Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list)

#1
New to the GMP world and thank you for all the helpful discussion treads so far...

Concerning Part11 GMP compliance: We have controlled (signed hardcopies) of our approved supplier list and equipment/calibration list templates (to name a few), but we are using the soft copy excel version as a living document where one person updates as needed whenever we add a new supplier or equipment, etc. We do not print off and sign a new version with each update of this type. Is this in breach of Part 11 compliance? Should we maintain a hard copy version that gets updated and signed off with each addition to be compliant? Thanks you.
 
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yodon

Staff member
Super Moderator
#2
This could be quite a can o' worms...

First, why do you think you need to have signed hardcopies of your approved supplier list. (For that matter, why do you think you need to have an approved supplier list at all? There *may* be a requirement - 210/211 isn't my strong suit but you need to base actions on the regulations not some long-standing "we've always done it this way" approach.)

This is probably a bit of a sucker-punch, but how are you ensuring that only approved suppliers are used (obviously not through a signed hardcopy of an approved supplier list).

Part 11 applies to (and I'm quoting from the regulation) "records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations." So first off, you need to realize that if the regulation doesn't require a record, Part 11 doesn't apply. (Well, maybe a little more than that but that's where it starts.) There would be a lot more non-compliance with Part 11 with the process you describe, by the way.

211 does require, for example, a "written record of major equipment cleaning, maintenance ..." If those records are maintained electronically, they should be maintained in compliance with Part 11.

Electronic signatures are somewhat similar.
 

indubioush

Quite Involved in Discussions
#3
I think what Yodon is trying to say is that you need to have the actual records showing the equipment was maintained and that the supplier was approved. I assume you do have supplier evaluation records. If you have this, you can have any method of communicating the list of approved suppliers that is accurate and works for you. Some companies have it just as an electronic file that is viewable by all but editable by Quality, and some have the approved supplier list as a controlled document. As long as you ensure you are only accepting parts/services from approved suppliers, you are fine.
 
#4
As far as I know there is NO requirement for a Approved Supplier List (ASL) either in the QSR or ISO. In spite of that most companies maintain an approved supplier list in Excel.

My take is that the ASL should be generated as a report from a validated ERP system. This would provide evidence that the Purchasing controls in your ERP system effectively control the status of your suppliers. Seems simple enough but I have not seen it yet.
 
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