Laboratory Information Management System standard requirements

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. 

ASTM E. Standard Guide for Functional requirements of Clinical Laboratory Information Management Systems American Society for Testing and Materials Philadelphia, PA, 1995 1639. 

The International Standards Organization 9000 (ISO 9000) standard, developed by the European Economic Community (EEC), also impacts manufacturers implementation of LIMS systems. ISO 9000 is a set of standards which are required for manufacturers selling products to the EEC. The 9000 standards are credited with playing an important part in the impetus to greater computerization of laboratory information management (9). 

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 requirements of the standard can be split into four major groups, which are those mentioned as activities in the quality management process. A fifth group is the quality management system per se. The model shown in the slide, taken from the ISO 9004 2000 standard, illustrates the process linkages as well as the interactions between the interested parties and the laboratory. Monitoring the satisfaction of interested parties requires the evaluation of information as to whether the laboratory has met their requirements. 

Scope of Validation The boundaries of the validation project must be defined to ensure that there is full coverage. For example, will the analytical equipment or Chromatography Data System interfaces be validated as part of the project, will Supplier Evaluations be required, etc. It is very important at this stage to determine what is within the scope of the LIMS Validation Plan and what will be validated under other associated Validation Plans. The validation of the implementation of processes and information management within the laboratory should be managed as a cohesive whole to ensure that all parts of the LIMS are developed and validated to the appropriate standards. This may be achieved by the use of a Validation Master Plan (VMP) for all the laboratory processes and information management. The Validation Plan for the LIMS and any associated plans for other interfaced systems would be referenced in and be under the control of this VMP. 

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. 

Exactly how the information is used in relation to uncertainty measurement is dependent on the laboratory environment and the level of accreditation or quality management programmes that exist within it. Individual laboratories will have quality systems and standard operating procedures that deal with the measurement and recording of uncertainty measurement. To deal with all of the possible outcomes and eventualities is beyond the scope of this book. Suffice to say that it is important to be aware of the requirement and reasoning behind the application of uncertainty measurement. 

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