Does Part 11 applies to this application

I was wondering if the ms-access based change control tracking application which auto generates change control number, allow the user to enter the change request information, print the change control forms and track the status of change control needs to be part 11 compliant, though electronic records are not used as official copy but only the printout generated (change control forms) from this application is used as official copy.

In other words we are using this application as any other word document, to enter information and to print it ,the only different is the application will stores the information, automatically assign change control number for each change request, informs and allow only the respective user role to complete and print his section of the change request.

Please comment…


Hi Azmat,‎

Do your users sign on the printed form or is it using electronic sig?‎

If they are signing on the printed form I think that since you do keep a paper record the application does not need to be part ‎‎11 compliant. If you have concerns about using auto generated numbers I would ‎recommend you produce specification/design and testing documents for the ‎application were you simply test its functionality. You can note in the URS that part ‎‎11 is not applicable since the printed form are signed and are kept for the period required in the applicable predicated rule.‎

Hope you will find it useful. Iam no expert on the matter so if anyone has a ‎different thought please advice.


In my opinion, Part 11 is not applicable as the application is like a template generator with auto numbering built into it. Because the change control forms that are generated are signed by the respective personnel, only minimum testing and documentation is required.
As oded mentioned, “you produce specification/design and testing documents for the ‎application were you simply test its functionality.”

hope this was useful.
any other users please confirm


Hi Azmat
You can’t have it both ways. From what you have stated the software issues the document numbers and is your master list as to what number does what.
This is regulatory required data and must comply with part 11.
However it is not difficult to use the software as you are currently using it, but keep a manual master list.
You have to remember that during a regulatory inspection, when an inspector asks to view a regulatory required document, he is in effect inspecting your document management system. If you retrieve a hard copy from your files, he won’t mention part 11. If on the other hand you have to go to a computer – need I say any more?

Alex Kennedy

When 21 CFR was first released regulated companies really struggled with this question. MS applications like Excel and Access do not require validation however, if these applications are being used to store data, formulations calculations you may want to consider validating those processes.