推荐回答（3个）
FE LIMS—制药企业执行新版GMP的利器FE LIMS系统严格遵循ISO 9000、ISO/IEC 17025、G(A)LP、GMP、FDA等标准规范，帮助企业建立完整的质量保证和质量控制体系，降低企业经营成本，完善质量风险控制，从而使企业快速健康发展起来。
规范---建立质量管理体系
FE LIMS系统提供全生命周期管理的质量管理模块，涵盖了供应商管理、变更管理、偏差管理、验证管理、审计管理、风险评估管理、放行管理、投诉管理、不良反应管理、质量目标管理等QA管理，还包括检验管理、留样管理、稳定性管理、人员管理、仪器管理等QC管理，为企业质量发展提供安全的保障。将各级管理人员从日常的GMP检查中解放出来，利用更多时间做好本职的工作。
可控—实现统一质量监管平台
FE LIMS系统从原材料采购、仓储检验、生产过程控制、成品检验、放行、投诉跟踪、召回等相关质量过程进行全程监控，质量受权人通过系统就能实时掌控一切质量情况，杜绝一切不规范的质量操作过程，在最短时间内作出相应措施，把质量风险最小化。在整个产品生命周期中采用前瞻或回顾的方式，对质量风险进行评估、控制、沟通、审核的管理过程。通过对偏差、变更、验证、投诉、供应商审计等环节进行质量风险评估，将风险最小化，实现风险可控，确保产品质量。
减耗--为企业节约成本
FE LIMS系统所提供的规范管理程序，减少和避免做样的反复，从而减少对照品、试剂、培养基平板等实验用品的消耗；对重点物料进行严密控制，杜绝浪费；对实验动物进行统一管理，重复利用，有的放矢，建立统一质量办公平台，实现办公无纸化，减少纸张浪费；对仪器使用进行统计分析，提高仪器的利用率；对人员进行量化考核，优化人力资源的分配，减少人工成本；整合企业内部协同办公平台，降低企业运营成本。
整合--资源整合、提高工作效率
FE LIMS系统整合了协同办公功能，使质检部门和其他部门更加紧密结合起来，形成一个统一质检业务协作平台。除了整合企业内部资源外，还具备良好的扩展和整合外部系统能力，即支持ERP、MES、OA、HR、CRM等系统进行整合，从而优化企业资源，减少手工录入的错误，加快数据传送的速度；统一的样品登记和调度系统，减少样品的周转时间，提高做样量，同时杜绝重复做样；通过对数据的统计与趋势分析，可以追踪产品的性能、标准、方法等情况，警告不良的质量变化趋势，防止不合格产品的产生，从而达到质量管理全过程的高效工作。 给分！给分
那只能严格执行GMP规范要求，否则吃亏的只有企业。以后的日子会越来越难。
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