Question about referencing software - Database Records

K

kmyers

#1
If as a company we have an all encompassing program which is essentially a dbase. But we create our CAPA's from this my question is how do I make these controlled? We can block anyone we want from getting into any area of the program so essentially it is controlled in that regard but I cannot put Doc. Id's or Rev's on these docs. The program is E2 by the way.

I know I tend to over complicate at times so please slap me and bring me out of my current idiocy.:bonk:
 
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Z

zancky

#2
Re: Question about referencing software

if You need to assure the doc is under control with id etc but You can not modify the actual program my suggestion is:

write a document in which You declare:

"We as Quality Manger XXXX approve the use of the software (name of the software) at rev (rev of the software) released on (date) as part of our Quality registration form.
We as (funcntion) have reviewed the software (name of the software) at rev (rev of the software) released on (date) and found compliance to our Quality System requirements
etc.
Attached standard template from the software (name of the software) at rev (rev of the software) released on (date)"

just a :2cents: idea
 
K

kmyers

#4
Re: Question about referencing software

Thanks Zancky:agree1:

Andy The question is how can I show the CAR's are controlled documents when I do not have the ability to give it a ID, with Rev and approval. I need to know how to satisfy my auditor regarding this.
 

Stijloor

Staff member
Super Moderator
#5
Re: Question about referencing software

Thanks Zancky:agree1:

Andy The question is how can I show the CAR's are controlled documents when I do not have the ability to give it a ID, with Rev and approval. I need to know how to satisfy my auditor regarding this.
When you file a CAR in the database it has an identifier (number/letter/date/time, whatever..) that uniquely identifies the CAR. Access to the database (no pun intended) is limited by appropriate and applicable database controls and privileges. Voila! That's your control. Don't make it more complex then necessary.... Easy and user-friendly is the word.

Stijloor.
 
#6
Re: Question about referencing software

Thanks Zancky:agree1:

Andy The question is how can I show the CAR's are controlled documents when I do not have the ability to give it a ID, with Rev and approval. I need to know how to satisfy my auditor regarding this.
Well, it's not so much a case of having ID, revs and approval as it is the design of this software and its approval. Since (I'm guessing here) most people don't have access to the software code of the databse, then it's not like it's going to be changed (without approval), someone 'approved' the database for use (do you have anything to show that, after some kind of trial etc.) and the document numbering thing is hokey (IMHO) for most situations - because who's going to confuse this 'form' with any other? It is what it is, after all!

Are you concerned about being asked a 'document control' auditor question, in respect to this database? If so, tell them "go look at something important and don't waste my time........":notme:
 
K

kmyers

#7
Andy,:thanx:

I like you morre and more as I read your replies. I spoke with my auditor company and they said as long as there is limited access and I have the rev. and version of the software then it is not an issue.

Kris
 

Caster

An Early Cover
Trusted Information Resource
#10
I spoke with my auditor company and they said as long as there is limited access and I have the rev. and version of the software then it is not an issue.Kris
Kris - you have a very rare commodity, auditors with good sense! Lucky you!
 
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