カテゴリ分類の神話

筆者がCSVセミナーをする中で、あまりにもカテゴリ分類にこだわっている人が多いのには辟易する。
規制当局が定義する「バリデーション」とは、当該システムがユーザ要求に完全に一致している状態をいう。
つまり、パッケージシステムを導入する場合、構成設定やカスタマイズを実施して、ユーザが要求する機能を実現するのである。

GAMPでは、ソフトウェアのカテゴリを5段階に分類している。
パッケージシステムの機能が、そのままでユーザ要求を満たしている場合、カテゴリは3である。
またパッケージシステムの機能を構成設定(コンフィグレーション)して、ユーザ要求に合わせた場合、カテゴリは4である。
さらにパッケージシステムの機能をカスタマイズして、ユーザ要求に合わせた場合、カテゴリは5である。
いずれの場合も、その目的は、ユーザ要求にシステムを合せることであって、カテゴリを分類することではない。

筆者はよく次のような質問を受ける。
「このシステムを何とかカテゴリ3と判定できないか。」
「パッケージの一部分でもカスタマイズしたら、カテゴリ5になるのか。」
これらの質問は、本末転倒である。
カテゴリ分類することが目的やゴールになっているとすら思えてくる。

コンピュータシステムにとって大切なことは、ユーザ要求を完全に満たし、患者の安全性、製品の品質、電子データの完全性を保証することである。
つまり、リスクに対して適切にシステムの品質保証を実施しなければならない。
したがって、カテゴリ3であっても、リスクの高いシステムがあり、逆にカテゴリ5でもリスクの低いシステムはある。

カテゴリ分類は、構造設備(プロセスコントロール)には有効的てあったが、ITアプリケーションではほとんど意味をなさない。
なぜならば、ITアプリケーションでは、カテゴリ3、4、5が混在してしまうからである。

厚労省が平成24年から施行した「コンピュータ化システム適正管理ガイドライン」では、カテゴリ分類が大きく取り上げられているが、その罪は重い。
そもそも、FDAやEMAのソフトウェアバリデーションに関する規制要件では、カテゴリ分類などはない。

ソフトウェアに限らず、製薬企業・医療機器企業で使用するシステムは、リスク(患者・ユーザに対する安全性、製品品質に対する影響等)に応じてその品質管理・品質保証の程度を決定するべきである。

Related post

Comment

  1. alternative to antihistamine for allergy prescription strength allergy meds best prescription allergy pills

  2. purchase online sleeping tablets phenergan 25mg uk

  3. deltasone 10mg ca prednisone without prescription

  4. vomiting medicine name list order generic ciprofloxacin 500mg

  5. list of prescription acne creams betamethasone 20 gm cream adult acne causes in female

  6. allergy medication without side effects buy depo-medrol paypal generic allergy medication list

  7. medications that cause gerd symptoms purchase allopurinol generic

  8. oral accutane buy generic accutane 20mg isotretinoin 10mg usa

  9. buy generic amoxil amoxil 250mg sale order amoxicillin 250mg online

  10. what is the strongest sleeping pill buy promethazine

  11. buy zithromax 500mg buy azithromycin order generic zithromax 250mg

  12. order gabapentin 100mg for sale cheap neurontin without prescription

  13. azithromycin tablet azithromycin for sale brand azipro 500mg

  14. buy furosemide generic buy lasix no prescription

  15. omnacortil 20mg tablet buy omnacortil 10mg prednisolone order

  16. amoxil order order generic amoxicillin 1000mg cheap amoxil 500mg

  17. doxycycline 100mg over the counter monodox without prescription

  18. buy generic ventolin buy albuterol 4mg albuterol over the counter

  19. amoxiclav cheap buy clavulanate online cheap

  20. levothroid oral synthroid online levothroid drug

  21. levitra 10mg for sale vardenafil 20mg cheap

  22. clomiphene 50mg generic serophene uk purchase clomid pill

  23. purchase tizanidine generic where to buy zanaflex without a prescription purchase tizanidine online

  24. prednisone 10mg us buy generic prednisone 5mg buy prednisone 40mg without prescription

  25. order rybelsus generic rybelsus over the counter order semaglutide 14mg pill

  26. isotretinoin 20mg pill accutane 10mg usa buy isotretinoin tablets

  27. order semaglutide sale order semaglutide 14 mg sale semaglutide order online

  28. ventolin inhalator cheap ventolin 4mg brand buy ventolin inhalator

  29. order amoxil 250mg online amoxil 250mg generic buy amoxicillin 1000mg online cheap

  30. order augmentin generic order augmentin 625mg sale buy augmentin online

  31. azithromycin uk zithromax cost order zithromax pill

  32. levoxyl over the counter cheap levothroid pills synthroid 100mcg pills

  33. prednisolone 5mg usa buy omnacortil pills for sale order prednisolone 20mg sale

  34. generic serophene clomiphene for sale online purchase serophene pill

  35. buy neurontin pill buy gabapentin 800mg buy neurontin sale

  36. order furosemide furosemide order online buy generic lasix diuretic

  37. buy generic sildenafil 100mg viagra 100mg pills for sale order sildenafil sale

  38. monodox us generic vibra-tabs purchase monodox online

  39. Rattling wonderful info can be found on web site. “The absence of flaw in beauty is itself a flaw.” by Havelock Ellis.

  40. buy rybelsus 14 mg online cheap rybelsus 14mg ca purchase rybelsus without prescription

  41. casino online blackjack money poker online best online casinos

  42. how to buy levitra vardenafil 10mg drug buy cheap vardenafil

  43. order pregabalin 75mg order lyrica sale order lyrica 150mg without prescription

  44. plaquenil 400mg uk hydroxychloroquine pills plaquenil 200mg pills

  45. order triamcinolone 10mg generic triamcinolone 10mg for sale aristocort 4mg oral

  46. buy cialis 5mg pills order cialis for sale order tadalafil 10mg without prescription

  47. clarinex without prescription purchase desloratadine sale how to buy clarinex

  48. purchase cenforce online cheap order cenforce 50mg online cheap buy cenforce medication

  49. buy loratadine generic buy claritin tablets claritin for sale

  50. chloroquine for sale buy chloroquine 250mg without prescription buy generic aralen 250mg

  51. priligy 60mg over the counter buy priligy 60mg pills purchase cytotec generic

  52. generic glucophage glucophage 500mg cheap metformin for sale

  53. xenical 60mg us diltiazem where to buy diltiazem 180mg for sale

  54. atorvastatin 20mg sale atorvastatin 80mg without prescription atorvastatin without prescription

  55. buy acyclovir 400mg online cheap buy zovirax no prescription order zyloprim pill

  56. buy norvasc paypal amlodipine 5mg ca order norvasc without prescription

  57. buy rosuvastatin no prescription zetia 10mg oral buy generic zetia

  58. cheap lisinopril 2.5mg lisinopril pills lisinopril 10mg sale

  59. motilium brand buy domperidone without prescription buy sumycin 250mg without prescription

  60. prilosec 10mg cheap buy prilosec 10mg for sale prilosec to treat esophagus

  61. cyclobenzaprine 15mg pills cyclobenzaprine 15mg ca buy baclofen 25mg online

  62. generic metoprolol 50mg buy metoprolol 50mg pills purchase lopressor online

  63. Hey there are using WordPress for your blog platform? I’m new to the blog world but I’m trying to get started and create my own. Do you need any coding knowledge to make your own blog? Any help would be really appreciated!

  64. toradol 10mg oral colcrys 0.5mg tablet buy colchicine without a prescription

  65. tenormin 50mg ca buy tenormin 100mg pill buy tenormin tablets

  66. buy generic depo-medrol buy depo-medrol pills for sale medrol ca

  67. inderal online buy generic propranolol for sale clopidogrel 75mg drug

  68. websites for essay writing order research paper assignment company

  69. buy methotrexate no prescription warfarin 5mg cheap purchase coumadin pill

  70. buy mobic for sale meloxicam 7.5mg uk order celecoxib 100mg for sale

  71. buy metoclopramide medication buy cheap metoclopramide losartan 50mg price

  72. order esomeprazole 20mg pills buy topiramate 100mg without prescription order topiramate 200mg for sale

  73. tamsulosin 0.4mg us order celebrex 100mg generic cost celebrex 200mg

  74. buy zofran 4mg for sale spironolactone 25mg cheap spironolactone pills

  75. generic imitrex 50mg buy generic levaquin 250mg cost levofloxacin 250mg

  76. simvastatin 20mg cost valtrex 1000mg sale buy valacyclovir 500mg online cheap

  77. buy avodart pills for sale dutasteride price buy zantac generic

  78. where to buy ampicillin without a prescription cheap amoxicillin pill amoxil pills

  79. where to buy finasteride without a prescription diflucan pill buy forcan online

  80. ciprofloxacin 500mg price – cephalexin 250mg ca buy clavulanate pills for sale

  81. purchase baycip generic – buy augmentin 375mg online order augmentin 375mg online

  82. buy ciplox 500 mg pill – buy tinidazole 500mg pill order erythromycin 250mg

  83. flagyl 200mg for sale – flagyl for sale buy zithromax pill

  84. can you buy stromectol over the counter – co-amoxiclav pills buy generic tetracycline online

  85. buy valacyclovir 500mg online – purchase zovirax pills acyclovir 400mg brand

  86. I’ve recently started a website, the information you provide on this web site has helped me greatly. Thanks for all of your time & work. “There can be no real freedom without the freedom to fail.” by Erich Fromm.

  87. acillin pills buy penicillin pills amoxicillin online buy

  88. metronidazole 200mg over the counter – cefaclor 250mg brand zithromax order

  89. Appreciating the time and energy you put into your blog and detailed information you offer. It’s great to come across a blog every once in a while that isn’t the same out of date rehashed material. Excellent read! I’ve saved your site and I’m including your RSS feeds to my Google account.

  90. lasix online – coumadin brand order capoten 25mg for sale

  91. glycomet 1000mg drug – lincocin 500mg brand lincocin 500mg generic

  92. order zidovudine generic – order lamivudine 100mg for sale oral allopurinol

  93. order clozapine 50mg online cheap – famotidine pills pepcid 20mg uk

  94. buy generic seroquel – order bupropion eskalith usa

  95. clomipramine 25mg pills – buy cymbalta 20mg without prescription order sinequan

  96. Hello! Do you know if they make any plugins to protect against hackers? I’m kinda paranoid about losing everything I’ve worked hard on. Any recommendations?

  97. order atarax 25mg sale – buy escitalopram online cheap order endep 10mg pill

  98. augmentin 625mg canada – buy ampicillin pills for sale buy ciprofloxacin without prescription

  99. buy amoxil without prescription – buy cephalexin generic cheap ciprofloxacin

  100. buy azithromycin pills – order tinidazole 300mg online buy ciprofloxacin online

  101. clindamycin price – cleocin 150mg pill order chloromycetin pills

  102. ivermectin 6 mg stromectol – order cefaclor 500mg generic cefaclor 250mg over the counter

  103. I respect your piece of work, appreciate it for all the interesting articles.

  104. order albuterol online cheap – oral allegra 120mg theophylline 400 mg over the counter

  105. What i don’t realize is if truth be told how you’re now not really much more well-liked than you might be now. You are very intelligent. You know thus significantly in the case of this subject, made me for my part consider it from numerous numerous angles. Its like women and men don’t seem to be interested unless it’s one thing to accomplish with Girl gaga! Your own stuffs nice. Always handle it up!

  106. Well I truly enjoyed studying it. This article offered by you is very effective for correct planning.

  107. depo-medrol pill – methylprednisolone over the counter azelastine 10 ml for sale

  108. buy desloratadine for sale – order albuterol without prescription buy allergy pills

  109. Only a smiling visitor here to share the love (:, btw great layout.

  110. buy micronase 2.5mg sale – buy pioglitazone 15mg sale buy forxiga 10mg generic

  111. order glycomet online cheap – order losartan pill generic acarbose 50mg

  112. repaglinide where to buy – buy prandin 1mg for sale empagliflozin canada

  113. You really make it appear so easy with your presentation however I to find this matter to be really something which I feel I’d by no means understand. It kind of feels too complex and extremely large for me. I am looking forward to your next submit, I will try to get the hold of it!

  114. rybelsus 14 mg cost – buy glucovance buy DDAVP online cheap

  115. terbinafine 250mg ca – purchase grifulvin v for sale grifulvin v online

  116. ketoconazole 200 mg usa – lotrisone generic itraconazole 100 mg cheap

  117. buy cheap famvir – valcivir us order valaciclovir 500mg pill

  118. digoxin order online – order furosemide furosemide without prescription

  119. lopressor for sale – order cozaar 50mg online cheap adalat 30mg sale

  120. order microzide 25 mg generic – norvasc 5mg generic bisoprolol online buy

  121. order nitroglycerin for sale – buy clonidine 0.1mg sale diovan price

  122. simvastatin number – lipitor gas lipitor broomstick

  123. rosuvastatin online fire – rosuvastatin online sorrow caduet musical

  124. viagra professional comrade – avana dean levitra oral jelly afternoon

  125. dapoxetine chimney – udenafil generation cialis with dapoxetine uncertain

  126. Renew is a nutritional supplement launched in 2024 to help anyone lose weight.

  127. cenforce mark – cenforce delicate brand viagra online race

  128. brand cialis clang – zhewitra law penisole excuse

  129. Thanx for the effort, keep up the good work Great work, I am going to start a small Blog Engine course work using your site I hope you enjoy blogging with the popular BlogEngine.net.Thethoughts you express are really awesome. Hope you will right some more posts.

  130. brand cialis wealth – viagra soft tabs grope penisole request

  131. cialis soft tabs pills relieve – cialis oral jelly sex viagra oral jelly online chap

  132. What Is Sugar Defender?Sugar Defender is a new blood sugar-balancing formula that has been formulated using eight clinically proven ingredients that work together to balance sugar levels.

  133. As a Newbie, I am permanently browsing online for articles that can benefit me. Thank you

  134. cialis soft tabs online rider – levitra soft stand viagra oral jelly online brain

  135. of course like your web-site however you have to take a look at the spelling on quite a few of your posts. Several of them are rife with spelling problems and I find it very troublesome to tell the truth then again I’ll definitely come again again.

  136. dapoxetine fro – sildigra tire cialis with dapoxetine last

  137. cenforce online weary – tadalis online believe brand viagra online which

  138. I got what you mean , appreciate it for putting up.Woh I am lucky to find this website through google. “I would rather be a coward than brave because people hurt you when you are brave.” by E. M. Forster.

  139. asthma medication clasp – asthma medication watch asthma treatment such

  140. acne treatment defend – acne treatment brave acne medication kind

  141. I don’t commonly comment but I gotta state regards for the post on this one : D.

  142. prostatitis treatment sway – prostatitis pills wheel prostatitis treatment frog

  143. uti antibiotics student – treatment for uti sparkler uti medication president

  144. claritin pills consider – loratadine medication birth claritin pills thousand

  145. valacyclovir grant – valacyclovir online run valacyclovir pills painful

  146. priligy native – dapoxetine waste dapoxetine voice

  147. Helpful info. Fortunate me I found your web site by chance, and I am stunned why this twist of fate didn’t took place in advance! I bookmarked it.

  148. claritin pie – claritin subtle claritin pills ocean

  149. ascorbic acid everyone – ascorbic acid admire ascorbic acid platform

  150. I simply couldn’t leave your web site before suggesting that I really enjoyed the usual info an individual provide to your visitors? Is going to be again steadily in order to check out new posts.

  151. promethazine justice – promethazine trouble promethazine mention

  152. biaxin pills tend – biaxin court cytotec specter

  153. Well I truly liked reading it. This information procured by you is very effective for good planning.

  154. fludrocortisone terror – prilosec pills misery prevacid doctor

  155. I am delighted that I found this web blog, precisely the right information that I was looking for! .

  156. excellent post, very informative. I wonder why the other experts of this sector don’t notice this. You must continue your writing. I am confident, you have a great readers’ base already!

  157. cost aciphex 10mg – motilium tablet buy generic motilium

  158. Lovely just what I was looking for.Thanks to the author for taking his time on this one.

  159. buy dulcolax 5mg generic – ditropan cost buy liv52 20mg for sale

  160. zovirax online buy – order duphaston generic buy generic dydrogesterone

  161. generic bactrim 480mg – cotrimoxazole 480mg cost oral tobramycin

  162. I was wondering if you ever considered changing the structure of your blog? Its very well written; I love what youve got to say. But maybe you could a little more in the way of content so people could connect with it better. Youve got an awful lot of text for only having 1 or 2 images. Maybe you could space it out better?

  163. order griseofulvin 250mg – dipyridamole 25mg over the counter lopid 300 mg us

  164. how to buy forxiga – how to get forxiga without a prescription acarbose 50mg tablet

  165. dimenhydrinate pill – prasugrel drug risedronate 35mg sale

  166. buy enalapril 5mg for sale – enalapril 5mg cheap order zovirax

  167. order etodolac online – monograph for sale buy cilostazol online

  168. Utterly indited articles, Really enjoyed looking at.

  169. order piroxicam 20mg online – buy exelon generic rivastigmine cheap

  170. Hello, you used to write fantastic, but the last few posts have been kinda boringK I miss your tremendous writings. Past few posts are just a little bit out of track! come on!

  171. I went over this web site and I conceive you have a lot of good info, bookmarked (:.

  172. you are actually a good webmaster. The website loading pace is amazing. It kind of feels that you’re doing any distinctive trick. Moreover, The contents are masterpiece. you’ve done a excellent process on this subject!

  173. nootropil order online – buy secnidazole 10mg online cheap sinemet 20mg cost

  174. where to buy hydrea without a prescription – where to buy pentoxifylline without a prescription methocarbamol brand

  175. divalproex online buy – order diamox 250mg generic topiramate 100mg ca

  176. What does the Lottery Defeater Software offer? The Lottery Defeater Software is a unique predictive tool crafted to empower individuals seeking to boost their chances of winning the lottery.

  177. oral disopyramide phosphate – brand disopyramide phosphate order thorazine online cheap

  178. Thanks for every other informative blog. Where else may just I get that type of info written in such an ideal method? I have a challenge that I’m just now running on, and I have been on the glance out for such information.

  179. You made a number of nice points there. I did a search on the subject matter and found mainly people will have the same opinion with your blog.

  180. order aldactone without prescription – buy persantine tablets revia 50 mg tablet

  181. cyclophosphamide medication – order cyclophosphamide online buy vastarel for sale

  182. Great blog here! Also your site loads up very fast! What web host are you using? Can I get your affiliate link to your host? I wish my site loaded up as quickly as yours lol

  183. Hey this is kind of of off topic but I was wanting to know if blogs use WYSIWYG editors or if you have to manually code with HTML. I’m starting a blog soon but have no coding experience so I wanted to get guidance from someone with experience. Any help would be greatly appreciated!

  184. I got what you mean ,saved to bookmarks, very decent internet site.

  185. buy cheap generic flexeril – prasugrel 10 mg cheap vasotec uk

  186. how to buy ondansetron – requip 2mg pills order ropinirole

  187. buy ascorbic acid sale – cheap kaletra for sale order compro without prescription

  188. order durex gel – order durex gel for sale cost zovirax

  189. What Is Java Burn? Java Burn is a natural health supplement that is formulated using clinically backed ingredients that promote healthy weight loss.

  190. I needed to write you that very small word to say thanks a lot again over the remarkable advice you’ve discussed here. It has been really strangely open-handed with you to deliver without restraint all that many people could possibly have marketed as an e-book to help make some profit on their own, even more so seeing that you might well have tried it in case you decided. These suggestions in addition served like the good way to comprehend other people online have a similar keenness similar to my own to know whole lot more in terms of this condition. I know there are several more pleasurable sessions in the future for many who discover your blog.

  191. buy minoxidil medication – finpecia price purchase finpecia sale

  192. It is perfect time to make a few plans for the long run and it’s time to be happy. I have read this publish and if I may just I desire to counsel you few interesting things or tips. Maybe you could write next articles referring to this article. I want to learn more things approximately it!

  193. arava over the counter – cost risedronate cheap cartidin for sale

  194. verapamil 120mg drug – order diltiazem generic buy tenoretic no prescription

  195. tenormin 100mg pill – order sotalol 40mg for sale carvedilol 25mg drug

  196. I don’t even know how I ended up here, but I thought this post was good. I don’t know who you are but certainly you’re going to a famous blogger if you are not already 😉 Cheers!

  197. atorvastatin tablet – order lisinopril pill nebivolol 20mg generic

  198. gasex order – where can i buy ashwagandha purchase diabecon generic

  199. Really Appreciate this post, can you make it so I get an email sent to me every time you publish a fresh article?

  200. buy lasuna medication – diarex tablets generic himcolin

  201. I have recently started a site, the info you offer on this website has helped me tremendously. Thanks for all of your time & work.

  202. I have been examinating out many of your posts and i can claim pretty clever stuff. I will make sure to bookmark your site.

  203. noroxin buy online – buy eulexin pill confido for sale online

TOP