Ask yourself this question - what do I use to manage and make decisions on CAPAs? If you use the sheet as a tickler file but always go to paper for the...
Hello all, We are performing Adverse Event remediation project, there was a discussion on versioning of the documents which we have written.The problem is,...
There is an approved plan and now you found there is a better way of getting the job done. So far, no problem. You know this new plan needs to be approved,...
From what you have written.. Absolutely. You are changing a process that may have an effect on migraton of your data. This, I would consider, a major change...
Hello! My question is the following: If a system is used to generate and maintain electronic records but you only rely in the paper record (print out) (this...
if we use citrix server(or windows terminal services) for remote users to connect and enter data in to application over internet what are the steps taken to ...
raju parikh
rajuparikhus@...
Jun 2, 2006 1:50 pm
15515
Exactly how you control the change is up to you and will depend on the policies and procedures that you have in place. If you don't have one already; then you...
If you're using the spreadsheet as a tickler file, then aren't you using it as part of the quality system? Even if you say "well we look at the spreadsheet but...
Part11 would not apply ... just be sure you have the situation clearly documented, and those with access to the erecords have been trained not to use them. I...
Don Kail
drkail@...
Jun 2, 2006 4:04 pm
15518
Be careful. Part 11 isn't applicable if you TRULY only use the paper record. Why are you maintaining the electronic record, if it's not the official record? If...
Same as any other system except you will want to understand whether your connection for remote (over the internet) users is secure. That connection should be...
I am astounded by your second link (the first one is pretty old and what I'd expect in 1999 for Part 11 interpretation). This second one, stating that SS's...
Hola David, La pregunta subsecuente seria "para que tienen el sistema electronico entonces"? Si es que el sistema genera los registros electronicos pero Uds....
I agree with Fernando's comments, partially. David, what you just described is a hybrid system where you create an electronic record but rely on the printed...
The need to validate an electronic system is not equal to the need to comply with Part 11. You can have a validation requirement involving a system not subject...
Hi guys, Have an enquiry which is more GMP-related than Part 11. I have an isolator which is PLC-based and is used in a GMP environment. So are there any...
... Just to clarify - though PLC systems are typically not subject to Part 11, they still typically must be validated to meet requirements of applicable...
Yes, if those studies are conducted in accordance with 21 CFR Part 58 (Good Laboratory Practices). Part 11.1 (b) states that "This part applies to records in...
... The 21 CFR Part 58 regulations are predicate rules so if you are capturing electronic data or using electronic signatures in your animal study then yes...
Hello All I belong to an organisation which is a vendor of a web-based EDC solution for use in global Phase IV/Post-marketing studies, so observational studies...
if there is such a thing i'd like to know this too...other than the school of hard knocks i don't know of any. i think most experience comes from going to...
Oops... I should say: Yes. 21 CFR part 11 apply to all E-data that support regulatory submission. ygw <yuguang@...> wrote: Yes. 21 CFR part 11 apply to...
I vaguely remember an ISPE initiative to certify validation professionals quite a while ago, but has not read anything lately. European professionals were...
The ISPE has been working on such a certification for some time. Details can be found on http://www.ispe-pcc.org/ Dee Dee Carri Founder and Director Torque...
Having problems with message search?
Fill out this form to ensure your group is one of the first to be migrated to the new message search system.
