Laboratory Information Management System documentation

Brown EH. Procedures and their documentation for a LIMS in a regulated environment. In RD McDowall, ed. Laboratory Information Management Systems. Wilmslow, UK Sigma, 1987, pp. 346-358. 

Databases are used widely in commercial applications and have become the foundation of modern data processing. Various bibliographic, financial and chemical reference databases are perhaps the most familiar to scientists at this time. However, the proliferation of Laboratory Information Management Systems (LIMS) makes analytical laboratory databases accessible to most laboratory personnel. Such databases store analytical data and scientific information from which a variety of documents and reports are generated. 

One of the major factors to be considered when implementing a GxP-compliant EDMS is validation. The basic validation approach is no different from that applied to other information management systems such as MRP 11 or Laboratory Information Management Systems (LIMS). An approach based on the validation life cycle in GAMP is appropriate. Figure 34.3 shows how validation documentation relates to typical project activities. Validation permeates all stages of the implementation process, as described below. 

VMS = Virtual Memory System LIMS = Laboratory Information Management System EDMS = Electronic Document Management System MRP II = Manufacturing Resource Planning DBMS = Database Management System ... 

The combination of 2-DE gels with mass spectrometry results in huge amounts of data. It is essential to manage this data in a centralised way in order to simplify its analysis and database updates. The bioinformatics analysis of experimental data also produce results and data, that must be managed and available at all times. A LIMS (Laboratory Information Management System) is a software application that uses a relational database to assemble heterogeneous data, such as gel images, mass spectra, samples, experiments, and related documents, and also provides the tools to allow such data to be entered, tracked and reported [175]. 

Many analytical laboratories also use a laboratory information management system (LIMS), an example of stand-alone software. Vahdation of such software is administered by the software developer but user-site testing is also an essential part of the software development and vahdation cycle. The FDA requirements for these systems are described in a guidance document (FDA 2002). 

Fortunately, the daunting task of setting up a sample-documentation scheme can be eased by resorting to computer programs written for the purpose, so-called LIMS - Laboratory Information Management Systems. There are many of these available, and in use in many commercial analysis laboratories. 

The laboratory must have policy and procedures for all purchasing requirements, whether laboratory consumables, equipment, or calibration services. Records must be kept and any checks to ensure the products are fit for purpose documented. Records of purchases should be sufficiently detailed to identify what was purchased, when it was purchased, and any other relevant information, and the management system standard under which they were made should be identified. 

The laboratory should verify and document the proper functioning of the software immediately after any new data acquisition or management systems have been installed. The baseline verification consists of manual calculations to confirm the correctness of all computer calculations. Ongoing verification takes place during laboratory data review process whenever a reviewer replicates one of the results generated by the computer or a manual calculation from a bench sheet. All information used in the calculations (raw data, calibration data, laboratory QC checks, and blank results) is kept on file for the reconstruction of the final result at a later date, should it become necessary. Bench sheets that document sample preparation are also kept on file for the same purpose. 

In study-based quality management systems, such as good laboratory practice (GLP) and good clinical practice (GCP), the study number is considered as the main index variable and any other information along the meta-data model can be derived from it. With the help of the meta-data model (see Box Meta-Data Model), it can be checked easily if the information of the documented GxP-relevant process is complete. 

The regulatory requirements aim at the controlled handling of documentation to achieve complete traceability of information over the regulated processes. The most widely used quality management systems in laboratories of pharmaceutical, biotech, medical device, and food (USA) industries are GMP, GLP, and ISO 17025 for accredited laboratories. The latter mentioned system is not a legal requirement, but an international standard, which is inspected by commercial certifiers. 

Information systems must be in place to maintain the documentation and to ensure that it is up to date. In addition there is a need to maintain and store quality records and training records. This can be carried out within the Office function of the laboratory under the guidance of a Quality Manager. 

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