StrainControl Laboratory Information Management System
Each can be developed and tested independently. The laboratory system is expected to produce a file with a particular format - that can be verified. The LIMS can be tested with files that conform to the expected file format, synthesized based on the specification. Now it must be shown that the LIMS can accept and integrate the files from the data system I All of the testing should be done on a LIMS test-bed data base,
2.3 Laboratory Information Management Systems (LIMS) 2.3.1 LIMS Hardware and Architectures 2.3.2 Different Types of LIMS 2.3.3 Implementation of LIMS LIMS laboratory information management systems Even though Part 11 has not yet been enforced by the FDA, the rules have impacted CDS, LIMS, and TIMS with regard to architectural design and security of these systems. Use of server-based computing is only one of the important features of the modern CDS. The other two important features are the use of embedded data structure and direct instrument control. The earlier generations of CDS used a directory file structure, meaning that the raw data and other files such as the instrument method and data processing method were stored at separate locations. There would either be no connections or only partial connections between these files. The most significant drawback of this type of file management was the potential for methods and raw data to be accidentally overwritten. To prevent this from...
ArrayExpress is an international repository for gene expression data, which uses the MAGE-OM model. The MAGE-OM model is an (array) platform independent data model which can equally represent data from single and dual channel experiments. This means that data from various LIMS databases, manufacturers and public databases can be mapped to MAGE and data exchanged in the same format -MAGE-ML. As MAGE is now an adopted OMG standard there has been significant take-up of the format and SMD, TIGR, RZPD, Agilent, Affymetrix and others are now making data and array designs available in MAGE-ML format.
Environmental Protection Agency (US EPA) issued a Good Automated Laboratory Practices (GALP) document in 1990 that applies to all laboratories that provide data to US EPA 11 . This document gives thorough recommendations for implementing and operating an automated laboratory however, each section of the GALP manual specifically states that its recommendations apply to automated data collection systems and Laboratory Information Management Systems (LIMS). No mention is made of automated sample preparation systems. United States Food and Drug Administration (FDA) has also recommended procedures for validation of computer software and hardware that are used for systems that collect, report, and store raw data, such as data acquisition systems, and LIMS. Like GALP, those regulatory policies do not refer to validations performed on automated laboratory robotic systems and workstations used for sample preparation.
When more than one person is involved in the process, it can be useful to store the data in a database. There are two main reasons for doing this Firstly, a Laboratory Information Management System (LIMS) database is useful to keep track of who has done what to which experiments and other useful information in the initial production of data. This is important when one wants to track the workflow of technicians running the biological processes to make the chips. Many vendors (such as Affymetrix) provide LIMS that work with their systems. Unfortunately, like all LIMS, it is often desired to have a LIMS that fits in perfectly with the local work flow, and this requires extensive customization.
A method is needed to acquire data from a balance during the course of a gravimetric analysis and perform calculations. The results of the calculations and the data used, should be put into a format that can be read by a LIMS without having to manually reenter any of the data. After careful consideration, it is decided that a computer will be used to capture the data, perform the results, and prepare an ASCII file that can be read by any LIMS system, given a known file format. The product requirements for the software are Have local storage to load programs and hold data for transmission to the LIMS Support communications to the balance and LIMS - over separate communication lines
The specifications should contain a list of the qualification criteria for computer hardware and software to be used for the project and the final target production system. In addition any changes to the LIMS system should be determined and a separate engineering schedule should be designed to meet those development requirements, including how the file from the lab data system is going to be transferred to the LIMS and incorporated into its data structure (note this is the equivalent of magic happens here in some cartoons, our intent is to outline a project not give the details of its implementation).
Gaia Paolini is Senior Principal Scientist at the Sandwich site of Pfizer Global Research and Development. Gaia joined Pfizer in 2002 at Sandwich, Kent, UK. Gaia received her degree (laurea) in Physics at the University of Rome, with a research thesis on statistical mechanics computer simulation of condensed matter systems. In her career, Gaia has held a number of positions in industry and academia, combining roles of research scientist, software specialist, and business systems analyst. At Pfizer, Gaia designed and developed a LIMS system for structural biology, and, in her current role, led the design, development and mining of a large chemogenomics knowledge base. For her contribution she has won a Pfizer Achievement Award in 2006. Gaia is the author of 18 peer-reviewed scientific publications, spanning the fields of applied mathematics, materials science, classical density functional theory, and chemogenomics. Gaia currently lives in Canterbury, Kent, UK.
We will also look at the direction that laboratory computing technology is taking, its impact on systems design and validation, and the possible problems that can occur as newer operating systems, tools and non-traditional programming environments develop. In doing this work we will make one departure from current practices. Laboratory computer information systems (applications - both commercial and custom developed, OS, and hardware) are usually treated as a collection of independent entities. One may validate a Laboratory Information Management System (LIMS), or a data acquisition analysis system, or a robotics system, each as an independent entity. The view of this author is that these should be treated as part of a laboratory-wide system and designed as such 3 . The intent of this chapter is to provide an overview of the considerations that should be taken into account in the development of validation programs for laboratory computer systems, networks, and automated equipment....