FDA Part 11 Compliance - Expectations & Evaluation
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- Опубліковано 16 чер 2020
- This training session will help you understand about expectations by FDA for the computerized systems as per part 11 and how we should evaluate the compliance.
- Наука та технологія
Sir
This is one of the best training platform available for pharma
Thank you !!! Please keep learning
Dear all; request you to post your questions about this topic. I will be happy to solve your queries.
Nice presentation. I have one question if an operator is running a compression machine having SCADA system and at specific time if he has to leave that room for doing in process testing of the hardness tester. So is it allowed for an operator to go in the next room though his login is on in the compression machine or would it be counted as a violation of 21 CFR part 11
I would like to suggest you that, once person login he/she should not leave the system. If he/she want to leave the system, and if it will not impact on operation, he/she should lock the screen so that, no body should able to access the same system. Otherwise, if his, login is on, any one can play with the system. This is to ensure the attributable requirement of the person. If still any doubt, please put your comments.
How many year data store in backup some equipment have limited user access support.
As per FDA part 11, "As long as predicate rule requirements are fully satisfied and the content and meaning of the records are preserved and archived, you can delete the electronic version of the records". But still I suggest, you should NOT DELETE ORIGINAL THE DATA. Because, if you refer eCFR, there is no such requirements. Also, the requirement is related to records and not DATA. Hope, you understood the point. Further if required, you can post your question.
Excellent training today
Thank you for your kind comment
Thank you sir. Nice training
Thanks and welcome
Dear All; you can download the training material by clicking the link below;
we.tl/t-zIB5nURc4n
Sir please do one detailed Class for LIMS
OK
How to store in data backup and data backup type.
I suggest, to go through in detail our complete data integrity learning package. I am sharing you link for accessing complete series of data integrity. You will get answer. ua-cam.com/video/pBnsXTe5jpw/v-deo.html
Still if you have any questions, please feel free to post your questions. I will be happy to answer your questions.
Hii Sir, Can you explain us to approach for open system with examples
Sure. Will take it.
this is really helpful. I have couple of queries ,could you please advise on these:
1. This is very basic but i want to get it clarify this once and for all :) ....when we say "system" its the software we are testing and not the actual system like laptop,computer etc ,correct?
2. When we look at actual 21 CFR Part 11 in FDA site ,there are 3 subparts and subsections under it, do we need to have all of them included in URS? Some of them may not be testable in that case can we have them out of scope and would it be okay ?
3. Difference between QA Analyst, CSV Analyst and Software tester, could you please clarify on this?
This training session is based on the FDA part 11 guide. During this session, I mainly focus the concepts and expectations under this requirements so that, every one should be clear from the guideline. For detail CSV, you can refer CSV training session.
How many type of SCADA system.
I suggest, can you please elaborate your question. Thank you
Audit trail which guideline & which section
You can find FDA, MHRA guidelines
Can I get QMS & risk assessment your session ?
Hi, you can go through a small video on QRM. I am planning different sessions on QMS, I suggest you subscribe to the channel and hit the bell icon so that, you will get notifications about these new updates. You can go through the QMS video below link;
ua-cam.com/video/Egkk6AoJSvg/v-deo.html
Desktop policy is mandatory for all computers systems.
YES. The desktop policy is mandatory. The desktop also should be validated. Because, it is hardware where your GMP activities are performed. All your GMP documents are created, modified and stored. All softwares are installed.
Hi sir from where can I download this ppt
You can use download button on your mobile. You can download entire video. you will not able to download PPT. As, it is in the form of video only.
[16/02, 22:49] gprabhakar35: Sample Spectrum not match with standard
[16/02, 22:49] gprabhakar35: Is it OOS
Yes of course
What FDA sir
FDA means USFDA