浅谈实验室信息管理系统的标准化现状

我国信息管理系统起步较晚,如今信息管理系统已经应用在各个领域.在检测和校准实验室中,实验室信息管理系统也得到了广泛的应用.大力发展实验室信息管理系统(Laboratory Information Management System,以下简称LIMS)为提高实验室核心竞争力有着重要意义.本文探讨运用LIMS提升实验室工作能力、效率,并结合ISO/IEC 17025:2005,GB/T 27025-2008,ASTM E1578-2013并以CNAS-CL35:2012为例分析了国内外对于实验室信息管理体系的标准化工作的发展现状.     

Computerization in the development of quality control system for analytical laboratories: State of the art and prospects

The state of the art and trends of computer use in Russian analytical laboratories conducting routine research are considered. The necessity to meet contemporary requirements forces laboratories to apply software in the development of quality control systems for results of analyses. Apart from the use of computers and software being an integral part of analytical devices, three trends in laboratory computerization can be discerned: LIMS, specialized universal laboratory software and nonspecialized or homemade software. LIMS use is limited by their high costs, complexity, and necessity of special personnel training. “Office” software does not provide solutions to quality control problems in full. Optimal for most laboratories is the use of specialized software that serves to computerize one or another block of the laboratory’s activities. Apart from requirements on the quality of the proper software, it should be inexpensive, simple, and convenient to use.     

计量实验室信息管理系统与现行证书出具模式的对接

实验室信息管理系统(LIMS)是提高实验室管理效能的重要手段,其与现行证书出具模式能否恰当地对接决定着二者性能的发挥。通过对LIMS证书管理模式的全面分析,分四种情况重点阐述了LIMS与现行出具证书模式之间的对接问题及解决方案,为LIMS开发与选型、自动测试系统设计与研制提供借鉴。     

Quality assurance growing pains: a state perspective on implementing an organizational-wide quality system in environmental laboratories.

To implement an effective and efficient quality system in a network of established environmental testing laboratories requires a committed long-term effort that is potentially fraught with multiple obstacles. This presentation discusses one state's ongoing efforts at implementing such a system. First is the need to convince management of the rationale for a quality systems-based approach versus the traditional QA/QC program. Once development of a quality system has been sanctioned, a team-based approach utilizing project planning tools is a good way to approach the effort. Resources are assigned to the development of key quality system components, and generally a phased-deployment or roll-out works best. Once implementation is underway, assuring operational utilization and compliance with the quality system are vital steps in the process. Important to successful implementation is ongoing assessment and refinement of the quality system. Fundamental and key elements of the laboratory quality system are numerous and need to work in concert with each other. Quality system elements to be discussed in the presentation range from management and QA roles and functions to the typical documentation of laboratory policies and procedures. Numerous QA assessment tools and other vital quality system practices that play an important role in making a complete quality system are addressed. In addition, efforts must be undertaken to integrate the laboratory quality system with other management systems within the organization. The bottom line is that all environmental laboratories need a quality system more now than ever. Data users need it. Customers' expectations for data quality are high. USEPA policy and/or programs call for it. Additionally, good quality systems can benefit the organization in multiple ways and help avoid the "pay-me-now or pay-me-later" syndrome. In conclusion, all environmental testing laboratories (i.e., academic, private, commercial and especially governmental) need to invest in and implement a quality system based on a recognized standard (e.g., NELAC, ISO 17025, ANSI/ASQC E-4). The author recommends pursuing NELAP laboratory accreditation with a NELAP-recognized accrediting authority.     

Applying GMP to Computerization in a Solid-Oral-Dosage-form-Factory

Quality Assurance and Pharmaceutical security as well must be given a particular consideration both for hardware and software when computerized pharmaceutical industrial operations are concerned

Hardware: The preparation of validation should begin with the design of a computerized system and rely upon specifications and upon defined operational limits

It is suitable to prepare documentation as from the development of the system in order to obtain a fruitful communication between all those concerned with design, implementation, maintenance, validation and auditing

A revalidation procedure should be prepared and maintained updated, in the event of a change in one or several operating conditions

Software: As with hardware, validation of software should be envisioned as early as the development phase. Preparation of test procedures and documentation should start at this very stage. Qualification and validation will be designed to find errors in the program and not to prove that no errors exist. They will be carried out at the operational boundaries of the software and will aim at testing the critical decision paths of the program. Verifications must be repeated a sufficient number of times to demonstrate that the results are repeatable

As with other pharmaceutical manufacturing systems, a formal procedure should exist to support changes made to the software. Vendor supplied software should be verified and documented with the same rigour and details that in-house developed software. Manual back-up systems must be provided for and regularly tested in the event of failure of the automated process. Computerized systems and good manufacturing practices applied to manufacturing of solid oral dosage forms: An application of the above-stated principles is given and illustrated     

A Methodology to Test Instrument Software: An Automotive Diagnostic System Application

This paper aims to describe a new methodology specifically designed for testing measurement and diagnostic software. A black-box procedure allows the user to verify whether the functional requirements of a software module under test are fulfilled. The robust experimental design techniques and statistical theories implemented to generate the software input test sets are described in detail. The reliability of the testing methodology is estimated by applying it to diagnostic software in wide use throughout the automotive industry. The results of validation tests carried out on data from a car engine measurement system are reported and analyzed.      

Applying GMP to Computerization in a Solid-Oral-Dosage-form-Factory

Abstract

Quality Assurance and Pharmaceutical security as well must be given a particular consideration both for hardware and software when computerized pharmaceutical industrial operations are concerned

Hardware: The preparation of validation should begin with the design of a computerized system and rely upon specifications and upon defined operational limits

It is suitable to prepare documentation as from the development of the system in order to obtain a fruitful communication between all those concerned with design, implementation, maintenance, validation and auditing

A revalidation procedure should be prepared and maintained updated, in the event of a change in one or several operating conditions

Software: As with hardware, validation of software should be envisioned as early as the development phase. Preparation of test procedures and documentation should start at this very stage. Qualification and validation will be designed to find errors in the program and not to prove that no errors exist. They will be carried out at the operational boundaries of the software and will aim at testing the critical decision paths of the program. Verifications must be repeated a sufficient number of times to demonstrate that the results are repeatable

As with other pharmaceutical manufacturing systems, a formal procedure should exist to support changes made to the software. Vendor supplied software should be verified and documented with the same rigour and details that in-house developed software. Manual back-up systems must be provided for and regularly tested in the event of failure of the automated process. Computerized systems and good manufacturing practices applied to manufacturing of solid oral dosage forms: An application of the above-stated principles is given and illustrated     

Validation of RF power standard in the frequency range of 100 MHz to 18 GHz by an inter laboratory data comparison

Radio frequency (RF) power is one of the most important quantities in RF metrology. An inter laboratory data comparison of RF power for the validation of a coaxial microcalorimeter has been carried out between Physikalisch-Technische Bundesanstalt (PTB-Germany) and National Physical Laboratory India (NPLI). A coaxial thermistor mount equipped with type N connector is used for this intercomparison. The results show good agreement in measuring the effective efficiency of the coaxial thermistor mount between the two laboratories within their claimed expanded uncertainty. It confirms the equivalence of national standards for RF power in the frequency range of 100 MHz to 18 GHz.     

基于C/S-B/S混合架构的道路施工实验室网络管理系统

我国公路建设深化管理与提高建设质量的关键环节是对各个道路施工工地实验室有效监督与管理。文章针对道路施工实验室网络化的实际需求,采用C/S与B/S相结合的方式,对LIMS系统架构进行了设计,并将其用于道路施工实验室网络化管理系统开发,所开发的LIMS已经得到实际应用,它对公路建设的管理水平和信息化水平的提高起到重要作用,对其它行业管理系统设计与开发有参考和借鉴意义。     

Validation of a Computer Spreadsheet Used to Perform Dissolution Calculations

Dissolution testing for various pharmaceutical dosage forms is an integral part of release and stability testing requirements. In order to assist in such testing, a spreadsheet has been written and validated to perform dissolution calculations using Microsoft Excel software. The spreadsheet has been written for a dissolution experiment where the volume of the dissolution medium is held constant for the vessel by replacing removed dissolution medium with fresh dissolution medium at each time point. The spreadsheet corrects for the amount of dissolved drug substance removed at each time point and reports results in terms of percent of label claim dissolved for each vessel. The use of computer software to assist in data manipulation in the pharmaceutical industry requires adequate documentation, and therefore a validation protocol has been written and is described. An example of the formulas used to generate the spreadsheet is also given and can be easily used by readers to implement design of their own spreadsheets for dissolution calculations.     

Validation of a Computer Spreadsheet Used to Perform Dissolution Calculations

Abstract

Dissolution testing for various pharmaceutical dosage forms is an integral part of release and stability testing requirements. In order to assist in such testing, a spreadsheet has been written and validated to perform dissolution calculations using Microsoft Excel software. The spreadsheet has been written for a dissolution experiment where the volume of the dissolution medium is held constant for the vessel by replacing removed dissolution medium with fresh dissolution medium at each time point. The spreadsheet corrects for the amount of dissolved drug substance removed at each time point and reports results in terms of percent of label claim dissolved for each vessel. The use of computer software to assist in data manipulation in the pharmaceutical industry requires adequate documentation, and therefore a validation protocol has been written and is described. An example of the formulas used to generate the spreadsheet is also given and can be easily used by readers to implement design of their own spreadsheets for dissolution calculations.     

基于LIMS开展的自动化检测

针对实验室信息管理系统(LIMS)在检测自动化方的应用,以扭矩板子检定仪的检测自动化为例,通过程序嵌套、数据导入/导出以及直接读写数据源等方面对LIMS中可实现的自动化检测的方法进行讨论,并对LIMS在实验室应用发展加以展望。     

实验室质量体系运行中的技术难点及解决方法 第一讲 实验室检测/校准结果符合性的判定

在实验室质量体系运行中,技术方面存在着许多难点问题,诸如在质量监控中检测或校准结果及与规范的符合性、方法的确认、测量不确定度评定、设备和标准物质的期间核查、人员比对、方法比对、实验室间比对结果的正确判断等。对于测量不确定度的评定、设备和标准物质的期间核查、能力验证和稳健统计等问题已进行过介绍。此次专门针对检测或校准结果及与规范的符合性判定、方法确认、质量监控中离群值的判定、结果可接受性的检查、最终测试结果的确定、人员和方法比对,实验室间比对的正确判定等技术难点的解决方法进行了详细的介绍。     

Internal dosimetry verification and validation database

Simulated-data internal dosimetry cases for use in intercomparison exercises or as a software verification and validation tool have been published on the internet (www.lanl.gov/bayesian/software Bayesian software package II). A user may validate their internal dosimetry code or method using this simulated bioassay data. Or, the user may choose to try out the Los Alamos National Laboratory codes ID and UF, which are also supplied. A Poisson-lognormal model of data uncertainty is assumed. A collection of different possible models for each nuclide (e.g. solubility types and particle sizes) are used. For example, for 238Pu, 14 different biokinetic models or types (8 inhalation, 4 wound and 2 ingestion) are assumed. Simulated data are generated for all the assumed biokinetic models, both for incidents, where the time of intake is known, and for non-incidents, where it is not. For the dose calculations, the route of intake, but not the biokinetic model, is considered to be known. The object is to correctly calculate the known true dose from simulated data covering a period of time. A 'correct' result has been defined in two ways: (1) that the credible limits of the calculated dose include the correct dose and (2) that the calculated dose is within a factor of 2 of the correct dose.     

Good clinical laboratory practice (GCLP): the need for a hybrid of good laboratory practice and good clinical practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries.

There has been a significant increase in the number of clinical drug trials (particularly phase III) being conducted in developing countries for infectious diseases such as HIV, malaria, and tuberculosis. Laboratory results provided by medical testing laboratories in the region are critical to ensuring the safety of patients and the generation of good quality data. A number of well accepted Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines govern the conduct of clinical trials internationally. Good Clinical Practice guidelines remain too vague with respect to sample analysis to ensure practical implementation in these laboratories. In their strictest sense, Good Laboratory Practice guidelines refer to the analysis of samples from non-clinical studies. A specific set of minimum standards or requirements for practical implementation of clinical trial requirements in medical testing laboratories in the developing world is urgently required.     

自动校准系统与实验室信息管理系统的连接

自动校准系统是指在程序特定运行环境中,由标准器、被校准仪器在计算机指令控制下,完成校准过程,获得、保存（或含处理）校准结果的程序。使用自动校准系统,可以提高校准速度和准确度。该文采用一种方法,在Labview7．1完成了MT8801无线通信分析仪自动校准系统的程序编写,通过LIMS数据库接口,完成与LIMS（实验室信息管理系统）的自动连接,出具PDF报告,做到了信息管理一体化。文中进一步探讨LIMS中的调度功能,并做有益的尝试,得出了综合性结论。     

Visual language and software development environment for image processing

The Khoros system integrates multiple user interface modes, code generators, instructional aids, data visualization, and information processing to produce a comprehensive image processing research tool. This system can easily be tailored to other application domains because the tools of the system can modify themselves as well as the system. This attribute is important in a system that is designed to be extensible and portable. The Khoros infrastructure consists of three major components: a high-level user interface specification, methods of software development embedded in a code generation tool set, and an interoperable data exchange format and algorithm library. These basic facilities have been used to build a set of applications for performing image processing research, algorithm development, and data visualization. One of the most powerful features of the system is its high-level abstract visual language. Khoros is a successful demonstration of how development programming, end-user applications programming, information processing, data display, instruction, documentation, and maintenance can be integrated to build a state-of-the-art image/data processing and visualization software environment.     

A new automatic system for calibrating the solid state DC voltage reference standards at NIS,Egypt

A new automatic system for calibrating the solid state DC voltage reference standards (Zener Diode reference standards) has been established at National Institute for Standards (NIS), Egypt to disseminate the unit of volt in the country. Besides, this system has been implemented as a coherent structure that, from the national DC voltage reference standards, can disseminate the traceability of all the instruments under calibration. The system consists of a set of programmable instruments and proper software. The software of the system has been built using the Laboratory Virtual Instrument Engineering Workbench (LabVIEW) graphical language. The system hardware is configurable by the operator on the basis of the specific calibration to be performed and it allows large number and different models of Zener diodes to be act either as reference units or as units under calibration. The design and the implementation of the system software have been discussed in details. Furthermore, the system validation has been carried out for the measurement repeatability and the results compatibility in both automatic and manual modes.     

Proficiency testing in AC power and energy

Proficiency testing (PT) program in AC Power & Energy measurements was conducted for 12 National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratories of India. The program is conducted to determine the performance of individual laboratories for specific measurements and to monitor continuing performance by assuring the quality of results. National Physical Laboratory, New Delhi, India (NPLI), has coordinated the PT program and acted as reference laboratory. A Technical Protocol was designed inline with internationally adopted method. The paper describes the results obtained durng the PT exercise