Document Control Procedure Header Content

shimonv

Trusted Information Resource
#1
Coming back to document control procedure:
The conventional method of document control is to put the signatures and revision history in the first page of each controlled document.
Has any of you been putting the ECO number in the document header and managing the signatures and revision history through the ECO form, thus eliminating the need for a cover page in each document released through ECO?

I have seen a Document Control procedure that calls for this aproach and was wondering if it works, especially with DHF records?
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Thanks,
Shimon
 
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chris1price

Trusted Information Resource
#2
HI, in a previous company, the policy was to have the header with just the title, document number and revision level, then have a change history at the end with ECO number and effective date. No signatures were shown on the document. It worked and went through FDA inspections without comment.
 

shimonv

Trusted Information Resource
#3
Thanks.
What did you do with DHF records during development or ECOs with multiple records included in terms of multiple signing authorities?
 

chris1price

Trusted Information Resource
#4
Procedures and work instructions all had specific document owners who were included in the ECO, I can't remember if each document change was unique with a single ECO or not.

In addition to all the usual things, we used our ERP system for all company documentation. So the system contained the DMR for each product, and included procedures, WI, and all DHF files. It was set up very well and everything was linked and indexed. It sounds complicated now, but actually worked well and wasn't too bureaucratic to operate.
 

pbojsen

Involved In Discussions
#5
Doc Control manager here. Also creator of most of the templates for our controlled docs.

Headers contain:
1. Our logo on the left
2. On the right hand side, document title, doc number, revision, page x of y

Footer contains company name, Proprietary and Confidential, Printed copy not controlled, the form number the doc was created with, and the form's change order number and release date.

We have the Revision History as the very last section of the document. That has the rev number (latest on top), effective date, change order number, brief description of change (as the more fulsome version is on the change order itself) and the initials of who released the document.

Change orders are numbered YY-MM-xxx with xxx being a consecutive number. Easy to find.

We do now have some docs in an ERP system, but it's a pain in the backside.
 
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