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-md/ title=”QMS（手順書）ひな形 医療機器関連” ]
best allergy pills for adults alternative to antihistamine for allergy strongest otc allergy med
strongest sleeping pills uk modafinil pills
order deltasone 20mg pills prednisone 40mg brand
strongest heartburn medicine order coversyl 4mg sale
acne medications list order dapsone 100mg pill teenage acne treatments that work
best allergy pill for itching purchase seroflo without prescription otc allergy medication comparison chart
does advil help stomach aches heartburn medications over the counter
order accutane for sale absorica order online accutane for sale
prescription sleeping pills online order provigil sale
amoxil usa amoxil 500mg without prescription amoxil 250mg cost
buy zithromax paypal zithromax 500mg cost buy azithromycin 250mg online cheap
gabapentin buy online neurontin over the counter
buy azipro pills order azipro pill azipro for sale
buy furosemide paypal buy furosemide tablets
prednisolone 10mg sale prednisolone 10mg drug omnacortil 20mg without prescription
cheap amoxil without prescription buy amoxil 250mg online amoxil 500mg oral
buy doxycycline 200mg online purchase vibra-tabs online
order ventolin 2mg albuterol over the counter buy ventolin tablets
augmentin 1000mg cheap order augmentin pill
synthroid 100mcg usa buy levothyroxine paypal order synthroid online
levitra for sale vardenafil 10mg without prescription
order clomiphene 100mg clomiphene order purchase clomiphene generic
brand tizanidine 2mg zanaflex cheap tizanidine 2mg us
semaglutide 14mg sale oral rybelsus 14 mg generic semaglutide 14 mg
deltasone pill prednisone 40mg sale deltasone 5mg without prescription
buy rybelsus 14mg buy generic rybelsus semaglutide without prescription
order accutane 10mg generic buy isotretinoin 40mg without prescription order isotretinoin 20mg generic
order amoxil amoxicillin 250mg uk amoxil tablets
purchase albuterol inhaler albuterol brand order ventolin 2mg sale
zithromax pills zithromax 250mg tablet zithromax 500mg ca
buy augmentin 625mg for sale order augmentin online cheap augmentin 1000mg sale
buy prednisolone online omnacortil 20mg pills buy omnacortil 20mg pills
purchase levothroid generic buy levothyroxine generic purchase levothroid online
neurontin 100mg without prescription order gabapentin generic order neurontin 600mg sale
serophene online order purchase clomiphene sale purchase clomid generic
lasix online order purchase furosemide generic buy lasix 40mg generic
viagra 50mg ca buy sildenafil pills buy viagra 100mg pill
buy generic doxycycline 200mg purchase monodox pill order doxycycline 100mg online
buy rybelsus 14mg generic buy semaglutide 14 mg pill semaglutide 14mg for sale
online gambling slots games online black jack real money spins
buy vardenafil online vardenafil 20mg for sale levitra 20mg tablet
buy lyrica 150mg online lyrica brand lyrica oral
hydroxychloroquine without prescription buy plaquenil pill order hydroxychloroquine 200mg for sale
aristocort 10mg sale buy cheap aristocort triamcinolone order
buy tadalafil 5mg pills buy tadalafil sale tadalafil brand name
desloratadine price order clarinex generic desloratadine ca
cenforce 50mg tablet order generic cenforce order cenforce 50mg generic
buy loratadine no prescription order claritin online claritin 10mg brand
chloroquine online order order generic chloroquine chloroquine uk
buy priligy for sale cytotec 200mcg pills order generic misoprostol
glucophage 500mg tablet buy metformin 500mg online cheap buy glucophage generic
xenical 60mg sale buy diltiazem 180mg generic diltiazem
zovirax price generic allopurinol 300mg buy generic zyloprim
buy cheap generic amlodipine buy norvasc 5mg sale buy norvasc without prescription
buy generic crestor 10mg crestor us generic zetia
zestril order online order lisinopril 2.5mg for sale order zestril 10mg sale
motilium 10mg price buy domperidone tablets tetracycline 250mg brand
how to get prilosec without a prescription order prilosec without prescription order omeprazole 10mg sale
buy generic flexeril 15mg cyclobenzaprine ca baclofen 10mg without prescription
brand lopressor 50mg metoprolol 100mg pill order metoprolol 100mg online cheap
order toradol generic toradol pill order colcrys 0.5mg generic
tenormin 50mg brand buy atenolol paypal cheap tenormin 50mg
medrol 16 mg for sale depo-medrol canada buy methylprednisolone
buy inderal 10mg pills how to get propranolol without a prescription order plavix 150mg pill
thesis writer write me a paper websites to write essays
methotrexate price warfarin buy online warfarin tablet
order metoclopramide 20mg pill order generic maxolon cozaar 50mg oral
meloxicam pill meloxicam 7.5mg generic celecoxib usa
flomax 0.4mg oral tamsulosin over the counter buy celecoxib 200mg sale
nexium 40mg us order topiramate 200mg order topamax pill
buy imitrex 25mg pill buy imitrex medication buy generic levaquin
zofran ca ondansetron 8mg cheap order aldactone generic
avodart 0.5mg uk zantac 150mg ca oral ranitidine
zocor 10mg pill order simvastatin 20mg without prescription buy valacyclovir without prescription
buy proscar online cheap diflucan where to buy where can i buy fluconazole
buy acillin without a prescription purchase amoxicillin pills order amoxil pill
cipro 500mg pills – buy amoxiclav online cheap augmentin tablet
ciprofloxacin generic – buy cephalexin paypal cost amoxiclav
buy cheap ciplox – ciprofloxacin price erythromycin buy online
where can i buy flagyl – oxytetracycline usa buy azithromycin 500mg online
stromectol tablets – buy cheap generic sumycin order generic sumycin 250mg
stromectol 3mg online – cheap sumycin generic order sumycin 500mg
buy valtrex 500mg for sale – buy valacyclovir paypal order acyclovir 400mg without prescription
buy generic ampicillin over the counter order amoxicillin for sale amoxicillin online order
buy generic flagyl online – purchase amoxil order zithromax 250mg generic
lasix order – purchase prograf generic buy captopril 25mg for sale
order generic glucophage 500mg – buy generic epivir buy lincomycin without prescription
clozaril us – cost glimepiride famotidine pills
pill zidovudine – buy cheap generic rulide buy allopurinol 300mg online
buy anafranil for sale – citalopram order online buy generic sinequan 25mg
quetiapine 50mg price – geodon where to buy purchase eskalith generic
hydroxyzine 25mg for sale – buy generic amitriptyline online order endep 10mg for sale
buy augmentin cheap – ciprofloxacin pills cipro 1000mg ca
buy amoxicillin online cheap – order duricef online cipro where to buy
azithromycin 250mg brand – order metronidazole 200mg online cheap order generic ciplox 500 mg
buy clindamycin no prescription – cefixime uk order chloramphenicol online
ivermectin 6mg otc – generic levaquin 250mg cefaclor cost
brand ventolin 4mg – fluticasone drug buy theo-24 Cr 400mg online cheap
methylprednisolone 16 mg otc – order loratadine 10mg pills buy astelin 10ml generic
order generic clarinex – buy generic triamcinolone for sale ventolin 4mg inhaler
glycomet 500mg cost – order precose 25mg online cheap order acarbose 25mg without prescription
buy cheap micronase – glucotrol pills forxiga 10mg us
where to buy semaglutide without a prescription – oral glucovance buy DDAVP sale
buy generic lamisil over the counter – forcan cheap buy griseofulvin for sale
order famvir 250mg for sale – famvir ca order valaciclovir online cheap
ketoconazole cost – buy itraconazole online cheap sporanox 100 mg over the counter
digoxin cost – buy digoxin 250mg without prescription buy generic lasix 100mg
lopressor pills – buy losartan online cost adalat
microzide 25mg without prescription – order microzide 25mg generic buy bisoprolol 10mg
nitroglycerin price – clonidine 0.1 mg ca buy diovan for sale
simvastatin jaw – fenofibrate notion lipitor convince
rosuvastatin online unlike – crestor online gold caduet buy perform
dapoxetine buzz – fildena steady cialis with dapoxetine duke
buy viagra professional object – viagra gold online concern levitra oral jelly online pit
brand cialis feature – tadora plain penisole wand
buy cheap generic cenforce – tadacip license brand viagra online grey
brand cialis focus – zhewitra limp penisole pit
cialis soft tabs pills appearance – viagra super active poke viagra oral jelly pillar
cialis soft tabs online phone – valif pills survey viagra oral jelly release
priligy harmony – sildigra career cialis with dapoxetine slam
cenforce online bend – cialis medication brand viagra online prevent
asthma treatment flush – inhalers for asthma ice asthma medication although
acne treatment school – acne treatment company acne treatment panic
pills for treat prostatitis confirm – prostatitis treatment approach pills for treat prostatitis principle
uti medication electric – treatment for uti flesh treatment for uti flicker
claritin dip – claritin tunnel loratadine medication invisible
valacyclovir repeat – valtrex pills citizen valtrex pills kick
dapoxetine compare – priligy forever dapoxetine gratitude
claritin drawer – claritin robot claritin treasure
ascorbic acid vain – ascorbic acid time ascorbic acid bubble
promethazine crystal – promethazine september promethazine riddle
biaxin captain – albendazole pills touch cytotec stain
fludrocortisone pills save – esomeprazole pills tent prevacid pills abyss
how to get aciphex without a prescription – how to buy reglan motilium for sale
aciphex 20mg ca – cheap aciphex 10mg buy domperidone 10mg for sale
buy generic bisacodyl – order oxybutynin 5mg for sale liv52 10mg cheap
buy zovirax – hydroquinone over the counter cheap duphaston 10mg
buy cotrimoxazole paypal – buy bactrim 960mg sale tobramycin for sale online
fulvicin 250mg without prescription – buy fulvicin no prescription order lopid 300mg for sale
forxiga 10 mg brand – precose 50mg for sale purchase acarbose online cheap
buy dimenhydrinate sale – cost actonel 35 mg order actonel 35 mg
enalapril pills – latanoprost eye drops order xalatan eye drops
buy etodolac 600 mg generic – etodolac cost buy generic cilostazol online
piroxicam sale – buy generic rivastigmine buy exelon paypal
order nootropil 800mg generic – levaquin 500mg without prescription purchase sinemet online
buy generic hydroxyurea – buy trental generic cheap methocarbamol
buy divalproex 250mg online – order acetazolamide 250mg generic buy generic topamax online
disopyramide phosphate online order – buy disopyramide phosphate online cheap buy chlorpromazine
aldactone pill – revia 50mg uk revia 50 mg ca
cheap cyclophosphamide sale – cost meclizine 25 mg vastarel where to buy
cost cyclobenzaprine – brand cyclobenzaprine 15mg vasotec pills
buy ascorbic acid online – buy bromhexine online cheap buy compro tablets
buy ondansetron 8mg without prescription – buy cheap generic oxybutynin buy requip 1mg without prescription
purchase cheap durex gel – buy xalatan generic where can i buy zovirax
buy rogaine no prescription – dutas over the counter proscar cheap
order generic arava 10mg – alfacalcidol buy online cartidin pills
order calan pill – cheap tenoretic without prescription order tenoretic for sale
buy atenolol pills for sale – cheap sotalol 40mg buy carvedilol online
purchase gasex online cheap – purchase gasex pills order diabecon generic
buy atorlip online cheap – order nebivolol 20mg sale bystolic canada
lasuna for sale online – purchase lasuna pill himcolin order
buy noroxin medication – how to buy noroxin cheap confido online
buy generic finasteride for sale – buy kamagra 100mg order alfuzosin 10mg for sale
order speman online – cheap generic finasteride buy fincar paypal
buy hytrin 5mg generic – buy generic terazosin over the counter priligy 90mg generic
buy trileptal 300mg pills – levothroid oral order synthroid 100mcg generic
order generic imusporin – buy cyclosporine generic colcrys tablet
purchase lactulose bottless – duphalac without prescription buy betahistine sale
cost deflazacort – alphagan over the counter buy alphagan sale
besifloxacin where to buy – sildamax tablet sildamax canada
buy gabapentin 100mg without prescription – buy ibuprofen without prescription azulfidine ca
benemid 500 mg brand – order carbamazepine 400mg pills order generic carbamazepine
celebrex price – buy generic celebrex online oral indomethacin 50mg
mebeverine medication – oral mebeverine 135mg pletal drug
diclofenac sale – brand aspirin order aspirin 75 mg generic
order rumalaya generic – buy rumalaya paypal order endep 50mg generic
mestinon 60 mg without prescription – azathioprine 25mg ca azathioprine us
cheap diclofenac online – order isosorbide 20mg without prescription nimotop medication
buy lioresal online cheap – baclofen order online feldene order online
buy mobic 7.5mg without prescription – mobic pills order toradol 10mg without prescription
cyproheptadine order – oral cyproheptadine 4 mg tizanidine 2mg usa
cheap trihexyphenidyl pills – purchase trihexyphenidyl where can i buy emulgel
order omnicef 300 mg generic – buy cleocin generic buy clindamycin generic
isotretinoin 20mg generic – order deltasone generic cost deltasone 10mg
order prednisone 10mg – buy prednisone online cheap elimite tubes
betnovate 20 gm cost – betnovate cream buy benoquin for sale
flagyl 200mg oral – buy cenforce 50mg pill order cenforce generic
augmentin usa – purchase synthroid generic order levothyroxine pills
clindamycin cost – indomethacin 75mg uk buy indocin paypal
order losartan 25mg online cheap – cephalexin 250mg cheap cephalexin 125mg pills
brand crotamiton – order aczone sale aczone medication
provigil cost – buy meloset 3mg where to buy melatonin without a prescription
bupropion pill – zyban pills shuddha guggulu drug
xeloda for sale online – buy generic naprosyn online order danocrine 100 mg without prescription
prometrium 100mg canada – clomiphene oral cheap clomiphene pill
order alendronate online cheap – alendronate 70mg oral order provera 10mg for sale
order aygestin without prescription – buy lumigan without prescription order yasmin generic
brand estrace – order anastrozole 1mg generic order arimidex
order generic dostinex – buy cabgolin tablets order generic alesse
Hi there! Do you know if they make any plugins to assist 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. Cheers! You can read similar article
here: Eco blankets