Quality Manual on a Network - Authorising Signatures - How do we handle?

[tomjess]

Manual on the network

I am puuting our companies quality manual on the network. This will control the documention control.

There will be only certain persons in the company who will be able to print it off, but the copies will have uncontrolled document across the copies. So at no time will there be any contolled copies in circulation.

On our hard copies we have the following:

Authorising Signature:

On the electric version I don't need this do I?

Happy New year to those who read this.

Thanking you in advance

 

[Craig H.]

tomjess:

It is possible to get away from a handwritten signature for an electronic document. You can use a secure server, and authorize only certain people the permission to write to that server. You can also use an Acrobat .pdf file that is difficult to change.

The main goal here is to make sure that the copy in use has been reviewed by the appropriate parties, that the copy in use is current, and the system protects the integrity of the document. From your description of your system, I would remove the signature line. Make sure your document procedure does not state that you have to have this signature. If it does, revise that, to make your new system comply.

I am no expert on the subject of electronic systems, but there are some people frequenting this forum who have experience with just this type of thing. I'm sure they will offer advice soon.

Have a great New Year!

Craig

 

[Mike S.]

Tomjess,

I'm sure you can get by with saying the QM is secure and controlled by using a write password with access limited to perhaps you and the approving party or parties -- this is a common scheme. As for the approval part, I dunno, maybe if everyone approving it tells the auditor (if asked) that yes, they did approve it prior to posting you might be okay there, too, or using e-signatures that some here have mentioned using would certainly work. Personally, (and this is just a personal preference, I'm not saying it is an ISO requirement) I prefer to have one hardcopy with written signatures of the approving person(s). This leaves no doubt (internally or externally) that it was reviewed and approved and often comes in handy to carry to the conference room to show customers our QM if/when asked. Sometimes the customer will want an uncontrolled hardcopy instead of an e-copy, so this hardcopy again makes it easy to make a copy for the customer, complete with signatures. Just a personal preference.

 

[Craig H.]

Mike:

We, too have 1 copy of the QM that is signed, green boarder, etc. Since we still use mostly paper, this is the only controlled copy - the rest are not.

The system works well for us, and it would solve tomjess' approval problem. I would either omit the approval line for the electronic copy, or, even better, just type in the names that signed the paper copy.

Tomjess, does this help?

Craig

 

[tomjess]

thanks

All good answers and have given me ideas.

Thanks to you all

 

[Jimmy Olson]

Tom,

I thought you considered this forum to be a flop and were dissapointed in it. Yet here you are asking questions and saying that the answers are good and have given you ideas. Having trouble making up your mind?

 

[Russ]

Here's how we handle this. Our entire Quality Manual is on the Intranet in .html format. The directory is write protected to everyone but myself. Any copies that get printed from this directory have a time stamp and a note that it is only viable for 24 hours after printing. Document changes had been made using signatures on hard copies, but now we use email saving the approvals as .msg files in the proper directory for each document making subsequent approvals easier. Havn't had any problem from any of our auditors since going this route. I do keep 2 hard copies for Internal Auditing.

 

[M Greenaway]

Perhaps is was the direct answer to a direct question

 

[Mike S.]

M Greenaway said:

Perhaps is was the direct answer to a direct question

That'll never catch on!

 

[Aaron Lupo]

Re: Manual on the network

tomjess said:

I am puuting our companies quality manual on the network. This will control the documention control.

There will be only certain persons in the company who will be able to print it off, but the copies will have uncontrolled document across the copies. So at no time will there be any contolled copies in circulation.

On our hard copies we have the following:

Authorising Signature:

On the electric version I don't need this do I?

Happy New year to those who read this.

Thanking you in advance

Tom-
I am not sure what your company does, however, if you are using electronic documents you need to look at the requirements in 21 CFR PART11 if you work in the Medical/Pharmaceutical industry.