{"id":12,"date":"2016-05-24T09:33:04","date_gmt":"2016-05-24T00:33:04","guid":{"rendered":"http:\/\/52.196.95.92\/wordpress\/?page_id=12"},"modified":"2025-05-12T14:36:02","modified_gmt":"2025-05-12T05:36:02","slug":"system-development","status":"publish","type":"page","link":"https:\/\/www.fsz.co.jp\/?page_id=12","title":{"rendered":"CSV\u5bfe\u5fdc GMP\u30b7\u30b9\u30c6\u30e0\u958b\u767a"},"content":{"rendered":"\n

\u533b\u85ac \u88fd\u85acCSV\u6e96\u62e0\u306e\u30b7\u30b9\u30c6\u30e0\u958b\u767a<\/h2>\n\n\n\n
\"\"<\/figure>\n\n\n\n

\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3
Computerized System Validation<\/h4>\n\n\n\n

\u539a\u751f\u52b4\u50cd\u7701\u304c\u7ba1\u8f44\u30fb\u95a2\u4fc2\u3057\u3066\u308b\u696d\u754c\uff08\u533b\u85ac\u88fd\u85ac\u3001\u533b\u7642\u6a5f\u5668\u3001\u5065\u5eb7\u98df\u54c1\u3001\u5316\u7ca7\u54c1\u3001\u98df\u54c1\u306a\u3069\uff09\u3067\u306f\u3001\u88fd\u9020\u3001\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u88fd\u54c1\u306e\u54c1\u8cea\u304c\u304a\u5ba2\u69d8\u306e\u5065\u5eb7\u306b\u305d\u306e\u307e\u307e\u95a2\u308f\u308a\u307e\u3059\u3002\u305d\u306e\u3088\u3046\u306a\u5927\u5207\u306a\u88fd\u54c1\u3001\u696d\u52d9\u3001\u6587\u66f8\u3067\u3059\u304b\u3089\u3001\u5229\u7528\u3059\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u3082\u8981\u6c42\u4e8b\u9805\u306b\u5bfe\u3057\u3066\u3001\u9069\u6b63\u306a\u7ba1\u7406\u306e\u5143\u306b\u958b\u767a\u3055\u308c\u305f\u3082\u306e\u304c\u8981\u6c42\u3055\u308c\u307e\u3059\u3002IT\u30d1\u30c3\u30b1\u30fc\u30b8\u3067\u306f\u5b9f\u73fe\u3067\u304d\u306a\u3044\u304a\u5ba2\u69d8\u306e\u696d\u52d9\u306e\u6c42\u3081\u306b\u3001\u30d4\u30c3\u30bf\u30ea\u3068\u5408\u3063\u305f\u30b7\u30b9\u30c6\u30e0\u3067\u4f5c\u696d\u3092\u52b9\u7387\u5316\u3001\u696d\u52d9\u3092\u30b9\u30e0\u30fc\u30ba\u306b\u9032\u3081\u307e\u3059\u3002\u30b7\u30b9\u30c6\u30e0\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08CSV\uff09\u8a08\u753b\u3001\u8981\u6c42\u5b9a\u7fa9\u66f8\uff08URS\uff09\u306e\u5fa1\u63d0\u6848\u304b\u3089\u8a2d\u8a08\u30fb\u958b\u767a\u30fb\u691c\u8a3c\uff08DQ\u3001IQ\u3001OQ\u3001PQ\uff09\u3001\u5c0e\u5165\u3001CSV\u3092\u524d\u63d0\u3068\u3057\u305f\u30b7\u30b9\u30c6\u30e0\u904b\u7528\u306b\u81f3\u308b\u307e\u3067\u3001\u304a\u5ba2\u69d8\u306e\u30d3\u30b8\u30cd\u30b9\u3092\u7dcf\u5408\u7684\u306b\u30b5\u30dd\u30fc\u30c8\u3044\u305f\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\uff13\u3064\u306e\u304a\u7d04\u675f<\/h3>\n\n\n\n

\u300c\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u7b49\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\uff08\u901a\u79f0CSV\uff5cComputerized System Validation\uff09\u306b\u6e96\u62e0\u3057\u305f\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002CSV\u306b\u6e96\u62e0\u3057\u305f\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u306e\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u3092\u7406\u89e3\u3057\u3066\u3044\u307e\u3059\u306e\u3067\u3001\u304a\u5ba2\u69d8\u306b\u304a\u624b\u9593\u3092\u53d6\u3089\u305b\u305a\u306b\u3001\u6e80\u8db3\u3044\u305f\u3060\u3051\u308b\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\u539a\u751f\u52b4\u50cd\u7701\u3000CSV\u95a2\u9023\u30b5\u30a4\u30c8\u306e\u30ea\u30f3\u30af\u306f\u3053\u3061\u3089<\/a>
GMP- manufacturing – \u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u3000\u539a\u52b4\u7701\u30b5\u30a4\u30c8<\/a>
GDP – Distribution – \u533b\u85ac\u54c1\u306e\u9069\u6b63\u6d41\u901a\u57fa\u6e96\u3000\u539a\u52b4\u7701\u30b5\u30a4\u30c8<\/a>
GQP – quality – \u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u53ca\u3073\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u3000\u539a\u52b4\u7701\u30b5\u30a4\u30c8
GCP – clinical – \u533b\u85ac\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96
GLP – laboratory – \u533b\u85ac\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u306e\u975e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96
GVP – vigilance – \u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u53ca\u3073\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u8ca9\u58f2\u5f8c\u5b89\u5168\u7ba1\u7406\u306e\u57fa\u6e96
GPSP – Post-marketing Study – \u88fd\u9020\u8ca9\u58f2\u5f8c\u306e\u8abf\u67fb\u30fb\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96<\/p>\n\n\n\n

\uff11 \u4e01\u5be7\u306b\u3001\u305d\u3057\u3066\u5c0f\u3055\u306a\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u304b\u3089\u304a\u5f15\u304d\u53d7\u3051\u3057\u307e\u3059\u3002<\/h4>\n\n\n\n

\u304a\u5ba2\u69d8\u306e\u3054\u5e0c\u671b\u3068\u696d\u52d9\u3092\u7d20\u65e9\u304f\u7406\u89e3\u3057\u3001\u696d\u52d9\u8ab2\u984c\u3092\u89e3\u6c7a\u3059\u308b\u63d0\u6848\u3092\u3054\u63d0\u4f9b\u3057\u307e\u3059\u3002\u304a\u5ba2\u69d8\u304b\u3089\u306e\u5fa1\u5e0c\u671b\u306b\u6cbf\u3046\u3060\u3051\u3067\u306f\u306a\u304f\u3001\u305d\u306e\u696d\u52d9\u306e\u4ed6\u793e\u4e8b\u4f8b\u306e\u30ce\u30a6\u30cf\u30a6\u3084\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u306e\u5c02\u9580\u5bb6\u3068\u3044\u3046\u7acb\u5834\u304b\u3089\u3001\u30b7\u30b9\u30c6\u30e0\u306b\u9650\u3089\u305a\u3001\u304a\u5f79\u306b\u7acb\u3064\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u3054\u63d0\u6848\u3092\u3044\u305f\u3057\u307e\u3059\u3002
\u307e\u305f\u3001EXCEL\u306e\u30b7\u30fc\u30c8\u3084\u30de\u30af\u30ed\u306a\u3069\u30c4\u30fc\u30eb\u4f5c\u6210\u3084\u6570\u65e5\u3067\u7d42\u308f\u308b\u3088\u3046\u306a\u5c0f\u898f\u6a21\u306a\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u3001\u4fee\u6b63\u306a\u3069\u3082\u304a\u5f15\u304d\u53d7\u3051\u3057\u307e\u3059\u3002\u3042\u3089\u3086\u308b\u6280\u8853\u3092\u6301\u3063\u305f\u958b\u767a\u8005\u304c\u304a\u308a\u3001\u305d\u306e\u5f97\u610f\u6280\u3092\u6d3b\u7528\u3057\u3066\u958b\u767a\u3092\u884c\u3044\u307e\u3059\u306e\u3067\u3001\u77ed\u671f\u9593\u3067\u5b89\u4fa1\u306a\u3054\u63d0\u4f9b\u304c\u53ef\u80fd\u3067\u3059\u3002\u3061\u3087\u3063\u3068\u3057\u305f\u4f5c\u696d\u3060\u304b\u3089\u3068\u624b\u4f5c\u696d\u3067\u3084\u3063\u3066\u3044\u308b\u3068\u30b3\u30b9\u30c8\u304c\u304b\u304b\u3063\u3066\u3044\u306a\u3044\u3088\u3046\u306b\u3082\u898b\u3048\u307e\u3059\u304c\u3001\u5b9f\u969b\u306b\u4f5c\u696d\u3055\u308c\u3066\u3044\u308b\u30b3\u30b9\u30c8\u306f\u9577\u3044\u671f\u9593\u8003\u3048\u308b\u3068\u601d\u3063\u305f\u4ee5\u4e0a\u306b\u539f\u4fa1\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u3002\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306f\u4fa1\u683c\u304c\u9ad8\u3044\u3068\u3044\u3046\u30a4\u30e1\u30fc\u30b8\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u9577\u671f\u9593\u3001\u591a\u304f\u306e\u5c40\u9762\u3067\u5229\u7528\u3055\u308c\u308b\u30c4\u30fc\u30eb\u3001\u30b7\u30b9\u30c6\u30e0\u3067\u3042\u308c\u3070\u539f\u4fa1\u3092\u4e0b\u3052\u308b\u975e\u5e38\u306b\u52b9\u679c\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n

\uff12 \u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3069\u304a\u308a\u3001\u304a\u898b\u7a4d\u91d1\u984d\u3067\u3084\u308a\u5207\u308a\u307e\u3059\u3002<\/h4>\n\n\n\n

\u305d\u306e\u696d\u754c\u306e\u5185\u5bb9\u3092\u719f\u77e5\u3057\u305f\u8a2d\u8a08\u30e1\u30f3\u30d0\u30fc\u3092\u53c2\u753b\u3055\u305b\u3066\u3001\u696d\u754c\u306e\u524d\u63d0\u306a\u3069\u306e\u8aac\u660e\u3084\u7406\u89e3\u3001\u8a2d\u8a08\u306a\u3069\u306b\u95a2\u308f\u308b\u6642\u9593\u3092\u6700\u5c0f\u9650\u306b\u3057\u307e\u3059\u3002\u793e\u54e1\u5168\u54e1\u306b\u3001\u88fd\u54c1\u54c1\u8cea\u3068\u30b3\u30b9\u30c8\uff08\u6642\u9593\u5229\u7528\uff09\u610f\u8b58\u3092\u5341\u5206\u6559\u80b2\u3057\u3066\u3044\u307e\u3059\u3002\u54c1\u8cea\u5411\u4e0a\u3001\u4f4e\u30b3\u30b9\u30c8\u306e\u70ba\u306b\u5229\u7528\u3067\u304d\u308b\u6a5f\u5668\u3001\u30bd\u30d5\u30c8\u3001\u4eba\u8ca1\u306f\u3059\u3079\u3066\u5229\u7528\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u5f0a\u793e\u8cac\u4efb\u306e\u4e0d\u5177\u5408\u306b\u304b\u304b\u308b\u30b3\u30b9\u30c8\u306f\u304a\u5ba2\u69d8\u306b\u306f\u8ca0\u62c5\u3092\u304b\u3051\u307e\u305b\u3093\u3002\u696d\u52d9\u3001\u30b7\u30b9\u30c6\u30e0\u3001CSV\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u304c\u304a\u5ba2\u69d8\u89b3\u70b9\u304b\u3089\u3001\u8981\u4ef6\u5b9a\u7fa9\uff08URS\uff09\u3001\u4ed5\u69d8\u6c7a\u5b9a\u3001\u6559\u80b2\u8a13\u7df4\u3001\u696d\u52d9\u3078\u306e\u5b9a\u7740\u307e\u3067\u30b5\u30dd\u30fc\u30c8\u3044\u305f\u3057\u307e\u3059\u3002<\/p>\n\n\n\n

\uff13 \u3088\u308a\u826f\u3044\u3082\u306e\u3092\u3001\u3088\u308a\u5b89\u304f<\/h4>\n\n\n\n

\u304a\u5ba2\u69d8\u306e\u3054\u8981\u671b\u3092\u304a\u805e\u304d\u3057\u3066\u3001\u3044\u308d\u3044\u308d\u306a\u5de5\u592b\u3068\u30b5\u30dd\u30fc\u30c8\u3092\u3055\u305b\u3066\u3044\u305f\u3060\u304d\u307e\u3059\u3002
\u30fb\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u306fCSV\u304c\u3069\u308c\u4f4d\u5fc5\u8981\u306a\u306e\u304b\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306b\u53c2\u52a0\u3057\u3066\u6b32\u3057\u3044\u3002
\u30fb\u6a5f\u80fd\u3082\u30c7\u30b6\u30a4\u30f3\u3082\u30b7\u30f3\u30d7\u30eb\u3067\u3044\u3044\u304b\u3089\u3001\uffe550\u4e07\u4ee5\u5185\u3067\u4f5c\u308a\u305f\u3044\u3002
\u30fbIT\u62c5\u5f53\u3082\u5c11\u306a\u304f\u3001\u696d\u52d9\u306b\u5f93\u4e8b\u3059\u308b\u793e\u54e1\u306f\u5927\u5909\u5fd9\u3057\u3044\u3002\u793e\u54e1\u304c\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306b\u95a2\u308f\u308b\u6642\u9593\u3092\u6700\u4f4e\u9650\u306b\u3057\u305f\u3044\u3002
\u30fbCSV\u306e\u30ce\u30a6\u30cf\u30a6\u304c\u5c11\u306a\u3044\u306e\u3067\u3084\u308a\u65b9\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3066\u6b32\u3057\u3044\u3002
\u30fbCSV\u306e\u4f5c\u696d\u3059\u308b\u30e1\u30f3\u30d0\u30fc\u304c\u5c11\u306a\u3044\u306e\u3067\u3001\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u4f5c\u6210\u3092\u5f15\u304d\u53d7\u3051\u3066\u6b32\u3057\u3044\u3002
\u30fb\u30b7\u30b9\u30c6\u30e0\u958b\u767a\u306e\u8cbb\u7528\u306f\u8cbb\u306f\u591a\u5c11\u4e0a\u304c\u3063\u3066\u3082\u3001\u904b\u7528\u8cbb\u3092\u6708\u984d\uffe510\u4e07\u306b\u4ee5\u4e0b\u306b\u3057\u305f\u3044\u3002
\u30fb\u30b7\u30b9\u30c6\u30e0\u904b\u7528\u3084\u7dad\u6301\u4fdd\u5b88\u3092\u81ea\u793e\u3067\u306f\u51fa\u6765\u306a\u3044\u306e\u3067\u3001\u5f15\u304d\u53d7\u3051\u3066\u6b32\u3057\u3044\u3002
\u30fbCSV\u306e\u904b\u7528\u4f5c\u696d\uff08\u65e5\u5e38\u70b9\u691c\uff09\u306a\u3069\u3092\u5f15\u304d\u53d7\u3051\u3066\u6b32\u3057\u3044\u3002<\/p>\n\n\n\n

<\/div>\n\n\n\n
\"\"<\/figure>\n\n\n\n
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