Document Version for Website Help/Training

A

anamensis

#1
This is my first time posting here, so please let me know if this question has already been asked and/or should be located in another thread.

I am new in the regulatory field, and currently working for a company with a website as part of the overall product. The website has the Help documentation online, and currently there is no document control in place for this (although I believe there should be one). I am looking to get the Help documentation to be compliant with FDA document control, but at the moment it is looking to be quite a difficult task, since the help file is quite large, and also because currently it is constantly changing.

To proceed with implementing the document version, should I just say from the time we had the help live online up until now (point where we want to start incrementing version number), that document has been v1.0?

Also, it has been suggested to me that any change in the help version should change the overall product version, so we can see trace what changed what in the product as a whole. It has been suggested that the version be done this way:

[overall product version] ? will get incremented when either the source code for the website or the help become updated
[source code version] ? will get incremented when the source code becomes updated
[help version] ? will get incremented when help gets incremented


Any thoughts on this would be greatly appreciated. Thanks!
 
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yodon

Staff member
Super Moderator
#3
Web content is tricky but, as you indicate is / can be considered labeling so it's important you do control it. Just like printed material, it should be revision controlled / identified and each revision identified / identifiable.

I recommend putting revision numbers in the displayed pages. But you might be able to use page metadata.

What you mention for version identification looks quite reasonable.

Expect pushback - this is not something web folks are used to. One approach to try to minimize impact is to partition the content that needs to be controlled from that which doesn't require control.

Regarding handling everything before, I would recommend that you open a CAPA (corrective action since, essentially, the lack of revision control / identification is an NC). Let the CA process define how you handle things. If you take the approach you mention, you will at least have the approach documented with rationale.

Defining a solution needs to be a collaborative effort between the folks maintaining and quality / regulatory. Be sure to know what the requirements are so you can be adaptive to developer's means / approaches.
 
A

anamensis

#4
Web content is tricky but, as you indicate is / can be considered labeling so it's important you do control it. Just like printed material, it should be revision controlled / identified and each revision identified / identifiable.

I recommend putting revision numbers in the displayed pages. But you might be able to use page metadata.

What you mention for version identification looks quite reasonable.

Expect pushback - this is not something web folks are used to. One approach to try to minimize impact is to partition the content that needs to be controlled from that which doesn't require control.

Regarding handling everything before, I would recommend that you open a CAPA (corrective action since, essentially, the lack of revision control / identification is an NC). Let the CA process define how you handle things. If you take the approach you mention, you will at least have the approach documented with rationale.

Defining a solution needs to be a collaborative effort between the folks maintaining and quality / regulatory. Be sure to know what the requirements are so you can be adaptive to developer's means / approaches.
Thank you yodon, your suggestions have been very helpful, especially on opening a CAPA which I've totally overlooked.
 
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