Laboratory Information Management System validation

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Computers were first used in laboratories to calculate results and generate reports, often from an individual instrument. As automated analysers were developed, so the level of computerization increased and computers now play a major role in the modem laboratory. They are associated with both the analytical and organizational aspects and the term Laboratory Information Management System (LIMS) is often used to describe this overall function. Such systems are available that link the various operations associated with the production of a validated test result, from the receipt of the sample to the electronic transmission of the report to the initiator of the request, who may be at a site removed from the laboratory. Other uses include stock control, human resource management and budgets. 

Chapter 6 provides specific standards and general guidelines for the vahdation of Laboratory Information Management Systems (LIMS) and other computerized laboratory systems. The chapter includes specific interpretations of the validation requirements in the post-Part 11 environment. 

Procedure or forms for logging in and pulling and tracking samples Validated laboratory information management system (LIMS) Handling... 

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. 

Snelham, M. and Wingate, G.A.S. (2000), Validating Laboratory Information Management System,... 

There are four cost-control strategies that if taken together can significantly control the cost of validation. Laboratory information management systems (or other regulated... 

CFR Part 11 validation of data acquisition system and laboratory information management system (TIMS)... 

It has been mentioned already that there are different levels of sophistication with regard to the involvement of computer applications in GLP studies and test facilities. These levels may range from the complex problems involved in the GLP compliant management of computer networks and of laboratory information management systems (LIMS) to the question of whether a simple instrument controlled by a built-in, pre-programmed chip should be treated in the same, extensive way with regard to software validation . It is certainly self-evident, as these two examples demonstrate, that not all types of IT applications have to be considered as equal with regard to GLP compliance it may indeed be impossible to do so. As it is commonplace nowadays that the silicon chip penetrates the operation of practically all kinds of work, the elucidation of its involvement in the operations of test facilities becomes an essential part of the implementation of GLP. 

Computer-related systems used in the laboratory for control of automatic analyzers and/or laboratory information management systems will be validated however, additional emphasis will be placed on the following specific concerns ... 

Outside the typical scope of these qualifications is the interface with Laboratory Information Management System (LIMS). In these instances, and where appropriate, archival file systems are established and the appropriate security access parameters are set up. Proper communication with the LIMS is verified. Often, a sample with known characteristics is run and the results are compared against those generated by a validated system. 

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