药品检验微生物限度ELN的设计思路与解决方案

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中图分类号：R927 文献标志码：A 文章编号：2095-2945（2025）31-0100-05

Abstract：ToembedtheElectronicLaboratoryNotebook（ELN）technologyintothemicrobiallimittestwithintheLaboratory InformatioManagementSystem（LIMS）ofthepharmaceuticalinspectioninustrysoastostandardize，complete，unifyandake theexperimentalrecordseficientlycontrolable，traceableandtrackable.Themicrobiallimittestisseparatelydesignedby dividingitintotwoparts：themicrobialcountingmethodandthespecifiedmicrorganisminspectionmethodThroughsolutions suchasobtainingthecurrentsystemtime，nesteduseofformulas，two-waydatawriting-back，intuitiveandsimplepagelayout， andimplementingpositivefedbackinthedevelopmentprocessthefurtherdigitalconstructionofexperimentalrecordsis achieved.Theelectroniclaboratorynotebook（ELN）projectforthemicrobiallimitinpharmaceuticalinspectionhasben established.Theformsofexperimentalrecordsareunifiedandstandardized，andtheideaofdigitalcontroledmanagementof recordsanddocuments'hasbeenrealized.Thissolutionhasgoodversatityandholdshighreferencevalueinthefieldof pharmaceutical microbiological inspection.

Keywords：electroniclaboratory notebook （ELN）;electronicrecord;microbial limit;drug testing laboratory：LIMSsystem

国内实验室已普及实验室信息管理系统（Labo-ratoryInformationManagementSystem，LIMS），以电子化办公的方式从人、机、料、法、环5个管理因素实现实验室流程管理和资源管理[1，而电子实验记录本（ELN，electronic labnotebook）[2-3]应用却存在滞后与挑战。（剩余5207字）