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首頁   >>   公司動態   >>   迎接制藥4.0浪潮,讓您面對數據完整性檢查成竹在胸

迎接制藥4.0浪潮,讓您面對數據完整性檢查成竹在胸

閱讀:655      發布時間:2022-6-30
  在過去的半個世紀中,制藥行業已經通過技術發展實現了從手工到“批量生產”(batch production)的變化。隨著工業4.0的到來,為了實現盡可能少的人工過程的干預,保證藥品質量,制藥行業已經開始探索用連續生產(continuous manufacturing )替代批量生產以實現制藥4.0。展望未來,一旦連續生產的方式被普遍采用,藥品生產效率提升的同時也會產生海量數據,進而對數據進行監管的難度也必定增加。
 
  自 1997 年關于電子記錄的USFDA 21 CFR Part 11 法規發布以來,監管機構對藥物開發和制造過程中創建的數據的關注日益提升。色譜儀器在藥品研發和質量控制中的廣泛使用,早已使得色譜數據系統(CDS)成為了監管的重點。國際法規和指南(包括GMP、GLP等)對數據完整性的控制,其中重要的一項措施就是審計追蹤。因此Chromeleon CDS提供了全面且精細化的審計追蹤體系以滿足法規監管要求和制藥企業內部的審計需求。按照色譜數據系統的主要組成,Chromeleon將審計追蹤分為3大類,然后根據其相關性進一步分為17小類,從而為用戶提供了非常清晰的內容結構(圖1)。
 
圖片2.png
 
  圖1 Chromeleon審計追蹤
 
  (點擊查看大圖)
 
圖片3.png
 
  · 審計追蹤的分組與篩選
 
  通過分組、篩選和檢索,并結合報告的輸出,Chromeleon可以非常便捷地對審計追蹤進行查找及審核。例如,在需要審核序列審計追蹤時,可以先將數據對象審計追蹤按照“類型”分組,關注類型為序列的部分;然后使用篩選工具在操作列輸入“Started Run” 或者“Aborted Run”。通過這兩步的操作可以發現一個或多個分析被重復的啟動和中斷,結合對應時間儀器的運行日志,使用者就能快速挖掘出這個數據對象是否存在數據完整性問題(見圖2)。
 
圖片4.png
 
  圖2 審計追蹤的分組與篩選
 
  (點擊查看大圖)
 
圖片5.png
 
  · 審計追蹤事件工具
 
  Chromeleon 7.3還創建了“審計追蹤事件”的概念,實現了以點見面:可以預先定義所關注的特定動作,從而可以更清晰地對其進行識別和監控。與所有審計追蹤記錄一樣,審計追蹤事件也可以進行查詢、搜索和報告。審計追蹤事件的使用既簡化了審查的過程,也使得審計的重點更為突出且易于讀取(如圖3)。
 
圖片6.png
 
  圖3 審計追蹤事件工具
 
  (點擊查看大圖)
 
圖片7.png
 
  · 審計追蹤檢索工具
 
  Chromeleon 7.3.1進一步增強了數據完整性審查框架?;诿嫦蛐蛄械臄祿ο髮徲嬜粉?,新的功能可以更方便的在軟件中高效和快捷的進行審計追蹤審查。在上述例子中,我們可以使用一個檢索文件去定義 “Started Run” 和 “Aborted Run” 操作,檢索結果即可清晰呈現(如圖4所示)。
 
圖片8.png
 
  圖4 審計追蹤檢索工具
 
  (點擊查看大圖)
 
  審計追蹤審查是一項繁瑣且枯燥的任務,使用傳統的方式不僅需要有經驗的使用者將孤立的單個信息連接起來以識別和評估潛在的數據完整性風險,還占用大量的時間。而在全新版本的Chromeleon中,不僅系統、儀器以及數據這三大類的審計追蹤可以完整地被記錄,您還可以簡單地通過 “審計追蹤事件” 與 “審計追蹤檢索工具” ,輕松實現更高程度的審查自動化。
 
  結語
 
  在制藥4.0時代的潮涌下,作為協助藥企進行質量改進的解決方案,Chromeleon始終緊密聯系法規與前沿技術,以智能化、高效的審計追蹤審查功能為切入點,時刻關注您的數據質量,讓您面對數據完整性檢查成竹在胸。

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