CSVにおける信頼性保証とは

米国では、80年代に医療機器のソフトウェアの不具合により、患者の死傷事故が発生しました。
それ以降、FDAはヘルスケア企業が製造する製品だけではなく、使用するソフトウェアに関しても品質保証を行うことを求めてきまし。
つまりシステムの開発・導入時においてもIndependentなQA部門が品質保証を行うことを要求しているのです。
これが現在のCSVの元になる考え方です。
日本ではこういう考え方はまだ浸透していません。
多くの企業におけるQAは業務プロセスに注力していて、システムのQAを実施できる部門やスキルを持った人の養成が遅れています。
さて、それではシステムの信頼性保証はどうあるべきでしょうか。
例えばバリデションマスタープランの承認、PQ計画書・報告書の承認、バリデーション報告書の承認など、プロジェクト期間中のオンゴーイングなレビュや助言がそれに相当します。
その際に重要なことは、文書中の誤字や整合性を指摘するのではなく、第三者による再現性を判定することです。
バリデーションチームによって作業が行われている記録や文書を照査し、もし自分が行ったとしても同様の結果や判定が得られただろうかという点を検討しなければなりません。
再現性というのは「たまたまやったらたまたまうまくいきました。」というような偶然性ではないこと-つまり誰がやっても同じ品質結果(基準)が得られるということを第三者的に保証することです。
牛肉などで有名になった「トレーサビリティ」は信頼性保証の最低限の要求事項です。

Related post

Comment

  1. allergy medications for itching skin what is allergy medicine called best generic allergy pills

  2. get insomnia medication online virtual visit online physician belsomra

  3. deltasone 10mg cheap deltasone pill

  4. prescribed medication for throwing up cost irbesartan 300mg

  5. most effective acne pills ranked omnicef uk strongest acne medication prescription

  6. drugs for heartburn prescription order lincocin online

  7. accutane 20mg price accutane for sale online buy isotretinoin online cheap

  8. strongest non prescription sleeping pills order phenergan 25mg generic

  9. amoxil 250mg pill amoxil 1000mg drug amoxicillin order online

  10. buy azithromycin 500mg generic zithromax 500mg ca buy generic zithromax

  11. neurontin 800mg oral neurontin 100mg pill

  12. how to get azipro without a prescription order azipro 250mg online azithromycin 250mg ca

  13. lasix online buy cheap lasix 100mg

  14. buy omnacortil 5mg pill prednisolone 5mg oral buy prednisolone 20mg online cheap

  15. deltasone 10mg uk purchase prednisone

  16. order amoxil 500mg generic order amoxil 250mg for sale amoxicillin pills

  17. purchase doxycycline online doxycycline online

  18. buy generic ventolin order ventolin inhalator without prescription buy albuterol inhalator online

  19. order augmentin 625mg generic buy augmentin sale

  20. buy levothyroxine for sale oral levothroid levoxyl brand

  21. levitra 20mg over the counter levitra 20mg cheap

  22. clomiphene 100mg usa buy clomid sale order clomiphene for sale

  23. tizanidine 2mg pills buy zanaflex online cheap buy zanaflex paypal

  24. order semaglutide 14 mg without prescription rybelsus online order rybelsus 14mg without prescription

  25. cheap prednisone 40mg buy generic prednisone 40mg order prednisone generic

  26. semaglutide online buy order rybelsus buy rybelsus paypal

  27. order generic isotretinoin 40mg order isotretinoin 20mg pill isotretinoin 40mg canada

  28. ventolin where to buy ventolin inhalator for sale ventolin inhalator for sale online

  29. amoxicillin 250mg uk brand amoxicillin 250mg amoxil 500mg brand

  30. order augmentin 1000mg buy augmentin 625mg online cheap purchase amoxiclav

  31. purchase zithromax online cheap order zithromax 500mg sale order azithromycin 250mg for sale

  32. levoxyl generic levothroid tablets synthroid without prescription

  33. omnacortil 5mg usa oral prednisolone 10mg prednisolone 5mg canada

  34. serophene online cost clomid 100mg order clomid for sale

  35. order gabapentin 800mg generic buy gabapentin without a prescription neurontin ca

  36. purchase furosemide generic lasix 40mg us furosemide us

  37. buy sildenafil 100mg without prescription buy sildenafil online buy viagra online cheap

  38. order doxycycline 100mg online purchase acticlate monodox brand

  39. rybelsus for sale semaglutide 14mg price rybelsus 14 mg ca

  40. poker games online blackjack online us world poker online

  41. buy levitra pills for sale buy levitra 10mg pills vardenafil order

  42. buy lyrica 150mg online order lyrica 75mg order generic lyrica

  43. order hydroxychloroquine 400mg pill buy cheap hydroxychloroquine buy hydroxychloroquine 400mg generic

  44. buy triamcinolone sale brand triamcinolone buy triamcinolone generic

  45. tadalafil us usa cialis overnight cialis mail order us

  46. buy clarinex 5mg without prescription purchase clarinex without prescription cost clarinex 5mg

  47. order cenforce buy cenforce without a prescription order cenforce 100mg online cheap

  48. loratadine 10mg cheap oral claritin 10mg buy loratadine 10mg online cheap

  49. cost chloroquine 250mg how to get chloroquine without a prescription order chloroquine generic

  50. priligy oral buy misoprostol 200mcg buy misoprostol for sale

  51. buy glucophage 500mg for sale buy cheap generic glucophage buy glycomet paypal

  52. xenical 60mg over the counter buy orlistat pill buy diltiazem no prescription

  53. norvasc tablet purchase amlodipine generic amlodipine 10mg us

  54. acyclovir 800mg for sale acyclovir us buy allopurinol pills

  55. cheap prinivil order lisinopril pill order generic zestril 10mg

  56. crestor 10mg pills rosuvastatin cost buy ezetimibe for sale

  57. prilosec cost order prilosec 20mg generic buy prilosec

  58. domperidone online order motilium drug buy tetracycline 500mg

  59. buy lopressor 50mg for sale metoprolol order metoprolol 50mg drug

  60. buy cheap generic cyclobenzaprine cheap baclofen 10mg purchase baclofen generic

  61. ketorolac uk generic toradol 10mg gloperba cheap

  62. purchase atenolol online purchase tenormin without prescription atenolol ca

  63. medrol buy online buy depo-medrol tablets buy medrol no prescription

  64. inderal 20mg pills buy clopidogrel 150mg without prescription buy clopidogrel 75mg online

  65. pay to do assignment how to write an essay about my family write papers for me

  66. methotrexate 5mg us cost methotrexate 10mg coumadin 5mg ca

  67. buy meloxicam tablets mobic 15mg brand order celecoxib 100mg sale

  68. metoclopramide for sale hyzaar price buy cozaar 25mg online

  69. flomax tablet flomax 0.2mg usa buy celecoxib 100mg

  70. cheap esomeprazole 40mg nexium 40mg price cheap topamax

  71. order ondansetron 8mg buy aldactone tablets aldactone 25mg for sale

  72. sumatriptan price brand levaquin cost levaquin

  73. order generic simvastatin 20mg order valtrex 1000mg without prescription buy valacyclovir 500mg online cheap

  74. avodart 0.5mg pill zantac pills zantac 150mg uk

  75. ampicillin pill cost amoxicillin buy amoxil tablets

  76. order finasteride 1mg generic buy diflucan pills for sale order fluconazole 100mg pills

  77. buy cipro 500mg online – clavulanate price order augmentin 375mg generic

  78. order ciprofloxacin 500mg – buy ethambutol online order augmentin 625mg pill

  79. buy metronidazole online cheap – brand oxytetracycline 250mg buy zithromax online cheap

  80. order ciplox pills – buy trimox generic
    order erythromycin 250mg generic

  81. order valacyclovir generic – acyclovir 400mg canada buy acyclovir online

  82. buy ivermectin 12 mg online – cheap sumycin for sale tetracycline cost

  83. flagyl 400mg uk – terramycin 250 mg drug zithromax over the counter

  84. acillin generic buy ampicillin pill amoxicillin usa

  85. lasix online buy – lasix us capoten generic

  86. retrovir 300mg brand – buy epivir 100mg generic buy zyloprim 100mg sale

  87. glycomet order – ciprofloxacin online buy lincomycin cheap

  88. cheap clozapine 100mg – famotidine 20mg tablet buy generic famotidine

  89. seroquel tablet – order geodon 80mg sale buy eskalith paypal

  90. hydroxyzine order – order nortriptyline 25mg online cheap endep online order

  91. purchase anafranil – paroxetine online order buy sinequan generic

  92. amoxicillin price – generic keflex 125mg baycip online buy

  93. clavulanate pills – where can i buy trimethoprim cipro online

  94. buy cleocin generic – buy cefpodoxime generic buy chloramphenicol online

  95. order zithromax 250mg pill – metronidazole usa buy generic ciplox 500mg

  96. buy albuterol generic – cheap promethazine 25mg purchase theo-24 Cr online

  97. ivermectin tablets – brand eryc 500mg buy cefaclor 500mg online cheap

  98. order desloratadine 5mg pill – ventolin 4mg oral buy albuterol generic

  99. methylprednisolone for sale online – buy methylprednisolone 8mg online astelin order

  100. order glyburide without prescription – forxiga sale buy forxiga for sale

  101. If some one wishes to be updated with hottest technologies afterward he must be pay a quick visit this
    web page and be up to date all the time.

  102. repaglinide for sale – cheap repaglinide 1mg purchase jardiance

  103. purchase metformin online cheap – purchase hyzaar online cheap buy precose 25mg without prescription

  104. lamisil ca – order diflucan 100mg online purchase griseofulvin online cheap

  105. buy semaglutide pill – buy semaglutide 14mg for sale buy cheap generic DDAVP

  106. cost ketoconazole 200mg – order sporanox 100 mg buy itraconazole generic

  107. digoxin 250mg over the counter – cost furosemide furosemide 40mg price

  108. famvir 500mg drug – buy famvir online cheap buy valaciclovir 1000mg generic

  109. microzide 25 mg uk – how to get bisoprolol without a prescription zebeta 10mg cheap

  110. buy metoprolol 50mg for sale – generic inderal 10mg where can i buy nifedipine

  111. buy nitroglycerin sale – catapres 0.1mg usa where can i buy valsartan

  112. crestor explain – caduet pills balloon caduet pills victim

  113. zocor cell – zocor susan buy lipitor 10mg online

  114. buy viagra professional saturday – avana bread levitra oral jelly online clue

  115. dapoxetine bend – cialis with dapoxetine small cialis with dapoxetine soften

  116. cenforce rapid – cenforce online rather brand viagra pills bathroom

  117. brand cialis cover – zhewitra odour penisole delicate

  118. cialis soft tabs online gloom – cialis super active carriage1 viagra oral jelly every

  119. brand cialis punish – brand levitra lucky penisole sawyer

  120. scammer

  121. cialis soft tabs pills conversation – cialis super active pills figure1 viagra oral jelly online local

  122. cenforce terror – kamagra pills twilight brand viagra online chapter

  123. acne medication burn – acne medication process acne medication recognize

  124. inhalers for asthma fist – inhalers for asthma mock inhalers for asthma ear

  125. uti treatment fright – uti antibiotics hail treatment for uti professor

  126. prostatitis pills jar – prostatitis medications speed prostatitis pills odd

  127. valtrex online lady – valacyclovir online correct valtrex pills ghastly

  128. claritin pills awful – loratadine utter loratadine medication slow

  129. loratadine anything – claritin trouble loratadine medication praise

  130. dapoxetine hear – dapoxetine fully priligy clue

  131. promethazine mystery – promethazine ahead promethazine establish

  132. ascorbic acid gulf – ascorbic acid threaten ascorbic acid protection

  133. florinef funeral – pantoprazole someone lansoprazole sufficient

  134. biaxin pills rise – cytotec file cytotec whip

  135. buy dulcolax 5mg generic – oxybutynin over the counter oral liv52 10mg

  136. rabeprazole 10mg usa – buy motilium cheap how to get motilium without a prescription

  137. oral bactrim – buy tobramycin 10mg online tobrex buy online

  138. buy hydroquinone – purchase hydroquinone creams dydrogesterone drug

  139. buy dapagliflozin 10 mg online – order doxepin 75mg generic buy generic acarbose 50mg

  140. buy fulvicin – lopid 300 mg without prescription gemfibrozil over the counter

  141. buy vasotec no prescription – buy generic enalapril 10mg purchase zovirax generic

  142. purchase dramamine online – order dimenhydrinate 50mg online actonel for sale

TOP