最近グローバルの規制当局は、医薬品企業・医療機器企業に対する電子記録・電子署名(ER/ES)の査察を活発に実施しています。
米国においては、1997年8月20日に21 CFR Part 11が施行されました。
また本邦においては、平成17年4月1日に「医薬品等の承認又は許可等に係る申請等における電磁的記録及び電子署名の利用について」(ER/ES指針)が発出されました。
2008年度から、EDCを利用した治験では、すでにER/ES指針査察が開始されています。
さらにPIC/Sにおいても、2013年1月1日に「PIC/S GMP Annex 11 Computerised Systems」が改定されました。
PIC/S GMP Annex 11は、21 CFR Part11への回答書と位置付けられ、最新のFDAの電子記録・電子署名に関する期待と指導を盛り込んだものとされています。
平成24年4月1日には、「コンピュータ化システム適正管理ガイドライン」が施行されました。この新ガイドラインの調査では、ER/ES指針を遵守しているかどうかも確認されています。
すでに指摘も出され始めました。
特にExcelを用いた、品質試験記録、品質試験成績書、出荷判定などは、要注意です。
なぜならば、Excelではセキュリティが十分ではなく、監査証跡も残せないからです。
再印刷し、バックデートでサインを行うといった不正も疑われます。
多くの製薬会社では、記録を電子で作成し、印刷したものに手書き署名(捺印)を行うといったハイブリッド運用を行っています。
ER/ES査察では、このようなハイブリッド運用において、紙が正か、電子が正かが問われます。
これまでほとんどの製薬会社では、紙を正としてきました。
しかしながら、今後はほとんどの場合、電子が正と判定されることになるでしょう。
Part11、ER/ES指針、ANNEX11は、非常に難解です。
本セミナーでは、電子記録・電子署名に関する規制要件をやさしく解説いたします。
お役立ち動画
【超入門】ERES指針、21 CFR Part 11対応セミナー
はじめに
1.電子化のリスク
2.電子生データとは
3.21 CFR Part 11入門
4.Part11の経緯と動向
5.ERES指針入門
6.PICS GMP Annex 11入門
7.Warning Letter
関連VOD配信セミナー
当社VOD配信セミナーは、視聴期間および回数制限はございません。
お好きな時間に、繰り返し何度でもご視聴いただけます。
・【超入門】厚労省ER/ES指針、21 CFR Part 11対応セミナー
セミナービデオはこちら。
関連商品
[blogcard url= https://xn--2lwu4a.jp/qms-csv/ title=”QMS(手順書)ひな形 CSV関連” ]
Asking questions are genuinely pleasant thing if
you are not understanding anything completely, but this article offers good understanding even.
hello there and thank you for your info – I have certainly picked
up something new from right here. I did however expertise some technical
points using this website, as I experienced to reload the site lots of times previous to I could get it to load correctly.
I had been wondering if your hosting is OK?
Not that I’m complaining, but sluggish loading instances
times will often affect your placement in google and can damage your
high quality score if advertising and marketing with Adwords.
Anyway I am adding this RSS to my e-mail and could look out for much more of your respective intriguing content.
Ensure that you update this again soon.
Hurrah, that’s what I was searching for, what a information! existing here at
this weblog, thanks admin of this website.
Thanks on your marvelous posting! I certainly enjoyed reading it,
you could be a great author. I will make certain to bookmark your blog and will often come
back from now on. I want to encourage yourself to continue your great posts, have a
nice day!
Howdy! This is my first visit to your blog! We are a group of volunteers and starting a new project in a community in the same niche.
Your blog provided us useful information to work on. You have
done a marvellous job!
I’m gone to tell my little brother, that he should also visit this
weblog on regular basis to take updated from hottest reports.
Thanks for finally writing about > 【超入門】ERES指針、21 CFR Part 11対応セミナー(4.Part11の経緯と動向)
| お役立ち情報 < Liked it!
Hi there colleagues, its wonderful post regarding tutoringand entirely explained, keep
it up all the time.
It’s remarkable designed for me to have a website, which is good
designed for my experience. thanks admin
I do not know if it’s just me or if everybody
else experiencing problems with your site. It appears
like some of the written text within your content are running off the screen. Can someone
else please comment and let me know if this is
happening to them as well? This might be a issue
with my web browser because I’ve had this happen previously.
Cheers
Hello, just wanted to say, I liked this article. It was inspiring.
Keep on posting!
That is really attention-grabbing, You’re a very professional blogger.
I’ve joined your feed and look forward to searching for more of your magnificent post.
Additionally, I’ve shared your website in my social networks
I think this is among the most vital info for me.
And i’m glad reading your article. But want to remark on some common issues, The site taste
is wonderful, the articles is truly great : D. Excellent job, cheers
Just want to say your article is as amazing. The clearness in your post
is just great and i could assume you are an expert on this subject.
Fine with your permission allow me to grab your RSS feed to keep up to date with forthcoming post.
Thanks a million and please continue the gratifying work.
What’s up, everything is going fine here and ofcourse every one is sharing information, that’s really excellent, keep up writing.
Hi there, I discovered your website by the use of
Google even as searching for a similar matter,
your site came up, it seems good. I’ve bookmarked it in my google bookmarks.
Hello there, simply turned into alert to your blog through Google, and located
that it is really informative. I’m gonna be careful for brussels.
I will be grateful if you happen to continue this in future.
A lot of folks will be benefited out of your writing.
Cheers!
The webb site adheres to strict requirements for player protection and fair play.
Also visit my website – Comprehensive
I really like your blog.. very nice colors & theme. Did you make this website yourself or did you hire someone to
do it for you? Plz respond as I’m looking to construct my
own blog and would like to find out where u got this from.
cheers
Social casinls offer you a variety of slot machines and online casino games such as roulette and blackjack.
Review my page: User-friendly
Awesome blog! Do you have any helpful hints for
aspiring writers? I’m hoping to start my own website
soon but I’m a little lost on everything. Would you advise starting with a
free platform like WordPress or go for a paid option? There are so many choices out there that I’m completely overwhelmed
.. Any recommendations? Thanks!
You’ll be able to withdraw your winnings only
immediately after you have met the respectyive bonus wagering requirement.
Have a look at my page; casino79.in
They function 280 slots games alone, as properly as 30 various kinds of
poker and blackjack variants.
my web blog :: 카지노친구
We’re a gaggle of volunteers and opening a brand new scheme in our community.
Your web site offered us with valuable information to work on. You have performed an impressive task and our entire
neighborhood can be grateful to you.
Amongst the providers forr Slots.lv you can uncover RTG, Betsoft,
and 12 other people.
My blog post :: user-friendly
The IRS has ruled that all gambling proeeds are regarded as
taxable income.
My webpage – casino79.In
This design is steller! You certainly know how to keep a reader amused.
Between your wit and your videos, I was almost moved to start my own blog (well, almost…HaHa!) Excellent job.
I really enjoyed what you had to say, and more than that, how you presented it.
Too cool!
Good site you have got here.. It’s difficult to find good
quality writing like yours nowadays. I honestly appreciate people like you!
Take care!!
Thank you, I have just been looking for information about this subject for ages and yours is the greatest I’ve found out so far.
But, what about the conclusion? Are you positive about the source?
Excellent site. A lot of helpful information here.
I’m sending it to some buddies ans also sharing in delicious.
And obviously, thanks for your sweat!
Hello! Someone in my Myspace group shared this website with us so I came
to check it out. I’m definitely enjoying the information. I’m bookmarking and will be tweeting this to
my followers! Superb blog and amazing design.
My family members all the time say that I am wasting my time here at net, but I know I am getting know-how every day by reading
thes nice articles or reviews.
Wow! Finally I got a website from where I can genuinely obtain useful facts regarding
my study and knowledge.
Hey there! This is my first visit to your blog! We are a group of volunteers and starting a new project
in a community in the same niche. Your blog provided us beneficial information to work on. You have done a extraordinary
job!
Fantastic goods from you, man. I have understand your stuff previous to
and you’re just too magnificent. I really like what
you have acquired here, certainly like what you are stating
and the way in which you say it. You make it entertaining and you still care for to keep it sensible.
I can’t wait to read much more from you. This is really a tremendous site.
Hey there would you mind letting me know which webhost you’re utilizing?
I’ve loaded your blog in 3 completely different internet browsers
and I must say this blog loads a lot faster then most.
Can you recommend a good internet hosting provider at a fair price?
Thanks a lot, I appreciate it!
After going over a few of the articles on your web site, I seriously like your way of blogging.
I saved it to my bookmark site list and will be checking back in the near future.
Please check out my website too and let me know what you think.
I like the valuable information you provide for your articles.
I’ll bookmark your weblog and test again right here regularly.
I’m relatively certain I will learn many new stuff proper right here!
Best of luck for the next!
What i don’t understood is if truth be told how you’re not really a lot more well-appreciated than you might be right now.
You’re so intelligent. You already know therefore
considerably in relation to this subject, produced me in my opinion consider it from numerous varied angles.
Its like women and men don’t seem to be interested except it’s
something to do with Lady gaga! Your individual stuffs outstanding.
All the time maintain it up!
Hmm is anyone else having problems with the images on this blog loading?
I’m trying to find out if its a problem on my end or if it’s the blog.
Any feed-back would be greatly appreciated.
Valuable information. Lucky me I discovered your website by
accident, and I am shocked why this twist of fate didn’t took place in advance!
I bookmarked it.
Wow, that’s what I was exploring for, what a data! existing here at this webpage, thanks admin of this web site.
I do not even know how I ended up here, but I thought this post was good.
I do not know who you are but certainly you are going to a famous blogger if you are not already
😉 Cheers!
Hello, the whole thing is going well here and ofcourse every one
is sharing information, that’s actually good, keep up writing.
It’s awesome designed for me to have a site, which is useful in favor of my experience.
thanks admin
I was recommended this blog by my cousin. I am not sure whether this post is written by him
as nobody else know such detailed about my difficulty. You are wonderful!
Thanks!
Hey, I think your website might be having browser compatibility
issues. When I look at your blog in Opera, it looks fine but when opening in Internet Explorer, it
has some overlapping. I just wanted to give you a quick heads up!
Other then that, wonderful blog!
Hi i am kavin, its my first time to commenting anywhere, when i read
this piece of writing i thought i could also make
comment due to this good post.
Good post but I was wondering if you could write a litte more on this topic?
I’d be very thankful if you could elaborate a little bit more.
Appreciate it!
Your way of telling all in this post is really fastidious,
all be capable of easily be aware of it, Thanks a lot.
Hello, constantly i used to check webpage posts here in the early hours in the morning, as i
like to gain knowledge of more and more.
What’s up, this weekend is pleasant in favor of me, because this moment i am reading this fantastic educational post here at my home.
Discovering the leading online casinos for US players in 2024 has never been simpler.
Also visit my blog post: visit this link
Unquestionably consider that which you stated.
Your favourite reason seemed to be on the web the simplest thing to remember of.
I say to you, I definitely get irked even as other people consider worries that they plainly do not realize about.
You managed to hit the nail upon the top and outlined out the entire thing
without having side effect , other folks could take a signal.
Will likely be again to get more. Thanks
Write more, thats all I have to say. Literally, it seems as
though you relied on the video to make your point.
You clearly know what youre talking about, why waste your intelligence on just posting
videos to your blog when you could be giving
us something enlightening to read?
Hey this is kind of of off topic but I was wanting to know if blogs use WYSIWYG editors or
if you have to manually code with HTML. I’m starting a blog soon but
have no coding expertise so I wanted to get
guidance from someone with experience. Any help would be greatly appreciated!
Everything is very open with a very clear clarification of the issues.
It was truly informative. Your website is very useful.
Thanks for sharing!
Write more, thats all I have to say. Literally, it seems as though you relied on the
video to make your point. You obviously know what
youre talking about, why waste your intelligence on just posting videos
to your weblog when you could be giving us something enlightening to
read?
Definitely believe that which you stated. Your favorite reason seemed to be on the net the easiest thing
to be aware of. I say to you, I certainly get annoyed while people think about worries that they plainly
don’t know about. You managed to hit the nail upon the top as well as defined out the whole thing without having side effect ,
people can take a signal. Will likely be back to get
more. Thanks
Whats up very nice site!! Man .. Excellent ..
Wonderful .. I will bookmark your site and take the feeds also?
I’m happy to find numerous helpful info here within the post,
we’d like develop more strategies on this regard, thanks for
sharing. . . . . .
I was very pleased to uncover this web site. I wanted to thank you for
ones time for this wonderful read!! I definitely liked every little bit
of it and I have you saved to fav to see new information in your website.
My brother recommended I might like this blog.
He was entirely right. This post truly made my day.
You cann’t imagine just how much time I had spent for this information! Thanks!
Hello, i believe that i saw you visited my website
thus i came to go back the desire?.I am attempting to to find things to enhance my site!I guess its good enough
to use a few of your ideas!!
This site truly has all the information and facts I wanted concerning this subject and didn’t know who to ask.
Because the admin of this web page is working, no doubt very shortly
it will be renowned, due to its feature contents.
Hello Dear, are you really visiting this website daily, if so afterward you will without doubt
obtain good know-how.
Hi there, You’ve done a great job. I’ll definitely digg it and personally recommend to
my friends. I’m confident they will be benefited from this site.
Good post. I learn something new and challenging on blogs I stumbleupon every day.
It’s always useful to read through content from other authors and use
something from their websites.
I’m impressed, I must say. Rarely do I encounter a blog that’s both equally educative
and engaging, and without a doubt, you have hit the nail on the head.
The problem is something not enough folks are speaking intelligently about.
I am very happy that I stumbled across this in my search for something concerning this.
I always spent my half an hour to read this webpage’s articles or
reviews daily along with a cup of coffee.
If some one needs to be updated with latest technologies therefore
he must be pay a quick visit this web site and be
up to date daily.
It is not my first time to visit this site, i am browsing this web page
dailly and get nice facts from here everyday.
Wow, superb blog layout! How long have you been blogging for?
you make blogging look easy. The overall look of
your site is excellent, as well as the content!
I do not know whether it’s just me or if everyone else experiencing problems with your site.
It appears like some of the text in your content are running off the screen. Can somebody else please provide
feedback and let me know if this is happening to them too? This may be a problem with my internet browser because I’ve had
this happen before. Many thanks
I’m really impressed with your writing skills and also with
the layout on your blog. Is this a paid theme or did you customize it yourself?
Either way keep up the excellent quality writing, it’s rare to see a nice blog like this one
these days.
I like what you guys are usually up too. This type of clever work and reporting!
Keep up the great works guys I’ve added you guys to my blogroll.
Hi! I could have sworn I’ve visited this blog before but after browsing
through some of the articles I realized it’s new to me.
Anyways, I’m certainly pleased I discovered it and I’ll be bookmarking it and checking back frequently!
These breakthroughs are usually ovverlooked by veterans thjat stick to attempted and tested gaming venues and titles.
Havee a look at my web site :: take a look at the Site here
What’s up Dear, are you really visiting this web site regularly, if
so afterward you will definitely get good experience.
First off I want to say wonderful blog! I had a quick question which I’d like to ask if you do not mind.
I was interested to find out how you center yourself and clear your
head prior to writing. I have had trouble clearing my mind
in getting my ideas out. I truly do take pleasure in writing however it just seems like the first 10 to 15 minutes are usually
wasted just trying to figure out how to begin. Any suggestions or hints?
Many thanks!
Everyone loves it when folks get together and share views.
Great site, stick with it!
I’m not that much of a online reader to be honest but your
blogs really nice, keep it up! I’ll go ahead and bookmark
your website to come back in the future. Cheers
Hello! This is my 1st comment here so I just wanted to give a quick shout out and tell you I
truly enjoy reading through your articles. Can you recommend any other blogs/websites/forums that deal
with the same topics? Thanks a lot!
It’s appropriate time to make some plans for the future and it is
time to be happy. I’ve read this post and if I could I wish to suggest
you some interesting things or suggestions. Maybe you could
write next articles referring to this article. I desire
to read even more things about it!
FlexJobs gives additional than 50 career categories with remote, hybrid, and versatile joob listings.
my web page … how Many hours is Part time
Hi there mates, how is everything, and what you want to say concerning this post, in my view its
really remarkable in favor of me.
I am sure this piece of writing has touched all the internet viewers, its really really good post on building up new web site.
Howdy! Do you know if they make any plugins to help with Search Engine Optimization? I’m trying
to get my blog to rank for some targeted keywords but I’m not seeing very good gains.
If you know of any please share. Kudos!
This site truly has all of the information I needed concerning this subject and didn’t know who to ask.
I’m extremely pleased to find this web site. I wanted to thank you for
ones time for this particularly fantastic read!!
I definitely liked every bit of it and I have you saved to fav to look at new stuff
on your site.
I was recommended this website by my cousin. I am not sure whether this post is written by him as no one else know such detailed about my trouble.
You are wonderful! Thanks!
The other day, while I was at work, my sister stole my iphone and tested
to see if it can survive a thirty foot drop, just so she can be a
youtube sensation. My apple ipad is now broken and she has 83 views.
I know this is completely off topic but I had to share it with someone!
It’s going to be end of mine day, however before
finish I am reading this impressive paragraph to increase my experience.
I’ve been browsing on-line greater than 3 hours these days, yet I never found any interesting
article like yours. It’s pretty value enough for me. In my opinion, if all website owners and
bloggers made excellent content material as you probably did,
the internet will likely be much more useful than ever
before.
I was recommended this website by my cousin. I am not sure whether this post is written by him as no one else
know such detailed about my difficulty. You’re wonderful!
Thanks!
Greetings from Colorado! I’m bored at work so I decided to check
out your blog on my iphone during lunch break.
I love the info you provide here and can’t wait to take a look when I get home.
I’m shocked at how quick your blog loaded on my cell phone ..
I’m not even using WIFI, just 3G .. Anyways, superb site!
An impressive share! I have just forwarded this onto a friend who had been conducting a little research on this.
And he in fact ordered me lunch because I found it for him…
lol. So allow me to reword this…. Thanks for
the meal!! But yeah, thanks for spending the time to discuss this topic here on your website.
Thanks for finally writing about > 【超入門】ERES指針、21 CFR
Part 11対応セミナー(4.Part11の経緯と動向) | お役立ち情報 < Loved it!
Hi, I would like to subscribe for this website to take newest updates, so where
can i do it please assist.
Write more, thats all I have to say. Literally, it seems as though you relied on the video
to make your point. You obviously know what youre talking about, why throw away your intelligence
on just posting videos to your weblog when you could be giving us
something enlightening to read?
each time i used to read smaller articles or reviews
which also clear their motive, and that is also happening with this paragraph which I
am reading at this time.
Very nice article, just what I wanted to find.
I think everything posted made a lot of sense.
But, consider this, suppose you were to create a awesome headline?
I am not suggesting your content isn’t solid., however suppose you added
something to maybe grab people’s attention? I mean 【超入門】ERES指針、21 CFR Part 11対応セミナー(4.Part11の経緯と動向) | お役立ち情報 is kinda
plain. You should peek at Yahoo’s front page and note
how they create article headlines to get viewers to open the links.
You might add a related video or a related picture or two to grab people excited about everything’ve
written. Just my opinion, it would bring your blog a little
bit more interesting.
Now I am going to do my breakfast, once having my breakfast coming over again to read other
news.
This excellent website definitely has all the
information I wanted concerning this subject and didn’t
know who to ask.
I’m impressed, I must say. Seldom do I come across a blog that’s equally educative and entertaining, and
without a doubt, you’ve hit the nail on the head. The problem is an issue that not enough men and
women are speaking intelligently about. I am very happy I came across this during my hunt for something concerning this.
Hello to every one, since I am genuinely keen of reading this website’s post to be updated daily.
It contains fastidious material.
I believe this is among the so much important info for me.
And i’m happy studying your article. But want to observation on some general issues, The website
style is wonderful, the articles is really excellent : D.
Good job, cheers
Good day! Would you mind if I share your blog with my myspace group?
There’s a lot of people that I think would really enjoy your content.
Please let me know. Cheers
Woah! I’m really loving the template/theme of this
site. It’s simple, yet effective. A lot of times it’s very difficult to get that “perfect balance” between superb
usability and visual appearance. I must say you’ve done a amazing job with
this. In addition, the blog loads extremely fast
for me on Internet explorer. Outstanding Blog!
You actually make it seem so easy with your presentation but I
find this matter to be really something that I think I would never understand.
It seems too complex and very broad for me. I am looking forward for your next post, I’ll
try to get the hang of it!
Write more, thats all I have to say. Literally, it seems
as though you relied on the video to make your point.
You clearly know what youre talking about, why throw away your intelligence
on just posting videos to your weblog when you could be giving us something enlightening to read?
Thanks a bunch for sharing this with all folks you really know what you’re talking approximately!
Bookmarked. Please additionally consult with my web site =).
We could have a link alternate agreement among us
Hi, I want to subscribe for this blog to obtain newest updates, therefore where
can i do it please help out.
When I originally commented I clicked the “Notify me when new comments are added” checkbox and now each time a comment is added I get three e-mails with the same comment.
Is there any way you can remove me from that service? Appreciate it!
Thanks for some other informative blog. The place else
may just I get that kind of info written in such a perfect means?
I have a challenge that I am just now running on, and I have been on the look
out for such info.
Just desire to say your article is as amazing.
The clarity in your put up is just spectacular and that i could assume you are an expert in this subject.
Fine with your permission let me to grab your feed to stay up to date with drawing close post.
Thank you 1,000,000 and please continue the
rewarding work.
You really make it seem so easy together with your presentation but I find this matter to be really something which I believe I’d never understand.
It kind of feels too complex and extremely huge for me.
I’m having a look forward to your subsequent submit, I will try to get the cling of it!
I’m not sure exactly why but this blog is loading incredibly slow for
me. Is anyone else having this problem or is it
a issue on my end? I’ll check back later and see if the
problem still exists.
Yes! Finally something about naga169.
Thank you for the good writeup. It in fact was a amusement account it.
Look advanced to more added agreeable from you! However, how could we
communicate?
Hello there, I discovered your website via Google while looking for a related topic, your web site came
up, it seems good. I have bookmarked it in my google bookmarks.
Hi there, simply turned into alert to your blog through Google,
and found that it’s truly informative. I am going to
watch out for brussels. I’ll be grateful should you continue
this in future. Lots of other people might be benefited out of your writing.
Cheers!
I am truly thankful to the holder of this website who has shared this wonderful paragraph at at this
time.
Simply want to say your article is as astounding.
The clearness for your put up is just spectacular and that i can assume you’re knowledgeable in this subject.
Fine along with your permission let me to take hold of your feed to keep updated with forthcoming post.
Thanks one million and please continue the enjoyable work.
Thanks for the good writeup. It in fact was a amusement account
it. Look complicated to far brought agreeable from you!
However, how could we keep up a correspondence?
Wonderful blog! Do you have any suggestions for aspiring writers?
I’m planning to start my own website soon but I’m
a little lost on everything. Would you advise starting with a free platform like WordPress or go for
a paid option? There are so many choices out there that I’m completely confused ..
Any recommendations? Thank you!
Wow, that’s what I was looking for, what a material! existing here at this website, thanks admin of this web site.
Hi there colleagues, its impressive post about educationand fully explained, keep
it up all the time.
I needed to thank you for this wonderful read!!
I definitely enjoyed every bit of it. I have you saved as a favorite to check out new
things you post…
Hi there! Someone in my Facebook group shared this site with us so I
came to take a look. I’m definitely enjoying the information. I’m book-marking and will be tweeting this
to my followers! Great blog and excellent design.