FDA validations and 21 CFR

HI Sap Gurus,
can anybody please provide me some FD validation documents and 21 CFR documents. I have interview on that for SAP MM position. Points will be awarded for helpful replies with documents and a brief idea
Thanks
Anusha

Hello!
I helped implement a compliance with 21 CFR Part 11. We added a history table for each table that held clinical data. Each history table carried all the fields for that table, plus fields for who made the change to the record, when the change was made, why the change was made, the process id that made the change, and related information for our site. That way we had everything and could query it for any reporting we needed.
Thanks Cecil for you information but I am hoping someone has an idea as to how to implement. Our concern as you pointed out is what else changes during an update, for example what other tables besides the one being updated are being touched.
If the interface we are using has one screen that updates more than 1 table all we can do is to record the reason for the change that would represent all the table(s) change inclusively. Thanks for the input.
Michael

Similar Messages

FD validation and 21 CFR

HI Sap Gurus,
can anybody please provide me some FD validation documents and 21 CFR documents. I have interview on that for SAP MM position. Points will be awarded for helpful replies with documents and a brief idea
Thanks
Anusha

Hello!
I helped implement a compliance with 21 CFR Part 11. We added a history table for each table that held clinical data. Each history table carried all the fields for that table, plus fields for who made the change to the record, when the change was made, why the change was made, the process id that made the change, and related information for our site. That way we had everything and could query it for any reporting we needed.
Thanks Cecil for you information but I am hoping someone has an idea as to how to implement. Our concern as you pointed out is what else changes during an update, for example what other tables besides the one being updated are being touched.
If the interface we are using has one screen that updates more than 1 table all we can do is to record the reason for the change that would represent all the table(s) change inclusively. Thanks for the input.
Michael

Running Windows XP service pack 3. Updated Firefox from 8.0 to 9.0. Now when Firefox opens "The URL is not valid and cannot be loaded" is displayed in a window and no home page appears. What's wrong?

Running Windows XP service pack 3. Updated Firefox from 8.0 to 9.0. Now when Firefox opens "The URL is not valid and cannot be loaded" is displayed in a window and no home page appears. What's wrong?

That issue can be caused by an extension that isn't working properly.
Start Firefox in <u>[[Safe Mode]]</u> to check if one of the extensions or if hardware acceleration is causing the problem (switch to the DEFAULT theme: Firefox (Tools) > Add-ons > Appearance/Themes).
*Don't make any changes on the Safe mode start window.
*https://support.mozilla.com/kb/Safe+Mode
*https://support.mozilla.com/kb/Troubleshooting+extensions+and+themes

Why do i keep getting an Alert message saying "The URL is not valid and cannot be loaded "?

Why do i keep getting an Alert message saying "The URL is not valid and cannot be loaded "?
This happens a lot regardless of the web page. I continually have to restart FF and it persists still

Start Firefox in [[Safe Mode]] to check if one of the add-ons is causing the problem (switch to the DEFAULT theme: Tools > Add-ons > Themes).
* Don't make any changes on the Safe mode start window.
See:
* [[Troubleshooting extensions and themes]]
* [[Troubleshooting plugins]]
If it does work in Safe-mode then disable all extensions and then try to find which is causing it by enabling one at a time until the problem reappears.
* Use "Disable all add-ons" on the [[Safe mode]] start window to disable all extensions.
* Close and restart Firefox after each change via "File > Exit" (Mac: "Firefox > Quit"; Linux: "File > Quit")

The URL is not valid and cannot be loaded

seems like maybe firefox mishandles untrusted certificates?
It gives error: Alert The URL is not valid and cannot be loaded.
example:
https://notes.corp.cat.com/
other browsers can load this URL just fine. When I visit it in Firefox, I get the error in a simple little message box with a yellow triangle exclamation point, titled "Alert".
ALSO.... when I click the "Home" button in firefox, I get the error, and the home page does not load. Currently the home page is set to "Mozilla Firefox Start Page."
changing the home page to: http://www.google.com/ allows the home page button to work normally.
restoring the home page to default brings the error behavior back when clicking the home button.
changing the home page to: https://notes.corp.cat.com/ produces the same error, just like when I manually type in an https URL with a funky security certificate.
This problem only seems to happen on secure URLs with untrusted certificates, i.e. sites that are too cheap to pay to have their certificate registered with one of the certificate vendors or however the hell that works, so as a result every time you visit their web site, your browser starts to whine that it might be a forgery or whatever.
It used to be in Firefox that I could load these pages and just specify that I want to trust the site anyway. Now firefox gives this error that doesn't allow the user to know what is really going on or what the reason for the error is. It is as if the developers decided that users are too stupid to decide if they really want to visit the site or not, so as a result Firefox is just refusing to visit any web sites where the authenticity of the certificate can't be verified? Hey, it's not a bad idea, to be honest. :-) But it's kind of annoying, because here I am, sort of smart enough to know what I'm doing, but I don't have the choice in the matter...
I restarted with all add-ons disabled and that didn't help. I don't have much installled in the way of add-ons anyway. All I have is JAVA quick starter 1.0, and Adobe Acrobat, Java development toolkit, Java platform SE, Microsoft DRM, and Windows Media Player Plug-in Dynamic Link Library. Not even Flash. All the above is disabled now that I rebooted with add-ons disabled, and I still have the issue.
thanks for any help you can provide.

Please [https://bugzilla.mozilla.org/show_bug.cgi?id=713167 see this.] Installing [https://www.microsoft.com/download/en/details.aspx?id=5638 Visual C++ 2005 SP1] or the .Net Framework 3.5 SP1 may help mitigate the issue.

HT204053 i want to change my icloud id on my iPhone, but it won't let me now that i have upgraded. I no longer have the password and the problem is It is using an old id which the email isn't valid and the security question does not think my birthday is

I want to change my icloud id on my iPhone, but it won't let me now that i have upgraded. I no longer have the password and the problem is It is using an old id which the email isn't valid and the security question does not think my birthday is valid. I cannnot delete the account because "find my iphone" wants the password linked to this old account. But when i go into the find my iphone app it is using my corect Apple ID. How do i fix this?

If you still have access to your old email address, go to https//appleid.apple.com, click Manage my Apple ID and sign in with your iCloud ID. Tap edit next to the primary email account, tap Edit, change it back to your old email account and verify it. Then edit the name of the account to change it back to your old email address. You can now use your current password to turn off Find My iPhone on your device. Then go to Settings>iCloud, tap Delete Account and choose Delete from My iDevice when prompted (your iCloud data will still be in iCloud). Next, go back to https//appleid.apple.com and change your primary email address and iCloud ID name back to the way it was. You can now go to Settings>iCloud and sign in with your correct iCloud ID and password.
If you don't have access to your old email address, you will have to contact Apple to have them reset the password so you can disable Find My iPhone and sign into your iCloud account. You can either go to https://expresslane.apple.com, select "More Products and Services", then "Apple ID", then on the next page select "Other Apple ID Topics", then "Lost or forgotten Apple ID password" and click "Continue"; or you can contact Apple Support (http://www.apple.com/support/icloud/contact/).

Apple changed my Apple ID to the email address associated with my iTunes account. I now can no longer access my account because the old user name is no longer valid and has no password. I have been on the phone with tech support for hours trying to fix.

Apple changed my Apple ID to the email address associated with my iTunes account. I now can no longer access my account because the old user name is no longer valid and has no password. I have been on the phone with tech support for hours trying to fix this. I can not update any of the apps associated with that user name.

Is this itunes on the iPad or on my computer? Thank you for the reply.

Why does my app store account tell me that my payment method does not match my bank's records. my card is valid and works for iTunes but not the app store.

While trying to change my Credit Card info: The app store tells me that my payment method information does not match my bank records and to try again or enter a new payment method. My CC is valid and its the same CC ive had for a while. This CC info works for iTunes but is not being accepted for the App store.I have changed this info online but cannot change it on my iPhone. Can anyone tell me what i need to do?

Apple Store Customer Service at 1-800-676-2775 or visit online Help for more information.
To contact product and tech support: Contacting Apple for support and service - this includes
international calling numbers..
For Mac App Store: Apple - Support - Mac App Store.
For iTunes: Apple - Support - iTunes.

HT2731 How do I remove an email address that is no longer vaild for the iTunes Store? A really old email address keeps popping up on my iPhone, the email address is not valid and I have no idea what the password was. It's been over two years.

How do I remove an email address that is no longer vaild for the iTunes Store or my iPhone? A really old email address keeps popping up on my iPhone, the email address is not valid and I have no idea what the password was. It's been over two years.

Hello tcnolen1,
It sounds like you are trying to change the Apple ID logged into the iTunes & App Stores on your iPhone. Use these steps:
Changing your Apple ID account
Tap Settings > iTunes & App Stores, then tap the Apple ID signed in.
Sign out of the current Apple ID account and then sign in with another account or create a new Apple ID.
You can find the full article here:
iOS: Changing the signed-in iTunes Store Apple ID account
http://support.apple.com/kb/ht1311
Thank you for using Apple Support Communities.
Best,
Sheila M.

HT5312 My rescue email address is no longer valid and I can't remember my security questions answers. How can I reset my security information

I have money in my Itunes account, but have forgotten the answers to my security questions.
The rescue email address that was linked to my account is no longer valid and I can't access it any more.
How do I re-set my security questions and rescue email so I can purchase itemsvia my iTunes account?
Help?

You will need to contact iTunes Support / Apple to get the questions reset.
Contacting Apple about account security : http://support.apple.com/kb/HT5699
When they've been reset you can then use the steps half-way down the HT5312 page that you posted from to update your rescue email address for potential future use.

How do I enable Firefox 4 to do a search on more than one word (e.g. "yahoo mail") without receiving the error message "the URL is not valid and cannot be loaded"?

After loading Firefox 4.0, I changed the address bar search engine to Google Search by Name, so I'd be taken straight to the most relevant webpage when I type in a word.
It works fine when I type in one word, but if I use a search with more than one word (e.g. "yahoo mail" or "google maps") I get an alert saying "The URL is not valid and cannot be loaded". Is there any way I can fix the address bar to accept multiple word searches?
I've tried disabling all my add-ons, but it didn't make any difference.

Hi, this should sort out your problem:
1. Type in "about:config" into the address bar, this will open the settings menu. Click on "I'll be careful, I promise!"
2. Search for "keyword.URL" in the filter bar.
3. Enter "http://www.google.com/search?btnI=I%27m+Feeling+Lucky&q=" into the value field.
I'm no expert, but I had the same problem which got on my nerves after being so used to being able to type anything in, and following these steps fixed it.

Validation and Error Message Dialog Box

hi,
I created 2 items DateFrom and DateTo.....when User enter dates into these items I need validate these dates i.e DateTo should be greater than DateFrom
if it is not so,,,,I need to Popup a Error message in Dialog Box.........
and this Error should not terminate the Program.
Thanks in Advanced
regards,
Radhika

Radhika,
You need to attach PPR event to the Date To column. In the event code in controller, you can validate do the validation and accordingly throw error on the page.
Why do you need a pop up(javascript alert) for that?
--Mukul

I have CS2 and I use it almost every day.. Today when I tried to launch it, a prompt came up saying my Activation was no longer valid and it closed automatically. Then when I tried to re-open it, a prompt came up saying "A serious error has occured" Ple

I have CS2 and I use it almost every day.. Today when I tried to launch it, a prompt came up saying my Activation was no longer valid and it closed automatically. Then when I tried to re-open it, a prompt came up saying "A serious error has occured" Please re-install the software... I have no idea where my software is... That was many many years ago? HELP!!

When you go to the download page, you must do two things:
Download this file: PhSp_CS2_English.exe on the download page.
Use the serial number on the download page in order to install your non-activation copy.
Do not use your old CD or serial number. It no longer works.
If you have Windows 7, the advice is to turn off UAC and run the installer as Administrator.
Gene

The certificate is not valid and cannot be used to verify the identity of this website

Question posted in Stack Overflow too: java - How to solve "The certificate is not valid and cannot be used to verify the identity of this website" error? - St…
The question is, How to solve "The certificate is not valid and cannot be used to verify the identity of this website" error?.
Here are the details:
I have a signed applet that has been working fine, until I updated Java to 8u25 (1.8.0_25-b18). Now, the application shows an alert message "Do you want to continue? The connection to this website is untrusted". There is a note in this message too, "The certificate is not valid and cannot be used to verify the identity of this website".
The applet is loaded without problems. But when the user tries to use a specific function of that application, the warning message is displayed.
I've checked the java console when this happens, and this warning message is displayed right after these lines:
security: Obtain certificate collection in SSL Root CA certificate store
security: Invalid certificate from HTTPS server
network: Cache entry not found [url: https://sub.domain.net:9876, version: null]
The application is downloaded from a different domain, say "https://app.domain.net/ .....", so no jars are downloaded from "https://sub.domain.net:9876 ", but the applet connects to "https://sub.domain.net:9876 " to send/receive data.
The applet is signed correctly, and so far, it meets all the security requirements according to Java. This issue seems to happen when the application tries to connect internally with an HTTPS url like https://sub.domain.net:9876. That sites' SSL certificate is valid, issued by GoDaddy and has not expired.
Again, this started to happen after updating my JRE to 8u25. I've tested adding the offending URL to Java security exception list, with no success.
Here are a few screenshot of this problem:
This is the warning message displayed:

For what it's worth we discovered what the issue was. When we installed the new certificates onto our servers we also discovered that you have to install the certificates of all intermediate servers listed in your certificate. This mean that all URLs listed on your certificate, have to have the intermediate certificate for the certificate authority installed. This also includes all the Alt Names of your domains, even if they do not use the applet.

My internet is on and I keep getting an alert window popping up saying the URL is not valid and can not be loaded?

I don't know what more details I can give you except for what I indicated. I am online and a window will pop up indicating the URL is not valid and can not be loaded. Make it stop! That's all! Furthermore you should not limit people on the length of their question. How can they explain it ?

Thats the annoying part! I have enough space and I'm putting things on a external hard drive and I keep deleting it off the computer.

FDA validations and 21 CFR

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