Implementing Change Control on Company Website

kisxena

Starting to get Involved
#1
Hello:

I was asked about how one would go about having change control on our company's public website.

There is some information on our company's website that would be considered "labeling".

Please advise.

Thanks
 
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R

Roland Cooke

#2
At the end of the day it's just a document, or, more likely, a collection of documents, so what's wrong with just bringing it under your document control procedure?

Make changes subject to appropriate approvals, in the usual way.

Also, ensure website document control is covered by your Internal Audit programme.
 
J

JaneB

#3
Hello:

I was asked about how one would go about having change control on our company's public website.

There is some information on our company's website that would be considered "labeling".
It's not always exactly the same as hardcopy. But answers depend on whether you're talking about controlling linked documents or whether the website content is just changed & published as is, eg, via an HTML editor/content management system or similar.

In general, I focus on control over who has access to change things on the website.

Without providing more info on what you have & what you're actually asking advice on, you'll only get broad responses.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Principles stay the same:

1) Limit change access to an approved group. That is, everyone except that group can only read the web page.

2) Make sure earlier versions are saved, archived and kept safe for reference via backups.

3) When changes are called for, make sure there are approvals of the change by those who would be affected by them. Have a process to see that changes only happen after the approvals are done.

4) When changes occur, make sure people are notified of what changed and when.

5) Make sure only the latest version is available for users to see.

6) You can use a date or revision number to "mark" the page, if it is controlled.
 
W

Watchwait

#5
We've also been down this path with FDA & discovered it's a battle not worth fighting. Much easier to just comply. Consequently, we developed a simple, separate procedure (attached) for dealing with Website content control. We've had the procedure in place for some time now and it's working fine the way we have it structured & everyone is now happy!:)
 

Attachments

#6
As always, I think the answer can be found in the standard itself. According to 4.2.1, there are specific types of documents that require control. So, just follow the list and ask if your website meets the requirements of a)-f). If it does not meet those requirements, and it is not part of the files referenced in the final paragraph (just above Note 1), then according to ISO 13485 it does not have to be controlled.
 
G

Gumaer

#7
4.2.1 has the national regulatory clause. The FDA is consistently sending out warning letters to companies making unapproved claims; your website could be considered no different than a product insert if it offers instructions for use or as advertisement if it suggests the drug/device helps users. Quality oversite may or may not be required, based on content, but you may want to make it a risk management decision. :notme:Don't trust marketing...:notme:
 
Last edited by a moderator:
W

Watchwait

#8
Just to clarify, FDA now considers a device manufacturer's website content as "labeling". Labeling is itself considered a component and as such subject to all controls applicable to components contained in a device, e.g. change control.
 
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