API瀵嗗害璁
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1锛氳嚜鍔ㄥ寲闆嗘垚锛屽疄鐜颁竴閿祴瀹氬姛鑳斤紱
2锛氬唴缃笗灏旇创鎺ф俯锛屾彁楂樼簿搴﹀拰绋冲畾鎬э紱
3锛氶珮娓呰棰戦伩鍏嶆皵娉″奖鍝嶏紱
4: 鍙€氳繃鎵撳嵃鏈虹洿鎺ユ墦鍗版暟鎹紱
5: 绗﹀悎21CFR Part 11銆佸璁¤拷韪€佽嵂鍏稿強鐢靛瓙绛惧悕銆
瀵嗗害璁★紝瀵嗗害浠紝U鍨嬪瘑搴︿华Digipol-D50
1锛氳嚜鍔ㄥ寲闆嗘垚锛屽疄鐜颁竴閿祴瀹氬姛鑳斤紱
2锛氬唴缃笗灏旇创鎺ф俯锛屾彁楂樼簿搴﹀拰绋冲畾鎬э紱
3锛氶珮娓呰棰戦伩鍏嶆皵娉″奖鍝嶏紱
4: 鍙€氳繃鎵撳嵃鏈虹洿鎺ユ墦鍗版暟鎹紱
5: 绗﹀悎21CFR Part 11銆佸璁¤拷韪€佽嵂鍏稿強鐢靛瓙绛惧悕銆
灞变笢閲戝煄鍖昏嵂鍖栧伐鏈夐檺鍏徃閲囪喘浣宠埅鐨勫叏鑷姩瀵嗗害璁igipol-D50
鎰熻阿灞变笢閲戝煄鍖昏嵂鍖栧伐鏈夐檺鍏徃瀵逛匠鑸华鍣ㄧ殑璁ゅ彲锛屽苟浜?024骞?鏈堜唤閲囪喘浣宠埅浠櫒鍏ㄨ嚜鍔ㄥ瘑搴﹁銆備匠鑸华鍣ㄥ皢浠ヤ紭璐ㄧ殑浜у搧鍜屽敭鍚庝负鎮ㄦ湇鍔★紝鏈熷緟灞变笢閲戝煄鍖昏嵂鍖栧伐鏈夐檺鍏徃涓庢垜鍙稿啀娆″悎浣滐紝骞舵杩庡北涓滈噾鍩庡尰鑽寲宸ユ湁闄愬叕鍙哥浉鍏虫妧鏈礋璐ｄ汉鍛樹负鎴戝叕鍙告彁鍑哄疂璐电殑鎰忚銆
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涓滈槼甯傞鍝佽嵂鍝佹楠屾娴嬩腑蹇冮噰璐匠鑸殑鍏ㄨ嚜鍔ㄥ瘑搴﹁Digipol-D70
鎰熻阿涓滈槼甯傞鍝佽嵂鍝佹楠屾娴嬩腑蹇冨浣宠埅浠櫒鐨勮鍙紝骞朵簬2024骞?鏈堜唤閲囪喘浣宠埅浠櫒鍏ㄨ嚜鍔ㄥ瘑搴﹁銆備匠鑸华鍣ㄥ皢浠ヤ紭璐ㄧ殑浜у搧鍜屽敭鍚庝负鎮ㄦ湇鍔★紝鏈熷緟涓滈槼甯傞鍝佽嵂鍝佹楠屾娴嬩腑蹇冧笌鎴戝徃鍐嶆鍚堜綔锛屽苟娆㈣繋涓滈槼甯傞鍝佽嵂鍝佹楠屾娴嬩腑蹇冪浉鍏虫妧鏈礋璐ｄ汉鍛樹负鎴戝叕鍙告彁鍑哄疂璐电殑鎰忚銆
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鍖椾含鑸ぉ璇曢獙鎶€鏈爺绌舵墍閲囪喘浣宠埅鐨勫叏鑷姩瀵嗗害璁igipol-D70
鎰熻阿鍖椾含鑸ぉ瀹為獙鎶€鏈爺绌舵墍瀵逛匠鑸华鍣ㄧ殑璁ゅ彲锛屽苟浜?023骞?2鏈堜唤閲囪喘浣宠埅浠櫒鍏ㄨ嚜鍔ㄥ瘑搴﹁銆備匠鑸华鍣ㄥ皢浠ヤ紭璐ㄧ殑浜у搧鍜屽敭鍚庝负鎮ㄦ湇鍔★紝鏈熷緟鍖椾含鑸ぉ瀹為獙鎶€鏈爺绌舵墍涓庢垜鍙稿啀娆″悎浣滐紝骞舵杩庡寳浜埅澶╁疄楠屾妧鏈爺绌舵墍鐩稿叧鎶€鏈礋璐ｄ汉鍛樹负鎴戝叕鍙告彁鍑哄疂璐电殑鎰忚銆
闀挎槬闆峰厑涓婅嵂涓氭湁闄愬叕鍙搁噰璐匠鑸殑鍏ㄨ嚜鍔ㄥ瘑搴﹁Digipol-D50
鎰熻阿闀挎槬闆峰厑涓婅嵂涓氭湁闄愬叕鍙稿浣宠埅浠櫒鐨勮鍙紝骞朵簬2023骞?1鏈堜唤閲囪喘浣宠埅浠櫒鍏ㄨ嚜鍔ㄥ瘑搴﹁銆備匠鑸华鍣ㄥ皢浠ヤ紭璐ㄧ殑浜у搧鍜屽敭鍚庝负鎮ㄦ湇鍔★紝鏈熷緟闀挎槬闆峰厑涓婅嵂涓氭湁闄愬叕鍙镐笌鎴戝徃鍐嶆鍚堜綔锛屽苟娆㈣繋鎰熻阿闀挎槬闆峰厑涓婅嵂涓氭湁闄愬叕鍙哥浉鍏虫妧鏈礋璐ｄ汉鍛樹负鎴戝叕鍙告彁鍑哄疂璐电殑鎰忚銆
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灞变笢绉戞簮鍖栧伐鏈夐檺鍏徃閲囪喘浣宠埅鐨勫叏鑷姩瀵嗗害璁igipol-D50
鎰熻阿灞变笢绉戞簮鍖栧伐鏈夐檺鍏徃瀵逛匠鑸华鍣ㄧ殑璁ゅ彲锛屽苟浜?023骞?8鏈堜唤閲囪喘浣宠埅浠櫒瀵嗗害璁°€備匠鑸华鍣ㄥ皢浠ヤ紭璐ㄧ殑浜у搧鍜屽敭鍚庝负鎮ㄦ湇鍔★紝鏈熷緟灞变笢绉戞簮鍖栧伐鏈夐檺鍏徃涓庢垜鍙稿啀娆″悎浣滐紝骞舵杩庡北涓滅婧愬寲宸ユ湁闄愬叕鍙哥浉鍏虫妧鏈礋璐ｄ汉鍛樹负鎴戝叕鍙告彁鍑哄疂璐电殑鎰忚銆
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灞变笢搴忓垪鐢熺墿绉戞妧鏈夐檺鍏徃閲囪喘浣宠埅鐨勫叏鑷姩瀵嗗害璁igipol-D70
鎰熻阿灞变笢搴忓垪鐢熺墿绉戞妧鏈夐檺鍏徃瀵逛匠鑸华鍣ㄧ殑璁ゅ彲锛屽苟浜?023骞?5鏈堜唤閲囪喘浣宠埅浠櫒鍏ㄨ嚜鍔ㄥ瘑搴﹁銆備匠鑸华鍣ㄥ皢浠ヤ紭璐ㄧ殑浜у搧鍜屽敭鍚庝负鎮ㄦ湇鍔★紝鏈熷緟灞变笢搴忓垪鐢熺墿绉戞妧鏈夐檺鍏徃涓庢垜鍙稿啀娆″悎浣滐紝骞舵杩庡北涓滃簭鍒楃敓鐗╃鎶€鏈夐檺鍏徃鐩稿叧鎶€鏈礋璐ｄ汉鍛樹负鎴戝叕鍙告彁鍑哄疂璐电殑鎰忚銆
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