FDAの医療機器センターであるCDRH（Center for Devices and Radiological Health）は、2020年後半に「Computer Software Assurance for Manufacturing, Operations and Quality Systems Software」（製造、運用、および品質システムソフトウェアのコンピュータソフトウェア保証）と呼ばれる新しいガイダンスドキュメントの発行をアナウンスしました。
このガイダンスはCDRHが主管していますが、ヒト用医薬品のセンターであるCDER（Center for Drug Evaluation and Research）およびバイオ医薬品のセンターであるCBER（Center for Biologics Evaluation and Research）も協力して活動しています。
さらに新ガイダンスの策定には、ISPEのGAMPワーキングチームも加わっています。
つまり医療機器のみならず、医薬品にも対応できるものとなる予定です。
これまで一般に医薬品企業や医療機器企業においては、IT化（自動化）が遅れてしまったり、またはITシステム（コンピュータシステム）の更新を躊躇する事例が多くありました。
その理由は何といってもCSV（Computerized System Validation）の実施が義務付けられてきたためです。
CSVでは、多くの文書化を実施しなければならず、医薬品企業や医療機器企業にとって労力、コスト、時間などの観点から、大きな負担になっていました。この負担から企業はIT化等の技術投資について消極的になっていました。
そもそもCSVにおける文書は、コンピュータシステムの品質保証のためというよりは、監査や当局査察に提示する目的で作成されてきました。
また、企業が費やしたコンプライアンスコストは薬価等に転嫁され、結果的には患者負担になっていました。
こういった問題点を解決すべく、新ガイダンスはこれまでのCSVにおける“煩雑さ”を取り除くものとなる見込みです。
また新ガイダンスは、1997年に施行された21 CFR Part 11 “Electronic Records; Electronic Signature”に代わる新しいコンピュータシステムにおけるFDA共通のガイダンスともなります。
新ガイダンスの適用範囲は、医薬品や医療機器の製造、測定・分析、品質システムの履行に使用するソフトウェアが対象となります。 品質システムの履行に使用するソフトウェアとは、具体的にはERP、LIMS（ラボデータベース）、LMS（教育管理システム）、EDMS（ドキュメント管理システム）、イベント管理システム（苦情・CAPA管理システム）などが相当します。
なお、製品としての医療機器に搭載されるソフトウェアや医療機器プログラムには適用されません。
新ガイダンスでは、FDAが2003年に発表したリスクベースドアプローチに加えて、クリティカルシンキングという概念も盛り込まれています。
このクリティカルシンキングと呼ばれる概念がCSAの核心となります。
コンピュータシステムで大事なことは、患者の安全性、データインテグリティ、製品の品質などを担保することです。
そのため、直接的ではなく、間接的にそれらに影響するシステム（例：教育管理システム）などはいたずらに文書数や文書量を増やす必要はありません。
例えば、必ずしもテストスクリプトを作成する必要はありません。大事なことはテスト結果を注視することです。
ただし、文書や記録がないということは、実施していないとみなされることになるという原則は変わりません。
また文書間におけるトレーサビリティマトリックスも依然として重要です。
本セミナーでは、CSVとCSAの相違点を分かりやすく解説いたします。
CSA（Computer Software Assurance）セミナー
1章 はじめに
2章 CSAの経緯
3章 医療機器におけるCSV要求
4章 CSA概要
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。
・CSA（Computer Software Assurance）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” ]
Thanks-a-mundo for the article.Thanks Again. Will read on…
major brand allergy pills list of otc allergy medications alphabetical list of allergy medications
where can i buy doxylamine phenergan price
deltasone cost deltasone online
common medications for nausea buy perindopril 4mg pills
prescription acne treatment products buy generic bactroban ointment online expensive acne medication
strongest otc allergy med buy astelin sprayer names of prescription allergy pills
best otc heartburn medicine reviews ramipril 5mg pill
isotretinoin cost accutane 40mg usa buy isotretinoin 20mg sale
order amoxil 500mg for sale amoxil tablet amoxil 1000mg cheap
best sleep aids for seniors provigil 200mg us
azithromycin online buy generic zithromax 500mg buy zithromax online
order neurontin 800mg sale neurontin price
buy azithromycin generic buy generic azipro buy azithromycin 250mg generic
buy lasix generic diuretic buy lasix online cheap
prednisolone 5mg oral buy omnacortil paypal omnacortil 5mg oral
amoxil for sale online buy amoxil sale amoxicillin for sale online
monodox generic acticlate tablet
order generic albuterol albuterol 2mg pill albuterol drug
amoxiclav brand brand amoxiclav
generic levothyroxine synthroid 100mcg without prescription levothroid pill
order generic vardenafil where can i buy levitra
tizanidine 2mg pills buy tizanidine online cheap buy generic tizanidine over the counter
order clomid 50mg buy clomiphene pill buy serophene pills
buy prednisone 10mg generic buy prednisone pill order prednisone generic
order rybelsus 14 mg pills buy semaglutide 14 mg without prescription order semaglutide for sale
buy isotretinoin online cheap buy generic isotretinoin 40mg order accutane 40mg generic
rybelsus 14 mg cheap rybelsus 14 mg generic order semaglutide 14 mg online
amoxil for sale order amoxicillin generic buy amoxicillin 250mg sale
albuterol 2mg drug order albuterol 2mg pills ventolin 2mg canada
order zithromax 500mg for sale purchase zithromax sale azithromycin 500mg ca
buy augmentin 375mg generic clavulanate price buy augmentin 375mg for sale
order omnacortil 20mg generic prednisolone 20mg usa where to buy prednisolone without a prescription
levoxyl pills cheap levoxyl tablets purchase levothroid pill
order neurontin 100mg buy neurontin 600mg generic buy neurontin sale
clomiphene 50mg brand clomid 50mg tablet clomid 50mg price
buy furosemide 40mg online cheap order furosemide 40mg online cheap buy furosemide 40mg for sale
buy viagra online cheap viagra 50mg canada sildenafil citrate
doxycycline order online order generic doxycycline 200mg order acticlate pill
rybelsus 14 mg canada rybelsus cost buy generic semaglutide 14mg
play roulette free for fun casino play free slot games online
buy vardenafil no prescription generic vardenafil 10mg vardenafil 10mg pill
buy lyrica pills generic lyrica 75mg pregabalin 150mg ca
order hydroxychloroquine 400mg pills hydroxychloroquine order online hydroxychloroquine 400mg pills
buy aristocort pill order aristocort 10mg generic triamcinolone over the counter
prices of cialis cialis next day delivery order cialis generic
order desloratadine generic desloratadine pills buy clarinex 5mg online
cenforce cost buy cenforce for sale cenforce brand
loratadine 10mg generic claritin without prescription buy claritin
buy chloroquine pills where to buy aralen without a prescription chloroquine uk
priligy 60mg tablet buy dapoxetine for sale cheap cytotec
glucophage 1000mg tablet glucophage 500mg cheap glucophage cost
order orlistat 120mg generic diltiazem over the counter purchase diltiazem online
glucophage 1000mg tablet buy glucophage for sale glycomet 1000mg for sale
buy generic acyclovir for sale buy zovirax without prescription buy allopurinol 300mg without prescription
atorvastatin 80mg drug lipitor 80mg brand atorvastatin brand
cheap amlodipine buy norvasc 5mg generic norvasc brand
crestor 20mg usa buy crestor without prescription buy generic zetia 10mg
lisinopril 2.5mg cost buy lisinopril 10mg generic buy zestril 5mg online cheap
motilium 10mg oral sumycin 500mg generic cost sumycin 500mg
prilosec 20mg without prescription purchase omeprazole online cheap buy prilosec medication
flexeril canada buy ozobax online cheap lioresal for sale online
buy generic metoprolol lopressor tablet cost lopressor 50mg
toradol generic ketorolac uk colchicine for sale
order atenolol generic order atenolol pill order tenormin 100mg online
generic depo-medrol online methylprednisolonee online buy depo-medrol paypal
order generic inderal 10mg order inderal 10mg sale clopidogrel 75mg cheap
essays writing academia writers write my paper for me
order methotrexate 10mg without prescription buy warfarin online cheap warfarin 5mg uk
buy metoclopramide 20mg generic cozaar medication buy cozaar tablets
brand meloxicam purchase mobic celebrex sale
order esomeprazole 40mg buy esomeprazole pills for sale buy topamax without a prescription
order flomax 0.2mg pills buy flomax 0.4mg for sale celebrex tablet
imitrex 25mg generic levaquin 500mg for sale buy generic levaquin
zofran tablet spironolactone medication spironolactone price
avodart 0.5mg oral purchase zantac pill zantac usa
order zocor 10mg sale buy zocor cheap cheap valacyclovir
oral ampicillin order amoxicillin generic order amoxicillin generic
proscar 5mg without prescription order proscar 5mg online cheap forcan
buy ciprofloxacin 500mg online – septra ca amoxiclav without prescription
buy cipro 500mg without prescription – buy augmentin generic buy augmentin pills for sale
ciplox over the counter – order chloramphenicol for sale erythromycin 500mg oral
buy generic flagyl 400mg – how to buy cleocin buy generic azithromycin
stromectol over the counter – suprax order tetracycline 250mg pill
order valacyclovir 500mg generic – starlix online buy buy zovirax sale
purchase ampicillin generic purchase penicillin generic amoxil online buy
order flagyl 400mg sale – flagyl 200mg usa azithromycin 250mg uk
order lasix online cheap – prograf usa buy captopril generic
order glycomet 1000mg generic – oral baycip buy generic lincocin
retrovir 300 mg canada – buy zyloprim sale cost zyloprim 100mg
oral clozaril 100mg – amaryl 4mg usa famotidine online order
seroquel price – sertraline order eskalith drug
clomipramine 50mg cost – order sinequan 75mg sale cost doxepin 25mg
order hydroxyzine online cheap – sarafem buy online order generic endep 25mg
order amoxiclav pill – zyvox 600mg tablet order cipro pills
buy amoxil without a prescription – buy generic amoxicillin 250mg purchase ciprofloxacin online
azithromycin 500mg pills – azithromycin without prescription order ciplox sale
clindamycin oral – suprax 100mg oral chloromycetin over the counter
generic stromectol – order cefaclor 250mg online cheap buy cefaclor 500mg for sale
albuterol ca – allegra 120mg price theophylline order online
methylprednisolone for sale online – how to buy fluorometholone astelin price
purchase clarinex pill – order flixotide nasal spray buy albuterol 2mg generic
micronase pills – buy actos 15mg buy generic dapagliflozin
cost glucophage 500mg – buy precose sale acarbose 25mg cost
buy prandin generic – order empagliflozin order empagliflozin 10mg sale
order semaglutide 14mg – buy desmopressin online cheap purchase DDAVP sale
lamisil 250mg over the counter – terbinafine ca grifulvin v for sale
ketoconazole 200 mg pill – lotrisone over the counter itraconazole us
famciclovir tablet – buy acyclovir 800mg generic buy valaciclovir cheap
digoxin 250mg price – order calan 120mg generic lasix 100mg us
metoprolol cheap – purchase metoprolol generic how to get adalat without a prescription
microzide 25 mg over the counter – order zebeta 5mg pills order zebeta without prescription
nitroglycerin uk – order nitroglycerin pills diovan 160mg cost
simvastatin fury – simvastatin unexpected atorvastatin pain
crestor pills eye – zetia buy ridiculous caduet buy freedom
viagra professional online colour – levitra oral jelly online flight levitra oral jelly online finger
priligy scarce – zudena grotesque cialis with dapoxetine dragon
cenforce linger – cialis daily brand viagra pills comfort
brand cialis temper – viagra soft tabs remember penisole grin
brand cialis pardon – zhewitra slide penisole fortunate
cialis soft tabs spoon – viagra oral jelly yield viagra oral jelly online may
cialis soft tabs online regard – caverta capital viagra oral jelly online ceremony
priligy curious – levitra with dapoxetine tower cialis with dapoxetine council
cenforce fruit – kamagra stroll brand viagra online sort
asthma medication provide – asthma treatment choice asthma treatment future
acne medication corpse – acne medication jerk acne medication blanket
prostatitis treatment cap – pills for treat prostatitis flicker pills for treat prostatitis cellar
treatment for uti desk – uti antibiotics pet treatment for uti bow
loratadine medication injury – claritin wife loratadine health
valtrex online lurk – valacyclovir pills science valtrex online passion
priligy ireland – priligy explore dapoxetine child
claritin breathless – claritin pills trace claritin pills sea
ascorbic acid quiet – ascorbic acid further ascorbic acid sink
promethazine soft – promethazine range promethazine least
clarithromycin fever – cytotec square cytotec yell
florinef press – nexium lodge prevacid scrap
purchase aciphex without prescription – reglan 20mg cheap order domperidone 10mg generic
order generic bisacodyl – pill imodium 2mg liv52 10mg generic
order zovirax creams – duphaston 10 mg sale brand dydrogesterone 10mg
bactrim 480mg tablet – cotrimoxazole oral tobramycin usa
how to buy griseofulvin – dipyridamole online order order lopid sale
forxiga 10 mg for sale – order sinequan 25mg for sale order generic precose 50mg
order dramamine 50mg for sale – buy dramamine 50mg online purchase risedronate online cheap
order enalapril 5mg sale – vasotec 10mg ca where to buy zovirax without a prescription
buy etodolac 600mg without prescription – monograph uk buy cilostazol 100mg sale
purchase feldene – rivastigmine 3mg canada exelon 6mg generic
nootropil 800mg generic – order generic levaquin 250mg sinemet 10mg pill
hydrea pills – buy trental medication buy generic methocarbamol over the counter
depakote 500mg us – depakote 250mg generic topamax 100mg cost
norpace tablet – buy cheap generic norpace buy thorazine sale
buy aldactone – dosulepin sale naltrexone 50 mg pill
cyclophosphamide canada – order strattera 25mg generic vastarel for sale online
flexeril 15mg for sale – cyclobenzaprine sale order enalapril 10mg generic
order zofran 4mg sale – cheap oxybutynin generic requip over the counter
ascorbic acid where to buy – how to buy ascorbic acid buy prochlorperazine tablets
order durex gel sale – durex condoms where to order brand xalatan
buy generic rogaine – order rogaine purchase propecia sale
purchase arava generic – cartidin medication cartidin for sale online
buy verapamil 120mg without prescription – cheap tenoretic pill buy tenoretic sale
tenormin 100mg brand – where can i buy carvedilol buy coreg without a prescription
atorvastatin for sale – order bystolic 20mg online cheap where to buy nebivolol without a prescription
order gasex for sale – ashwagandha tablet how to buy diabecon
buy lasuna without a prescription – himcolin oral himcolin online
order norfloxacin without prescription – buy noroxin paypal confido over the counter
finasteride tablet – buy doxazosin without a prescription alfuzosin 10mg cheap
buy speman paypal – buy speman generic buy fincar pill
hytrin tablet – order terazosin 5mg generic dapoxetine 30mg cheap
trileptal 600mg price – pirfenex online order cost levothyroxine
buy cheap cyclosporine – where can i buy imusporin order colcrys 0.5mg generic
order duphalac generic – lactulose price buy betahistine 16mg generic
cheap calcort – deflazacort oral brimonidine cheap
purchase besifloxacin without prescription – besivance price sildamax for sale
neurontin 800mg uk – ibuprofen 400mg cheap cost sulfasalazine
benemid price – buy benemid without a prescription purchase tegretol generic
celecoxib for sale online – order flavoxate without prescription indocin 50mg ca
mebeverine usa – buy colospa online cheap pletal 100mg over the counter
buy voltaren generic – aspirin buy online aspirin 75mg drug
buy rumalaya online cheap – endep 10mg pills buy endep 50mg pills
mestinon for sale online – order imitrex 50mg generic buy azathioprine 25mg generic
diclofenac drug – cheap diclofenac generic buy nimodipine pills for sale
baclofen 10mg oral – feldene 20mg cost buy cheap generic feldene
buy generic mobic for sale – order maxalt 10mg without prescription buy toradol tablets
buy generic cyproheptadine for sale – order generic tizanidine tizanidine 2mg drug
buy artane pills for sale – buy generic artane purchase emulgel for sale
cheap cefdinir 300mg – how to get omnicef without a prescription clindamycin price
order xeloda without prescription – order naproxen 500mg generic order danazol 100 mg pills
order progesterone 200mg pill – clomid 100mg pills buy fertomid pills
fosamax 35mg generic – fosamax 35mg canada order medroxyprogesterone 5mg generic
buy aygestin for sale – buy generic lumigan yasmin order online
Hi there! Do you know if they make any plugins to assist with Search Engine Optimization? I’m
trying to get my website to rank for some targeted keywords
but I’m not seeing very good results. If you know of any please share.
Thank you! I saw similar art here: Warm blankets
buy cabergoline paypal – order premarin 0.625mg generic buy alesse tablets
estradiol 1mg cheap – buy ginette 35 pills buy anastrozole 1 mg pill