A
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!
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!