I am working for company dealing with medical device with CE mark.
For each of our product, our marketing created a product website providing general information (creative marketing info) about the product. Crucial info such as approved claims are included on the site.

I would like to enquire others opinion and experience on how the product websites are treated from QMS perspective. Are they treated as a controlled documents (properly controlled; identification, creation, issuance, approval, posting, revision) given the creative nature of the websites (moving images, hyperlinks etc). ?.

We treat our web site as a controlled document. It is released by an Engineering Change Order. Part of the ECO incorporation process is the posting of the information on the web site and verifying the content against the released version.

We treat our web site as a controlled document. It is released by an Engineering Change Order. Part of the ECO incorporation process is the posting of the information on the web site and verifying the content against the released version.

Is this not a OVERKILL ? Why is it required ?

The only care should be taken that the website doesnot put up information that is false and fictitious. I doubt even regulators like FDA, TGA etc would not be treating their websites as "Controlled Documents".

This is an interesting question and would like to hear from many respondents.
:thanx:

I think it depends upon the content. Since they are posting information such as "Crucial info such as approved claims are included on the site" I would think it would be inportant to ensure the information contained is up to date.

Howard was recently in Cincinnati. He wanted to eat at an Indian restaurant, so, since I really don't know of any, Howard looked for one on the internet and found one and they had a coupon there - Which expired last June.... We printed it out anyway and they took it, but it wasn't 'critical' so their web site being out of date isn't going to hurt anyone. I use this as a simple example.

Medical device companies are targeted for lawsuits and such. Not to mention, if someone is a potential customer I would think it would be very important that the most up-to-date information is on the site.

If it were me, I would insist on control in this case. I like the engineering change system as a vehicle idea.

I agree with Marc. My understanding is that the FDA considers all claims on medical devices to fall under the category of "labeling". It is therefore better to CYA and run website product descriptions and claims through a CN approval.

John

My understanding is that the FDA considers all claims on medical devices to fall under the category of "labeling". It is therefore better to CYA and run website product descriptions and claims through a CN approval.


Your understanding is correct. Many a warning letter (http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=L) (look for "Labeling and Promotional Violations") has been issued for claims made on web sites.

I understand the logic behind controlling web pages with critical data, but would I be right in assuming that general info pages like company background would fall outside this issue? Is it easier to control everything, or is it overkill?

I understand the logic behind controlling web pages with critical data, but would I be right in assuming that general info pages like company background would fall outside this issue? Is it easier to control everything, or is it overkill?

(just happened to bump into some old threads...)

Any web pages making claims - even if made on the company background pages (Welcome to XYZ Company, home of the Best Thing Since Sliced Bread Severed Limb Growth Cream) - would be considered labeling by the FDA.

Whether it's controlled or not depends on the system. QA and regulatory folks should review their company website often. Stuff could be uploaded by IT or sales folks without knowing there could be an issue with the FDA.

On this subject...did you guys assign an actual part number to your websites? If so, was there a "revision level suffix", e.g. PN 111-11111-001A? Or did you go with just a revision date, e.g. XYZ Website 1/04/08? Small question in the grand scheme of things, but I'd like to get a feel of how this was handled from a practical standpoint.

BTW, given that that FDA absolutely considers websites "labeling" all content changes need to be controlled. Thankfully, we can still define the levels of control for any given type of change! :thanx:

The conventional wisdoms of document control - such as numbering etc. don't always apply to websites. Certainly the content should be reviewed and approved and changes tracked etc. How many websites do you visit where it's not clear when it was last updated? I don't have confidence in any I can't tell the maintenance status of. Regardless or incidental to the FDA etc. many websites contain information on which the customer bases their purchase and, as such, can/will be construed as 'contracts'.

You had better have your stuff right if you are expecting the customer to buy from website info. I just made a product purchase from a website which didn't mention anything about the (long) leadtime (apparently since the product is 'hand crafted') - I got an email back saying it would take two weeks - but only after I wrote and said I needed it by a certain date for a present.

caveat emptor! Or better still, let the seller put customer oriented info on websites.........

We are in the transition of posting our controlled documents in the website. In my end as Document Controller, we document the process of uploading and converting the controlled documents to pdf. And our IT make sure that these online documents are read only in which the printer was disabled.
Raffy:cool: