Part11の経緯と動向
21 CFR Part11(以下、Part11)は、ペーパレスを実現するため、米国製薬業界の要請を受けて「電子署名」利用のための指針をFDAが検討したのが発端である。
Part11は1997年3月20日に発表されて以来、これまで一度も改定されていない。
しかしながら、日進月歩のコンピュータの世界にあって、25年も前に作成されたルールが現在も通用するものではない。
Part11を運用するうち、当初は電子署名に注目していたが、電子記録の方がより重要であることが認識された。
Part11施行後に、電子記録・電子署名に関する新たな知見が見出され、FDAはPart11を改定しないまま、運用により期待や指導を変更してきた。Part11は改定されていないため、最新のFDAの期待や指導は記載されていない。
Part11の条文解釈の難解さと要件遵守の困難さ(特にコンプライアンスコスト)から、業界はFDAに対し、幾度もPart11の取り下げ(緩和)を要求した。
Part11の指摘を恐れるばかりに、多くの企業が紙媒体へと、いわば先祖返りをしてしまった。FDAは、電子で査察を行いたいのである。検索が早く、多くの記録を調査出来るためである。企業が電子化を躊躇することはFDAにとっても好ましいことではない。
現在、FDAは電子か紙媒体かではなく、データインテグリティについて関心がある。
Scope and Application
FDAは、2003年9月に「Scope and Application」を発行して、リスクベースドアプローチをとることを提唱した。
いたずらにコンプライアンスコストを高めると、製品の価格に転嫁され、患者負担になる。FDAは、医療費の高騰にもセンシティブである。
リスクベースドアプローチでは、患者の安全性、有効性、製品の品質に焦点をあてなければならない。
Part11が厳しく適用されるのは、生データが中心である。文書は別の管理が必要だ。そもそも悪意をもって文書を作成すれば、セキュリティや監査証跡の機能をもっても不正は防げないからだ。
注意しなければならないことは、Part11やScope and Applicationは、今でも有効であるということである。
Part11不遵守を懸念し、紙媒体に印刷したものを“正”とする企業が多く見受けられるが、本末転倒である。最終形式が紙媒体であったとしても、電子記録を作成した時点からPart11は適用される。
2001年以降、Part11を根拠としたワーニングレターは発行されていない。そもそも“Part11査察”というものは存在しない。
2010年以降にPart11に関する査察(調査)が再開されたが、ヒト用の医薬品に限定している。その目的はOOS(Out of Specification:規格外製品)の監視である。故意であれ事故であれ、記録が改ざんされた場合、患者の安全性に問題が生じるためである。
関連商品
[blogcard url= https://xn--2lwu4a.jp/qms-csv/ title=”QMS(手順書)ひな形 CSV関連” ]
[blogcard url= https://ecompliance.co.jp/SHOP/EL-006.html title=”【セミナービデオ】データインテグリティSOP作成セミナー”]
[blogcard url= https://ecompliance.co.jp/SHOP/O089.html title=”【VOD】データインテグリティの具体的な手順書作成セミナー 【データインテグリティ書籍付】”]
[blogcard url= https://ecompliance.co.jp/SHOP/P099.html title=”【書籍】 3極当局の指摘事例にみる ラボにおけるデータ記録・管理と電子化への移行”]
[blogcard url= https://ecompliance.co.jp/SHOP/ON150519P.html title=”【セミナービデオ】ER/ES指針、21 CFR Part 11対応セミナー”]
allergy pills over the counter antihistamine generic names piriton allergy tablets canada
sleeping pills over the counter order melatonin 3 mg without prescription
buy prednisone 5mg generic order generic prednisone 40mg
latest on heartburn medication ramipril price
sudden adult acne female cheap monobenzone best dermatologist acne medication
alternatives to allergy pills buy generic medrol non drowsy allergy medication canada
medications that cause gerd symptoms purchase lincocin pills
order accutane sale accutane 10mg tablet purchase absorica online
sleeping pills prescription online phenergan over the counter
amoxicillin 250mg uk amoxil 1000mg price amoxil 1000mg oral
buy zithromax for sale zithromax sale zithromax 500mg canada
buy neurontin 600mg for sale neurontin 100mg us
buy azipro online azithromycin buy online order azithromycin 250mg online
buy furosemide without prescription lasix us
prednisolone for sale order omnacortil 5mg sale order prednisolone 10mg generic
prednisone 5mg sale prednisone 10mg pills
buy amoxicillin generic brand amoxil 1000mg cheap amoxicillin pill
purchase monodox online doxycycline 200mg us
buy albuterol 2mg for sale order albuterol 2mg generic buy albuterol 4mg online
order augmentin 1000mg online buy augmentin 625mg without prescription
buy generic levothyroxine levothyroxine us purchase synthroid for sale
buy generic vardenafil for sale levitra 10mg usa
buy generic clomiphene clomid 50mg pills clomiphene 100mg price
buy zanaflex generic order tizanidine for sale zanaflex pills
order semaglutide 14mg pill buy semaglutide 14 mg pills buy rybelsus 14 mg
order deltasone 10mg online cheap order deltasone 5mg pill deltasone canada
buy generic semaglutide 14mg purchase semaglutide online cheap semaglutide 14mg without prescription
purchase isotretinoin for sale accutane 40mg for sale accutane 10mg without prescription
albuterol without prescription ventolin inhalator drug buy albuterol pills
brand amoxicillin 250mg buy amoxil medication amoxicillin over the counter
purchase augmentin online cheap buy clavulanate without prescription buy augmentin paypal
zithromax 250mg cheap order azithromycin 500mg online cheap buy zithromax online cheap
buy levothyroxine sale order synthroid 100mcg sale levothroid canada
order prednisolone 10mg pills omnacortil 10mg cheap buy prednisolone 10mg for sale
order clomid 100mg generic cost clomid clomid 100mg without prescription
brand neurontin order generic gabapentin neurontin 100mg without prescription
lasix 100mg cost lasix for sale lasix online order
viagra 50mg for sale cheap sildenafil tablets viagra 100mg pill
acticlate price monodox order order vibra-tabs pill
I’m not that much of a online reader to be honest but your sites really nice, keep it up! I’ll go ahead and bookmark your website to come back down the road. Cheers
semaglutide 14mg us buy generic rybelsus over the counter rybelsus 14 mg uk
slot games real casino online casino online
brand vardenafil 10mg generic levitra 20mg order vardenafil 20mg without prescription
lyrica 150mg brand buy generic pregabalin for sale buy generic lyrica 150mg
generic hydroxychloroquine 200mg buy hydroxychloroquine 200mg generic plaquenil brand
buy cheap generic triamcinolone where to buy aristocort without a prescription aristocort 4mg canada
tadalafil 40mg usa tadalafil 5mg drug cialis 10mg cost
clarinex sale clarinex sale clarinex ca
buy cenforce 50mg pill buy cenforce 100mg pills purchase cenforce pill
buy loratadine 10mg sale purchase loratadine sale order loratadine for sale
chloroquine over the counter buy aralen without prescription chloroquine 250mg cost
buy priligy 30mg pill order misoprostol pill cytotec us
buy metformin 500mg pills glycomet online buy cheap glucophage 1000mg
buy xenical 60mg online cheap xenical 60mg cost buy diltiazem tablets
order atorvastatin 20mg sale order lipitor 40mg online atorvastatin online order
cost amlodipine 5mg buy norvasc 5mg order amlodipine pill
buy zovirax online cheap order allopurinol for sale allopurinol cost
order zestril 10mg for sale buy generic lisinopril over the counter zestril 2.5mg sale
rosuvastatin 20mg sale buy ezetimibe online zetia pill
omeprazole 10mg brand prilosec to treat esophagus prilosec 10mg sale
domperidone price how to buy sumycin buy generic sumycin over the counter
oral metoprolol order lopressor online cheap metoprolol online buy
flexeril 15mg drug buy baclofen sale ozobax sale
I discovered your blog site on google and check a few of your early posts. Continue to keep up the very good operate. I just additional up your RSS feed to my MSN News Reader. Seeking forward to reading more from you later on!…
buy toradol 10mg gloperba cheap buy colcrys 0.5mg without prescription
atenolol 50mg drug order tenormin 50mg generic buy atenolol sale
buy cheap depo-medrol depo-medrol over counter methylprednisolone us
inderal canada inderal online buy clopidogrel 150mg cost
my friend essay writing write essay for money help me with my essay
cost methotrexate methotrexate 2.5mg sale buy warfarin 5mg pill
order meloxicam 15mg without prescription buy celecoxib without prescription celebrex generic
buy metoclopramide paypal purchase cozaar pill cheap losartan
flomax where to buy buy celebrex 100mg for sale brand celecoxib 200mg
nexium 40mg drug buy generic topamax for sale topamax pill
zofran 4mg sale order spironolactone 100mg generic order spironolactone without prescription
order generic sumatriptan 25mg order levofloxacin 250mg online levaquin 500mg us
order zocor 10mg generic order valacyclovir pills valacyclovir 1000mg oral
buy generic avodart for sale zantac ca order zantac online cheap
ampicillin drug amoxicillin pills amoxicillin buy online
buy propecia 5mg without prescription finasteride online order buy fluconazole 200mg generic
buy cipro generic – buy cephalexin no prescription augmentin 1000mg pill
buy baycip online – order generic bactrim augmentin 1000mg for sale
oral metronidazole 400mg – buy amoxil no prescription azithromycin order online
order ciprofloxacin 500 mg – buy chloromycetin no prescription buy erythromycin pill
valacyclovir 1000mg drug – buy starlix 120 mg for sale acyclovir price
buy ivermectin canada – order ciprofloxacin 500mg online cheap buy sumycin 500mg online cheap
metronidazole us – buy amoxicillin cheap buy generic azithromycin 500mg
how to buy acillin buy ampicillin online buy amoxicillin medication
order lasix – buy capoten 25 mg for sale order generic captopril 25 mg
cost glucophage – cefadroxil pills order lincomycin sale
I am lucky that I observed this blog, just the right info that I was looking for! .
zidovudine sale – oral zyloprim 100mg
brand clozapine 100mg – quinapril uk pepcid pills
buy seroquel 100mg sale – buy sertraline medication eskalith buy online
order clomipramine 50mg online – order imipramine 25mg online purchase doxepin without prescription
hydroxyzine 10mg usa – buy pamelor without a prescription endep cheap
I like this website because so much useful material on here : D.
whoah this weblog is great i love reading your articles. Keep up the good paintings! You know, many individuals are looking round for this information, you could help them greatly.
Woah! I’m really loving the template/theme of this blog. It’s simple, yet effective. A lot of times it’s hard to get that “perfect balance” between superb usability and visual appearance. I must say you have done a fantastic job with this. Additionally, the blog loads extremely quick for me on Firefox. Excellent Blog!
buy amoxil pill – buy cefuroxime 250mg for sale cipro 1000mg pill
amoxiclav buy online – linezolid drug buy ciprofloxacin paypal
cost clindamycin – order suprax 100mg for sale buy chloromycetin online cheap
What Is FitSpresso? As you may know, FitSpresso is a natural weight loss supplement that comes in capsule form.
order azithromycin pills – ciplox 500 mg canada cost ciplox 500mg
ventolin 2mg oral – buy phenergan sale theophylline 400 mg drug
buy ivermectin uk – stromectola online buy cefaclor pills for sale
Great write-up, I am normal visitor of one’s blog, maintain up the nice operate, and It’s going to be a regular visitor for a lengthy time.
great points altogether, you simply gained a brand new reader. What would you suggest about your post that you made some days ago? Any positive?
cheap clarinex – purchase flixotide online cheap brand ventolin
Usually I do not read article on blogs, but I wish to say that this write-up very forced me to try and do so! Your writing style has been amazed me. Thanks, quite nice article.
I?¦m no longer positive the place you are getting your information, however great topic. I must spend a while learning much more or understanding more. Thank you for great info I was on the lookout for this info for my mission.
buy methylprednisolone cheap – purchase astelin sale order azelastine 10ml sale
Hiya! I simply wish to give a huge thumbs up for the great information you could have here on this post. I shall be coming back to your blog for extra soon.
micronase 5mg cost – order glyburide 5mg pills dapagliflozin 10mg sale
order repaglinide sale – cost prandin empagliflozin 25mg cost
glucophage 500mg generic – acarbose 25mg usa order precose 50mg pills
buy terbinafine generic – griseofulvin 250 mg ca griseofulvin cheap
brand semaglutide 14mg – DDAVP us DDAVP
nizoral online order – purchase lotrisone online cheap sporanox 100 mg for sale
hello there and thank you for your info – I have definitely picked up anything new from right here. I did however expertise a few technical points using this web site, since I experienced to reload the website many times previous to I could get it to load correctly. I had been wondering if your web host is OK? Not that I am complaining, but sluggish loading instances times will sometimes affect your placement in google and can damage your quality score if ads and marketing with Adwords. Anyway I am adding this RSS to my email and could look out for a lot more of your respective fascinating content. Make sure you update this again very soon..
famvir 500mg tablet – purchase zovirax online cheap order valaciclovir 1000mg generic
order generic digoxin 250 mg – buy verapamil generic buy generic furosemide 100mg
order hydrochlorothiazide – buy plendil medication buy bisoprolol 5mg
purchase lopressor pills – inderal 10mg drug cost adalat 10mg
buy nitroglycerin generic – buy combipres for sale order valsartan 80mg online cheap
Hiya, I am really glad I’ve found this info. Nowadays bloggers publish only about gossips and internet and this is really irritating. A good web site with exciting content, that’s what I need. Thanks for keeping this web-site, I’ll be visiting it. Do you do newsletters? Cant find it.
Very interesting information!Perfect just what I was looking for!
rosuvastatin pills okay – pravachol buy hasten caduet shutter
simvastatin now – zocor firebolt atorvastatin perhaps
viagra professional online photograph – eriacta palm levitra oral jelly online response
dapoxetine whistle – levitra with dapoxetine lend cialis with dapoxetine wet
I was very happy to seek out this net-site.I wanted to thanks in your time for this glorious learn!! I undoubtedly enjoying every little little bit of it and I have you bookmarked to check out new stuff you weblog post.
cenforce online river – tadalis online darken brand viagra pills wonder
I have not checked in here for a while because I thought it was getting boring, but the last few posts are great quality so I guess I will add you back to my everyday bloglist. You deserve it my friend 🙂
brand cialis trifle – brand levitra gracious penisole coach
Java Burn: What is it? Java Burn is marketed as a natural weight loss product that can increase the speed and efficiency of a person’s natural metabolism, thereby supporting their weight loss efforts
cialis soft tabs online dismiss – viagra oral jelly online solid viagra oral jelly concern
brand cialis deep – viagra soft tabs blood penisole america
I like this web site very much, Its a really nice office to read and receive info . “There is no human problem which could not be solved if people would simply do as I advise.” by Gore Vidal.
so much good information on here, : D.
cialis soft tabs online permit – viagra oral jelly online bury viagra oral jelly online later
The root of your writing while sounding agreeable at first, did not sit properly with me after some time. Somewhere throughout the paragraphs you actually managed to make me a believer unfortunately just for a short while. I still have a problem with your leaps in assumptions and one might do nicely to fill in all those gaps. In the event that you actually can accomplish that, I could surely end up being impressed.
cenforce online utmost – kamagra pills exchange brand viagra endure
acne medication state – acne treatment puzzle acne medication member
asthma treatment organ – asthma medication exchange inhalers for asthma kindle
uti treatment steam – uti treatment patch treatment for uti remain
prostatitis treatment glint – prostatitis medications preserve prostatitis pills creep
valtrex online utmost – valtrex gain valacyclovir pills entertain
Great amazing issues here. I am very satisfied to look your article. Thanks a lot and i am looking forward to contact you. Will you kindly drop me a mail?
claritin whisper – loratadine huddle loratadine medication nowhere
A powerful share, I simply given this onto a colleague who was doing a little analysis on this. And he the truth is bought me breakfast because I found it for him.. smile. So let me reword that: Thnx for the treat! But yeah Thnkx for spending the time to debate this, I feel strongly about it and love reading extra on this topic. If possible, as you change into expertise, would you thoughts updating your blog with extra particulars? It’s highly helpful for me. Huge thumb up for this weblog publish!
Tonic Greens: An Overview. Introducing Tonic Greens, an innovative immune support supplement
Hello There. I found your blog using msn. This is an extremely well written article. I will make sure to bookmark it and come back to read more of your useful info. Thanks for the post. I will definitely comeback.
Thanks for a marvelous posting! I definitely enjoyed reading it, you might be a great author.I will make sure to bookmark your blog and definitely will come back later in life. I want to encourage one to continue your great work, have a nice holiday weekend!
claritin pills scream – loratadine medication warrior claritin pills incredible
dapoxetine mile – dapoxetine how dapoxetine august
Good day! I know this is kinda off topic but I’d figured I’d ask. Would you be interested in trading links or maybe guest authoring a blog article or vice-versa? My site discusses a lot of the same subjects as yours and I believe we could greatly benefit from each other. If you happen to be interested feel free to send me an email. I look forward to hearing from you! Excellent blog by the way!
I am not real great with English but I get hold this very easy to read .
promethazine cruel – promethazine task promethazine road
ascorbic acid phone – ascorbic acid crash ascorbic acid toward
Great – I should certainly pronounce, impressed with your site. I had no trouble navigating through all tabs and related information ended up being truly simple to do to access. I recently found what I hoped for before you know it in the least. Reasonably unusual. Is likely to appreciate it for those who add forums or something, web site theme . a tones way for your customer to communicate. Excellent task..
biaxin hurt – zantac pills cave cytotec icy
florinef pills dot – esomeprazole classroom lansoprazole eastern
My brother recommended I might like this blog. He was totally right. This post actually made my day. You can not imagine just how much time I had spent for this information! 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 site when you could be giving us something informative to read?
Just wish to say your article is as surprising. The clearness in your post is simply excellent and i could assume you’re an expert on this subject. Fine with your permission let me to grab your RSS feed to keep updated with forthcoming post. Thanks a million and please continue the enjoyable work.
Its like you read my mind! You seem to know so much about this, like you wrote the book in it or something. I think that you could do with a few pics to drive the message home a little bit, but instead of that, this is magnificent blog. An excellent read. I’ll definitely be back.
dulcolax us – loperamide over the counter order liv52 10mg pills
This web site is really a walk-through for all of the info you wanted about this and didn’t know who to ask. Glimpse here, and you’ll definitely discover it.
aciphex 10mg without prescription – metoclopramide 10mg oral oral domperidone
bactrim generic – buy generic cotrimoxazole online cost tobrex 5mg
buy hydroquinone no prescription – duphaston 10 mg pills purchase duphaston online
order dapagliflozin 10 mg without prescription – acarbose 25mg usa buy acarbose 25mg sale
generic griseofulvin – dipyridamole for sale online order gemfibrozil 300mg online
FitSpresso: An Outline FitSpresso is a weight management formula made using five herbal ingredients.
vasotec where to buy – vasotec price buy latanoprost no prescription
brand dramamine – cheap dimenhydrinate 50 mg actonel 35 mg without prescription
I’m still learning from you, but I’m trying to achieve my goals. I definitely liked reading everything that is posted on your blog.Keep the information coming. I liked it!
feldene 20 mg generic – rivastigmine 3mg drug order rivastigmine generic
monograph generic – purchase cilostazol online cheap cilostazol for sale
Great paintings! This is the type of info that are meant to be shared across the internet. Shame on Google for not positioning this submit higher! Come on over and talk over with my web site . Thanks =)
It’s hard to find knowledgeable people on this topic, but you sound like you know what you’re talking about! Thanks
I like this weblog so much, saved to fav. “American soldiers must be turned into lambs and eating them is tolerated.” by Muammar Qaddafi.
I believe this site has got some rattling fantastic information for everyone. “A sense of share is not a bad moral compass.” by Colin.
Some truly interesting information, well written and generally user pleasant.
generic nootropil 800 mg – buy biltricide 600mg online cheap order sinemet without prescription
I enjoy you because of all of the work on this web site. Debby takes pleasure in participating in internet research and it’s really simple to grasp why. Almost all notice all of the powerful medium you convey informative guides via the blog and therefore foster contribution from others about this subject matter plus my daughter is certainly studying a great deal. Enjoy the remaining portion of the year. You have been performing a fantastic job.
hydroxyurea order online – oral robaxin 500mg order methocarbamol for sale
What Is Neotonics? Neotonics is a skin and gut supplement made of 500 million units of probiotics and 9 potent natural ingredients to support optimal gut function and provide healthy skin.
buy divalproex pill – cost topamax topamax 100mg pills
norpace for sale – purchase disopyramide phosphate pills chlorpromazine 100mg over the counter
buy cytoxan medication – buy strattera 25mg pill buy generic trimetazidine
I carry on listening to the rumor talk about getting boundless online grant applications so I have been looking around for the top site to get one. Could you advise me please, where could i get some?
brand spironolactone 100mg – where to buy revia without a prescription order revia online
cyclobenzaprine price – enalapril 5mg over the counter buy generic vasotec for sale
buy zofran online – ropinirole for sale ropinirole 1mg pill
ascorbic acid for sale online – ascorbic acid 500mg drug purchase compro generic
how to order durex gel – order durex condoms online cheap zovirax cost
Perfectly written content material, regards for information. “In the fight between you and the world, back the world.” by Frank Zappa.
generic arava 20mg – buy arava 10mg sale cartidin generic
I like what you guys are up also. Such smart work and reporting! Keep up the superb works guys I’ve incorporated you guys to my blogroll. I think it’ll improve the value of my website 🙂
cheap minoxidil for sale – buy proscar sale finpecia over the counter
I went over this web site and I think you have a lot of superb information, saved to favorites (:.
tenormin 100mg drug – purchase atenolol generic order carvedilol 6.25mg generic
order calan for sale – cheap tenoretic sale order tenoretic
Hey there just wanted to give you a quick heads up. The words in your article seem to be running off the screen in Internet explorer. I’m not sure if this is a format issue or something to do with browser compatibility but I thought I’d post to let you know. The layout look great though! Hope you get the issue solved soon. Kudos
atorvastatin buy online – order generic vasotec 10mg order bystolic
purchase lasuna sale – cheap generic diarex buy himcolin without a prescription
gasex cheap – generic ashwagandha how to buy diabecon
cheap noroxin tablets – buy flutamide online buy confido without prescription
buy generic speman online – himplasia price buy finasteride online cheap
purchase finax online cheap – sildenafil price uroxatral drug
cheap terazosin 1mg – order terazosin buy priligy without prescription
Hi! Someone in my Facebook group shared this site with us so I came to give it a look. I’m definitely loving the information. I’m book-marking and will be tweeting this to my followers! Excellent blog and excellent style and design.
Thanks for every other informative site. The place else may just I am getting that kind of info written in such a perfect way? I’ve a project that I am simply now working on, and I’ve been at the look out for such info.
oxcarbazepine 600mg tablet – buy pirfenex tablets levothroid uk
Hiya, I am really glad I’ve found this information. Nowadays bloggers publish only about gossips and net and this is really irritating. A good website with interesting content, this is what I need. Thanks for keeping this website, I’ll be visiting it. Do you do newsletters? Can not find it.
I cling on to listening to the newscast talk about getting free online grant applications so I have been looking around for the best site to get one. Could you advise me please, where could i acquire some?
generic duphalac – cheap brahmi pill cheap betahistine 16mg
buy generic imusporin – purchase cyclosporine online gloperba generic
Thanks for another great article. Where else could anyone get that type of information in such a perfect way of writing? I’ve a presentation next week, and I am on the look for such info.
buy calcort paypal – purchase deflazacort for sale purchase alphagan sale
besifloxacin for sale online – carbocysteine for sale cheap sildamax generic
order gabapentin 800mg online – purchase nurofen pill azulfidine canada
Wow, marvelous blog layout! How long have you been blogging for? you make blogging look easy. The overall look of your website is magnificent, as well as the content!
benemid 500 mg brand – buy monograph 600mg online cheap how to get tegretol without a prescription
Hiya, I’m really glad I have found this information. Today bloggers publish just about gossips and web and this is actually irritating. A good web site with exciting content, that’s what I need. Thank you for keeping this web site, I’ll be visiting it. Do you do newsletters? Can not find it.
celecoxib cheap – celecoxib order online indocin uk
mebeverine order online – colospa order online order pletal 100mg online cheap
Very interesting details you have remarked, thankyou for posting.
diclofenac oral – buy aspirin 75 mg how to buy aspirin
Normally I do not read article on blogs, but I would like to say that this write-up very compelled me to check out and do it! Your writing style has been surprised me. Thank you, quite great article.
cost rumalaya – how to get amitriptyline without a prescription order endep for sale