extremely helpful. I happened to stumble upon your question searching for a document related question. We are looking into software systems that can help us manage document control among other things.

I think your approach of a simple, high-level SOP along with a detailed work instruction will help this company. I knew someone a couple of lifetimes ago that used to tell me he was not interested in getting zero 483s, just zero warning letters. I have always taken this to heart when thinking of things like this. It is usually better to have something simple that the FDA may find fault with, than something that takes a committee a year to work on to try for perfection. In that year you had nothing, plus when something this big goes into effect, habits are already in place so people will continue doing hat they have been doing despite the SOP.

The FDA would probably appreciate the growth of a system from a simple high-level SOP to more detailed as needs arise. Hope this helps and good luck.

Mike

Sometimes, it's just hearing the obvious from someone else that just brings it all into perspective. Thanks for the common sense approach, Mike. Sometimes you just gotta go back to KISS and work your way up, and I think that's the perfect approach here.

Thanks again,

 

[MIREGMGR]

One of the advantages of a source control package, of course, is that any checkin with a new CRC (or sometimes, any checkin period) results in a version-save. Thus all the change history is retained, irrespective of what was changed...at the cost of lots of storage, and a potentially massive thicket of records to search through if looking for a particular change-element in the change-train of a busy file/document.

Of course, in a source control package world, items/files have immutable identifiers. Changes to those are both not permitted and not possible, no matter what.

 

[Chris Ford]

One of the advantages of a source control package, of course, is that any checkin with a new CRC (or sometimes, any checkin period) results in a version-save. Thus all the change history is retained, irrespective of what was changed...at the cost of lots of storage, and a potentially massive thicket of records to search through if looking for a particular change-element in the change-train of a busy file/document.

Of course, in a source control package world, items/files have immutable identifiers. Changes to those are both not permitted and not possible, no matter what.

Exactly. I still really like this idea best. I don't think my client does though. He didn't seem to keen on the idea, but he's considering it. I have a call scheduled with him and my regulatory assistant tomorrow, actually so I'll get a final answer out of him then.