Graham I agree and disagree. <Agree> Conceptually, it's as simple as you describe. <Disagree> In practice, it's not so simple. These are complex systems that...
Steve Contact Oracle and ask them for help. Make sure you ask for someone proficient in the Life Sciences part of the business. If you have trouble hooking...
I am looking for some basic benchmarks for validation for software development. For example, does an industry standard exist that stipulates the average...
I hate this answer but it's kind of true: It depends. Simple applications or complex app? An app that is twice as complicated as some other app won't take...
All, I was thumbing through a trade magazine (GEN) and noticed an ad for the Biacore systems from GE. The ad shows pictures of 2 products (equipment) and have...
thx, If you are doing a bespoke-code project, start with Barry Boehm's "Software Engineering Economics" and the follow-on, "Software Cost Estimation with...
It is not unusual to find such statements, mostly concocted by some marketing department. Only a few years ago a well-known software provider stated in writing...
Well GE can certify their own products all they want. Hey, I suppose if they can do it, then my company should do it too. The question would be can we all...
I was at an ISPE GAMP 5 meeting on March 4th & 5th. Several speakers spoke of leveraging vendor documentation espcially at the Unit Test and Integration...
I disagree with your statement "Compliant" implies able to be validated. If my boss comes up to me and asks if system X is compliant and I say yes, he/she will...
Jim I agree with your statement aabout other work to be done such as SOP's and processes for Change Control, Backup and Restore etc. I wonder what word you...
Agree. Unfortunately it is the end user of said software that will be inspected/audited etc so the responsibility USUALLY lies there. Even if a software...
Craig Williams
csvalidationltd@...
Mar 19, 2009 1:33 pm
19198
Charlatan - one making usually showy pretenses to knowledge or ability Compliable - flexible and moldable solution easily made compliant Your turn.. _____ ...
From the original poster, this was seen in an ad in a trade magazine. The ad only stated that the software was compliant to 21§11. IMHO there is nothing...
Dux, Tom
tdux@...
Mar 19, 2009 1:34 pm
19200
John A vendor can design a system in such a way that it can be installed and operated in a compliant manner by a regulated healthcare company. The catchphrase...
Siegfried, Agreed. "Designed for Compliance" is probably a better way for a vendor to portray itself. John ________________________________ From: "Schmitt,...
Hello, I'd have a question about electronic records. On a manufacturing equipment, I have regulatory records (ie Time, temp, threshold, ...required by GMPs)...
Yann, These records sound pretty much like Master Production and Control Records, and Batch Production and Control Records, respectively. Therefore, by the...
I am looking for an answer regarding an old precept, that a document is not signed by Quality until all other signatures have been affixed. IMO Quality cannot...
Thomas: I know that if the electronic records were the main production records, Part 11 would certainly apply. However, In Yann's case, he stated that the...
I always thought that if you used a system to generate a printed report, you needed to keep sufficient raw data to be able to re-generate that report at the...
Thank you very much, Thomas and Brad for your answer, but my main question is about Production "parameters" stored in equipment receipes. Are those receipes...
Yann, I'd have to get a closer look at your process control network topology, but I would probably still recommend some kind of e-sig process around process...
When we say a document which has electronic signature, can any one tell what kind of documents with some simple examples. If a Pharma company is developing a...
Dear Yann In my opinion the recipe is not a record. Configuration parameters however are records; their purpose can be likened to metadata. Regards Siegfried ...
I think it depends on how you define it. Here's an excerpt from "Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and...
The seminars I've been to in the last few years ask 'do you rely on the electronic record even if you create a paper record?'. If you USE the electronic...
Brad, In the past, US FDA has said, from the podium, that the electronic records, if they existed, would be considered the "official copy," but in the last few...
Hi All! If anyone has experience with virtual machines, please contact me directly. An IQ is performed on the IBM ESX Computer. Another IQ is created for the...
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