{"id":11820,"date":"2021-09-07T08:45:06","date_gmt":"2021-09-07T06:45:06","guid":{"rendered":"https:\/\/www.agilelabs.co.za\/?page_id=11820"},"modified":"2021-09-07T08:45:36","modified_gmt":"2021-09-07T06:45:36","slug":"software-validation-testing","status":"publish","type":"page","link":"https:\/\/www.agilelabs.co.za\/ja\/software-validation-testing\/","title":{"rendered":"\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u59a5\u5f53\u6027\u78ba\u8a8d\u3068\u30c6\u30b9\u30c8"},"content":{"rendered":"<p>\u304a\u4f4f\u307e\u3044\u306e\u5730\u57df\u3067\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3059\u308b<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u691c\u8a3c\u306e\u8a08\u753b\u3001\u30c6\u30b9\u30c8\u3001\u304a\u3088\u3073\u7ba1\u7406<\/h4>\n\n\n\n<p>\u79c1\u305f\u3061\u306f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u5c02\u9580\u5bb6\u3067\u3059\u3002 ProCalV5\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u3059\u3079\u3066\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u306f\u3001\u30ea\u30ea\u30fc\u30b9\u524d\u306b\u5185\u90e8\u3067\u30c6\u30b9\u30c8\u304a\u3088\u3073\u691c\u8a3c\u3055\u308c\u3066\u3044\u307e\u3059\u3002 IQ \/ OQ \/ PQ\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u63d0\u4f9b\u3067\u304d\u307e\u3059\u3002 GAMP 5\u30ec\u30d9\u30eb\u306e\u691c\u8a3c\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u8a08\u753b\u3001\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3001\u304a\u3088\u3073\u5fc5\u8981\u306a\u30b5\u30fc\u30d3\u30b9\u3092\u5229\u7528\u3057\u3066\u3001\u304a\u5ba2\u69d8\u306e\u5834\u6240\u3067\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6e96\u62e0\u3057\u305f\u4f7f\u7528\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002\u901a\u5e38\u306e\u5c55\u958b\u306b\u306f\u3001\u901a\u5e388\u9031\u9593\u672a\u6e80\u304b\u304b\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p><strong>\u691c\u8a3c\u8a08\u753b\u3001\u30c6\u30b9\u30c8\u3001\u304a\u3088\u3073\u7ba1\u7406\u30b5\u30fc\u30d3\u30b9\u306b\u306f\u3001\u6b21\u306e\u3082\u306e\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>VMP\uff08\u691c\u8a3c\u30de\u30b9\u30bf\u30fc\u30d7\u30e9\u30f3\uff09<\/li><li>\u691c\u8a3c\u306e\u671f\u5f85\u3092\u8a2d\u5b9a\u3057\u3001\u591a\u304f\u306eSDLC\uff08\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\uff09\u306e\u53d6\u308a\u7d44\u307f\u306f\u3001\u627f\u8a8d\u3068\u6307\u793a\u3092VMP\u306b\u4f9d\u5b58\u3057\u3066\u3044\u307e\u3059<\/li><li>\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8<\/li><li>\u8981\u4ef6\u30c6\u30b9\u30c8\u306e\u512a\u5148\u9806\u4f4d\u4ed8\u3051\u306e\u6839\u62e0<\/li><li>\u30c6\u30b9\u30c8\u8a08\u753b<\/li><li>\u30b9\u30af\u30ea\u30d7\u30c8\u306e\u958b\u767a\u3092\u660e\u78ba\u306a\u76ee\u6a19\u3067\u958b\u59cb\u3067\u304d\u308b\u3088\u3046\u306b\u3001\u30c6\u30b9\u30c8\u306e\u671f\u5f85\u3092\u65e9\u671f\u306b\u5b9a\u7fa9\u3057\u3001\u8aa4\u3063\u305f\u65b9\u5411\u6027\u3084\u8aa4\u3063\u305f\u958b\u59cb\u3092\u56de\u907f\u3057\u307e\u3059<\/li><li>\u30b9\u30af\u30ea\u30d7\u30c6\u30a3\u30f3\u30b0<\/li><li>\u30ea\u30bd\u30fc\u30b9<\/li><li>\u30c6\u30b9\u30c8\u5b9f\u884c\u306e\u30b5\u30dd\u30fc\u30c8<\/li><li>\u504f\u5dee\u306e\u89e3\u6c7a<\/li><li>VSR\uff08\u691c\u8a3c\u8981\u7d04\u30ec\u30dd\u30fc\u30c8\uff09<\/li><li>\u30c6\u30b9\u30c8\u3001\u9038\u8131\u3001\u89e3\u6c7a\u7b56\u3001\u304a\u3088\u3073\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u4f8b\u5916\u3092\u8981\u7d04\u3057\u307e\u3059<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u30ad\u30e3\u30ea\u30d6\u30ec\u30fc\u30b7\u30e7\u30f3\u30d7\u30ed\u30b0\u30e9\u30e0\u306eQSR\u304a\u3088\u3073GMP\u306e\u6982\u8981<\/h4>\n\n\n\n<p>\u65b0\u3057\u3044\u6821\u6b63\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u4e8b\u696d\u904b\u55b6\u306b\u5b9f\u88c5\u3059\u308b\u3068\u304d\u306f\u3001\u88fd\u9020\u6163\u884c\u3068\u3068\u3082\u306b\u54c1\u8cea\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u6163\u884c\u3092\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4ee5\u4e0b\u306e\u8cea\u554f\u3092\u3059\u308b\u3053\u3068\u3067\u3001\u76ee\u7684\u3092\u6574\u7406\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p><strong>\u6761\u9805\uff1a<\/strong><br>GMP =\u9069\u6b63\u88fd\u9020\u57fa\u6e96<br>QSR =\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u898f\u5236<\/p>\n\n\n\n<p><strong>\u6a5f\u5668\u306e\u6821\u6b63\u304cGMP \/ QSR\u306e\u4e00\u90e8\u3067\u3042\u308b\u306e\u306f\u306a\u305c\u3067\u3059\u304b\uff1f<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u88fd\u9020\u696d\u8005\u306f\u3001\u3059\u3079\u3066\u306e\u5b8c\u6210\u54c1\u304c\u4f1a\u793e\u306e\u30c7\u30d0\u30a4\u30b9\/\u85ac\u5264\u30de\u30b9\u30bf\u30fc\u30ec\u30b3\u30fc\u30c9\u306e\u4ed5\u69d8\u3092\u6e80\u305f\u3059\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3092\u958b\u767a\u304a\u3088\u3073\u5b9f\u88c5\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li><li>\u4fdd\u8a3c\u306f\u3001\u8a2d\u8a08\u304a\u3088\u3073\u88fd\u9020\u4e2d\u306e\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3001\u88fd\u54c1\u3001\u304a\u3088\u3073\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u6e2c\u5b9a\u3092\u542b\u3080\u591a\u304f\u306e\u65b9\u6cd5\u3067\u53d6\u5f97\u3055\u308c\u307e\u3059\u3002<\/li><\/ul>\n\n\n\n<p><strong>\u30e1\u30fc\u30ab\u30fc\u306e\u8cac\u4efb\u306f\u4f55\u3067\u3059\u304b\uff1f<\/strong><\/p>\n\n\n\n<p>\u6a5f\u68b0\u3001\u96fb\u5b50\u3001\u81ea\u52d5\u3001\u5316\u5b66\u6a5f\u5668\u3092\u542b\u3080\u3059\u3079\u3066\u306e\u751f\u7523\u304a\u3088\u3073QA\u30c6\u30b9\u30c8\u6a5f\u5668\u304c\u6b21\u306e\u3068\u304a\u308a\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u4f7f\u7528\u76ee\u7684\u306b\u9069\u3057\u3066\u3044\u307e\u3059<\/li><li>\u6709\u52b9\u306a\u7d50\u679c\u3092\u751f\u307f\u51fa\u3059\u3053\u3068\u304c\u3067\u304d\u308b<\/li><li>\u8a13\u7df4\u3092\u53d7\u3051\u305f\u5f93\u696d\u54e1\u304c\u904b\u55b6<\/li><li>\u9069\u5207\u306b\u6821\u6b63\u3055\u308c\u305f\u3082\u306e\u3068\u9069\u5207\u306a\u6a19\u6e96<\/li><\/ul>\n\n\n\n<p><strong>\u624b\u9806\u306b\u306f\u4f55\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u304b\uff1f<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u76ee\u7684\u3068\u7bc4\u56f2<\/li><li>\u30ad\u30e3\u30ea\u30d6\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u983b\u5ea6<\/li><li>\u5fc5\u8981\u306a\u6a5f\u5668\u3068\u57fa\u6e96<\/li><li>\u7cbe\u5ea6\u3001\u7cbe\u5ea6\u3001\u30d0\u30a4\u30a2\u30b9\u306e\u9650\u754c<\/li><li>\u30ad\u30e3\u30ea\u30d6\u30ec\u30fc\u30b7\u30e7\u30f3\u30d7\u30ed\u30bb\u30b9\u306e\u8aac\u660e<\/li><li>\u662f\u6b63\u63aa\u7f6e<\/li><li>\u6587\u66f8\u5316\u306e\u8981\u4ef6<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u76ee\u7684\u3068\u7bc4\u56f2<\/h4>\n\n\n\n<p>\u54c1\u8cea\u4fdd\u8a3c\u306f\u3001\u30c7\u30d0\u30a4\u30b9\/\u85ac\u5264\u306e\u8a2d\u8a08\u3068\u30d7\u30ed\u30bb\u30b9\u306e\u30d1\u30e9\u30e1\u30fc\u30bf\u304c\u3001\u7cbe\u5ea6\u3001\u7cbe\u5ea6\u3001\u30d0\u30a4\u30a2\u30b9\u306b\u95a2\u3057\u3066\u78ba\u7acb\u3055\u308c\u305f\u4ed5\u69d8\u306e\u7bc4\u56f2\u5185\u306b\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u6e2c\u5b9a\u5024\u3092\u6c7a\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u30ad\u30e3\u30ea\u30d6\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u983b\u5ea6<\/h4>\n\n\n\n<p>\u6a5f\u5668\u306e\u7a2e\u985e\u3001\u4f7f\u7528\u983b\u5ea6\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u305d\u306e\u91cd\u8981\u6027\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u6a5f\u5668\u306e\u52d5\u4f5c\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u305d\u306e\u4ed6\u306e\u8981\u56e0\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u6e29\u5ea6<\/li><li>\u6e7f\u5ea6<\/li><li>\u6c5a\u67d3<\/li><li>\u9759\u96fb\u6c17<\/li><li>\u78c1\u5834<\/li><li>\u96fb\u6e90\u5909\u52d5<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u6a5f\u5668\u3068\u898f\u683c<\/h4>\n\n\n\n<p>\u4f7f\u7528\u3059\u308b\u3059\u3079\u3066\u306e\u6a5f\u5668\u3068\u898f\u683c\u306f\u3001\u30c7\u30d0\u30a4\u30b9\/\u85ac\u7269\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u307e\u305f\u306f\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u8a18\u9332\u306b\u5b8c\u5168\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6a5f\u5668\u306e\u6821\u6b63\u304a\u3088\u3073\u4f7f\u7528\u6642\u306b\u306f\u3001\u6e29\u5ea6\u3001\u6e7f\u5ea6\u3001\u632f\u52d5\u3001\u6e05\u6d44\u5ea6\u306a\u3069\u306e\u74b0\u5883\u7279\u6027\u3092\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p><strong>\u88c5\u7f6e<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u8a2d\u7f6e\u8cc7\u683c\uff08IQ\uff09\uff1a\u6a5f\u5668\u3068\u88dc\u52a9\u30b7\u30b9\u30c6\u30e0\u304c\u9069\u5207\u306b\u8a2d\u7f6e\u3055\u308c\u3001\u30e1\u30fc\u30ab\u30fc\u306e\u4ed5\u69d8\u3068\u8a2d\u8a08\u610f\u56f3\u3092\u6e80\u305f\u3057\u3001\u610f\u56f3\u3055\u308c\u305f\u4f7f\u7528\u7bc4\u56f2\u3067\u9069\u5207\u306b\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u53d6\u3089\u308c\u308b\u63aa\u7f6e<\/li><li>\u904b\u7528\u8cc7\u683c\uff08OQ\uff09\uff1a\u6a5f\u5668\u3068\u30b5\u30d6\u30b7\u30b9\u30c6\u30e0\u304c\u78ba\u7acb\u3055\u308c\u305f\u5236\u9650\u3068\u8a31\u5bb9\u7bc4\u56f2\u5185\u3067\u4e00\u8cab\u3057\u3066\u52d5\u4f5c\u3067\u304d\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u53d6\u3089\u308c\u305f\u30a2\u30af\u30b7\u30e7\u30f3<\/li><li>\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u8a8d\u5b9a\uff08PQ\uff09\uff1a\u30b7\u30b9\u30c6\u30e0\u5185\u306e\u6a5f\u5668\u304c\u9577\u671f\u306b\u308f\u305f\u3063\u3066\u52b9\u679c\u7684\u304b\u3064\u4e00\u8cab\u3057\u3066\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u53d6\u3089\u308c\u308b\u30a2\u30af\u30b7\u30e7\u30f3<\/li><\/ul>\n\n\n\n<p><strong>\u6a5f\u5668\u3068\u898f\u683c<\/strong><\/p>\n\n\n\n<p>\u5b9f\u7528\u7684\u306a\u5834\u5408\u3001\u6a19\u6e96\u306f\u7c73\u56fd\u56fd\u7acb\u6a19\u6e96\u6280\u8853\u7814\u7a76\u6240\u307e\u3067\u8ffd\u8de1\u53ef\u80fd\u3067\u3042\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<br>\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\uff08NIST\uff09\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u30d7\u30e9\u30a4\u30d9\u30fc\u30c8\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9\u306f\u3001\u30ad\u30e3\u30ea\u30d6\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u305f\u3081\u306bNIST\u306b\u9001\u4fe1\u3055\u308c\u3001\u8fd4\u9001\u3055\u308c\u307e\u3059<\/li><li>NIST\u306f\u3001\u6821\u6b63\u30d7\u30ed\u30b0\u30e9\u30e0\u3067\u4f7f\u7528\u3055\u308c\u308b\u6a19\u6e96\u6a19\u6e96\u7269\u8cea\u3092\u63d0\u4f9b\u3057\u307e\u3059<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u7cbe\u5ea6\u3001\u7cbe\u5ea6\u3001\u30d0\u30a4\u30a2\u30b9\u306e\u9650\u754c<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>&nbsp;\u7cbe\u5ea6\uff1a\u771f\u306e\u5024\u307e\u305f\u306f\u7d76\u5bfe\u5024\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306e\u6a5f\u5668\u306e\u80fd\u529b\u306e\u5c3a\u5ea6<\/li><li>\u7cbe\u5ea6\uff1a\u76f8\u5bfe\u7684\u306a\u518d\u73fe\u6027\u306e\u7a0b\u5ea6\u3092\u793a\u3057\u307e\u3059<\/li><li>\u30d0\u30a4\u30a2\u30b9\uff1a\u4e00\u9023\u306e\u6e2c\u5b9a\u5024\u306e\u5e73\u5747\u5024\u304c\u771f\u306e\u5024\u306b\u3069\u308c\u3060\u3051\u8fd1\u3044\u304b\u3092\u793a\u3059\u5c3a\u5ea6<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u662f\u6b63\u63aa\u7f6e<\/h4>\n\n\n\n<p>\u5236\u9650\u304c\u6e80\u305f\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u306b\u767a\u751f\u3057\u307e\u3059\u3002\u662f\u6b63\u63aa\u7f6e\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u898f\u5b9a\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u3053\u308c\u3089\u306e\u5236\u9650\u3092\u518d\u78ba\u7acb\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u30a2\u30af\u30b7\u30e7\u30f3\u3092\u8aac\u660e\u3057\u3066\u958b\u59cb\u3057\u307e\u3059\uff08\u518d\u8abf\u6574\uff09<\/li><li>\u30c7\u30d0\u30a4\u30b9\/\u85ac\u5264\u306e\u54c1\u8cea\u306b\u60aa\u5f71\u97ff\u304c\u3042\u3063\u305f\u304b\u3069\u3046\u304b\u3092\u8a55\u4fa1\u3057\u307e\u3059<\/li><li>\u5b9f\u884c\u3055\u308c\u305f\u30a2\u30af\u30b7\u30e7\u30f3\u3068\u5b9f\u884c\u3055\u308c\u305f\u8a55\u4fa1\u3092\u6587\u66f8\u5316\u3057\u307e\u3059<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u6587\u66f8\u5316\u306e\u8981\u4ef6<\/h4>\n\n\n\n<p>\u7d19\u306e\u30b7\u30b9\u30c6\u30e0\u307e\u305f\u306f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30d7\u30ed\u30b0\u30e9\u30e0\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u6a5f\u5668\u306e\u8b58\u5225\uff08\u30e2\u30c7\u30eb\u756a\u53f7\u3092\u542b\u3080\uff09<\/li><li>\u30b7\u30ea\u30a2\u30eb\u30ca\u30f3\u30d0\u30fc<\/li><li>\u6821\u6b63\u65e5<\/li><li>\u6821\u6b63\u8005\u306e\u540d\u524d<\/li><li>\u6b21\u306e\u6821\u6b63\u65e5<\/li><li>\u6821\u6b63\u4ed5\u69d8<\/li><li>\u88fd\u9020\u5143\u306e\u30a2\u30c9\u30ec\u30b9\uff08\u30aa\u30d7\u30b7\u30e7\u30f3\uff09<\/li><li>\u30ad\u30e3\u30ea\u30d6\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u7406\u7531\uff08\u30aa\u30d7\u30b7\u30e7\u30f3\uff09<\/li><li>\u30b3\u30e1\u30f3\u30c8\uff08\u30aa\u30d7\u30b7\u30e7\u30f3\uff09<\/li><li>\u5916\u90e8\u30b5\u30fc\u30d3\u30b9\u60c5\u5831\uff08\u30aa\u30d7\u30b7\u30e7\u30f3\uff09<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u6821\u6b63\u62c5\u5f53\u8005<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>\u30ad\u30e3\u30ea\u30d6\u30ec\u30fc\u30b7\u30e7\u30f3\u3092\u5b9f\u884c\u3059\u308b\u306b\u306f\u3001\u6559\u80b2\u3084\u7d4c\u9a13\u3092\u901a\u3058\u3066\u9069\u5207\u306b\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li><li>\u8a08\u6e2c\u3068\u6821\u6b63\u306e\u6982\u5ff5\u306b\u95a2\u3059\u308b\u57fa\u672c\u7684\u306a\u77e5\u8b58\u304c\u5fc5\u8981\u3067\u3059<\/li><li>\u6e2c\u5b9a\u5206\u91ce\u306e\u57fa\u672c\u539f\u5247\u3001\u51e6\u7406\u624b\u9806\u3001\u304a\u3088\u3073\u53d7\u3051\u5165\u308c\u8981\u4ef6\u3092\u7406\u89e3\u3057\u3066\u3044\u308b<\/li><li>\u5168\u4f53\u7684\u306a\u6821\u6b63\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u77e5\u8b58<\/li><li>\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u3068\u6a5f\u5668\u306e\u4f7f\u7528\u306b\u95a2\u3059\u308b\u6307\u793a\u306b\u5f93\u3046\u80fd\u529b<\/li><li>\u8aa0\u5b9f\u306a\u614b\u5ea6<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u78ba\u8a8d<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>\u6821\u6b63\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u76e3\u67fb<\/li><li>\u5185\u90e8\u76e3\u67fb\uff08QSR\u304c\u5fc5\u8981\uff09<\/li><li>\u9069\u5207\u306a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3092\u7dad\u6301\u3059\u308b<\/li><li>\u9069\u5207\u306a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u7dad\u6301<\/li><li>\u6a19\u6e96\u306e\u9069\u5207\u306a\u7dad\u6301<\/li><li>\u662f\u6b63\u63aa\u7f6e\u306e\u9069\u5207\u6027<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u5916\u90e8\u76e3\u67fb<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>FDA\u306f\u3001\u5951\u7d04\u30e9\u30dc\u3092\u30e1\u30fc\u30ab\u30fc\u306eGMP\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u5ef6\u9577\u3068\u898b\u306a\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u5b9a\u671f\u7684\u306b\u884c\u3046\u3053\u3068\u304c\u9069\u5207\u3067\u3059\u3002<\/li><li>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u3042\u308b\u6a19\u6e96\u3092\u4f7f\u7528\u3057\u3066\u3001\u5236\u5fa1\u3055\u308c\u305f\u6761\u4ef6\u4e0b\u3067\u6a5f\u5668\u304c\u6821\u6b63\u3055\u308c\u305f\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u6587\u66f8\u3092\u5165\u624b\u3057\u307e\u3059<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u305d\u306e\u4ed6\u306e\u61f8\u5ff5\u4e8b\u9805<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3067\u4f7f\u7528\u3055\u308c\u308b\u88fd\u9020\u88c5\u7f6e\uff08\u81ea\u52d5\u5316\u3055\u308c\u3066\u3044\u308b\u5834\u5408\uff09\u306f\u3001\u5b9a\u671f\u7684\u306b\u6821\u6b63\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059<\/li><li>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30fc\u5236\u5fa1\u306e\u88fd\u9020\u88c5\u7f6e\u306f\u3001\u305d\u306e\u4f7f\u7528\u76ee\u7684\u3092\u691c\u8a3c\u3057\u3001\u6821\u6b63\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u5b9a\u7fa9\u306e\u88dc\u907a<\/h4>\n\n\n\n<p><strong>\u30a4\u30f3\u30b9\u30c8\u30fc\u30eb\u8cc7\u683c\uff08IQ\uff09\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u3042\u306a\u305f\u306f\u3042\u306a\u305f\u304c\u671b\u3080\u3082\u306e\u3092\u624b\u306b\u5165\u308c\u307e\u3057\u305f\u304b\uff1f<\/li><li>\u305d\u308c\u3092\u4f7f\u7528\u3059\u308b\u305f\u3081\u306e\u9069\u5207\u306a\u8a2d\u5099\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/li><li>\u3059\u3079\u3066\u306e\u6a5f\u5668\u304c\u9069\u5207\u306b\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1a<ul><li>\u30b7\u30ea\u30a2\u30eb\u30ca\u30f3\u30d0\u30fc<\/li><li>\u30e1\u30fc\u30ab\u30fc<\/li><li>\u793e\u5185\u8cc7\u7523\u756a\u53f7<\/li><li>\u9069\u5207\u306a\u30a4\u30f3\u30b9\u30c8\u30fc\u30eb<\/li><li>\u8a08\u5668\u30ed\u30b0\u30d6\u30c3\u30af\u304c\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u308b<\/li><li>\u30e9\u30dc\u306e\u5834\u6240<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>\u904b\u7528\u8cc7\u683c\uff08OQ\uff09\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u30e9\u30dc\u6a5f\u5668\u304c\u4e88\u60f3\u3055\u308c\u308b\u4f7f\u7528\u7bc4\u56f2\u5168\u4f53\u3067\u6a5f\u80fd\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8<\/li><li>\u6a5f\u5668\/\u30b7\u30b9\u30c6\u30e0\u304c\u4e8b\u524d\u306b\u6c7a\u5b9a\u3055\u308c\u305f\u4e00\u9023\u306e\u57fa\u6e96\u306e\u5236\u9650\u5185\u3067\u52d5\u4f5c\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u4e00\u9023\u306e\u6a5f\u80fd\u30c6\u30b9\u30c8<\/li><\/ul>\n\n\n\n<p><strong>\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u8a8d\u5b9a\uff08PQ\uff09\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u5c65\u6b74\u30e1\u30bd\u30c3\u30c9\u306e\u691c\u8a3c\u306b\u95a2\u3057\u3066\u3001\u7279\u5b9a\u306e\u30e1\u30bd\u30c3\u30c9\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u30bb\u30c3\u30c8\u304c\u9069\u5207\u306b\u6a5f\u80fd\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u307e\u3059<\/li><li>\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u306e\u9069\u5408\u6027\u304c\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u8a8d\u5b9a\u3068\u3057\u3066\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059<br>\u518d\u8a8d\u5b9a\uff08RQ\uff09\uff1a<\/li><li>\u4fee\u7406\u3001\u30d9\u30f3\u30c0\u30fc\u30b5\u30fc\u30d3\u30b9\u3001\u5834\u6240\u306e\u5909\u66f4\u3001\u307e\u305f\u306f\u8abf\u6574\u304c\u884c\u308f\u308c\u305f\u5f8c\u306e\u6a5f\u5668\u304c\u671f\u5f85\u3069\u304a\u308a\u306b\u52d5\u4f5c\u3057\u3066\u3044\u308b\u3053\u3068\u306e\u78ba\u8a8d<\/li><li>\u8003\u616e\u4e8b\u9805<ul><li>\u6a5f\u5668\u306f\u78ba\u7acb\u3055\u308c\u305f\u5143\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u6e80\u305f\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/li><li>\u305d\u3046\u3067\u306a\u3044\u5834\u5408\u3001\u3069\u306e\u3088\u3046\u306a\u6c7a\u5b9a\u3092\u4e0b\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/li><\/ul><\/li><\/ul>","protected":false},"excerpt":{"rendered":"<p>Ensure Compliance At Your Location Validation Planning, Testing And Management We are software compliance experts. All versions of ProCalV5 software are internally tested and validated before release. IQ\/OQ\/PQ protocols can be provided. GAMP 5 level validation project plans, all necessary documents and any needed services are available to ensure compliant use at your locations. 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