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Corrective Action Request (CAR) Form Examples and Discussion

M

Mike S.

Happy to be Alive
Trusted Information Resource
#61
#61
Suneela,

I know almost nothing about Access, but I do know an auditor can't correctly ding you for using Access, Excel, Word, dBase, WordPerfect, or even paper for your system as long as it does the job for you. Does your system meet the ISO shalls? Does it do what your documentation says it will do? If yes, it is okay.
 
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J

Jimmy Olson

#62
#62
Suneela,

Mike is right. Whatever method you use is up to you , not the auditor. As long as it works, use it. We use both Excel and Access for various purposes and our auditor never even hinted at a problem with using one or the other.

By the way, welcome to The Cove :bigwave:
 
S

Suneela

#63
#63
Thanks.. my major concern was signitures, all our old forms
contained a section for a signiture(s), and ACCESS only allows for
user ids .....Ok I'm not that freaked out anymore..you know how
ISO auditors can be!
 
M

M Greenaway

#64
#64
Suneela

I too discovered the wonders of Access about 4 years ago, and set about creating databases for all sorts. Never been pinged yet !!

Access has full blown security features, and you can create some smart reasonably robust security without going down the route of creating user groups - just make sure no one knows the secret of the F11 key !!

I have buttons on forms for 'authorisation' fields that pull in the user name if their security pass allows (via macros). The fileds themselves are locked data so cannot be changed by typing.

I think so long as you can demonstrate that the security system is reasonably robust (i.e. passworded) you should be OK - bear in mind that we are not creating bank notes here, and even a signature can be scanned and copied these days !
 
G

Greg B

#65
#65
My Database

Joe,

My database has mulitple tables (78). It has everything from lists of Revisions, Audits, Schedules and Document registers. Half of the tables are sub tables for drop down boxes etc. It will be cleaned out over the coming monmths as we get everything back to basics.

Greg B
 
H

hlozano - 2005

#66
#66
Al
I´ll like to your CA/PA word format.
e-mail removed


Thanks

Herb
 
Last edited by a moderator:
A

Aaron Lupo

#68
#68
Originally posted by M Greenaway
Suneela

I too discovered the wonders of Access about 4 years ago, and set about creating databases for all sorts. Never been pinged yet !!

Access has full blown security features, and you can create some smart reasonably robust security without going down the route of creating user groups - just make sure no one knows the secret of the F11 key !!

I have buttons on forms for 'authorisation' fields that pull in the user name if their security pass allows (via macros). The fileds themselves are locked data so cannot be changed by typing.

I think so long as you can demonstrate that the security system is reasonably robust (i.e. passworded) you should be OK - bear in mind that we are not creating bank notes here, and even a signature can be scanned and copied these days !
Click to expand...
Be careful MG, if you are in a FDA Regulated Industry you need to be aware of the Electronic Records Requirements 21CF11, not as easy to get around.
 
Claes Gefvenberg

Claes Gefvenberg

Admin
#69
#69
Originally posted by Suneela
---X---Does anyone know if inhouse developed ACCESS based
programs used to maintain CA/PA and performance measures will
cause problems with ISO auditors?

I recently discovered the wonders of ACCESS and have been
going crazy creating databases to manage the entire quality
system...I just want to be sure that I won't be slammed by the auditors.

Thanks,
Suneela.
Click to expand...
Hello Suneela, and welcome to the Cove. :bigwave:

Not to worry... I have done exactly what you are describing: I have all sorts of database applications running. Among them is one that's been handling our entire Internal audit system since 1997 (with data from as far back as 1990). It's been more or less constantly upgraded since then. The external auditors have always loved it...

The trick is to point to the applications from the proper written procedures (in this case the IA procedure). If instructions are included in the application, the written procedure can be mercifully brief.

/Claes
 
A

Andrei Viorel - 2009

#70
#70
Hello Suenela,

I decided to build an Access application to cover not only ISO requirements, but Problem solving too.
Few days ago I had the document system audit, and the auditor agreed with this application.
In order to cover traceability needs, (information, acceptance, responsibilities, status), database can keep e-mail messages.
The application it is sustained by documents and forms.

vio
 
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