Software Validation for Vantage 8

We have discussed curtailing SP and patch deployments but currently there are outstanding bugs (we have eleven) that need to be corrected. Once all of these SCRs are addressed and no new ones develop, we will revisit that option. Also we are very eager to employ the kitting capabilities of 803 so we will no doubt be installing that and be prepared for a new batch of bugs to work out. Our quality sytem right now works very well and because we specialize in a specific area of sports medicine, we are not overburdened with excessive paper. We will validate Vantage but probably not for a least a year.

I am attending perspectives with three of my coworkers although I'm the only techy, the others are just users. I also have a contact for someone from Synovis and I will find out if they are atending and see if I can touch base with them while we are there.

________________________________

From: vantage@yahoogroups.com on behalf of Joe Rojas
Sent: Fri 9/1/2006 5:24 PM
To: vantage@yahoogroups.com
Subject: RE: [Vantage] Software Validation for Vantage 8



Hi Gerard!
I remember you from the Road Show! I was sitting in the back row.
I am disappointed to here that there has not been a medical device user group yet.

Thanks for the information on your validation experiences.
Have you guys thought about "sticking a stake in the ground" with regards to installing patches, do your validation, and then put a configuration management procedure in place so that you only apply the latest patch once a year or twice a year?

I am trying very hard to get the funding for Perspectives....are you going?

Thanks,
Joe Rojas

________________________________

From: vantage@yahoogroups.com <mailto:vantage%40yahoogroups.com> on behalf of Gerard Wadman
Sent: Fri 9/1/2006 1:53 PM
To: vantage@yahoogroups.com <mailto:vantage%40yahoogroups.com>
Subject: RE: [Vantage] Software Validation for Vantage 8

Are you going to Perspectives, Joe?

________________________________

From: vantage@yahoogroups.com <mailto:vantage%40yahoogroups.com> <mailto:vantage%40yahoogroups.com> [mailto:vantage@yahoogroups.com <mailto:vantage%40yahoogroups.com> <mailto:vantage%40yahoogroups.com> ] On Behalf
Of Joe Rojas
Sent: Friday, September 01, 2006 10:13 AM
To: vantage@yahoogroups.com <mailto:vantage%40yahoogroups.com> <mailto:vantage%40yahoogroups.com>
Subject: [Vantage] Software Validation for Vantage 8

Hello,

Our current Epicor consultant has been telling us that we need to have a
Regulatory Plan in place to perform a software validation for Vantage.

We are an FDA regulated medical device company who manufactures Class 2
and Class 2b devices.

On our Go-Live date, we are looking to implement lot control in Vantage
for all our parts and will be replacing our paper lot control system
with Vantage.

As time goes on, we will be looking to replace other paper system with
Vantage.

Is there anyone on this list who had to do the same kind of Validation?
If so, would you be will to share your validation protocol or help point
us in the redirection to better understand what we have to do?

Any help would be appreciated!

Thanks,

Joe Rojas

IT Manager

TNCO, Inc.

781-447-6661 x7506

jrojas@... <mailto:jrojas%40tnco-inc.com> <mailto:jrojas%40tnco-inc.com> <mailto:jrojas%40tnco-inc.com>

[Non-text portions of this message have been removed]

[Non-text portions of this message have been removed]

[Non-text portions of this message have been removed]






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



Our current Epicor consultant has been telling us that we need to have a
Regulatory Plan in place to perform a software validation for Vantage.

We are an FDA regulated medical device company who manufactures Class 2
and Class 2b devices.

On our Go-Live date, we are looking to implement lot control in Vantage
for all our parts and will be replacing our paper lot control system
with Vantage.

As time goes on, we will be looking to replace other paper system with
Vantage.



Is there anyone on this list who had to do the same kind of Validation?
If so, would you be will to share your validation protocol or help point
us in the redirection to better understand what we have to do?

Any help would be appreciated!



Thanks,

Joe Rojas

IT Manager

TNCO, Inc.

781-447-6661 x7506

jrojas@...



[Non-text portions of this message have been removed]
We are also a medical device company, and decided to stay with our paper
system. We came to the conclusion that Vantage cannot be validated
because every patch release creates bugs which violate our validation
procedures resulting in the creation of numerous corrective actions
which FDA and ISO do not like to see.

Our paper process has already been validated and through two ISO audits.


We were initially told by the Epicor salesman that vantage meets FDA
requirements which turns out is not true.

They claim that Synovis has validated their Vantage V8 install but our
ISO auditor has advised us not to attempt to validate the system as it
is obvious that Epicor performs very poorly in the testing department
before releasing their patches.



When we were at the Boston road show, our CAM was there as well as some
sales execs from MN. We indicated that we would like to see a UG meeting
at perspectives for Medical device companies. They said they would
definitely accommodate that request, but so far we cannot find anything
on the agenda. Just another broken promise.



________________________________

From: vantage@yahoogroups.com [mailto:vantage@yahoogroups.com] On Behalf
Of Joe Rojas
Sent: Friday, September 01, 2006 10:13 AM
To: vantage@yahoogroups.com
Subject: [Vantage] Software Validation for Vantage 8



Hello,

Our current Epicor consultant has been telling us that we need to have a
Regulatory Plan in place to perform a software validation for Vantage.

We are an FDA regulated medical device company who manufactures Class 2
and Class 2b devices.

On our Go-Live date, we are looking to implement lot control in Vantage
for all our parts and will be replacing our paper lot control system
with Vantage.

As time goes on, we will be looking to replace other paper system with
Vantage.

Is there anyone on this list who had to do the same kind of Validation?
If so, would you be will to share your validation protocol or help point
us in the redirection to better understand what we have to do?

Any help would be appreciated!

Thanks,

Joe Rojas

IT Manager

TNCO, Inc.

781-447-6661 x7506

jrojas@... <mailto:jrojas%40tnco-inc.com>

[Non-text portions of this message have been removed]





[Non-text portions of this message have been removed]
Are you going to Perspectives, Joe?



________________________________

From: vantage@yahoogroups.com [mailto:vantage@yahoogroups.com] On Behalf
Of Joe Rojas
Sent: Friday, September 01, 2006 10:13 AM
To: vantage@yahoogroups.com
Subject: [Vantage] Software Validation for Vantage 8



Hello,

Our current Epicor consultant has been telling us that we need to have a
Regulatory Plan in place to perform a software validation for Vantage.

We are an FDA regulated medical device company who manufactures Class 2
and Class 2b devices.

On our Go-Live date, we are looking to implement lot control in Vantage
for all our parts and will be replacing our paper lot control system
with Vantage.

As time goes on, we will be looking to replace other paper system with
Vantage.

Is there anyone on this list who had to do the same kind of Validation?
If so, would you be will to share your validation protocol or help point
us in the redirection to better understand what we have to do?

Any help would be appreciated!

Thanks,

Joe Rojas

IT Manager

TNCO, Inc.

781-447-6661 x7506

jrojas@... <mailto:jrojas%40tnco-inc.com>

[Non-text portions of this message have been removed]





[Non-text portions of this message have been removed]
Hi Gerard!
I remember you from the Road Show! I was sitting in the back row.
I am disappointed to here that there has not been a medical device user group yet.

Thanks for the information on your validation experiences.
Have you guys thought about "sticking a stake in the ground" with regards to installing patches, do your validation, and then put a configuration management procedure in place so that you only apply the latest patch once a year or twice a year?

I am trying very hard to get the funding for Perspectives....are you going?

Thanks,
Joe Rojas

________________________________

From: vantage@yahoogroups.com on behalf of Gerard Wadman
Sent: Fri 9/1/2006 1:53 PM
To: vantage@yahoogroups.com
Subject: RE: [Vantage] Software Validation for Vantage 8



Are you going to Perspectives, Joe?

________________________________

From: vantage@yahoogroups.com <mailto:vantage%40yahoogroups.com> [mailto:vantage@yahoogroups.com <mailto:vantage%40yahoogroups.com> ] On Behalf
Of Joe Rojas
Sent: Friday, September 01, 2006 10:13 AM
To: vantage@yahoogroups.com <mailto:vantage%40yahoogroups.com>
Subject: [Vantage] Software Validation for Vantage 8

Hello,

Our current Epicor consultant has been telling us that we need to have a
Regulatory Plan in place to perform a software validation for Vantage.

We are an FDA regulated medical device company who manufactures Class 2
and Class 2b devices.

On our Go-Live date, we are looking to implement lot control in Vantage
for all our parts and will be replacing our paper lot control system
with Vantage.

As time goes on, we will be looking to replace other paper system with
Vantage.

Is there anyone on this list who had to do the same kind of Validation?
If so, would you be will to share your validation protocol or help point
us in the redirection to better understand what we have to do?

Any help would be appreciated!

Thanks,

Joe Rojas

IT Manager

TNCO, Inc.

781-447-6661 x7506

jrojas@... <mailto:jrojas%40tnco-inc.com> <mailto:jrojas%40tnco-inc.com>

[Non-text portions of this message have been removed]

[Non-text portions of this message have been removed]






[Non-text portions of this message have been removed]
We are also a medical device company and the stick has been stuck for
almost 2 years now (release 518). I am currently executing the
validation on release 538 where we will drive another stake until we
upgrade to version 8 probably middle of next year sometime. I agree it
is the easiest way to manage the paperwork.

Butch

________________________________

From: vantage@yahoogroups.com [mailto:vantage@yahoogroups.com] On Behalf
Of Joe Rojas
Sent: Friday, September 01, 2006 2:24 PM
To: vantage@yahoogroups.com
Subject: RE: [Vantage] Software Validation for Vantage 8



Hi Gerard!
I remember you from the Road Show! I was sitting in the back row.
I am disappointed to here that there has not been a medical device user
group yet.

Thanks for the information on your validation experiences.
Have you guys thought about "sticking a stake in the ground" with
regards to installing patches, do your validation, and then put a
configuration management procedure in place so that you only apply the
latest patch once a year or twice a year?

I am trying very hard to get the funding for Perspectives....are you
going?

Thanks,
Joe Rojas

________________________________

From: vantage@yahoogroups.com <mailto:vantage%40yahoogroups.com> on
behalf of Gerard Wadman
Sent: Fri 9/1/2006 1:53 PM
To: vantage@yahoogroups.com <mailto:vantage%40yahoogroups.com>
Subject: RE: [Vantage] Software Validation for Vantage 8

Are you going to Perspectives, Joe?

________________________________

From: vantage@yahoogroups.com <mailto:vantage%40yahoogroups.com>
<mailto:vantage%40yahoogroups.com> [mailto:vantage@yahoogroups.com
<mailto:vantage%40yahoogroups.com> <mailto:vantage%40yahoogroups.com> ]
On Behalf
Of Joe Rojas
Sent: Friday, September 01, 2006 10:13 AM
To: vantage@yahoogroups.com <mailto:vantage%40yahoogroups.com>
<mailto:vantage%40yahoogroups.com>
Subject: [Vantage] Software Validation for Vantage 8

Hello,

Our current Epicor consultant has been telling us that we need to have a
Regulatory Plan in place to perform a software validation for Vantage.

We are an FDA regulated medical device company who manufactures Class 2
and Class 2b devices.

On our Go-Live date, we are looking to implement lot control in Vantage
for all our parts and will be replacing our paper lot control system
with Vantage.

As time goes on, we will be looking to replace other paper system with
Vantage.

Is there anyone on this list who had to do the same kind of Validation?
If so, would you be will to share your validation protocol or help point
us in the redirection to better understand what we have to do?

Any help would be appreciated!

Thanks,

Joe Rojas

IT Manager

TNCO, Inc.

781-447-6661 x7506

jrojas@... <mailto:jrojas%40tnco-inc.com>
<mailto:jrojas%40tnco-inc.com> <mailto:jrojas%40tnco-inc.com>

[Non-text portions of this message have been removed]

[Non-text portions of this message have been removed]

[Non-text portions of this message have been removed]






[Non-text portions of this message have been removed]