药品检验行业LIMS系统ELN模板格式化解决方案

Format Solution of ELN Template of LIMS System in Pharmaceutical Inspection Industry

目的提供LIMS系统中药品检验行业ELN模板格式化解决方案,使ELN原始记录规范、完整、统一、高效且可控。方法将测定数据分为共享数据与独立数据两类,独立数据与计算结果横向排列,以方便添加多组分;各类测定数据录入位置相对固定,最大程度的使不同仪器方法、不同测定方法所用表格形式基本统一,缩减模板数量;设置“其他系数”栏,大幅提高计算表格的兼容性;使用适宜的逻辑函数与命令符提高计算的自动化程度,避免检验员编辑公式。结果该解决方案完整的包含了多种药品检验方法计算所需的必要元素,自动化程度高,形式规范统一,大幅减少了所需模板的数量,也减少了检验员培训时间,同时也实现了对含有公式的结果单元格的锁定,使受控管理切实可行。结论此类格式化解决方案可行性高,对药品检验行业LIMS系统建设具有较好的借鉴意义。

OBJECTIVE To provide the format solution of ELN template in the pharmaceutical inspection industry in LIMS system,to make the original records of ELN are standardized,complete,unified,efficient and controllable.METHODS The measurement data was divided into two categories:shared data and independent data.The independent data and results were arranged horizontally to facilitate the addition of other component;the input positions of various measurement data were relatively fixed,so as to basically unify the forms used by different instrument methods and different measurement methods and reduced the number of templates;the"other coefficient"column was set to greatly improve the compatibility of calculation tables.Use appropriate logic functions and command symbols to improve the automation of calculation and the inspector did not need to edit the formula.RESULTS The solution completely contains the necessary elements for the calculation of various drug inspection methods,with high degree of automation and unified form,greatly reducing the number of templates required,reducing the training time of inspectors,and also realizing the locking of result cells containing formulas,which makes the controlled management feasible.CONCLUSION This kind of format solution is feasible and has a good reference significance for the construction of LIMS system in drug inspection industry.