A dedicated LIMS for routine gamma-ray spectrometry

We developed a Microsoft^® Access-based LIMS (Laboratory Information and Management Systems), γ-LIMS, for the management of our gamma-spectrometry laboratory, in which thousands of routine, but high-quality analyses are performed each year. This paper explains the main features of the γ-LIMS and puts special attention on the interfacing methods and solutions for using the Genie™2000 spectrometry software in conjunction with the EFFTRAN package, which serves for efficiency transfer calculations, coincidence summing corrections and a procedure for uncertainty estimation.     

食品药品检验检测信息化建设发展现状与经营介绍——以山东省食品药品检验研究院为例

本文总结了我院2016~2018信息化全面建设工作,包括机房、网络和应用系统建设,重点介绍实验室信息管理系统（LIMS）建设情况、经验和教训,以期为全国食品药品检验检测单位的信息化建设工作提供参考。     

药检机构实验室信息化建设中ELN系统应用的探讨

目的探讨药检机构实验室信息化建设中电子实验室记录本（ELN）系统的选型和实施。方法结合我国药检机构实验室信息化平台建设的现状,论述ELN系统的意义和具体功能,并提出如何在药检系统信息化中进行ELN系统的选型。结果作为第三方检测实验室的药检机构,在ELN的选型上应该区别于医药生产行业的ELN选型方式,需要选择一款灵活的ELN,同时选择适应日常检验和分析的ELN产品。结论选择灵活的可定制的ELN产品,能够满足药检实验室日常检验和分析的需求,适用于药检行业分析实验室的解决方案。     

Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics

The administration of biological therapeutics may result in the development of anti-drug antibodies (ADAs) in treated subjects. In some cases, ADA responses may result in the loss of therapeutic efficacy due to the formation of neutralizing ADAs (NAbs). An important characteristic of anti-drug NAbs is their direct inhibitory effect on the pharmacological activity of the therapeutic. Neutralizing antibody responses are of particular concern for biologic products with an endogenous homolog whose activity can be potentially dampened or completely inhibited by the NAbs leading to an autoimmune-type deficiency syndrome. Therefore, it is important that ADAs are detected and characterized appropriately using sensitive and reliable methods. The design, development and optimization of cell-based assays used for detection of NAbs have been published previously by Gupta et al. 2007 [1]. This paper provides recommendations on best practices for the validation of cell-based NAb assay and suggested validation parameters based on the experience of the authors.     

药检机构信息化建设与质量管理工作的融合

目的探讨药检机构信息化建设与质量管理工作的融合。方法阐述药检机构质量管理的本质内容与风险因素,结合我国药检机构信息化建设的历史和现状,围绕数字化药检平台的建设,论述了信息化与质量管理工作的关系。结果药检系统信息化建设的过程和内容,都与质量管理有密不可分的联系。结论药检系统的信息化建设工作,过去、现在以及未来,都应当以质量管理为核心。     

实验室信息管理系统的技术与应用进展

实验室信息管理系统(LIMS)自问世以来,在世界范围内取得了令人惊叹的技术进展和应用成就。该文从现代化实验室实施LIMS的意义,LIMS主要的技术发展阶段,目前国内LIMS的应用情况,分析测试性实验室在实施LIMS后预期达到的目标,以及当前LIMS项目实施中存在的问题和应用前景等方面进行综述。     

深圳市药品检验所信息化建设及体会

目的为药品检验所信息化建设和发展提供借鉴,促进药检系统信息化发展。方法介绍深圳市药品检验所的信息化建设成效和体会。结果与结论深圳市药品检验所信息化建设的背景也反映出大部分药品检验所目前的状况,其信息化建设的实践和经验可以给其他药检所提供借鉴和启示,共同为打造数字化药检而努力。     

Open-source LIMS in Vietnam: The path toward sustainability and host country ownership

ObjectiveThe objectives of this case report are as follows: to describe the process of establishing a national laboratory information management system (LIMS) program for clinical and public health laboratories in Vietnam; to evaluate the outcomes and lessons learned; and to present a model for sustainability based on the program outcomes that could be applied to diverse laboratory programs.MethodsThis case report comprises a review of program documentation and records, including planning and budgetary records of the donor, monthly reports from the implementer, direct observation, and ad-hoc field reports from technical advisors and governmental agencies. Additional data on program efficacy and user acceptance were collected from routine monitoring of laboratory policies and operational practices.ResultsLIMS software was implemented at 38 hospital, public health and HIV testing laboratories in Vietnam. This LIMS was accepted by users and program managers as a useful tool to support laboratory processes. Implementation cost per laboratory and average duration of deployment decreased over time, and project stakeholders initiated transition of financing (from the donor to local institutions) and of system maintenance functions (from the implementer to governmental and site-level staff). Collaboration between the implementer in Vietnam and the global LIMS user community was strongly established, and knowledge was successfully transferred to staff within Vietnam.ConclusionImplementing open-sourced LIMS with local development and support was a feasible approach towards establishing a sustainable laboratory informatics program that met the needs of health laboratories in Vietnam. Further effort to institutionalize IT support capacity within key government agencies is ongoing.     

Laboratory information and management system: A tool to increase laboratory productivity

‘Information is a crucial capital asset of any business and its commercial prospect is directly related to successful management of its information resources’. Laboratory Information Management System (LIMS) is software that is designed to administer samples, acquire and manipulate data, and report results via a database. It automates the process of sampling, analysis, and reporting. This paper discusses components, sample workflow, application, and validation of LIMS. The contents of this paper are easy to understand. The objective of this paper is to discuss how LIMS works and its application, and to discuss a potential approach to validation of the LIMS. A literature search was conducted in various journals. Based on title and abstract, 30 papers were identified. Extraction of useful information was done after thorough study of selected papers. Components of LIMS, how it works, its application, and potential approach of validation of LIMS was compiled in an easy-to-understand way. In conclusion, LIMS is a critical component of successful commercial laboratory in quality control, process control, and R&D environment.