Post your question on SAPFANS.com. I find the best results for getting answers to SAP related questions there. Bill Murali Iyer <muralig2000@...> wrote:...
Hello to everyone on board. Not long ago, we started a project to implement Trackwise in my company, URL/Mutual Pharmaceuticals Inc. at Philly. I read all...
Hi All, I've been tasked to develop a process of conducting User Acceptance Test for a software application - transactional database for adverse event...
Hi, I have a question concerning Audit trails in CFR21. Should the user be allowed to export/import his acquired data to a plain text file? What happens with...
Wijy, It all comes down to the evidence you have for the testing. Provided you take screen shots where you can, I see no issue with writing As expected (And...
Great example, let me take it a little further using TW. The car I'm buying happens to be an ambulance and your life depends on the ambulance getting to the...
Does anyone know the requirements for record keeping for an IRB? Currently we keep all paper files, and would like to PDF some of these...we're running out of...
Hi Jay, Thank you for your response. Wijy jay07059 <jay07059@...> wrote: Wijy, It all comes down to the evidence you have for the testing. Provided you...
So import/export should be completely removed OR if the user imports/exports his username should be added to the audit trail with the import/export date/time...
It is not a question of Import/Export being allowed in 21 CFR Part 11. Yes you can do import and export. The question is what controls are in place? Once data...
Hi, Please give me the difference between SQL*LIMS and Labware LIMS Thanks __________________________________ Yahoo! Mail - PC Magazine Editors' Choice 2005 ...
John, The audit trail requirements are that whenever a change (addition, deletion, or modification) is made to a file of data subject to 21cfr requirements,...
Please don't confuse export/import with archive/restore. I see exporting as copying data from the system to be reviewed/inspected elsewhere. Archiving is...
Just an FYI, Please don't confuse Export with Archiving. Exporting may not be removing the data from the system, archiving definitely is. A system like...
I've been fighting over a lot of conflicting interpretations of this guideline and I'm hoping this board will help me reach a final understanding. At the most...
Lisa I suggest that you look at the predicate rule for IRBs (21 CFR 56) this will deline what your record requirements are and how long you should keep them....
Bob McDowall
r_d_mcdowall@...
Oct 5, 2005 6:53 pm
14367
Why unnamed? The FDA does work for the public right? I called George Smith with CDER, who is listed as their computer val/eres contact. (Really nice guy by the...
This is what risk assessment is for. I would figure that most likely culprit for changing data that they are not supposed to is a disgruntled employee. I don't...
It's easy. If the record has been altered or is invalid in any way, the system needs to detect it. The person who bypasses controls in order to change...
John (Leonard), Thank you for the kind words, but I have to be a bit of an ogre, here. (If I don't, and Greg V. beats me to the punch line, I'll never live it...
Only real digital signatures (not electronic signatures) can assure you whether your record has been changed or not. And if you are paranoid, you should also...
Dear All I am exploring different approaches to reporting Requirements Traceability, both through the use of electronic tools, e.g DOORS, Serena RTM, and...
When you say 'wordy' does that mean that the document does not follow an outline or if it does, you think it should be more detailed? Greg Ventura ... From:...
Instead of keeping backup of PLC/HMI programs on CD's we have moved to a server based solution, wherein the program files are saved on the server. It allows us...
I am really confused by your questions. I don't understand what you are asking or what the context is. Are you talking specifically about the SAP database...
Does anyone know whether it is necessary to be able to print a summary of an electronic record/signature? I am envisioning being able to print the user name,...
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