I don't know of any that could prepare them for a job interview. There are many books out there. Do a search on Amazon.com and then taket that information and...
To bring to thought a couple of ideas regarding the purchase of a validation suite from the vendor that sells/develops the application. Please be aware that ...
Hello, Is necessary to validate the software that compile the temperatures of the reactors and make graphics, if the supervisor don't take decision with the...
Dave, If the information is only informative, what is the information used for? Let's assume the software provides summary information. Will no one make a ...
The question to ask is, "If this software were taken away, would production change at all? Does anyone use this software which compiles measurements to make a...
Hi, David! You are using the software to recording data, so, not matter if you take decisions on data recorded or not, you are using the software as data ...
Mauro Scasso
mauro.scasso@...
Jan 4, 2006 7:14 pm
14816
Hi Your question is incomplete I guess. Can you be more elaborative. What type of reactors are you talking about ? What do you mean by graphics ? Do you mean...
There is a reason for measuring the temperature. It may be either for controlling the reaction (quality) or to avoid overheating (safety). In the case of...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Jan 5, 2006 3:39 pm
14818
The general concept of validation still applies to software validation. I would determine if the software's job is associated with any specific process that...
Greetings all, I volunteer for an ambulance corps in NJ where we keep track of our calls using a home grown database program. I was wondering if the volunteer...
21 CFR Part 11 regulates the pharmaceutical industry, not ambulances. HIPAA is another matter. You might have to secure your database for that regulation. Greg...
If you are printing the data at the same tame they are collected, is not it enough to calibrate the thermometer? Patricia ... De: 21cfrpart11@yahoogroups.com...
Patricia Vila
patricia.vila@...
Jan 9, 2006 1:28 pm
14822
I'm an EMT-B in Massachusetts. I've never seen a provider record system that mentioned being compliant to part 11. Your compliance should follow state and...
Health Care Providers, including EMTs and ambulance services, are required to follow the HIPAA privacy regulations promulgated by HHS for Individually...
do medical records have to be compliant with 21cfrpart11? J.ose ... Yahoo! Photos Ring in the New Year with Photo Calendars. Add photos, events, holidays,...
Hi folks, have a question for this distinguished forum. If you have an equipment, developed in house and connects to a Data Acquisition System which is an off...
Last year I posted to this group (and a few others) for help with my Masters Dissertation in Computing. Due to work and family, I had to postpone submission...
21 CFR Part 11 deals with pharmaceutical and medical device companies. If you mean a doctor's office records, then it is probably HIPPA. Are these records...
I'll throw out two cents. Two additional items to consider: GxP's may need to be considered in the equation. At least in the GLP world, entries and changes...
My opinion is that the overall system is as complex and critical as its most complex and critical component. You COULD conduct the validation in a different...
Hi An updated version of the Rule was meant to have been issued as a draft for comment last year. Has anyone got any information on when we are likely to see...
Sims, Fraser
fsims@...
Jan 13, 2006 4:27 pm
14833
Hi Juan, Want to provide more details? Regards, Sabbas J. D'Souza 647-883-5666 (¯`'·.¸..(¯`'·.¸ // ¸.·'´¯)..¸.·'´¯) From: "QCSV Inc."...
That's got to be a Category 5, no way could you justify any other approach. That's almost like trying to claim that an application written in VB or C++ is COTS...
has anyone validated OEM? This application can do so much, where do you start (and stop) validating. Any advise from someone that has been through it would...
Why would you need to validate OEM? That is a tool and as such is not subject to validation by itself. This is pretty similar to Excel; which as a program is...
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