Hi Doug, Nothing like patching to expose the soft underbelly of computer system validation. If we had any visibility into the build or operating state, then we...
Ted, For some, verification is the demonstration that a validated system performs as validated. Stan Alekman Let charm be thy spear, wit thine armor. In a...
STANLEY110@...
Feb 2, 2009 2:53 am
19080
The major disagreement is whether the initial login can constitute first signing, therefore being the only time the userid is required for entry (there was a...
re: "continuous evolutionary software development" not being the best way to meet the needs of a business in Life Sciences. My experience is that the business...
Ted, I cannot subscribe fully to "re-validation as significant amounts of changes are applied - not necessarily for each change." Key to GxP systems is...
I wish I had an answer. We are adding better reporting and trending capability to our software to build information on costs and risks associated with...
I think oftentimes you have to use the evolutionary approach in order to get things moving. You may not be able to, as Greg points out, accomplish everything...
I look at it like this: Verification - does the single entity (module, procedure) work (e.g. unit/integration testing) Qualification - does the system meet...
The normal practice is for the user to re-enter their credentials whenever a signature is required. If you use most commercial packages that support electronic...
Stanley110 Toally off-topic. Feel free to respond out-of-band. ... Are you a re-enactor? You'd be amazed at how many of our little community are.... At Your...
Phillip, We have assisted with the design of several e-sig systems where "waving the badge" brought up the UserID and the person's full name, and the user then...
Datasets received from a vendor are often zipped, when you extract the files to include in an FDA delivery the file creation date changes to the current date....
Off the top, I personally do not as long as the date/time stamp on the records collected is not changed. The zip-file is nothing more than a vehicle for the...
Tom, I am laughing so hard right now that tears are running down my cheeks...thanks for the post! Seriously, thank you for your response. I'm glad to know...
Tom, I just did a bit of poking around in my library and ran into an interesting discussion in one of my books. "The Computer System Risk Management and...
The preamble to 21 CFR Part 11 indicates that they believe the login is the first signing. Now I understand that many probably disagree with this. I just bring...
Where is Orlando when you need him! Biometric ID is the way to go. Until you have that, the agency requires a unique UserID and password. The UserID is...
I need a clarification on your understanding of when electronic data becomes raw data (or must be considered raw data). We have several digital imaging...
I do not believe that logging in to a computer application is in fact signing anything because there is typically no reason to apply a true signature. That...
I am reminded of the last time I refinanced my mortgage. There were tons of papers to sign. Fortunately there were also several forms that I only had to...
Hello all. Our company (software manufacturer) is working on complete requirements/testing documentation for validation purposes, but we also want to cut down...
Logging in to a computer cannot constitute a signature as there is no electronic record that is required by the GMPs that is being signed during that process. ...
Ted, I agree with your QA group's take on matters. Here is my rationale... We are talking data with electronic origins. Once the raw data is printed and the...
While I applaud the use of automation in testing, my experience and research has shown it to be a double-edged sword... people tend to overestimate its scope...
I agree with your comments with respect to script based testing, however there are many levels of automation. Our software allows a gradual approach up to...
By definition, a GMP record is not required to have an electronic signature. For example, if you have an affadavit on login that you certify you are an...
Rod You are right, I should have put in the proviso that I am only referring to e-sigs as described in 21 CFR Part 11. There has to be a GMP record for Part 11...
Seigfied, I agree. I can't find any GxP predicate rule that requires logon to be a 21CFR11-compliant electronic signature, either. However, (Isn't there ALWAYS...
I appreciate the insight Graham. Yes, your comment regarding screen prints is very apt. The achievement of paperless testing, and the associated efficiencies...
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