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.
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 benefits of 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 software that is used to control an NMR device and evaluate the relevant data does not meet the regulatory requirements (no access control, no audit trail, no version control). Sample-specific data (e.g. the designation of the sample, sample preparation, measuring method) is transferred from the LDMS to the device software using device interfaces prior to measurement.
After measurement has been completed using these parameters and the raw data (including the meta data) has been saved on the computer used for controlling the device, the data is automatically and immediately transferred to the LDMS database.
Separate software is used for the evaluation of the data, which has direct access to the data saved in the LDMS, i.e. in a controlled environment. Processed data is stored in the LDMS or in an archiving solution, e.g. in PDF format. This ensures that raw data is handled in accordance with the regulatory requirements. It also offers optimum traceability of data generation and evaluation despite the shortcomings of the device software (with the exception of the access control for the device software).
Figure 1: Example for the migration of data into a regulated environment
An LDMS is a quality-related computerised system which must be validated. When introducing an LDMS in a regulated environment, several regulatory requirements must be met, including the EU GMP Guidelines Annex 11 and 21 CFR Part 11.
With regard to GLP, the OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring, No 10 (The Application of the Principles of GLP to Computerised Systems) must also be observed.
Along with various, sometimes older standards, GAMP – currently version 5, also referred to as GAMP 5 – has established itself as the leading industry standard for the validation of computerised systems. At this stage, the FDA also refers to GAMP for the validation of computerised systems (Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application). For this reason, GAMP should be taken into account when an LDMS is introduced.
The text is an excerpt of the GMP MANUAL, Chapter 14.M Laboratory data management systems (LDMS).
Dr. Ulf Fuchslueger
Consultant for laboratory data management, laboratory process optimisation, LIMS, electronic lab notebooks (ELN) and system integration in a regulated environment