Laboratory automation and laboratory informatics Building a Smart Laboratory 2012
Computerised instrument systems
Some of the more sophisticated laboratory instruments have a separate computer system running soſtware to control the instrument. Tis soſtware is generally proprietary to the instrument vendor and has the capability to acquire, store and process analytical data and to report results. Typically, most of these instruments are designed to operate primarily in standalone mode, although there is increasing ability to transfer data to a central server for secure data storage. Examples of this type of system are chromatography data systems (CDS), UV spectrometers, mass spectrometers and nuclear magnetic resonance spectrometers. Tere is typically a gap, however, in the
soſtware capability and how the system is used in a laboratory. Te soſtware of these computerised systems has the ability to process and interpret the data as well as produce the final reportable value. In practice, many labs do not use the soſtware to its full capabilities and will print out the data and enter it manually into a spreadsheet for calculation, print out the calculation and then enter it manually into a LIMS or ELN for reporting. Obviously this is not efficient and the process needs to be redesigned to work electronically as outlined earlier: acquire data electronically at the point of origin and never retype or check for transcription error (see ‘Laboratory automation’). Te instrument data system must process
the acquired data and then pass the reduced data or a final result to a LIMS or ELN for reporting. To ensure this is effective, some procedural controls need to be in place if the data system does not provide the functions. Te primary requirement is a file-naming convention to identify files uniquely for a specific analysis or analytical run. A potential downside of integrating
systems in this way is that decision-making can be divorced from the instrument. For example, if a result is generated in a pharmaceutical lab where a computerised system is connected to a LIMS containing the product specification, the analyst knows the results is out of specification (OOS), but the data needs to be transferred to the LIMS to make the formal determination of this fact. It is a regulatory requirement that ‘poor’ results must not be discarded, otherwise the laboratory can be accused or testing into compliance or falsification.
10 Some considerations for design of
computerised systems: • Data generated by instruments must be capable of being stored directly on secure servers rather than local hard drives to protect the records;
• Databases are preferable to flat file structures as the audit trails are more encompassing and that trending is possible across analytical runs;
• Networked data systems are better than several standalone data systems of the same type. Te best example of this is a networked chromatography data system where data can be acquired in one laboratory and reviewed in an office.
Most computerised systems are not designed for fully electronic working; electronic signature capability may be present to enable work to be undertaken with an electronic
“Te major business benefits of a LIMS are typically associated with increasing workflow efficiencies by eliminating manual data entry and transcription errors”
process, but there is little, if any, ability to hand off work electronically. As an example, if an analyst completes an analysis, would a supervisor know to review the data when they logged onto the system? In the large majority of instrument data systems the answer is no. Tis is a challenge for a really effective smart laboratory.
What is a LIMS?
A laboratory information management system (LIMS) provides the basic functions to address sample and test management and has become the standard tool for analytical and QC laboratories for registering samples, assigning tests, gathering and managing results, and issuing reports. With a growing level of sophistication in the relevant information technologies and configurability, most LIMS now offer a range of functionalities associated with sample and test management to provide a more integrated solution to support workflows and processes customised to a range of industry- specific requirements. Te basic functions to be found in
a LIMS are the registration of samples and associated data, such as provenance, customer, due dates, etc.; the assignment of tests to the sample; scheduling and tracking of the sample and tests; recording the test procedure, equipment and materials used during testing; the review, approval and aggregation of test results for the sample; and the preparation of customer reports. Te major business benefits of a LIMS
are typically associated with increasing workflow efficiencies by eliminating manual data entry and transcription errors. Tis is achieved through interfacing lab instruments for two-way communication of sample IDs, work lists and results, and by the integration with other lab systems such as electronic laboratory notebooks (ELN) and scientific data management systems (SDMS). A LIMS also acts as a major repository
of the records of analytical testing and can be a source of historical data associated with the organisation’s products and production processes. In addition, the transactional nature of a LIMS enables a secondary record system to be maintained as an audit trail to track date, time, user and, if necessary, what change was made within the system. Tis data may then be used to satisfy quality assurance requirements in terms of data integrity and can also be used to generate a wide variety of management reports of the lab’s performance. Where a LIMS is used in a regulated
environment, it is necessary that the system be validated and placed under change control. See ‘Regulatory compliance and systems validation’ for more detail on regulatory compliance. In reality, a LIMS is more complex than
just a single application, due in part to the convergence issues described in ‘An overview of laboratory informatics’. In practice, the term LIMS can refer to the LIMS application; analytical instruments interfaced directly with the LIMS; lab data systems and computer systems interfaced with the LIMS (chromatography data systems, scientific data management systems, electronic laboratory notebooks, etc.); and applications outside of the laboratory that are also interfaced to the LIMS (enterprise resource planning systems). As an example, Figure 3 shows the full
scope of a computerised system that could represent a smart analytical/QA/QC lab. Designing the LIMS environment means
that you need to consider all the other systems in the lab that must interface with the LIMS. Tis includes other applications
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