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21 CFR Part 11 Requirements - Microsoft Excel Add-on Functions

L

lightbug

#1
Hello,
I am brand spankin new to the Cove!

I was hoping someone could help with 3rd parties that offer part 11 add-on functionality for Microsoft Excel spreadsheets. There appear to be several companies that offer this solution.

Limiting System Access (21 CFR 11.10d)
Program Time-Outs (21 CFR 11.10d)
Audit Trails (21 CFR 11.10e)
Authority Checks (21 CFR 11.10g)
Electronic Signatures (21 CFR 11, Subpart B)

Does anyone have experience with implementing this and preferred company. If so, how does one go about validating the add-on features - do the companies that offer this feature also claim they have validated the functionality?

I apologize up-front if I have asked this question to the wrong forum. Thanks so much for considering my question.
 
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N

njhoost

#2
With respect to the validating functionality, that is solely incumbent upon you and your organization. At least as far as the FDA is concerned. You need to kick the tires, try and break it, etc. Assuming this software company might even give you the validation testing&results you generally could only use that as a road map or aid in your Validating activities.

Unfortunately I find that the lengths you need to go to learn their macros and the ins and outs of them you become somewhat proficient enough to make most of them on your own.

Which, while is more work, it would be more comforting in the whole cGMP realm of things (You make the specs/deliverable, inputs/outputs, V&V etc.) as you have complete control and tracebility & ownership of the product (or the respective add-ons). Ultimately making your QMS just a little bit deeper and stronger.

Plus if Office 2012 comes out you won't be tapped by the vendor for the new update as you should conceivably be able to make your own.

This is the path I have taken. I am a functioning macro illiterate, however Office 2010 is the enabler and has thus far made the writing/recording of macros fairly straightforward. Not easy mind you, just straight forward. But the bonus is it makes all of the supporting documentation,V&V, approvals etc. for the software easy to produce as you are the process creator/owner and makes one more area of your QMS more robust, flexible & supported.
 
#3
Hello,
I am brand spankin new to the Cove!

I was hoping someone could help with 3rd parties that offer part 11 add-on functionality for Microsoft Excel spreadsheets. There appear to be several companies that offer this solution.

Limiting System Access (21 CFR 11.10d)
Program Time-Outs (21 CFR 11.10d)
Audit Trails (21 CFR 11.10e)
Authority Checks (21 CFR 11.10g)
Electronic Signatures (21 CFR 11, Subpart B)

Does anyone have experience with implementing this and preferred company. If so, how does one go about validating the add-on features - do the companies that offer this feature also claim they have validated the functionality?

I apologize up-front if I have asked this question to the wrong forum. Thanks so much for considering my question.

Personally, I wouldn't touch those companies.

My advice is to look to validating your in house system using the Excel add-ons rather than attempting to validate any software.

I hope that helps.
 
A

Al Dyer

#4
The decision has already been made to use Excel. Whether practical or not MS makes upgrades to Excel and offers the required packages that integrate with the package, not "might" integrate. Remember, make life easier, not harder. (Even though it might cost a bit more):)

Al...
 
N

njhoost

#5
Hi Al,

I was taking about a 3rd party vendor who might be providing the add-ons. In turn with new MS Office's they (3rd party add-on vendor) will want to supply you (for a fee) the most current revision/supported product level. We have this issue with a software program we use that is is built of MS Access. And between XP/Vista/7 and Office 03/07/10, they (This 3Party Software vendor [Not MS]) has constantly had their hand out for additional money with each configuration change.
 
L

lightbug

#6
Thanks for the response(s). There is never really a simple answer in life, is there. At least this info helps me feel better educated. I will delve into this further. Thanks again - still can't believe I got a response! :)
 
#7
2 Years later what was your experience? I have been tasked with this responsibility in my company. I too am looking at 3d party add ons and trying to find which is the best financially for our needs. I have heard about "DACS" but don't know about the cost. Anyone else have current information on excel calculation validation?
 
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