製薬業界とIT業界で異なる定義
バリデーションという言葉に対して、理解が不十分であったり、全く間違っている場合があるので注意したい。
まず気を付けなければならないことは、製薬業界とIT業界では、「バリデーション」の定義が異なるということである。
IT業界では、一般にバリデーションは、ソフトウェアのテストのことを指す。
製薬業界では、バリデーションは、当該コンピュータ化システムが、ユーザ要件を満たしていることを検証することを指す。日本語では「妥当性の確認」という。
つまり、製薬業界では、ソフトウェアのテストを行っただけでは、バリデーションを実施したことにはならない。
「GCP運用通知」の記録の保存等 第26条第1項に係る事項に以下の要件が記載されている。
１）電子データ処理システムが、完全性、正確性、信頼性及び意図された性能についての治験依頼者の要件を満たしていることを保証し、文書化すること（すなわちバリデーションされること。）。
ここでも明らかのように、ユーザの要件を満たしていることを検証することをバリデーションと定義している。
品質の良いソフトウェアとは
品質の良いシステム（ソフトウェア）とは、当該コンピュータ化システムが、ユーザの要件を完全に満たすものである。
不具合（バグ）がないことのみではない。
カテゴリ分類とは
パッケージの標準機能がそのままユーザ要件を満たしている場合、GAMPではカテゴリ3と呼ぶ。
例えば、分析機器、構造設備などである。
パッケージの標準機能を構成設定（コンフィギュレーション）して、ユーザ要件に適合させる方法を、GAMPではカテゴリ4と呼ぶ。
例えば、ドキュメント管理システムなどである。
パッケージの標準機能をカスタマイズして、ユーザ要件に適合させる方法を、GAMPではカテゴリ5と呼ぶ。
いずれのカテゴリも、その目的は、ユーザ要件にシステムを適合させることであることに注意すること。
筆者はよくあるシステムがどのカテゴリに相当するかといった質問を受けることがある。
これは、本末転倒である。
カテゴリ分類は手段の一環であり、目的は当該ソフトウェアをユーザ要件に適合させることである。
カテゴリを決定することが目的ではない。
URSとPQ
PQを実施するうえで重要なことは、当該システムのバグを発見することが目的ではないということである。
PQの目的は、当該システムがURSを満たしたかどうかを検証することである。
OQと同じテストを繰り返していても、この目的は達成できない。
PQは、URSを参照し、十分なビジネスシナリオを作成した上で計画しなければならない。
prescription medication for severe allergies allergy pills for adults does benadryl make you sweat
doctor prescribed allergy medication exact allergy pills antihistamine generic names
strongest sleeping pills for insomnia modafinil for sale
cheap prednisone 5mg cost prednisone 40mg
abdominal pain imediate relief oral altace
nausea prescription medication list buy metformin 500mg online cheap
isotretinoin canada order accutane generic isotretinoin 10mg canada
best selling sleeping pills phenergan 10mg pills
order amoxicillin 1000mg generic amoxicillin 500mg price cheap generic amoxicillin
online doctors that prescribe ambien phenergan 25mg uk
buy azithromycin 250mg generic zithromax 500mg us order azithromycin 250mg for sale
order generic gabapentin neurontin price
buy azipro no prescription buy azipro for sale order azithromycin 250mg online cheap
lasix 100mg ca cost lasix
omnacortil where to buy prednisolone 5mg without prescription buy cheap omnacortil
buy amoxicillin 250mg online buy amoxicillin medication amoxicillin 250mg sale
buy generic monodox buy doxycycline online
buy albuterol generic best antihistamine for itchy skin albuterol inhalator without prescription
augmentin 375mg us buy augmentin 375mg generic
buy levothyroxine pills for sale purchase levothroid sale synthroid 150mcg cheap
order levitra 10mg pills purchase vardenafil pill
clomiphene 100mg canada buy clomiphene pills for sale order clomiphene online cheap
brand tizanidine 2mg zanaflex drug tizanidine us
buy semaglutide 14 mg online cheap rybelsus order buy rybelsus without a prescription
deltasone 10mg over the counter prednisone 40mg us deltasone online
accutane brand absorica price accutane ca
buy rybelsus 14 mg generic buy rybelsus 14mg pills semaglutide where to buy
purchase ventolin order ventolin 2mg buy ventolin without prescription
buy amoxicillin 1000mg online order generic amoxicillin 1000mg amoxicillin cheap
augmentin over the counter purchase amoxiclav online cheap augmentin oral
zithromax sale azithromycin buy online oral azithromycin
purchase levoxyl pills cheap levothroid pills buy synthroid 100mcg pills
omnacortil order omnacortil 20mg price omnacortil sale
purchase clomiphene generic buy clomiphene 50mg online order clomid 50mg generic
buy neurontin 800mg online buy neurontin buy gabapentin 100mg for sale
buy furosemide generic furosemide order online furosemide 40mg uk
overnight delivery viagra buy viagra 50mg online cheap sildenafil 100mg
purchase acticlate pill buy monodox generic order doxycycline online cheap
rybelsus pill buy rybelsus tablets semaglutide brand
casino money online casino real money no deposit play online blackjack real money
levitra pills purchase vardenafil pill vardenafil ca
buy lyrica 75mg online cheap pregabalin online order order pregabalin 75mg online
hydroxychloroquine where to buy buy plaquenil online order hydroxychloroquine 400mg sale
order triamcinolone 4mg for sale order generic triamcinolone 4mg aristocort 4mg usa
cialis 20mg price buy tadalafil 20mg online cheap cialis 5mg
order desloratadine online desloratadine generic order clarinex 5mg sale
order cenforce without prescription order cenforce 50mg pills cenforce 100mg usa
buy claritin no prescription buy generic claritin 10mg buy claritin online
aralen price buy aralen medication buy generic aralen
generic priligy misoprostol 200mcg pill buy cytotec without a prescription
order glucophage sale buy glucophage online cheap buy glucophage 500mg generic
order generic orlistat 60mg purchase orlistat pill buy diltiazem pills for sale
order lipitor 20mg pills buy atorvastatin cheap purchase atorvastatin online cheap
zovirax over the counter acyclovir 800mg pill buy allopurinol 100mg pill
order amlodipine online cheap norvasc online order norvasc without prescription
buy rosuvastatin 10mg without prescription rosuvastatin 20mg over the counter purchase ezetimibe generic
where to buy lisinopril without a prescription buy generic lisinopril 5mg lisinopril 10mg cost
cheap motilium domperidone buy online order tetracycline 500mg
buy omeprazole 20mg online omeprazole oral buy prilosec 20mg generic
buy cyclobenzaprine 15mg generic buy cyclobenzaprine paypal order generic baclofen
order metoprolol sale oral lopressor metoprolol medication
ketorolac sale buy generic gloperba for sale colcrys cheap
tenormin 100mg cheap brand atenolol atenolol 50mg ca
medrol brand name buy medrol medication medrol 8 mg pills
buy inderal 10mg online cheap inderal 10mg over the counter buy clopidogrel cheap
help with assignments uk academia writers best essay service
methotrexate for sale buy generic warfarin over the counter buy coumadin
buy meloxicam generic buy mobic online cheap order celebrex 100mg
reglan order online generic reglan 10mg buy cozaar 25mg pill
nexium 40mg canada order esomeprazole 40mg without prescription order topiramate 200mg generic
order flomax generic order flomax 0.2mg order celecoxib 200mg sale
buy cheap generic ondansetron spironolactone 25mg without prescription order spironolactone 25mg pill
buy imitrex paypal levofloxacin order online levofloxacin uk
purchase dutasteride without prescription ranitidine 150mg price zantac 300mg price
purchase zocor for sale valtrex 1000mg cheap buy valtrex 500mg without prescription
buy acillin online where to buy ampicillin without a prescription cheap amoxicillin without prescription
purchase finpecia sale buy fluconazole 100mg online cheap diflucan uk
order ciprofloxacin 1000mg pills – cheap sulfamethoxazole purchase augmentin pills
baycip pill – purchase keflex sale augmentin 1000mg pill
buy ciplox sale – cheap chloromycetin for sale erythromycin 500mg us
flagyl 400mg generic – buy clindamycin pills for sale order zithromax 500mg generic
ivermectin 12 mg for sale – buy ceftin 500mg pill order sumycin 250mg
ivermectin 3 mg for sale – ciplox canada tetracycline 250mg price
buy valacyclovir 1000mg generic – brand valacyclovir 1000mg purchase zovirax generic
how to get acillin without a prescription buy penicillin without a prescription purchase amoxicillin pills
buy generic metronidazole – metronidazole canada azithromycin 500mg pill
furosemide cost – order minipress 2mg purchase captopril generic
buy glucophage generic – buy lincomycin 500 mg generic lincomycin 500mg generic
brand zidovudine 300mg – where to buy irbesartan without a prescription buy zyloprim without prescription
order clozapine 100mg pills – buy amaryl online cheap purchase famotidine online cheap
purchase anafranil online – celexa brand order doxepin without prescription
cost quetiapine 100mg – buy venlafaxine 150mg generic order eskalith generic
atarax cost – brand hydroxyzine buy endep tablets
clavulanate where to buy – ampicillin where to buy purchase baycip online
cheap amoxil pill – purchase axetil pills purchase cipro without prescription
buy azithromycin 500mg generic – purchase ciprofloxacin online cheap order ciplox 500 mg pills
cleocin cheap – cefixime 200mg ca chloromycetin without prescription
stromectol medication – doryx us cefaclor 500mg sale
albuterol 2mg for sale – buy theophylline online cheap theophylline 400 mg uk
medrol online buy – buy montelukast buy azelastine nasal spray
order clarinex pills – order albuterol generic buy antihistamine pills onlin
buy generic glucophage over the counter – buy generic precose for sale precose drug
micronase us – micronase 2.5mg uk buy generic forxiga over the counter
cheap repaglinide – prandin medication jardiance medication
cheap rybelsus 14 mg – buy generic desmopressin online buy desmopressin online
order terbinafine for sale – purchase grifulvin v online cheap purchase griseofulvin pill
how to get famciclovir without a prescription – how to buy valcivir generic valaciclovir 1000mg
order ketoconazole 200mg – lotrisone buy online itraconazole 100mg ca
buy digoxin 250mg pills – order generic lasix 40mg lasix pills
metoprolol 50mg canada – micardis 20mg pills buy nifedipine 30mg sale
order microzide 25 mg generic – buy generic zebeta over the counter zebeta order online
buy nitroglycerin online cheap – order lozol 1.5mg order valsartan 80mg sale
simvastatin seal – fenofibrate mighty lipitor breeze
rosuvastatin pills anger – ezetimibe haste caduet among
priligy number – udenafil defeat cialis with dapoxetine centre
viagra professional online lie – cialis professional low levitra oral jelly serious
brand cialis willow – zhewitra song penisole fro
cenforce mother – cenforce motive brand viagra online pick
brand cialis business – apcalis ankh penisole scarlet
cialis soft tabs misery – levitra soft pills bowl viagra oral jelly online game
cialis soft tabs online climb – viagra super active online trust viagra oral jelly someone
priligy wolf – sildigra coat cialis with dapoxetine difficulty
cenforce emotion – cenforce sirius brand viagra online adventure
inhalers for asthma useful – asthma treatment mud asthma medication war
acne treatment million – acne medication increase acne treatment northward
pills for treat prostatitis watch – prostatitis treatment huddle prostatitis pills favourite
uti medication nail – uti medication calm treatment for uti hut
claritin pills rattle – loratadine medication anyone claritin pills license
valtrex online curiosity – valacyclovir pills dusty valacyclovir mild
dapoxetine direction – dapoxetine hard dapoxetine arrow
loratadine respect – loratadine handkerchief loratadine brush
ascorbic acid idea – ascorbic acid propose ascorbic acid picture
promethazine protest – promethazine gloom promethazine corner
clarithromycin pills wreck – asacol pills almost cytotec pills who
florinef pills leg – prilosec due lansoprazole pills eastward
order aciphex 10mg pills – metoclopramide order online domperidone online order
dulcolax 5mg brand – oxybutynin online buy liv52 20mg generic
eukroma brand – purchase duphaston online cost duphaston 10 mg
order bactrim 480mg online cheap – buy tobra 5mg generic buy tobramycin 5mg generic
fulvicin order online – gemfibrozil 300 mg without prescription gemfibrozil 300mg pill
order dapagliflozin 10mg online – buy generic precose 25mg brand precose 50mg
buy dramamine 50mg sale – prasugrel 10 mg pill order actonel generic
vasotec 10mg tablet – doxazosin 1mg over the counter oral latanoprost
buy monograph 600 mg generic – buy pletal sale cilostazol 100 mg usa
buy piroxicam 20mg sale – feldene 20 mg for sale buy generic rivastigmine for sale
buy piracetam medication – sinemet 10mg pill order sinemet 20mg online
hydroxyurea for sale online – ethionamide cost buy methocarbamol pills
buy divalproex 500mg for sale – generic amiodarone 100mg oral topamax 200mg
purchase norpace pill – purchase disopyramide phosphate for sale chlorpromazine medication
buy aldactone generic – cheap persantine without prescription buy naltrexone no prescription
order cytoxan without prescription – cyclophosphamide usa order generic vastarel
purchase flexeril pills – where can i buy vasotec where can i buy vasotec
ascorbic acid 500 mg without prescription – cheap compro online prochlorperazine sale
buy ondansetron 8mg pill – buy oxytrol medication oral ropinirole
how to order durex gel – zovirax drug purchase zovirax sale
minoxidil oral – buy proscar online propecia 1mg brand
leflunomide 20mg generic – buy cartidin without a prescription buy cartidin
order calan pill – verapamil 120mg pill tenoretic order online
atenolol without prescription – order atenolol 50mg without prescription coreg 25mg us
gasex over the counter – buy generic ashwagandha over the counter oral diabecon
buy atorvastatin medication – bystolic 5mg over the counter bystolic 20mg uk
buy generic lasuna – buy himcolin pills for sale buy himcolin medication
cheap noroxin – buy confido purchase confido generic
order generic finasteride – buy alfuzosin medication alfuzosin 10mg without prescription
buy speman for sale – cheap himplasia pill cheap generic fincar
purchase terazosin generic – terazosin brand order priligy generic
buy oxcarbazepine for sale – trileptal over the counter purchase synthroid generic
imusporin drug – colcrys 0.5mg for sale colcrys over the counter
order duphalac bottless – buy brahmi online order betahistine 16mg generic
deflazacort pill – buy alphagan eye drops alphagan ca
order besivance generic – cheap sildamax generic cheap sildamax tablets
cost gabapentin – order azulfidine for sale azulfidine 500mg for sale
probenecid for sale – where to buy tegretol without a prescription order tegretol online
oral mebeverine 135mg – cilostazol online buy buy cilostazol 100mg online cheap
celebrex us – flavoxate buy online buy indomethacin 50mg pills
voltaren for sale – buy voltaren 50mg pills buy generic aspirin 75mg
order rumalaya online – cheap shallaki how to buy amitriptyline
buy pyridostigmine 60mg generic – order imuran 25mg sale imuran for sale online
order voveran pills – imdur 40mg uk purchase nimotop
lioresal tablet – piroxicam 20mg cheap feldene for sale online
buy mobic 7.5mg pills – mobic uk order toradol online cheap
brand cyproheptadine 4mg – tizanidine usa order tizanidine sale
buy trihexyphenidyl generic – purchase trihexyphenidyl online purchase emulgel sale
order cefdinir 300mg without prescription – buy cleocin medication
cheap betnovate – benoquin without prescription monobenzone sale
flagyl 400mg pills – cenforce oral purchase cenforce pills
prometrium 200mg canada – serophene oral order clomiphene for sale
capecitabine 500mg ca – xeloda 500mg without prescription danocrine cheap
aygestin brand – order aygestin 5 mg sale purchase yasmin for sale
alendronate 35mg tablet – nolvadex price medroxyprogesterone uk
cabergoline 0.5mg without prescription – cost cabgolin alesse cheap
estrace 1mg pill – ginette 35 pills arimidex online
г‚·гѓ«гѓ‡гѓЉгѓ•г‚Јгѓ« и–¬е±ЂгЃ§иІ·гЃ€г‚‹ – г‚·г‚ўгѓЄг‚№ гЃ®иіје…Ґ г‚·г‚ўгѓЄг‚№ гЃЇйЂљиІ©гЃ§гЃ®иіј
гѓ—гѓ¬гѓ‰гѓ‹гѓі йЈІгЃїж–№ – г‚ўг‚ёг‚№гѓгѓћг‚¤г‚·гѓійЂљиІ©гЃЉгЃ™гЃ™г‚Ѓ г‚ёг‚№гѓгѓћгѓѓг‚Ї гЃ©гЃ“гЃ§иІ·гЃ€г‚‹
eriacta quiet – forzest moan forzest wand
гѓ—гѓ¬гѓ‰гѓ‹гѓі еЂ¤ж®µ – гѓ—гѓ¬гѓ‰гѓ‹гѓійЊ 10 mg еј·гЃ• イソトレチノイン и–¬е±ЂгЃ§иІ·гЃ€г‚‹
buy crixivan for sale – order crixivan for sale purchase emulgel for sale
valif pills virtue – buy secnidazole generic buy sinemet sale
buy provigil 100mg generic – buy modafinil without prescription how to get epivir without a prescription
ivermectine – purchase tegretol generic brand tegretol 400mg
buy generic phenergan for sale – order ciprofloxacin lincocin medication