The term laboratory information management system (LIMS) was introduced in the first half of the 1970s when laboratories began to computerise and automate processes and data evaluation. If at the beginning, an attempt was made to use individual solutions to automate individual and highly repetitive tasks, things have since moved on, and a wide range of commercial and partly specialised LIMS products with a comprehensive range of functions is now available. These products support all areas including early research, development and quality control.
For a long time, the term laboratory information management system (LIMS) was used as a synonym for the more general term laboratory data management system (LDMS). In addition to the classical LIMS products, a number of other product categories that offer supplementary functions have established themselves since the beginning of the 21st century. These include, first and foremost, electronic lab notebooks (ELN) and lab execution systems (LES). ELNs are typically used in research and development with LESs more likely to be found in subsequent analytical development and quality control. Different providers offer various strategies and use different terminology, which sometimes leads to an obscuring and merging of product categories.
This chapter focuses on laboratory data management systems for quality control and analytical development in the pharmaceutical industry. The term LDMS is now used to refer to LIMS, LES and ELN. A large part of this chapter also applies to other IT systems in regulated environments.
There are many arguments in favour of the introduction of an LDMS. The more important ones include:
Increased efficiency mainly results from
With the introduction of an LDMS, complex stand-alone solutions such as validated Excel sheets and local databases can be eliminated.
The systematic introduction of an LDMS can also lead to a significant increase in quality of processes and data. On the one hand, an LDMS defines the processes, ensuring that the individual process steps are carried out in the correct sequence by authorised persons only. On the other hand, the automatic transfer of data (e.g. numeric values) from the analysis device to the LDMS and the automatic documentation of data in a certificate eliminate transfer errors and reduce the burden of control. Using an LDMS, the monitoring of calibration and maintenance intervals, the training level of the employees, the expiry dates of reagents and compliance with standards can be carried out at no extra cost, which leads to a further increase in quality. The same applies to the use of bar codes for identifying samples, reagents, devices and consumables.
The introduction of an LDMS has further positive effects due to the inherent benefitsof electronic data management. These include the immediate availability of data regardless of location (depending on the system, this may even include raw data), the introduction of company-wide standards for quality processes, data management, data backup and data security as well as quick and partly automated sharing of information between departments, locations or companies and the subsequent reduction of barriers and acceleration of processes.
As a rule, modern LDMSs meet all the technical requirements defined in 21 CFR Part 11 and EU GMP Guidelines Annex 11. For this reason, a fully validated LDMS can also be used to help meet the regulatory requirements that apply to electronic data management. It can, for example, migrate data generated by systems that do not fulfil the current regulatory requirements into a regulated environment (see example in Figure 1).
The text is an excerpt from GMP Series How to design a Laboratory Data Management System
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