Documentation Control of Digital Forms

Fadhilah Cholish Azhari

Starting to get Involved
Dear All,

I want to ask about how to control Documentation Control of Digital Formats.

In the clause of ISO 9001:2015 says,
7.5.2 Creating and updating
When creating and updating documented information, the organization shall ensure appropriate: a) Identification and description (e.g. a title, date, author or reference number); b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic); c) review and approval for suitability and adequacy.

and also For the control of documented information,
the organization shall address the following activities, as applicable: a) distribution, access, retrieval and use; b) storage and preservation, including preservation of legilibilty; c) control of changes (e.g. version control); d) retention & disposition.

So, my company is starting to digitalize some of our forms and process through our own system (some kind of SAP).
The previous documents (hardcopy) are controlled by Document No. and their revision number.
Form No (Rev. No.) Reference Doc ; Form Name
Form 17 (R7) WI-MKT-SM-08 ; Manufacturing Feasibility Study (MFS)

If we consider to change the medium of the forms from hardcopy to a digital portal, should we use the same control method as the hardcopy one?
Or the control of the software version is enough?

I would also like to ask some opinion/reference from you guys which use SAP as main documentation process.
How do you control the document? How do you control the document numbering and revisions?
Does the software patch notes may cover all the forms/features inside the software?
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