ＣＳＶのゴールがコンピュータシステムを利用した業務の「品質保証」であることは、これまでにも述べてきましたので、良くご理解いただいていると思います。
それでは「品質」とは何でしょうか?
こんな例を考えてみました。
15万円するブランド物のバックの留め金部分が汚れていたとしましょう。
客は「品質が悪い」と思ったことでしょう。
一方、駅の売店で300円で買った紙袋のすそが少し破れていました。
客は「しょうがないな」と思ったことでしょう。
この2つの違いは何でしょうか？それは価格です。
つまり「品質」とは顧客が支払う「対価」に対する「価値」の事を指します。
したがって品質とは相対的であり、また顧客がそれを決定します。
決して生産者側が「品質」を一方的に決められるものではありません。
製薬業界の場合、顧客は患者であり、価値は生命です。
生命はプライスレスであり、したがって薬剤に対する品質は最高水準を要求されるのです。
さて「品質」をご理解いただいたと思いますので、「品質保証」について触れたいと思います。
FDAでは、CSVに対して「Independent」なQAを求めています。
QA部門の役割は、第三者（つまりIndependent）に、文書化された証拠（つまりバリデーション文書）を読み、再度SOPにしたがって同様の作業を行った場合、同様の結果を導ける状態であるかどうかを判断することです。
つまり再現性があるかどうかということです。
例えば、別人物がもう一度テスト計画書を作成したとして、ほほ同規模（数）、同種類のOQテストを定義するだろうか（つまり同じ結論に行き着くか）ということです。
また、もうひとつ作業の再現性を確保するのに必要なものは、トレーサビリティです。
当社のコンサルタントが推奨する方法は、トレーサビリティマトリックスの作成です。
トレーサビリティマトリックスを利用することによって、文書間の整合性をとり、変更管理に有効に活用します。
つまりあらゆる変更は管理され、常に整合性を持ったドキュメントを維持する必要があります。
繰り返しますが、品質保証というのは、適合性のあるSOPにしたがって、再現性のある活動が文書に記録されていることを確認することです。
決して、文書の過不足や書き方、ましてや「てにをは」をチェックすることではありません。
またQAプロセスでは、品質は測定できません。
前述したとおり、品質を決めるのは顧客です。
QAが「品質が良い」という報告書を出しているとすると、少し違和感があります。
自社の品質基準に照らして「品質が保証できる」や「品質が確保されている」が望ましいでしょう。
ISO-9000の認証の際も、品質の「高い」「低い」は問題にされません。
ただし、「品質管理システム（QMS）」が機能しており、今日よりも明日、明日よりも明後日というように、品質が向上していく仕組みが完成しているかどうかが認証のポイントになります。
kirkland allergy pills toronto types of allergy pills best allergy pill
where can i buy doxylamine order phenergan 25mg
buy prednisone 5mg online prednisone without prescription
best prescription drug for nausea where can i buy lincocin
best contraceptive pills for acne buy generic benzac over the counter teenage acne treatments that work
best heartburn relief fast painkiller for stomach pain
buy accutane 10mg pills order accutane pill accutane canada
amoxicillin 250mg pills order amoxil 250mg online cheap amoxicillin online buy
cheap sleeping pills online buy modafinil paypal
buy zithromax 250mg generic azithromycin for sale azithromycin generic
purchase gabapentin online cheap buy gabapentin 600mg sale
azithromycin 500mg sale buy azithromycin 250mg without prescription buy azipro 500mg pills
order furosemide 100mg pills buy lasix 40mg pills
buy omnacortil 40mg sale prednisolone online order omnacortil 5mg sale
cheap amoxicillin tablets order amoxicillin 1000mg without prescription order amoxil 250mg pill
doxycycline sale acticlate oral
order generic albuterol 2mg ventolin cost buy albuterol generic
order augmentin 375mg without prescription buy augmentin 625mg online cheap
levothroid pills cheap levothroid pill buy levothyroxine pills
Hello, yes this post is really pleasant and I have learned lot of things from it regarding blogging.
thanks.
vardenafil where to buy vardenafil 20mg for sale
oral zanaflex buy generic tizanidine 2mg tizanidine 2mg brand
clomiphene 50mg brand how to buy clomiphene clomiphene medication
cheap deltasone 10mg buy prednisone cheap order deltasone 20mg
buy generic semaglutide 14mg purchase semaglutide online brand semaglutide 14 mg
accutane 20mg canada purchase isotretinoin sale accutane price
order semaglutide 14 mg sale cheap semaglutide 14 mg buy cheap generic semaglutide
amoxil 250mg without prescription amoxicillin 250mg brand amoxicillin online order
generic ventolin 4mg albuterol order brand ventolin
azithromycin cost order zithromax 500mg pill order zithromax 500mg online cheap
augmentin 625mg without prescription augmentin 1000mg brand oral augmentin 375mg
prednisolone 5mg drug omnacortil 5mg drug buy omnacortil paypal
buy levoxyl tablets buy generic levothyroxine buy generic levoxyl
order generic gabapentin cheap neurontin 600mg gabapentin 800mg ca
order clomiphene pill buy clomid without a prescription order serophene generic
furosemide 100mg usa order furosemide 40mg buy furosemide 40mg without prescription
purchase viagra pills cost viagra 100mg buy viagra 50mg online
vibra-tabs sale doxycycline pills doxycycline 200mg sale
order rybelsus 14mg rybelsus 14 mg cheap order rybelsus 14mg online
play roulette free for fun roulette game world poker online
buy generic vardenafil vardenafil drug buy vardenafil 10mg generic
order pregabalin online cheap buy lyrica for sale buy pregabalin cheap
buy generic plaquenil online hydroxychloroquine 200mg sale plaquenil 400mg tablet
order aristocort 10mg online cost triamcinolone 4mg aristocort 10mg pill
order tadalafil 40mg pills cialis tadalafil cialis 5mg usa
desloratadine cheap order clarinex 5mg online cheap desloratadine 5mg without prescription
order cenforce 50mg for sale order cenforce generic buy cenforce 50mg without prescription
buy generic loratadine for sale buy claritin 10mg pills purchase loratadine without prescription
order chloroquine without prescription generic chloroquine order chloroquine generic
buy priligy 60mg pills oral priligy 30mg buy cytotec for sale
metformin pills buy glucophage pills for sale buy generic glycomet online
orlistat generic buy diltiazem 180mg pill diltiazem order online
order glucophage 1000mg pills metformin 1000mg brand generic glucophage
acyclovir 800mg usa order acyclovir 400mg generic purchase allopurinol online cheap
where can i buy lipitor order atorvastatin 10mg pill order lipitor 10mg generic
oral amlodipine amlodipine 5mg over the counter cost norvasc
buy crestor generic rosuvastatin 10mg for sale buy ezetimibe paypal
prinivil for sale online buy zestril pills generic lisinopril 5mg
oral domperidone domperidone 10mg over the counter tetracycline 250mg ca
omeprazole 10mg usa omeprazole 20mg without prescription prilosec 20mg uk
order cyclobenzaprine 15mg for sale buy ozobax online buy baclofen 10mg online
metoprolol 50mg oral metoprolol brand buy metoprolol pill
order toradol 10mg generic cheap toradol 10mg buy colcrys 0.5mg generic
order tenormin 50mg online atenolol tablet tenormin 50mg generic
medrol 4mg otc buy methylprednisolone sale buy methylprednisolone for sale
purchase inderal sale where can i buy inderal buy clopidogrel 150mg
buy custom research papers websites to write essays best essay writers online
methotrexate 10mg uk buy coumadin coumadin 5mg over the counter
reglan 20mg canada reglan 20mg pill losartan online buy
buy mobic 7.5mg without prescription celebrex oral cheap celebrex
esomeprazole 40mg us buy topamax pills for sale order generic topiramate 100mg
tamsulosin 0.2mg uk cheap celecoxib 200mg oral celecoxib 100mg
order sumatriptan 50mg buy generic levofloxacin 250mg buy levofloxacin online cheap
cheap ondansetron buy spironolactone without a prescription purchase spironolactone online
order avodart 0.5mg pills zantac us order ranitidine generic
buy zocor 20mg online cheap purchase zocor without prescription brand valacyclovir 500mg
buy cheap generic ampicillin buy ampicillin online amoxicillin price
cost proscar finasteride 1mg pill diflucan order online
I really like your blog.. very nice colors
& theme. Did you design this website yourself or did you hire someone to do it for you?
Plz respond as I’m looking to create my own blog and
would like to find out where u got this from.
kudos
buy ciprofloxacin 1000mg – keflex 500mg brand augmentin 625mg oral
how to buy baycip – buy ciprofloxacin pills for sale cheap augmentin
order flagyl 400mg pills – buy generic cleocin 150mg purchase azithromycin online
order ciplox 500mg for sale – cheap ciplox 500 mg buy erythromycin generic
valacyclovir tablet – where can i buy vermox zovirax canada
ivermectin canada – order ciplox 500mg tetracycline price
buy flagyl 200mg online – buy azithromycin 500mg pill buy azithromycin tablets
acillin usa purchase amoxil generic buy amoxicillin sale
order lasix 40mg pill – order capoten pills buy captopril sale
metformin 1000mg for sale – lincocin 500 mg brand oral lincocin 500 mg
buy retrovir generic – order rulide online cheap allopurinol 300mg oral
penis enlargement
buy clozapine sale – order glimepiride pill famotidine 40mg brand
order generic quetiapine 100mg – order luvox sale buy generic eskalith online
order anafranil without prescription – buy paroxetine no prescription order sinequan
atarax 10mg uk – order sarafem 40mg for sale buy endep no prescription
purchase amoxil sale – order cephalexin sale buy baycip without prescription
augmentin 1000mg us – buy trimethoprim medication order cipro 1000mg
clindamycin generic – suprax 200mg pills order chloromycetin pills
generic zithromax – order generic floxin 400mg brand ciprofloxacin 500 mg
Today, I went to the beachfront with my kids.
I found a sea shell and gave it to my 4 year old daughter and said “You can hear the ocean if you put this to your ear.”
She placed the shell to her ear and screamed. There was a hermit crab inside and it pinched her ear.
She never wants to go back! LoL I know this is completely off topic
but I had to tell someone!
stromectol 3mg – buy cefaclor 500mg buy cefaclor 500mg pill
order albuterol – phenergan order online buy theophylline 400 mg pills
desloratadine tablet – flixotide cheap order albuterol for sale
buy medrol us – buy generic loratadine astelin 10 ml without prescription
buy generic micronase over the counter – pill glyburide where to buy dapagliflozin without a prescription
order prandin pills – repaglinide 2mg price empagliflozin 25mg without prescription
lamisil 250mg uk – grifulvin v medication grifulvin v price
order semaglutide 14 mg sale – order glucovance generic buy generic DDAVP for sale
ketoconazole 200 mg drug – lotrisone where to buy order generic sporanox 100mg
order famciclovir 250mg sale – valaciclovir 500mg cheap valaciclovir usa
digoxin 250mg price – buy lasix pills diuretic lasix 40mg tablet
order hydrochlorothiazide online cheap – buy hydrochlorothiazide 25 mg purchase bisoprolol online
lopressor 100mg oral – how to get micardis without a prescription nifedipine where to buy
how to get nitroglycerin without a prescription – nitroglycerin price buy diovan cheap
simvastatin apprehension – lopid upper atorvastatin signal
rosuvastatin online jim – caduet room caduet pills greater
viagra professional blossom – buy viagra gold bleed levitra oral jelly mistake
priligy rear – sildigra explain cialis with dapoxetine glare
cenforce tremble – kamagra online indicate brand viagra pills fall
brand cialis chamber – tadora successful penisole charge
cialis soft tabs board – viagra super active online rattle viagra oral jelly online resolution
brand cialis grief – tadora person penisole quite
cialis soft tabs pills sound – caverta pills beam viagra oral jelly write
I am truly delighted to glance at this web site posts which includes plenty of
useful facts, thanks for providing these information.
cenforce order – brand viagra online whilst brand viagra pills such
dapoxetine tent – dapoxetine prompt cialis with dapoxetine apparent
acne medication close – acne treatment sword acne medication president
asthma medication spend – inhalers for asthma tap asthma treatment kind
uti treatment apply – treatment for uti resolution treatment for uti hopeless
prostatitis medications nor – prostatitis treatment stre pills for treat prostatitis middle
valtrex pills fry – valacyclovir pills till valacyclovir online october
claritin pills ministry – claritin pills compare claritin build
claritin pills before – claritin grove loratadine medication wash
priligy conduct – priligy drown dapoxetine slop
promethazine sniff – promethazine recall promethazine department
ascorbic acid condition – ascorbic acid bank ascorbic acid awful
clarithromycin pills appeal – zantac pills action cytotec pills tree
fludrocortisone success – esomeprazole pills contrary prevacid pills cut
buy bisacodyl paypal – bisacodyl 5 mg tablet buy liv52 generic
aciphex for sale – buy domperidone 10mg online buy motilium medication
cotrimoxazole 960mg oral – tobra 5mg sale buy generic tobramycin
buy hydroquinone cream – purchase duphaston pills dydrogesterone price
forxiga brand – how to get doxepin without a prescription buy acarbose
order griseofulvin – dipyridamole for sale buy gemfibrozil pills
vasotec 5mg for sale – buy doxazosin 1mg sale buy generic zovirax for sale
buy dimenhydrinate 50 mg for sale – dramamine 50 mg tablet risedronate 35mg cheap
order feldene 20 mg for sale – order feldene 20mg sale rivastigmine 3mg over the counter
purchase monograph – etodolac 600 mg usa buy generic cilostazol for sale
buy piracetam no prescription – order secnidazole generic buy sinemet 20mg without prescription
purchase hydroxyurea – trecator sc oral order robaxin 500mg pill
depakote 500mg oral – amiodarone 100mg us buy topiramate generic
how to get disopyramide phosphate without a prescription – order chlorpromazine online order thorazine 100mg for sale
purchase cyclophosphamide for sale – dimenhydrinate 50mg price buy trimetazidine cheap
aldactone 25mg ca – phenytoin uk naltrexone 50mg sale
order cyclobenzaprine online – buy enalapril where can i buy vasotec
ondansetron online buy – buy procyclidine pill ropinirole oral
ascorbic acid 500mg cheap – buy ferrous pills compro canada
where can i buy durex gel – latanoprost over the counter buy xalatan online cheap
where can i buy minoxidil – rogaine price finpecia for sale online
arava price – order risedronate 35 mg without prescription cheap cartidin pills
tenormin pills – atenolol 50mg uk carvedilol medication
verapamil for sale online – order valsartan 160mg sale tenoretic sale
atorlip order online – order nebivolol 20mg online bystolic 20mg us
brand gasex – buy ashwagandha generic cheap diabecon tablets
purchase lasuna for sale – himcolin buy online cheap himcolin
cheap generic speman – speman where to buy order finasteride sale
norfloxacin for sale – eulexin cost buy confido pills