Hi all, I have a question on the IQ. Is it common practice to accept a vendor as the person performing the official IQ at the customer environment for a LIMS...
19470
Bill Stimson
bstimson@...
May 27, 2009 6:55 pm
Try using just http://www.bioprocessintl.com . You may have to register, but the basic registration is free. Once you register, a link to this article...
19469
V.S. Venturella
maiui5
May 27, 2009 3:05 pm
Siegfried: Is there another link? The one you gave http://www.bioprocessintl.com/popups/articles.asp?id=50120093 doesn't go there. Vince ... From: Schmitt,...
19468
Mike Emeigh
mwemeigh
May 27, 2009 1:58 pm
Graham Tinsley wrote: (snip) ... Exactly. Before rushing out and investing money in ANY tool, you need to ask yourself why you would do it and what you hope to...
19467
Graham Tinsley
graham_tinsl...
May 27, 2009 1:06 pm
This question comes up a lot on this forum, and I always dance around a little in a detailed response, mainly because we have a software product that does this...
19466
Schmitt, Siegfried
parexel
May 27, 2009 11:26 am
In the May 2009 edition of BioProcess International <http://geo.yahoo.com/serv?s=97359714/grpId=517152/grpspId=1705083206/ms ...
19465
validation_slave
validation_s...
May 27, 2009 11:26 am
I heard FDA certifies embedded medical device software for compliance, but NOT for 21 CFR Part11....
19464
validation_slave
validation_s...
May 27, 2009 11:25 am
Anyone has experience in using automated testing tools for validation? I understand testing tools are designed for testing requirements not for validation. If...
19463
Tom Mizukami
tom_mizukami
May 26, 2009 8:21 pm
Hi, I'm looking for leads on a good part 11 compliance auditor. SOPs, chage control, individual systems (ERP, LIMS, etc.). Maybe someone with an ex-FDA ...
19462
Jim Validation
jimvalidation
May 26, 2009 1:58 pm
One must be careful to make sure the time is being spend doing VALUABLE risk assessment. If you are creating tons of documentation stating that there is...
19461
gmp_dude
May 26, 2009 11:25 am
Since we are now in a risk-based world, I believe there is a middle ground on this issue. For example, if I have a test script with the objective to verify an...
19460
Naude, Mark
mnptl
May 26, 2009 11:24 am
Often more than that. A single test step may require generation of multiple screenshots as well as a report to be compared against the screen shots. Mark ...
19459
Cinzia
lu_ciz2003
May 26, 2009 11:23 am
Are you referring to the electronic signature certification? That is the only certification I am aware of under Part 11. ciao! ...
19458
Orlando Lopez
olopez6102
May 21, 2009 12:39 pm
Saludos Shawn, The FDA does not certify any software as compliant with Part11. Then, your clients should not be asking such certification. Any...
19457
Graham Tinsley
graham_tinsl...
May 20, 2009 8:04 pm
...and yet Doctors, Lawyers and Engineers can all gain professional status such that their signature / stamp can be applied to certify their actions subject to...
19456
Greg Ventura
gwventura
May 20, 2009 8:03 pm
If I understand your terms script and test case correctly, then my answer is yes. So you understand where I am coming from, a test case tests one feature of...
19455
Carl Dourambeis
qalims
May 20, 2009 7:32 pm
Greg, you take screens shot of every single test script? i.e. 50 scripts in a test case means 50 screen captures? ... [Non-text portions of this message have...
19454
Mike Emeigh
mwemeigh
May 20, 2009 7:32 pm
... Nor can there be such a thing, in my opinion - simply because what it takes to validate a system depends on the context in which it is used, and the body...
19453
Jim Validation
jimvalidation
May 20, 2009 7:31 pm
I would be careful to say screen shot. Many steps would consist of numerous screen shots to show the evidence. Lets say your test is to verify the output...
19452
Jim Validation
jimvalidation
May 20, 2009 5:12 pm
I agree Graham. I have worked for a handful of companies and they all have a different definition/responisbility set. Plus the reporting structure is always...
19451
Greg Ventura
gwventura
May 20, 2009 5:12 pm
I would think writing out the results AND taking a screen shot to be redundant. What happens when they are not in sync? Why not just go with the screen shot? A...
19450
Graham Tinsley
graham_tinsl...
May 20, 2009 1:10 pm
It would be a good example, except there is no universally agreed definition of a "validation specialist". As a Professional Engineer, I can afix my official...
19449
Carl Dourambeis
qalims
May 20, 2009 12:54 pm
Good Testing Practice - Write out the actual results (include an area in the scriipt for this) and take screen shots where appropriate. Use blue or black ink...
19448
Jim Validation
jimvalidation
May 20, 2009 12:54 pm
This is an example of where a validation specialist comes in. If you have an independent validation person testing the system they are providing an unbiased...
19447
Greg Mendizabal
mendi
May 19, 2009 7:45 pm
On the other hand, simply parroting "Expected Results" doesn't prove anything either. Screen shots (or whatever) are best proof (except when people think...
19446
Finner, Doug
mrdfin47
May 19, 2009 6:19 pm
'What does it mean'...per the biggest computer ever...the answer is 42... I think what's being described would be a test protocol that says 'Do x and you...
19445
Graham Tinsley
graham_tinsl...
May 19, 2009 1:42 pm
What does it mean? ... -- Graham Tinsley Director, Business Relations THINQ Compliance Ltd. +1 613 246 3601 +44 7843 602093 [Non-text portions of this message...
19444
Finner, Doug
mrdfin47
May 19, 2009 12:53 pm
Anything to do with government regulation is a growth industry; once a law/reg is written, it's rare that it is rescinded. Every year - more regs - more work...
19443
Pat
mfsprague
May 19, 2009 12:53 pm
Is there any authoritative cite/reference for the usage (or rather, non-usage) of the term "As Expected" when documenting Actual Results?...
19442
Hanson, Mark
vanalan04
May 18, 2009 4:00 pm
A high level response. This sounds like a business analyst type of position. Within this, working for your organization or as a consultant for another...
