Printed Copies of Controlled Documents

[bonnieblue]

good morning everyone!
i was wondering if anyone has any thoughts on the necessity of printing "master" copies of controlled documents like procedures, forms, etc. we are an animal pharmaceutical company governed by FDA, USDA, EMEA, CVMP. we currently print master copies and stamp them with the approval date, but isnt using an electronic format like PDF just as good? we do not use electronic signatures and the approvals are captured via a document tracking record.

 

[GStough]

good morning everyone!
i was wondering if anyone has any thoughts on the necessity of printing "master" copies of controlled documents like procedures, forms, etc. we are an animal pharmaceutical company governed by FDA, USDA, EMEA, CVMP. we currently print master copies and stamp them with the approval date, but isnt using an electronic format like PDF just as good? we do not use electronic signatures and the approvals are captured via a document tracking record.

Hi bonnieblue!

That would depend on who is on the distribution list for the master copies. If there are shop operators who do not have access to a computer to use the PDFs, then it makes sense to have printed & stamped copies available to them for reference during their work shift(s).

However, if everyone has access to a computer and can see/use the PDFs, then it really is just a business decision for your company to make as whether they want to print and stamp the hard copies or use the PDF version.

Hope this helps...

 

[bonnieblue]

However, if everyone has access to a computer and can see/use the PDFs...

i probably should have mentioned this is doc control for the IT shop. i should hope we all have computers!

 

[edelsal]

I agree that the PDF versions should be enough; in fact I have set it up that way now in my company. However I still have 1 printed copy of controlled documents (which essentially becomes uncontrolled once it is printed within our system) just in case that our network is off-line and someone needs to see something at that very moment.

I added a note to our intranet access manual in PDF that says that the only master, controlled version is the one contained within it (printed copies are uncontrolled)

So far it’s working… approval signatures are captured through a document tracking sheet as well.

 

[Qualqueen]

I agree that the PDF versions should be enough; in fact I have set it up that way now in my company. However I still have 1 printed copy of controlled documents (which essentially becomes uncontrolled once it is printed within our system) just in case that our network is off-line and someone needs to see something at that very moment.

I agree with the 1 printed controlled doc system and anything that goes out after that is stamped uncontrolled and stated in your Procedures as such.

I added a note to our intranet access manual in PDF that says that the only master, controlled version is the one contained within it (printed copies are uncontrolled).

I also agree with this although that's assuming that there's no one else on the distribution list for master copies as GStough stated.

So far it’s working… approval signatures are captured through a document tracking sheet as well.

 

[CalRich]

However, if everyone has access to a computer and can see/use the PDFs...

i probably should have mentioned this is doc control for the IT shop. i should hope we all have computers!

If the "controlled" documents will only be on the network, then you may want to have some kind of disclaimer or expiration on the documents when printed. (e.g. "Document valid only on [today's date]." or "Expires 24 hours after [print date]". In these cases, folks often use the auto date/time feature for headers and footers in word processors.)
So if it's just controlled on the computer, you want to make sure people are not using old revisions that they printed out "for convenience" and slipped in their files for the audit.

 

[Helmut Jilling]

I agree that the PDF versions should be enough; in fact I have set it up that way now in my company. However I still have 1 printed copy of controlled documents (which essentially becomes uncontrolled once it is printed within our system) just in case that our network is off-line and someone needs to see something at that very moment.

I added a note to our intranet access manual in PDF that says that the only master, controlled version is the one contained within it (printed copies are uncontrolled)

The flaw with this idea is that ISO says all docs must be controlled. If people are using the printed copies then either you or they must ensure they are in control (correct revision and info is up to date). Just having a disclaimer does not control them, it just disclaims that you are not controlling them. They still must be "in control."

The use of PDF's online is a great solution. Just try to get people to quit printing copies "for convenience." That is the real solution. And, where printed copies are needed, then they must be controlled.

 

[bonnieblue]

Just having a disclaimer does not control them, it just disclaims that you are not controlling them. They still must be "in control."

during an fda audit, the auditor said that the "valid only on current date" is sufficient for fda purposes. we are not iso certified, so i can't speak to the validity for these purposes. according to the auditor, that statement is an indication to the person that this is a controlled doc and to look for the most current version. this is something that could be open to interpretation, i guess.

 

[Helmut Jilling]

during an fda audit, the auditor said that the "valid only on current date" is sufficient for fda purposes. we are not iso certified, so i can't speak to the validity for these purposes. according to the auditor, that statement is an indication to the person that this is a controlled doc and to look for the most current version. this is something that could be open to interpretation, i guess.

I also routinely accept that approach, if the date is current. That method is based on the idea that the information is current (because it was just printed). ISO would accept that. My comment was addressed to routine disclaimers that printed are not controlled. They don't accomplish anything as to doc control and are just a disclaimer.

 

[Jim Wynne]

I also routinely accept that approach, if the date is current. That method is based on the idea that the information is current (because it was just printed). ISO would accept that. My comment was addressed to routine disclaimers that printed are not controlled. They don't accomplish anything as to doc control and are just a disclaimer.

One component of control is the ability to locate and replace printed copies when changes happen. The rationale is that if the printed document states that it's not controlled after a certain date and time, there's no need to locate and replace the document unless, of course, changes happen within the time period when the document is considered "live."

The best course of action (imo) is to either disallow printing altogether, or assign responsibility to users to verify the status of the document before it's used. Just saying that the "control" is valid only during a specified time period doesn't prevent a stray obsolete version from being used.