Audits / Software (Vantage 6.1) Validation

Yahoo Archive
1
We are in the same boat: Vantage 6.1, medical devices, ISO, public...
We've been live since Nov 04 and have been through several audits:
internal, SOX, FDA, etc. and no hits have come back to me so I think we
did ok. Our approach was the following:



1) Document all processes (who does what)

2) Risk analysis on processes (what could the user or system do
wrong)

3) Validation plan based on the risk analysis (prove that the
risks were mitigated)



We also turned on the changelog on all tables to track the changes (FDA
21CFR Part 11 regs) and included that in the risks and validation
testing. Since the paperwork was extensive, we've only installed one of
the updates (started on 519, updated 2 years later to 538 and are still
there).



Butch

________________________________

From: vantage@yahoogroups.com [mailto:vantage@yahoogroups.com] On Behalf
Of Zack Ready
Sent: Friday, April 10, 2009 10:32 AM
To: vantage@yahoogroups.com
Subject: [Vantage] Audits / Software (Vantage 6.1) Validation

Hello all,

My owner wants me to research software validation in relation to our
system (Vantage 6.1) and internal/external audits. We are a medical
device company and ISO/FDA certified, so guidelines are a bit more
strict than regular manufacturing companies. We are in the middle of a
complete 2009 internal audit and possibly an external one at the end of
the year. I'll paste what I submitted to Epicor below which might sum up
what we're looking for better. I was wondering if anyone here had any
experience in the past. I did some searching on here and all posts
mentioning validating didn't look that hopeful, but I figured I'd try.

call submitted to Epicor:
We are currently going through a company-wide audit for 2009. We (the
owner especially) want to know if Epicor offers any kind of service or
utility for software validation across the entire system besides just
plugging in data to the test database. Either system-wide or per each
major module (inventory, a/r, a/p, production, etc.). He would like some
sort of documentation available for when outside audits ask about our
system being reliable & validated. Thank you.

Thanks everyone.
-Z





[Non-text portions of this message have been removed]
2
Hello all,

My owner wants me to research software validation in relation to our system (Vantage 6.1) and internal/external audits. We are a medical device company and ISO/FDA certified, so guidelines are a bit more strict than regular manufacturing companies. We are in the middle of a complete 2009 internal audit and possibly an external one at the end of the year. I'll paste what I submitted to Epicor below which might sum up what we're looking for better. I was wondering if anyone here had any experience in the past. I did some searching on here and all posts mentioning validating didn't look that hopeful, but I figured I'd try.

call submitted to Epicor:
We are currently going through a company-wide audit for 2009. We (the owner especially) want to know if Epicor offers any kind of service or utility for software validation across the entire system besides just plugging in data to the test database. Either system-wide or per each major module (inventory, a/r, a/p, production, etc.). He would like some sort of documentation available for when outside audits ask about our system being reliable & validated. Thank you.

Thanks everyone.
-Z