@@ganesh659 21 CFR Part 11, clears that, we should comply the guideline requirement and predicate rules. The predicate rules means, basic GMP guides that means- 21 part 210 & part 211 for example 'records and reports" and other GMP requiremnents under data integrity guides etc. Hope this is clear to you. If not clear, you can put your comment further to clarify. Thank you
Yes. It is applicable for all medicinal products.This annex 11 applies to all forms of computerised systems used as part of a GMP regulated activities.The medical devices are used for human being and manufactured by following GMP principles. Now CSA is being discussed. You can access CSA related video from link below; ruclips.net/video/SINUmcPqHKo/видео.html If you have further question/s, please put in comment section
The training is available as a part of a recorded session. You can just search on this channel. If you are interested in any other topic, please feel free to put it in the comment section. Will do it. Thanks
There are many differences. For computerised system, you can go through FDA part 11. The link for this training is - ruclips.net/user/liveI7dA6A7TdZE?feature=share
If you change the antivirus or if you update the patches of software, you need to evaluate its impact on system performance. If it is not affected, revalidation not required. But the impact assessment is required to prove it.
Request you to go through the link above and put your questions in comment box. I will answer your queries in comment box itself
What is predicate rule?
@@ganesh659 21 CFR Part 11, clears that, we should comply the guideline requirement and predicate rules. The predicate rules means, basic GMP guides that means- 21 part 210 & part 211 for example 'records and reports" and other GMP requiremnents under data integrity guides etc. Hope this is clear to you. If not clear, you can put your comment further to clarify. Thank you
PLC and scada comes under which category of GAMP
These are the complex systems
Is eu annex 11 applicable for medical devices industry.?
Yes. It is applicable for all medicinal products.This annex 11 applies to all forms of computerised systems used as part of a GMP regulated
activities.The medical devices are used for human being and manufactured by following GMP principles. Now CSA is being discussed. You can access CSA related video from link below;
ruclips.net/video/SINUmcPqHKo/видео.html
If you have further question/s, please put in comment section
Hi , can you please share the link to next session which you have mentioned as (tomorrow session) again and again in this session.
The training is available as a part of a recorded session. You can just search on this channel. If you are interested in any other topic, please feel free to put it in the comment section. Will do it. Thanks
Very very informative and useful explanation
Thank you so much
What are major difference between EU GMP and WHO gmp
There are many differences. For computerised system, you can go through FDA part 11. The link for this training is - ruclips.net/user/liveI7dA6A7TdZE?feature=share
Nice presentation
Is it required to do computer system validation in case we change the antivirus??
If you change the antivirus or if you update the patches of software, you need to evaluate its impact on system performance. If it is not affected, revalidation not required. But the impact assessment is required to prove it.
Q
Sir Hindi me bole to good rahega
OK. Thanks