LABORATORY INFORMATICS Capture data entry using Biovia software g
side-by-side. This doesn’t just satisfy the regulatory requirement for full and complete data, but also allows the lab to derive far greater value from that data over the short and longer term. ‘Critical to this is the ability to handle
disparate forms of scientific data,’ Jansen notes. The context in which that data was derived is similarly critical, she adds, whether your result is a simple weight or pH measurement, or a more complex set of chromatographic and mass spectrometry data. ‘A result that is just a number is meaningless. But if you know that number is a pH, then it gets a value, and if you know what you measured the pH of and why, then you provide some initial context. Combine this fundamental ‘answer’ with information on which pH meter was used, when it was calibrated, under what conditions the measurement was made, the workflow in which that the pH measurement was taken, and who performed the measurement, and then you can start to derive some meaning.’ Today’s laboratory informatics
solutions are ideally suited to managing data acquisition and contextualisation, in parallel with providing complete audit trails. Layered on top of this, Jansen continues, laboratories also need to demonstrate that they have followed correct procedures throughout an analytical or experimental workflow. ‘Has your complete, accurate and unadulterated data been acquired by following the correct procedures?’ Whereas, historically, standard
operating procedures (SOPs) and laboratory workflows have been written as paper-based instructions – with no way of verifying that the scientist or technician carries out every step according to specifications – smart laboratories are incorporating laboratory execution system (LES) software into their informatics infrastructure, whether as bolt-on
18 Scientific Computing World June/July 2018
modules, or directly embedded into their laboratory informatics environment . ‘The LES effectively leads staff through each stage of an SOP, whether for an experimental or an analytical workflow, and progression to the next stage is only permitted once the previous step has been completed and, if necessary, signed off,’ Jansen notes. ‘Combine procedural control and management with management of personnel authorisation – and confirmation that they have been trained to run a process or instrument – with management of instrumentation calibration and maintenance, consumables and other reagents, and you have a complete data package that should satisfy all regulatory requirements.’
Assisted compliance SoftNLabs is a specialist laboratory IT consultancy that works with laboratories in any kind of industry, such as pharmaceutical, food and contract labs, who are looking to select and implement software solutions that will help them achieve regulatory compliance as well as optimise laboratory operations and business processes. ‘We work with companies are looking for
a complete informatics infrastructure or LIMS, as well as clients who are looking to add new functionality or complementary systems to an existing platform, whether to help meet compliance, or to expand the system into other departments,’ comments Julien Alvo, president of the France-based firm. ‘Adding new LES functionality, for
example, may not involve a complete reorganisation of the informatics infrastructure. We can identify an LES solution that will work with the customer’s existing informatics systems, to digitise their protocols and procedures, and allow them to embed SOPs into their business rules,’ Alvo continued. For regulated industries, lack of
procedural oversight and validation can lead to potentially devastating consequences, Alvo comments. ‘Within the last five years or so one pharmaceutical company lost millions of euros when they were shut down by the regulator because they had not implemented adequate process validation before moving into full production.’ Encouragingly, Alvo notes, ‘in most
cases companies come to us because they have failed to find the right solution, not because they have failed from a regulatory perspective.’ Sometimes stepping back and stripping down needs from a business and regulatory perspective can help point to a more
streamlined, efficient informatics solution. Despite the warning stories that hit the headlines, there are, perhaps surprisingly, still companies operating in regulated sectors who continue to rely on paper- based records and spreadsheets to a lesser or greater degree. ‘They may use the software from their instruments, but have no LIMS to underpin management of their samples and the resulting data. This makes it hugely problematic to ensure either a complete chain of custody for data, or to confirm its integrity, as there may not be any system for maintaining an audit trail. One of our roles is to help these companies transition to electronic systems so that they can comply with FDA regulation 21 CFR Part 11,’ Alvo notes. So, what are the main criteria that should be applied companies who work in regulated industries when they start to think about selecting a new or upgraded informatics system? Perhaps surprisingly, one of the first things that companies should consider is their user groups and user roles, he suggests. ‘Once we have a basic understanding of the field in which the client’s laboratory
“The timely and adequate appraisal of both the data and the process by which that data was derived is central to the issue of data quality”
operates, say, quality control or bioanalysis, then we have a foundation on which to build. One of the first things we then try to define is the user groups and user roles, the types of data that the laboratory produces and handles, and in particular who will have control of the system.’ If user groups and roles aren’t managed
quickly, then once the system has started to generate a large volume of data it becomes hard to keep tabs on security. ‘Say you have a laboratory with a chemistry and a bacteriology unit. If you don’t add your user roles and data groups at inception, then it very quickly becomes difficult to define where new data should be channelled,’ comments Richard Vaysse, technical director at SoftNLabs. ‘You can add new groups and individual
users in at any time, but the rules must be established at the beginning of the project, and establishing user roles will make it possible to control who is authorised to add, modify or view data’ Vaysse concludes.
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