バリデーション報告書の目的

各社でCSVドキュメントのレビュ依頼を受けることが多くあります。
その中でよくコメントするのは「バリデーション報告書」の書き方です。
何社かで経験したのは「バリデーション計画書」と「バリデーション報告書」がほぼ同じ内容になっているということです。
つまり、Cut & Pasteをして「~をする」を「~をした」に変更しているのでしょう。
「計画」と「結果」が一致するというのは、実は奇妙です。
「バリデーション報告書」を執筆する際に必要なのは、「計画」からの逸脱を記載することです。
つまり、計画通り実施できた事項に関してはあまり記載の必要がなく、むしろ計画通り実施できなかったことを「正当化できる理由」と共に記載しなければなりません。
バリデーション期間中の障害や、変更のサマリーとそれらによるインパクト(リスク)を十分評価し、たとえ障害や変更があったとしてもサービスインしてもかまわないという理由(または回避すべき事項)を検討してください。

Related post

Comment

  1. We are a gaggle of volunteers and starting a brand new scheme in our
    community. Your site offered us with helpful information to work on. You’ve performed a formidable job and our whole community will
    likely be thankful to you.

  2. What’s up colleagues, nice piece of writing and pleasant
    arguments commented at this place, I am really enjoying by these.

  3. Hi terrific blog! Does running a blog like this take a lot
    of work? I’ve very little understanding of computer
    programming but I had been hoping to start my own blog soon. Anyhow, should you have
    any suggestions or tips for new blog owners please share.
    I know this is off subject but I simply wanted to ask.
    Thanks a lot!

  4. claritin allergy sinus 12hr costco can flonase make you sleepy prescription allergy medication without antihistamines

  5. buy sleep meds online melatonin pills

  6. prednisone 10mg sale buy prednisone 10mg without prescription

  7. brand name anti nausea medication generic trimethoprim

  8. permanent treatments for acne buy deltasone sale strong acne medication pills

  9. major brand allergy pills buy montelukast medication different types of allergy medicine

  10. names of heartburn medication roxithromycin 150mg sale

  11. accutane over the counter purchase isotretinoin sale accutane 20mg cost

  12. amoxicillin 500mg sale amoxil 250mg oral buy generic amoxil for sale

  13. telehealth consultation for cpap machine modafinil buy online

  14. buy azithromycin no prescription buy generic azithromycin for sale purchase zithromax online cheap

  15. order neurontin 800mg pills buy neurontin 800mg online

  16. cheap azipro 250mg order azipro online cheap azithromycin pills

  17. lasix price buy furosemide for sale

  18. buy cheap omnacortil order prednisolone 5mg online prednisolone 20mg drug

  19. purchase amoxil pill order amoxicillin generic amoxicillin cost

  20. order doxycycline pill buy acticlate online cheap

  21. purchase ventolin generic purchase albuterol ventolin 4mg brand

  22. buy augmentin 625mg without prescription buy generic clavulanate online

  23. buy generic levothyroxine over the counter buy generic levothroid levothroid cheap

  24. levitra 10mg canada cheap vardenafil

  25. buy clomid paypal buy clomiphene 50mg online cheap clomiphene 50mg pill

  26. buy tizanidine 2mg generic tizanidine sale tizanidine order online

  27. buy generic rybelsus 14mg purchase semaglutide generic order rybelsus 14 mg sale

  28. prednisone 10mg tablet prednisone 40mg cheap brand prednisone

  29. semaglutide 14 mg generic buy rybelsus tablets rybelsus pills

  30. buy isotretinoin generic order isotretinoin 20mg without prescription accutane 10mg usa

  31. ventolin 2mg over the counter cheap albuterol 2mg purchase ventolin inhalator generic

  32. generic amoxil amoxil ca order amoxil 500mg for sale

  33. augmentin 625mg drug augmentin 625mg tablet amoxiclav over the counter

  34. zithromax usa purchase azithromycin online cheap zithromax cheap

  35. how to buy synthroid where can i buy levothyroxine purchase synthroid without prescription

  36. buy omnacortil 40mg pills order omnacortil 10mg online buy prednisolone 20mg without prescription

  37. buy serophene sale order serophene pills buy clomid

  38. where can i buy gabapentin gabapentin canada neurontin 600mg ca

  39. viagra pharmacy us viagra sales viagra 100mg england

  40. buy lasix generic diuretic order furosemide 40mg online cheap buy furosemide diuretic

  41. semaglutide 14mg sale order rybelsus 14mg generic purchase rybelsus sale

  42. doxycycline 100mg ca monodox over the counter vibra-tabs cheap

  43. real casino games casino online casino online slots

  44. vardenafil 20mg brand buy generic levitra oral levitra 20mg

  45. lyrica cheap lyrica 75mg generic pregabalin tablet

  46. buy hydroxychloroquine 400mg without prescription plaquenil 400mg uk hydroxychloroquine for sale online

  47. buy triamcinolone 4mg pills oral triamcinolone triamcinolone 4mg over the counter

  48. real cialis sites generic cialis 40mg order generic cialis

  49. buy clarinex pills for sale clarinex over the counter clarinex medication

  50. cenforce 100mg ca cenforce 100mg uk cenforce 50mg sale

  51. buy generic loratadine over the counter order claritin 10mg sale buy generic loratadine over the counter

  52. chloroquine pills order chloroquine generic buy chloroquine online cheap

  53. priligy 30mg over the counter buy cytotec paypal misoprostol 200mcg oral

  54. glycomet uk order metformin pills order metformin 500mg sale

  55. glycomet 500mg uk order glucophage 1000mg generic glycomet 500mg tablet

  56. buy generic orlistat for sale diltiazem 180mg ca diltiazem order

  57. atorvastatin 80mg generic buy atorvastatin sale cheap lipitor 20mg

  58. buy amlodipine 10mg for sale norvasc 5mg drug generic amlodipine 5mg

  59. zovirax 800mg sale zyloprim 300mg us buy zyloprim

  60. purchase lisinopril without prescription buy generic zestril for sale order zestril 10mg without prescription

  61. buy generic crestor purchase rosuvastatin generic zetia 10mg canada

  62. omeprazole 10mg generic buy omeprazole 10mg without prescription oral omeprazole

  63. motilium medication order tetracycline 500mg sale tetracycline 500mg ca

  64. buy generic lopressor 50mg order lopressor for sale metoprolol over the counter

  65. cyclobenzaprine price buy baclofen pills baclofen 25mg brand

  66. purchase tenormin pill tenormin without prescription buy tenormin without a prescription

  67. toradol 10mg canada where to buy colchicine without a prescription buy gloperba without a prescription

  68. buy oral medrol medrol australia medrol 16 mg for sale

  69. buying a term paper paperwriter help writing a research paper

  70. buy propranolol online order plavix 75mg online cheap buy plavix 75mg without prescription

  71. order methotrexate online cheap warfarin online order coumadin without prescription

  72. buy meloxicam 15mg pills generic celecoxib 200mg celebrex canada

  73. metoclopramide drug metoclopramide 20mg generic buy hyzaar pills for sale

  74. order flomax pills order generic flomax 0.4mg order celecoxib

  75. order nexium pills nexium 20mg pill topiramate over the counter

  76. order zofran 4mg without prescription purchase aldactone without prescription order spironolactone 100mg generic

  77. buy imitrex 25mg sale imitrex 25mg cost levaquin 500mg brand

  78. purchase simvastatin generic valacyclovir over the counter buy valacyclovir generic

  79. buy dutasteride tablets dutasteride online order buy zantac without a prescription

  80. ampicillin over the counter buy ampicillin pills for sale amoxil usa

  81. proscar 5mg uk cheap diflucan 200mg forcan cheap

  82. cipro medication – cipro drug buy cheap clavulanate

  83. cipro 500mg canada – buy generic keflex order augmentin 1000mg pills

  84. flagyl 200mg usa – flagyl 400mg over the counter buy azithromycin no prescription

  85. ciprofloxacin order online – amoxicillin 500mg us
    erythromycin cheap

  86. order valtrex 500mg for sale – nateglinide 120mg for sale buy zovirax no prescription

  87. ivermectin 6 mg for humans – cefuroxime 250mg uk tetracycline 250mg price

  88. metronidazole online – cefaclor sale zithromax 500mg without prescription

  89. buy generic ampicillin over the counter vibra-tabs pills buy generic amoxicillin for sale

  90. buy lasix generic diuretic – atacand cheap capoten order online

  91. buy glycomet sale – buy baycip paypal buy generic lincomycin

  92. brand zidovudine – generic irbesartan 150mg purchase allopurinol pill

  93. seroquel 50mg brand – trazodone oral order eskalith

  94. https://www.atlasflorapyrenaea.org Atlas Flora Pyrenaea

  95. hydroxyzine 10mg price – cheap prozac endep 25mg brand

  96. clomipramine cost – buy amoxapine without a prescription cost sinequan 75mg

  97. cost amoxicillin – order axetil sale cipro pills

  98. order generic augmentin 1000mg – buy cheap septra cipro 500mg usa

  99. https://epharmnutrition.com/

    Your style is so unique compared to other folks I’ve read stuff from.

    Many thanks for posting when you’ve got the opportunity, Guess
    I’ll just bookmark this blog.

  100. https://www.billhull.net/

    Quality articles or reviews is the main to be a focus for the visitors to visit
    the web page, that’s what this website is providing.

  101. buy clindamycin no prescription – cefixime 100mg generic where can i buy chloramphenicol

  102. zithromax 500mg pill – order ciprofloxacin pill buy ciprofloxacin generic

  103. purchase albuterol inhalator generic – cost theophylline 400 mg theophylline for sale

  104. ivermectin 6mg tablets for humans – doxycycline where to buy cefaclor 250mg over the counter

  105. buy desloratadine pill – albuterol 2mg uk where to buy albuterol without a prescription

  106. cost of depo-medrol – order claritin 10mg without prescription purchase azelastine without prescription

  107. buy micronase for sale – buy actos 30mg online order dapagliflozin 10 mg generic

  108. order prandin 2mg without prescription – empagliflozin for sale empagliflozin 25mg without prescription

  109. buy generic glycomet 500mg – buy hyzaar generic order acarbose 25mg online cheap

  110. terbinafine ca – cheap grifulvin v order grifulvin v

  111. rybelsus over the counter – DDAVP generic DDAVP where to buy

  112. order ketoconazole 200mg generic – butenafine drug order generic sporanox 100 mg

  113. buy lanoxin medication – furosemide 100mg pills buy furosemide 100mg pill

  114. famciclovir canada – famvir 250mg brand valcivir uk

  115. purchase hydrochlorothiazide without prescription – buy generic hydrochlorothiazide over the counter buy zebeta sale

  116. lopressor sale – losartan pills nifedipine 10mg cheap

  117. where to buy nitroglycerin without a prescription – buy lozol 2.5mg generic order diovan sale

  118. crestor pills eager – rosuvastatin online announce caduet pills trip

  119. simvastatin golden – lopid common atorvastatin figure

  120. viagra professional bill – buy viagra professional invisible levitra oral jelly promise

  121. dapoxetine hard – sildigra range cialis with dapoxetine mail

  122. cenforce obtain – tadalis frequent brand viagra online chew

  123. brand cialis scent – tadora punish penisole front

  124. cialis soft tabs online kindle – tadarise pills practice viagra oral jelly spy

  125. brand cialis survive – viagra soft tabs careless penisole envelope

  126. cialis soft tabs breath – tadarise state viagra oral jelly those

  127. cenforce observation – coupons for cialis brand viagra pills superior

  128. dapoxetine thoughtful – sildigra establish cialis with dapoxetine bare

  129. acne medication afraid – acne medication pant acne medication huge

  130. inhalers for asthma fond – asthma treatment slop inhalers for asthma beast

  131. uti medication sooner – uti antibiotics deserve uti antibiotics defense

  132. pills for treat prostatitis less – prostatitis treatment request pills for treat prostatitis monster

  133. valacyclovir online burn – valtrex arch valtrex pills shallow

  134. claritin pills period – loratadine keep claritin pills doubtful

  135. claritin pills permit – claritin pills light loratadine medication form

  136. priligy save – priligy grass priligy petunia

  137. promethazine sign – promethazine sergeant promethazine mother

  138. ascorbic acid weird – ascorbic acid upset ascorbic acid use

  139. fludrocortisone pills library – pantoprazole uncle lansoprazole broomstick

  140. bisacodyl 5mg ca – buy ditropan no prescription order liv52 20mg without prescription

  141. order rabeprazole 20mg – buy reglan without prescription cost motilium 10mg

  142. order bactrim 480mg pill – keppra 500mg pill tobramycin 5mg cost

  143. order hydroquinone generic – purchase cerazette online buy dydrogesterone 10 mg without prescription

  144. buy dapagliflozin pills – purchase acarbose acarbose 25mg pills

  145. Awesome article.

  146. griseofulvin us – brand dipyridamole 25mg lopid 300 mg ca

  147. order vasotec 5mg sale – cost zovirax zovirax online buy

  148. order dimenhydrinate 50mg for sale – prasugrel cost actonel 35 mg cost

  149. order piroxicam 20mg for sale – buy rivastigmine 6mg order exelon for sale

  150. order etodolac 600mg sale – monograph cost buy cilostazol 100 mg generic

  151. generic hydroxyurea – buy ethionamide paypal purchase robaxin generic

  152. oral nootropil 800 mg – order sustiva 20mg generic order sinemet 20mg online cheap

  153. buy norpace generic – oral norpace thorazine order online

  154. depakote 500mg cost – purchase lariam for sale topamax brand

  155. order generic cyclophosphamide – buy antivert 25mg pill buy generic trimetazidine for sale

  156. buy generic aldactone for sale – purchase revia online cheap revia 50 mg pills

  157. cost cyclobenzaprine 15mg – cyclobenzaprine 15mg sale order enalapril 5mg generic

  158. buy zofran 4mg for sale – oxybutynin order buy requip 1mg

  159. purchase ascorbic acid online cheap – buy generic ferrous sulfate 100mg buy compro

  160. where can i order durex gel – xalatan online order xalatan over the counter

  161. arava generic – buy actonel without a prescription cheap cartidin pill

  162. cheap minoxidil generic – order dutas pill oral finpecia

  163. where can i buy tenormin – cheap sotalol 40 mg coreg for sale

  164. calan 120mg for sale – buy diovan 80mg cheap generic tenoretic

  165. cheap generic atorlip – zestril over the counter nebivolol order

  166. buy lasuna without prescription – himcolin pill buy himcolin pills

  167. gasex online buy – ashwagandha generic buy diabecon medication

  168. speman pills – finasteride tablet purchase fincar

  169. buy generic noroxin online – brand eulexin confido usa

TOP