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Are signatures required on every page of a controlled document?

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insect warfare

insect warfare

QA=Question Authority
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#32
#32
keldez said:
I'm more used to the revision history table within the SOP tracing the document's approval to a record that is solely for the approval of the document change/creation. I find this method cleaner but perhaps more work. If anyone has comments/advice against this approach, I welcome your opinion.
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I use this approach and I personally think it is a much cleaner method. Having said that, I sometimes have support staff who try and nudge us in the opposite direction "Hey, let's put actual signatures on the SOP itself", but it is usually due to a difference of opinion, nothing more, and nothing ever materializes from it because they cannot demonstrate the efficacy of signing on an SOP when they are already required to sign a change request form that is designed for that, plus traceability.

Brian :rolleyes:
 
H

Helmut Jilling

Auditor / Consultant
#33
#33
insect warfare said:
I use this approach and I personally think it is a much cleaner method. Having said that, I sometimes have support staff who try and nudge us in the opposite direction "Hey, let's put actual signatures on the SOP itself", but it is usually due to a difference of opinion, nothing more, and nothing ever materializes from it because they cannot demonstrate the efficacy of signing on an SOP when they are already required to sign a change request form that is designed for that, plus traceability.

Brian :rolleyes:
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ISO 9001 does not require signatures at all. Not sure about ISO 13485 or AS 91xx series. Signatures are one common method of course. But I see it gradually declining. Using passwords and email methods seem to be gaining. Whatever method works for you. But remember, these are not legal contracts, they are SOPs.
 
E

Einalem

#34
#34
My experience - the approval signature/time stamp/date, etc. is the approval of all content during a particular point in time. If there is opportunity to change content of the document without obtaining approval of the change, the doc control process is not fulfilling the purpose of control.
 
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