{"id":905,"date":"2024-04-21T12:32:05","date_gmt":"2024-04-21T03:32:05","guid":{"rendered":"https:\/\/cloudsecurityalliance.jp\/newblog\/?p=905"},"modified":"2024-04-21T12:32:05","modified_gmt":"2024-04-21T03:32:05","slug":"devsecops","status":"publish","type":"post","link":"https:\/\/cloudsecurityalliance.jp\/newblog\/2024\/04\/21\/devsecops\/","title":{"rendered":"\u533b\u7642\uff0f\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u306b\u304a\u3051\u308bDevSecOps (\u524d\u7de8)"},"content":{"rendered":"<p>\u30af\u30e9\u30a6\u30c9\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u30a2\u30e9\u30a4\u30a2\u30f3\u30b9(CSA)\u3067\u306f\u3001\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u30b3\u30f3\u30c6\u30ca\uff0f\u30de\u30a4\u30af\u30ed\u30b5\u30fc\u30d3\u30b9WG\u304cDevSecOps WG\u306b\u5408\u6d41\u3057\u3001\u6700\u65b0\u306e\u30af\u30e9\u30a6\u30c9\u30cd\u30a4\u30c6\u30a3\u30d6\u74b0\u5883\u3068DevSecOps\u3092\u524d\u63d0\u3068\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u958b\u767a\u30e9\u30a4\u30af\u30b5\u30a4\u30af\u30eb(SDLC)\u306b\u304a\u3051\u308b\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u306e\u96c6\u7a4d\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u308b\u3002\u533b\u7642\uff0f\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u9818\u57df\u3067\u306f\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40(FDA)\u304c\u3001\u30c8\u30fc\u30bf\u30eb\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb(TPLC)\u3084DevSecOps\u3092\u57fa\u76e4\u3068\u3059\u308b\u30c7\u30b8\u30bf\u30eb\u30c8\u30e9\u30f3\u30b9\u30d5\u30a9\u30fc\u30e1\u30fc\u30b7\u30e7\u30f3(DX)\u65bd\u7b56\u3092\u5c55\u958b\u3057\u3066\u304a\u308a\u3001\u305d\u306e\u5f71\u97ff\u304c\u533b\u7642\u6a5f\u5668\u30fb\u533b\u85ac\u54c1\u306e\u958b\u767a\u30fb\u904b\u7528\u3092\u884c\u3046\u4f01\u696d\u3084\u533b\u7642\u6a5f\u95a2\u306b\u3082\u53ca\u3093\u3067\u304d\u305f\u3002<\/p>\n<h4>\u30c8\u30fc\u30bf\u30eb\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u8d77\u70b9\u3068\u3059\u308b\u7c73\u56fdFDA\u306e\u5b89\u5168\u6027\u5bfe\u7b56<\/h4>\n<p>\u7c73\u56fdFDA\u5098\u4e0b\u306e\u533b\u7642\u6a5f\u5668\u30fb\u653e\u5c04\u7dda\u4fdd\u5065\u30bb\u30f3\u30bf\u30fc(CDRH)\u306f\u30012018\u5e744\u670816\u65e5\u306b\u516c\u8868\u3057\u305f\u300c\u533b\u7642\u6a5f\u5668\u5b89\u5168\u6027\u884c\u52d5\u8a08\u753b:\u60a3\u8005\u306e\u4fdd\u8b77\u3068\u516c\u8846\u885b\u751f\u306e\u4fc3\u9032\u300d(<a href=\"https:\/\/www.fda.gov\/about-fda\/cdrh-reports\/medical-device-safety-action-plan-protecting-patients-promoting-public-health\">https:\/\/www.fda.gov\/about-fda\/cdrh-reports\/medical-device-safety-action-plan-protecting-patients-promoting-public-health<\/a>)\u306e\u4e2d\u3067\u3001\u5e02\u8ca9\u524d\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u306e\u5c02\u9580\u6027\u3001\u30c7\u30fc\u30bf\u3001\u77e5\u8b58\u3084\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30fb\u8a55\u4fa1\u30fb\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u306e\u5404\u30b9\u30c6\u30fc\u30b8\u306b\u304a\u3051\u308b\u3059\u3079\u3066\u306e\u30c4\u30fc\u30eb\u3092\u5e45\u5e83\u304f\u6d3b\u7528\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u30c8\u30fc\u30bf\u30eb\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb(TPLC)\u5168\u4f53\u3067\u3001\u6d88\u8cbb\u8005\u3084\u60a3\u8005\u3001\u4ecb\u8b77\u8005\u3001\u533b\u7642\u6a5f\u95a2\u304c\u3001\u4e88\u9632\u3001\u8a3a\u65ad\u3001\u6cbb\u7642\u306b\u95a2\u3059\u308b\u5341\u5206\u306a\u60c5\u5831\u3092\u96c6\u3081\u3066\u610f\u601d\u6c7a\u5b9a\u3059\u308b\u305f\u3081\u306b\u3001\u5fc5\u8981\u306a\u60c5\u5831\u306b\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u3057\u3066\u3044\u308b\u3002<\/p>\n<p>\u307e\u305fFDA\u306f\u3001\u300c\u533b\u7642\u6a5f\u5668\u5411\u3051\u30c8\u30fc\u30bf\u30eb\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u300d(<a href=\"https:\/\/www.fda.gov\/about-fda\/cdrh-transparency\/total-product-life-cycle-medical-devices\">https:\/\/www.fda.gov\/about-fda\/cdrh-transparency\/total-product-life-cycle-medical-devices<\/a>)\u306e\u4e2d\u3067\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u30c8\u30fc\u30bf\u30eb\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb(TPLC)\u30a2\u30d7\u30ed\u30fc\u30c1\u306e\u30e1\u30ea\u30c3\u30c8\u3092\u6319\u3052\u3066\u3044\u308b\u3002<\/p>\n<ul>\n<li>CDRH\u306e\u30b9\u30bf\u30c3\u30d5\u306b\u3001\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u4ecb\u3057\u305f\u6a5f\u5668\u958b\u767a\u304b\u3089\u306e\u30db\u30ea\u30b9\u30c6\u30a3\u30c3\u30af\u306a\u8996\u70b9\u3092\u63d0\u4f9b\u3057\u3001\u6a5f\u5668\u306e\u5e02\u8ca9\u524d\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u306e\u610f\u601d\u6c7a\u5b9a\u3092\u5c0e\u304f\u306e\u306b\u5f79\u7acb\u3066\u308b<\/li>\n<li>\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u524d\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u306e\u30ec\u30d3\u30e5\u30fc\u6d3b\u52d5\u306b\u304a\u3051\u308b\u900f\u660e\u6027\u3084\u4e00\u8cab\u6027\u3092\u4fc3\u9032\u3057\u3066\u3001\u6a5f\u5668\u88fd\u9020\u696d\u8005\u306b\u5bfe\u3059\u308b\u4e88\u6e2c\u53ef\u80fd\u3067\u660e\u78ba\u306a\u898b\u901a\u3057\u3092\u63d0\u4f9b\u3059\u308b<\/li>\n<li>\u5e02\u8ca9\u524d\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u306e\u6d3b\u52d5\u30921\u3064\u306e\u30c1\u30fc\u30e0\u306b\u7d44\u307f\u5408\u308f\u305b\u3066\u3001FDA\u304c\u8fc5\u901f\u306a\u65b9\u6cd5\u3067\u5b89\u5168\u4e0a\u306e\u8ab2\u984c\u306b\u5bfe\u5fdc\u3059\u308b\u306e\u306b\u5f79\u7acb\u3066\u308b<\/li>\n<li>\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u3001\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3084\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u306b\u95a2\u3059\u308b\u900f\u660e\u6027\u3092\u4fdd\u8a3c\u3057\u3001CDRH\u304c\u512a\u308c\u305f\u5185\u90e8\u5411\u3051\u304a\u3088\u3073\u5916\u90e8\u5411\u3051\u306e\u9867\u5ba2\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3059\u308b<\/li>\n<li>\u5e02\u8ca9\u524d\u30c7\u30fc\u30bf\u304b\u3089\u306e\u77e5\u8b58\u3092\u6d3b\u7528\u3059\u308b\u3053\u3068\u306b\u3088\u3063\u3066\u3001\u5e02\u8ca9\u5f8c\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u610f\u601d\u6c7a\u5b9a\u3092\u77e5\u3089\u3057\u3081\u308b<\/li>\n<li>\u5e02\u8ca9\u524d\u30c7\u30fc\u30bf\u3084\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u6d3b\u52d5\u304b\u3089\u306e\u77e5\u8b58\u3092\u6d3b\u7528\u3059\u308b\u3053\u3068\u306b\u3088\u3063\u3066\u3001\u3088\u308a\u3088\u3044\u60c5\u5831\u306b\u57fa\u3065\u304f\u5e02\u8ca9\u524d\u533b\u5e2b\u6c7a\u5b9a\u3092\u884c\u3046\u306e\u306b\u5f79\u7acb\u3066\u308b<\/li>\n<\/ul>\n<p>\u3053\u306e\u3088\u3046\u306a\u80cc\u666f\u304b\u3089\u3001FDA\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u5e02\u8ca9\u524d\u30c7\u30fc\u30bf\u3068\u5e02\u8ca9\u5f8c\u30c7\u30fc\u30bf\u3092\u7d71\u5408\u3057\u305f\u30c8\u30fc\u30bf\u30eb\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb(TPLC)\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u69cb\u7bc9\u3057\u3001\u30aa\u30fc\u30d7\u30f3\u30c7\u30fc\u30bf\u3068\u3057\u3066\u516c\u958b\u3057\u3066\u3044\u308b(<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfTPLC\/tplc.cfm\">https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfTPLC\/tplc.cfm<\/a>)\u3002TPLC\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u304c\u53ce\u8f09\u3055\u308c\u3066\u304a\u308a\u3001\u901a\u5e38\u3001\u6708\u6b21\u3067\u66f4\u65b0\u3055\u308c\u3066\u3044\u308b\u3002<\/p>\n<ul>\n<li>\u5e02\u8ca9\u524d\u627f\u8a8d(PMA)<\/li>\n<li>\u4eba\u9053\u7684\u4f7f\u7528\u533b\u7642\u6a5f\u5668\u514d\u9664(HDE)<\/li>\n<li>De Novo \u5206\u985e\u7533\u8acb<\/li>\n<li>\u5e02\u8ca9\u524d\u901a\u77e5[510(k)]<\/li>\n<li>\u6709\u5bb3\u4e8b\u8c61(\u533b\u7642\u6a5f\u5668\u4e0d\u5177\u5408\u60c5\u5831\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9(MAUDE)<\/li>\n<li>\u533b\u7642\u6a5f\u5668\u30ea\u30b3\u30fc\u30eb<\/li>\n<\/ul>\n<h4>\u30c8\u30fc\u30bf\u30eb\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb(TPLC)\u3092\u6d3b\u7528\u3057\u305f\u533b\u7642\u6a5f\u5668\u958b\u767a\u4fc3\u9032\u30d7\u30ed\u30b0\u30e9\u30e0<\/h4>\n<p>\u4ed6\u65b9\u3001FDA\u306f\u3001\u30c8\u30fc\u30bf\u30eb\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb(TPLC)\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u6d3b\u7528\u3057\u305f\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u63a8\u9032\u6d3b\u52d5\u306b\u3082\u7a4d\u6975\u7684\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u308b\u3002\u305f\u3068\u3048\u3070FDA\u5098\u4e0b\u306eCDRH\u306f\u30012023\u5e7410\u67082\u65e5\u3001\u30c8\u30fc\u30bf\u30eb\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u8aee\u554f\u30d7\u30ed\u30b0\u30e9\u30e0(TAP)\u30d1\u30a4\u30ed\u30c3\u30c8\u304a\u3088\u3073\u53c2\u52a0\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u516c\u8868\u3057\u305f(<a href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/total-product-life-cycle-advisory-program-tap\">https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/total-product-life-cycle-advisory-program-tap<\/a>)\u3002TAP\u30d1\u30a4\u30ed\u30c3\u30c8\u306f\u30012023\uff5e2027\u4f1a\u8a08\u5e74\u5ea6\u533b\u7642\u6a5f\u5668\u30e6\u30fc\u30b6\u30fc\u6599\u91d1\u6539\u5b9a(MDUFA V)\u518d\u8a8d\u53ef\u306e\u4e00\u90e8\u3068\u3057\u3066\u3001FDA\u3068\u7523\u696d\u754c\u304c\u5408\u610f\u3057\u305f\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u306e1\u3064\u3067\u3042\u308a\u30012023\u4f1a\u8a08\u5e74\u5ea6\u5185\u306b\u521d\u671f\u30d5\u30a7\u30fc\u30ba\u3092\u958b\u59cb\u3059\u308b\u4e88\u5b9a\u3067\u3042\u308b\u3002<\/p>\n<p>TAP\u30d1\u30a4\u30ed\u30c3\u30c8\u3067\u306f\u3001\u516c\u8846\u885b\u751f\u4e0a\u3001\u5b89\u5168\u3067\u6709\u52b9\u306a\u3001\u9ad8\u54c1\u8cea\u306e\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3057\u3066\u3001\u3088\u308a\u8fc5\u901f\u306a\u958b\u767a\u3068\u3088\u308a\u8fc5\u901f\u3067\u5e45\u5e83\u3044\u60a3\u8005\u306e\u30a2\u30af\u30bb\u30b9\u3092\u5968\u52b1\u3059\u308b\u306e\u306b\u5f79\u7acb\u3066\u308b\u3053\u3068\u3092\u3001\u9577\u671f\u7684\u306a\u30d3\u30b8\u30e7\u30f3\u3068\u3057\u3066\u3044\u308b\u3002FDA\u306f\u3001TAP\u30d1\u30a4\u30ed\u30c3\u30c8\u3092\u901a\u3058\u3066\u3001\u516c\u8846\u885b\u751f\u4e0a\u5fc5\u8981\u306a\u9769\u65b0\u7684\u533b\u7642\u6a5f\u5668\u5411\u3051\u306b\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u6226\u7565\u7684\u30a8\u30f3\u30b2\u30fc\u30b8\u30e1\u30f3\u30c8\u3092\u63d0\u4f9b\u3059\u308b\u3068\u3057\u3066\u3044\u308b\u3002<\/p>\n<ul>\n<li>\u3088\u308a\u8fc5\u901f\u306a\u5e02\u8ca9\u524d\u306e\u76f8\u4e92\u4f5c\u7528\u306e\u305f\u3081\u306b\u63d0\u4f9b\u3059\u308b\u3053\u3068\u306b\u3088\u3063\u3066\u3001\u53c2\u52a0\u8005\u3068FDA\u3068\u306e\u9593\u306e\u30a8\u30af\u30b9\u30da\u30ea\u30a8\u30f3\u30b9\u3092\u5411\u4e0a\u3055\u305b\u308b<\/li>\n<li>\u6a5f\u5668\u958b\u767a\u304a\u3088\u3073\u30ec\u30d3\u30e5\u30fc\u30d7\u30ed\u30bb\u30b9\u3092\u901a\u3057\u3066\u3001FDA\u30b9\u30bf\u30c3\u30d5\u3092\u542b\u3080\u5168\u53c2\u52a0\u8005\u306e\u30a8\u30af\u30b9\u30da\u30ea\u30a8\u30f3\u30b9\u3092\u5f37\u5316\u3059\u308b<\/li>\n<li>\u65e9\u671f\u6bb5\u968e\u306b\u304a\u3051\u308b\u6a5f\u5668\u958b\u767a\u30ea\u30b9\u30af\u306e\u7279\u5b9a\u3001\u8a55\u4fa1\u3001\u4f4e\u6e1b\u306a\u3069\u3001\u6a5f\u5668\u958b\u767a\u4e2d\u306e\u6226\u7565\u7684\u610f\u601d\u6c7a\u5b9a\u306e\u5411\u4e0a\u3092\u4fc3\u9032\u3059\u308b<\/li>\n<li>\u6a5f\u5668\u958b\u767a\u306e\u65e9\u671f\u6bb5\u968e\u3088\u308a\u3001FDA\u306e\u30ec\u30d3\u30e5\u30fc\u30c1\u30fc\u30e0\u3001\u53c2\u52a0\u8005\u3001FDA\u4ee5\u5916\u306e\u30b9\u30c6\u30fc\u30af\u30db\u30eb\u30c0\u30fc(\u4f8b. \u60a3\u8005\u3001\u533b\u7642\u6a5f\u95a2\u3001\u4fdd\u967a\u8005)\u306e\u9593\u306e\u5b9a\u671f\u7684\u306a\u3001\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306b\u7126\u70b9\u3092\u5f53\u3066\u305f\u30a8\u30f3\u30b2\u30fc\u30b8\u30e1\u30f3\u30c8\u3092\u4fc3\u9032\u3059\u308b<\/li>\n<li>\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u751f\u6210\u306b\u95a2\u3059\u308b\u3088\u308a\u3088\u3044\u671f\u5f85\u306e\u4e00\u81f4\u3001\u7533\u8acb\u54c1\u8cea\u306e\u5411\u4e0a\u3001\u5e02\u8ca9\u524d\u30ec\u30d3\u30e5\u30fc\u30d7\u30ed\u30bb\u30b9\u306e\u6709\u52b9\u6027\u306e\u5411\u4e0a\u306e\u305f\u3081\u306b\u5354\u50cd\u3059\u308b<\/li>\n<\/ul>\n<p>FDA\u306f\u30012023\u4f1a\u8a08\u5e74\u5ea6\u4e2d\u306b\u5fc3\u8840\u7ba1\u7cfb\u6a5f\u5668\u5ba4(OHT2)\u5411\u3051\u306e\u53c2\u52a0\u53d7\u4ed8\u3092\u958b\u59cb\u3057\u30012024\u4f1a\u8a08\u5e74\u5ea6\u306b\u306f\u3001\u795e\u7d4c\u7cfb\u30fb\u7406\u5b66\u7642\u6cd5\u7cfb\u6a5f\u5668\u5ba4(OHT5)\u5411\u3051\u306e\u53c2\u52a0\u53d7\u4ed8\u3092\u958b\u59cb\u3057\u305f\u30022024\u5e744\u670812\u65e5\u73fe\u5728\u3001TAP\u30d1\u30a4\u30ed\u30c3\u30c8\u306b\u306f\u3001\u7dcf\u657043\u4ef6\u306e\u533b\u7642\u6a5f\u5668\u304c\u53c2\u52a0\u3092\u8868\u660e\u3057\u3066\u3044\u308b\u3002FDA\u306f\u3001\u305d\u306e\u5f8c2027\u4f1a\u8a08\u5e74\u5ea6\u307e\u3067\u3001TAP\u30d1\u30a4\u30ed\u30c3\u30c8\u306e\u5bfe\u8c61\u6a5f\u5668\u9818\u57df\u3092\u62e1\u5927\u3057\u3066\u3044\u304f\u4e88\u5b9a\u3067\u3042\u308b\u3002<\/p>\n<p>\u53c2\u8003\u307e\u3067\u306b\u3001\u533b\u7642\u6a5f\u5668\u3060\u3051\u3067\u306a\u304f\u533b\u85ac\u54c1\u306b\u304a\u3044\u3066\u3082\u3001FDA\u306f\u3001\u30c8\u30fc\u30bf\u30eb\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u524d\u63d0\u3068\u3059\u308b\u5b89\u5168\u6027\u5bfe\u7b56\u3092\u8b1b\u3058\u3066\u3044\u308b\u3002\u305f\u3068\u3048\u3070\u3001FDA\u5098\u4e0b\u306e\u533b\u85ac\u54c1\u8a55\u4fa1\u7814\u7a76\u30bb\u30f3\u30bf\u30fc(CDER)\u3068\u751f\u7269\u88fd\u54c1\u8a55\u4fa1\u7814\u7a76\u30bb\u30f3\u30bf\u30fc(CBER)\u306f\u30012021\u5e745\u670811\u65e5\u3001\u300cQ12 \u533b\u85ac\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u304a\u3051\u308b\u6280\u8853\u4e0a\u30fb\u898f\u5236\u4e0a\u306e\u8003\u616e\u4e8b\u9805 \u2013 \u7523\u696d\u754c\u5411\u3051\u30ac\u30a4\u30c0\u30f3\u30b9\u300d(<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q12-technical-and-regulatory-considerations-pharmaceutical-product-lifecycle-management-guidance\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q12-technical-and-regulatory-considerations-pharmaceutical-product-lifecycle-management-guidance<\/a>)\u3092\u516c\u8868\u3057\u3066\u3044\u308b\u3002<\/p>\n<h4>\u201dDevOps\u201d\u304b\u3089\u201dDevSecOps\u201d\u3078\u3068\u9032\u5316\u3059\u308b\u7c73\u56fdFDA\u306eDX<\/h4>\n<p>FDA\u306f\u3001\u30c8\u30fc\u30bf\u30eb\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb(TPLC)\u306b\u57fa\u3065\u304f\u5b89\u5168\u6027\u5bfe\u7b56\u3068\u4e26\u884c\u3057\u3066\u3001IT\u30e2\u30c0\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3\u3078\u306e\u53d6\u7d44\u3092\u63a8\u9032\u3057\u3066\u304d\u305f\u3002\u305f\u3068\u3048\u3070\u30012019\u5e749\u670818\u65e5\u306b\u516c\u8868\u3057\u305f\u300c\u6280\u8853\u30e2\u30c0\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3\u884c\u52d5\u8a08\u753b(TMAP\uff09\u300d(https:\/\/www.fda.gov\/about-fda\/reports\/fdas-technology-modernization-action-plan)\u306e\u4e2d\u3067\u3001FDA\u306e\u516c\u8846\u885b\u751f\u30df\u30c3\u30b7\u30e7\u30f3\u3092\u9032\u6b69\u3055\u305b\u308b\u305f\u3081\u306b\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3001\u30c7\u30fc\u30bf\u3001\u5206\u6790\u306a\u3069\u3001\u6280\u8853\u5229\u7528\u306e\u30e2\u30c0\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3\u306b\u5411\u3051\u305f\u77ed\u671f\u7684\u5b9f\u884c\u8a08\u753b\u3092\u793a\u3057\u305f\u3002\u3053\u306e\u8a08\u753b\u306f\u3001\u4ee5\u4e0b\u306e3\u8981\u7d20\u304b\u3089\u69cb\u6210\u3055\u308c\u308b\u3002<\/p>\n<ul>\n<li>FDA\u306e\u6280\u8853\u30a4\u30f3\u30d5\u30e9\u30b9\u30c8\u30e9\u30af\u30c1\u30e3\u306e\u30e2\u30c0\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3<\/li>\n<li>\u898f\u5236\u306e\u30df\u30c3\u30b7\u30e7\u30f3\u3092\u652f\u63f4\u3059\u308b\u6280\u8853\u88fd\u54c1\u3092\u958b\u767a\u3059\u308bFDA\u306e\u6a5f\u80fd\u306e\u5f37\u5316<\/li>\n<li>\u30b7\u30b9\u30c6\u30e0\u3092\u8d8a\u3048\u305f\u76f8\u4e92\u904b\u7528\u6027\u3092\u6709\u3057\u3001\u6d88\u8cbb\u8005\u3068\u60a3\u8005\u306b\u4fa1\u5024\u3092\u63d0\u4f9b\u3059\u308b\u6280\u8853\u7684\u9032\u6b69\u3092\u3051\u3093\u5f15\u3059\u308b\u305f\u3081\u306e\u3001\u30b9\u30c6\u30fc\u30af\u30db\u30eb\u30c0\u30fc\u3068\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3068\u5354\u50cd<\/li>\n<\/ul>\n<p>\u7279\u306b\u300cFDA\u306e\u6280\u8853\u30a4\u30f3\u30d5\u30e9\u30b9\u30c8\u30e9\u30af\u30c1\u30e3\u306e\u30e2\u30c0\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3\u300d\u306f\u3001\u5805\u7262\u306a\u30a4\u30f3\u30d5\u30e9\u30b9\u30c8\u30e9\u30af\u30c1\u30e3\u3001\u30af\u30e9\u30a6\u30c9\u6700\u524d\u7dda\u306e\u8a08\u753b\u3001\u660e\u78ba\u3067\u52b9\u7387\u7684\u306a\u5916\u90e8\u30c7\u30fc\u30bf\u30a4\u30f3\u30bf\u30d5\u30a7\u30fc\u30b9\u3001\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u3078\u306e\u30d5\u30a9\u30fc\u30ab\u30b9\u306a\u3069\u3001\u6280\u8853\u30e2\u30c0\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u306e\u6700\u512a\u5148\u8ab2\u984c\u3068\u306a\u3063\u3066\u304a\u308a\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u5177\u4f53\u7684\u30a2\u30af\u30b7\u30e7\u30f3\u3092\u63b2\u3052\u3066\u3044\u308b\u3002<\/p>\n<ul>\n<li>\u30af\u30e9\u30a6\u30c9\u6226\u7565<\/li>\n<li>\u30d3\u30b8\u30cd\u30b9\u7279\u6709\u306e\u30cb\u30fc\u30ba\u5411\u3051\u306b\u7c21\u7d20\u5316\u3055\u308c\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u958b\u767a\u6a5f\u80fd\uff08DevOps\uff09<\/li>\n<li>\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0\u30a4\u30f3\u30bf\u30d5\u30a7\u30fc\u30b9\uff08API\uff09\u3001\u6a19\u6e96\u898f\u683c\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u4ea4\u63db\u30e1\u30ab\u30cb\u30ba\u30e0\u3084\u30c4\u30fc\u30eb<\/li>\n<li>\u30c7\u30fc\u30bf\u306e\u30af\u30ea\u30fc\u30f3\u30ca\u30c3\u30d7\u3068\u30af\u30e9\u30a6\u30c9\u74b0\u5883\u3078\u306e\u79fb\u690d<\/li>\n<li>as a service\u30e2\u30c7\u30eb\u306e\u7d99\u7d9a\u7684\u63a1\u7528<\/li>\n<li>\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u30fb\u30a8\u30af\u30bb\u30ec\u30f3\u30b9\u3078\u306e\u7d99\u7d9a\u7684\u306a\u5c02\u5ff5<\/li>\n<li>\u79d1\u5b66\u8a08\u7b97\u306e\u30a8\u30f3\u30bf\u30fc\u30d7\u30e9\u30a4\u30baIT\u8a08\u753b\u3078\u306e\u7d71\u5408<\/li>\n<li>\u30a8\u30f3\u30bf\u30fc\u30d7\u30e9\u30a4\u30ba\u30ec\u30d9\u30eb\u306e\u6280\u8853\u7d44\u7e54\u3067\u3042\u308b\u60c5\u5831\u7ba1\u7406\u6280\u8853\u5ba4\uff08OIMT\uff09\u5185\u304a\u3088\u3073FDA\u5168\u4f53\u306b\u308f\u305f\u308b\u7d44\u7e54\u7684\u30a2\u30e9\u30a4\u30f3\u30e1\u30f3\u30c8<\/li>\n<li>\u30aa\u30da\u30ec\u30fc\u30b7\u30e7\u30ca\u30eb\u30fb\u30a8\u30af\u30bb\u30ec\u30f3\u30b9\u3068\u8907\u6570\u5e74\u306b\u6e21\u308b\u6280\u8853\u8a08\u753b<\/li>\n<li>\u8cbb\u7528\u6291\u5236\u3068\u91cd\u8907\u6392\u9664<\/li>\n<li>\u30a8\u30f3\u30bf\u30fc\u30d7\u30e9\u30a4\u30baIT\u30ac\u30d0\u30ca\u30f3\u30b9<\/li>\n<li>\u9069\u5207\u306a\u5834\u5408\u3001\u30ec\u30ac\u30b7\u30fc\u30b7\u30b9\u30c6\u30e0\u304a\u3088\u3073\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u5ec3\u6b62<\/li>\n<\/ul>\n<p>\u3055\u3089\u306bFDA\u306f\u3001\u6280\u8853\u30e6\u30fc\u30b9\u30b1\u30fc\u30b9\u306e\u69cb\u7bc9\u306b\u5411\u3051\u3066\u3001\u6700\u65b0\u6280\u8853\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u751f\u6210\u3059\u308b\u305f\u3081\u306e\u6280\u8853\u201d\u88fd\u54c1\u201d\u958b\u767a\u30b1\u30fc\u30d1\u30d3\u30ea\u30c6\u30a3\u3092\u69cb\u7bc9\u3057\u3001\u60c5\u5831\u306b\u57fa\u3065\u3044\u3066\u898f\u5236\u4e0a\u306e\u610f\u601d\u6c7a\u5b9a\u3092\u884c\u3046\u305f\u3081\u306b\u3001\u65b0\u305f\u306a\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u52b9\u7387\u7684\u306b\u8a55\u4fa1\u30fb\u5206\u985e\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3068\u3057\u3066\u3044\u308b\u3002\u7279\u306b\u3001FDA\u304c\u958b\u767a\u3057\u305f\u6280\u8853\u88fd\u54c1\u306f\u3001\u77ed\u4e2d\u671f\u7684\u306aFDA\u6280\u8853\u30ed\u30fc\u30c9\u30de\u30c3\u30d7\u306b\u5fc5\u8981\u306a\u30b1\u30fc\u30d1\u30d3\u30ea\u30c6\u30a3\u3092\u8a3c\u660e\u3057\u3001\u5b9f\u73fe\u3059\u308b\u3068\u3068\u3082\u306b\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u88fd\u54c1\u958b\u767a\u30de\u30a4\u30f3\u30c9\u30bb\u30c3\u30c8\u3092\u7d44\u8fbc\u3080\u3068\u3057\u3066\u3044\u308b\u3002<\/p>\n<ul>\n<li>\u7570\u306a\u308bFDA\u30d7\u30ed\u30b0\u30e9\u30e0\u9818\u57df\u306b\u63a1\u7528\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3088\u3046\u306a\u3001\u91cd\u8981\u306a\u30d3\u30b8\u30cd\u30b9\u304a\u3088\u3073\u30c7\u30fc\u30bf\u306e\u8981\u6c42\u4e8b\u9805\u306b\u53d6\u7d44\u307f\u3001\u91cd\u8907\u3092\u524a\u6e1b\u3059\u308b\u3053\u3068\u306b\u3088\u3063\u3066\u3001\u88fd\u54c1\u306b\u7126\u70b9\u3092\u5f53\u3066\u308b<\/li>\n<li>\u30c6\u30b9\u30c8\u5411\u3051\u306e\u201d\u6700\u5c0f\u9650\u306e\u5b9f\u884c\u53ef\u80fd\u306a\u88fd\u54c1\u201d\u306e\u958b\u767a<\/li>\n<li>\u201dDevOps\u201d\u306e\u30de\u30a4\u30f3\u30c9\u30bb\u30c3\u30c8\u3068\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u306e\u63a1\u7528\u201d<\/li>\n<li>\u901f\u304f\u5931\u6557\u3059\u308b\u201d\u53cd\u5fa9\u3068\u5c55\u958b\u306b\u5bfe\u3059\u308b\u610f\u6b32<\/li>\n<li>FDA\u74b0\u5883\u5411\u3051\u306e\u201d\u30d7\u30ed\u30c0\u30af\u30c8\u30de\u30fc\u30b1\u30c3\u30c8\u30d5\u30a3\u30c3\u30c8\u201d\u306b\u7126\u70b9\u3092\u5f53\u3066\u308b;<\/li>\n<li>\u5354\u50cd\u7684\u306a\u6587\u5316<\/li>\n<li>\u30e6\u30fc\u30b6\u30fc\u30a8\u30af\u30b9\u30da\u30ea\u30a8\u30f3\u30b9\u3001\u6e80\u8db3\u5ea6\u3001\u63a1\u629e\u306e\u5411\u4e0a;<\/li>\n<li>\u77ed\u4e2d\u671f\u7684\u306b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3082\u306e\u3092\u7d39\u4ecb\u3059\u308b\u6a5f\u4f1a<\/li>\n<\/ul>\n<p>\u3053\u3046\u3057\u3066\u3001FDA\u306e\u6280\u8853\u30e2\u30c0\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u3092\u62c5\u3046\u88fd\u54c1\u958b\u767a\u30de\u30a4\u30f3\u30c9\u30bb\u30c3\u30c8\u3068\u3057\u3066\u3001\u201dDevOps\u201d\u306e\u6982\u5ff5\u304c\u7d44\u307f\u8fbc\u307e\u308c\u305f\u3002<\/p>\n<p>\u3055\u3089\u306b\u3001\u7c73\u56fd\u5927\u7d71\u9818\u884c\u653f\u5e9c\u304c20021\u5e745\u670812\u65e5\u306b\u767a\u51fa\u3057\u305f\u300c\u56fd\u5bb6\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u306b\u95a2\u3059\u308b\u5927\u7d71\u9818\u4ee4\u300d(<a href=\"https:\/\/www.whitehouse.gov\/briefing-room\/presidential-actions\/2021\/05\/12\/executive-order-on-improving-the-nations-cybersecurity\/\">https:\/\/www.whitehouse.gov\/briefing-room\/presidential-actions\/2021\/05\/12\/executive-order-on-improving-the-nations-cybersecurity\/<\/a>)\u3092\u53d7\u3051\u3066\u30012022\u5e743\u670820\u65e5\u3001FDA\u5098\u4e0b\u306e\u30c7\u30b8\u30bf\u30eb\u30c8\u30e9\u30f3\u30b9\u30d5\u30a9\u30fc\u30e1\u30fc\u30b7\u30e7\u30f3\u5ba4\uff08ODT\uff09\u304c\u516c\u8868\u3057\u305f\u300c\u30e2\u30c0\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3\u30fb\u30a4\u30f3\u30fb\u30a2\u30af\u30b7\u30e7\u30f32022\u300d(<a href=\"https:\/\/www.fda.gov\/news-events\/fda-voices\/fdas-technology-and-data-modernization-action-2022\">https:\/\/www.fda.gov\/news-events\/fda-voices\/fdas-technology-and-data-modernization-action-2022<\/a>)\u3067\u306f\u3001\u524d\u8ff0\u306e\u300c\u6280\u8853\u30e2\u30c0\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3\u884c\u52d5\u8a08\u753b(TMAP)\u300d\u306e\u6700\u512a\u5148\u9805\u76ee\u3068\u3057\u3066\u300c\u30a2\u30b8\u30e3\u30a4\u30eb\u3068\u88fd\u54c1\u306e\u6587\u5316\u300d\u304c\u793a\u3055\u308c\u305f\u3002<\/p>\n<p>\u305d\u306e\u4e2d\u3067\u3001\u30bc\u30ed\u30c8\u30e9\u30b9\u30c8\u30e2\u30c7\u30eb\u3084\u3001\u30bb\u30ad\u30e5\u30a2\u306a\u30af\u30e9\u30a6\u30c9\u30b3\u30f3\u30d4\u30e5\u30fc\u30c6\u30a3\u30f3\u30b0\u3001\u591a\u8981\u7d20\u8a8d\u8a3c\u3001\u6697\u53f7\u5316\u3001\u8105\u5a01\u691c\u77e5\u3001\u8106\u5f31\u6027\u7ba1\u7406\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u30c7\u30a3\u30d5\u30a7\u30f3\u30b9\u6a5f\u80fd\u306e\u5c0e\u5165\u3092\u652f\u3048\u308b\u6a19\u6e96\u898f\u683c\u30fb\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u306e1\u3064\u3068\u3057\u3066\u660e\u8a18\u3055\u308c\u305f\u306e\u304c\u3001\u201dDevSec\u201d\u3068\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u3092\u7d71\u5408\u3057\u305f\u201dDevSecOps\u201d (Development, Security and 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