JohanJ
Member
Posts: 228
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Hi there,
just wanted to start a small discussion here on the forum. A discussion which I also had with our IT manager.
We zre in the process of modernising and switching to electronic systems.
General perception and position they take at my firm is that every old paper signature needs to be substituted by an electronic signature.
My question: to what level is this true?
Cause my opninion:
Having a CLOSED electronic system means
- you need to login with a personal ID and password.
- audit trailing must log activities such as who did what and when.
- different security levels give access to different responsibilities and as such different functionalities
So the combination of these three will make that approvals by a higher level need to be signed.
But activities of an operator to which he is entitled musn't be signed off since they are logged. As such these signature in 'ye olde paper world' have become obsolete in electronic systems.
What are your opinions?
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AndrewAllenMC
Beginner
Posts: 3
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In response to JohanJ
Actually, this is a very hot topic right now... Especially after the new law went into place.
We have a customer who is a law firm and have been dealing with issue of this nature.
I want to subscribe to this topic and keep an eye on it.
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Kevin at Sanyo
Beginner
Posts: 40
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In response to JohanJ
In my experience old signatures on hard copy documents need to be archived according to the companies SOPs and regulatory standards. Making a copy, even an electronic one, does not negate the responsibility of maintaining the original.
Kevin Loomis
Validation Engineer
Sanyo Biomedical Solutions
(630) 694-8218
(800) 858-8442 x8218
kloomis@sss.sanyo.com |
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complianceguru
Beginner
Posts: 23
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In response to JohanJ
In my experience, original documentation must be retained in accordance with applicable predicate rules and internal SOPs and Policies. Furthermore, it is a good idea to scan in old documentation to have a backup copy of the original documentation.
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JohanJ
Member
Posts: 228
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In response to complianceguru
I think some have you have misinterpreted the meaning of my post. This is purely theoretical as a lot of things are still done in double (paper and electronic) just to be sure not to have any cGMP ingressions.
The discussion I want to have here does not regard any paperwork or archivinf of such. All old raw data (paperwork is stored and archived conform regulatory requirement.
My question regards the substitition of old practices (written signatures) by new practices (electronic signatures) when you are switching over to a more electronic system which logs all actions.
As an electronic system works in logon- sessions you can easily identify the tags that must be monitored throughout the process (operational audit trail). In my opinion this audit trail can easily replace the sheet with signatures which an operator needed to provide during his activities.
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