Has anyone out there done any work on making an MS Access database 21 CFR Part 11 compliant? In particular we are looking at audit trail of field...
8187
Fellner, Karen
kfellner@...
Apr 1, 2003 9:41 pm
Hi Kim, We also are about to install and validate Oracle AERS. However, we're doing an upgrade from EventNet, which is the software Oracle purchased and ...
8188
Fellner, Karen
kfellner@...
Apr 1, 2003 9:41 pm
Hi Arthur, We have performed "equivalency checks" of this nature when installing oracle apps. We have used simple SQL statements to verify rows, tables, etc....
8189
Kathryn Manchester
buggsy401
Apr 1, 2003 9:41 pm
I agree...but there are a number of years before I am required to re-certify. I think my point was we should be looking more for these programs for...
8190
robert trask
trask@...
Apr 1, 2003 9:42 pm
Well, there is the 'Registered Engineer' approach. Although not specific to the Pharm industry, we are bound by law to only practice in areas we are...
8191
Larry Schneller
lschneller_y2k
Apr 1, 2003 9:49 pm
The official GMP record is the paper reocord. Right on. ... ===== Larry Schneller Test Project Manager __________________________________________________ Do...
8192
Angela vogell
seaselkys
Apr 1, 2003 9:49 pm
I have a dilemma, since the new 'draft guidance' document the owners of the lab I work for are now under the impression that Risk Assessment/GAP Analysis is...
8193
Michael Kinder
michaelkinde...
Apr 2, 2003 2:54 pm
Bob, I am interested to more about how you are bound by law. This would require a state by state law, would it not? Also, what is the process by which a...
8194
Robert Beck
robertjbeckmn
Apr 2, 2003 2:54 pm
I've a lot of that for the audit trail. I usually deal with passwords administratively, through SOPs and scheduled changes rather than software, but include...
8195
Michael Kinder
michaelkinde...
Apr 2, 2003 2:54 pm
Angela, How in the world did they read the Scope & App guidance and conclude Risk Assessment is no longer needed. It was a direct result of FDAs effort ...
8196
Torsten Richter
torstenri
Apr 2, 2003 2:55 pm
Dear Christiaan, it's difficult to meet all requirements of GMP and Part 11, with an Microsoft Access Database. This database system is not recommended for...
8197
Kathryn Manchester
buggsy401
Apr 2, 2003 2:57 pm
Angela, I find it sad to see this type of attitude. It is a 'lets do the least amount possible to get through' attitude. You are right on with how you feel. ...
8198
inweinberg@...
Apr 2, 2003 9:17 pm
Hi guys Anybody know a Corrective and Preventive Action (CAPA) software module that is Linux-based? --Irving Weinberg PEM Technologies [Non-text portions of...
8199
millbiker
Apr 2, 2003 9:17 pm
Yes, risk assesment/gap analysis remains very important. The new Part 11 guidance appears to let you define the scope/definitions on how you're going to...
8200
docontrol2003
Apr 2, 2003 9:18 pm
Thanks to several of you for taking the time to respond to a rather vague (Oracle AERS) question on my part. I am pleased to see that several of you have had...
8201
nlkotter
Apr 2, 2003 9:18 pm
... From the National Society of Professional Engineers(www.nspe.org): Like doctors who have passed the medical boards or lawyers who have passed the bar exam,...
8202
gbutler@...
Apr 2, 2003 9:19 pm
It can be done, with a lot of custom work. Then again, you need to extend Oracle to get it to meet all of Part 11 as well. As I see it, it's a matter of how...
8203
UCM.G
ucm.g@...
Apr 2, 2003 9:19 pm
Hi Michael, training and education is one - essential - part of Part 11: Everybody involved in cGxP processes must be educated and trained in adequate manner. ...
8204
Rosendale, Don
don.rosendale@...
Apr 3, 2003 2:23 pm
I have to agree with Peter on certification of validation technicians. Certifying a person to be competent in "validation" per-se cannot be done over the full...
8205
nguyenn@...
Apr 3, 2003 2:23 pm
George, Now you get me more curious. Thank you for all the information. Would you please educate me more on how SQL server can protect the security? Thank...
8206
Bob McDowall
r_d_mcdowall@...
Apr 3, 2003 5:27 pm
Hi Kim In response to your e-mail, here's my take on your questions. 1. You mentioned that you did an FMEA risk analysis. Can you tell me what this is?...
8207
Graham Tinsley
Graham_Tinsley@...
Apr 3, 2003 5:28 pm
<<Certifying a person to be competent in "validation" per-se cannot be done over the full range of validation expertise, that much is a given.>> I can tell you...
8208
gbutler@...
Apr 3, 2003 5:28 pm
I'm not an expert in SQL Server, so hopefully others who are can comment with better details. Here's how I see the issue: 1. Security is much stronger with...
8209
robert trask
trask@...
Apr 3, 2003 5:29 pm
And even beyond what Nancy looked from the NSPE site - from the North Carolina Engineering and Land Surveying Act: "The licensee shall perform services only...
8210
Robert Beck
robertjbeckmn
Apr 4, 2003 3:32 pm
Access always gets a bad rap, especially from SQL Server and Oracle advocates. All of issues raised in George Butler's email can be dealt with. For instance:...
8211
Graham Tinsley
Graham_Tinsley@...
Apr 4, 2003 3:32 pm
I for one am not necessarily looking for *another* certification process provided that certain provisions become acceptable: 1. If the "validation" profession...
8212
Kathryn Manchester
buggsy401
Apr 4, 2003 3:32 pm
You can certify a person to be qualified in the principles of validation (body of knowledge). You can certify an auditor...and there is just as much depth of...
8213
eruff1
Apr 4, 2003 3:32 pm
Refer to USP General Notices--Significant Figures and Tolerances. ... THERE ARE LOTS OF USP PROCEDURES, ... ORANGE ... measurements, and ... round up ... you ...
8214
support@...
steve_mossuk
Apr 4, 2003 3:32 pm
"SQL Server" is a generic term not just Microsoft SQL Server. There are many different SQL servers. Some are "free" such as PostgreSQL others cost nothing...
8215
Luksander, Judith
luxi1968
Apr 4, 2003 3:33 pm
Morning All, We are looking at the MVI System 3 training software, but have a hard time to figure out how it hooks up to the SOP database. Could someone who...
