Controlled Forms Conundrum

I'm implementing an electronic quality management system software and the question keeps coming up whether the electronic forms should have control numbers and revision letters. If the 'content' is controlled and the revision history is in the audit trail is it necessary to keep the old school from numbers and revision info actually 'on' the electronic form?

Chuck in QA said:

I'm implementing an electronic quality management system software and the question keeps coming up whether the electronic forms should have control numbers and revision letters. If the 'content' is controlled and the revision history is in the audit trail is it necessary to keep the old school from numbers and revision info actually 'on' the electronic form?

Click to expand...

Chuck,

One of great benefits of electronic management systems should be that the user does not have to find the right form and the right issue of that form.

So, provided the form is uniquely identified (no two forms with same name) and changes are reviewed and approved before going live, I see no need to continue the traditional hardcopy document controls.

And of course, the electronic system would be configured so only the right forms can be accessed by a particular workstation or log-in ID.

John

Welcome to the Cove, Chuck!

I've learned to keep an open mind when dealing with electronic systems.

Where software includes a section in its code listing changes and the team can exhibit appropriate reviews and approvals, that has sufficed for the standard's intent because the users (engineers) knew how to find the descriptions and dates of changes. Lots of other options for showing revision control would also work, including making a list of changes to all your documents available in a central place.

As for revision numbers: we see software carry revisions such as Windows 8 or 8.1. Can you do something like that? Just something to alert users that the form has changed. A date can also work.

That said, I hope you don't think you need to revision control every form there is, or for every tiny change that's made. I would use the control plan to decide what form to control. I would consider what the document does, and if the change represents something added or taken away, something done differently or by different specific people.

I hope this helps!