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LABORATORY INFORMATICS


which can search across an organisation and platforms using just a few keywords.’ Two primary issues that must be


addressed are those of outsourcing key analytical workflows, and long-term data retention, notes Burkhard Schaefer, BSSN-Software president. ‘At the good laboratory practice (GLP) level there is an increasing trend for industry – and in particular the pharmaceutical industry – to outsource analytical workflows. In some instances pharmaceutical companies are shutting down their in-house bioanalytical capabilities in totality, and outsourcing to contract research organisations (CRO). ‘This raises the question, how can


experimentation, but this still integrates with all the other pieces of the Biovia laboratory informatics offering. ‘Labs can add our Compose module for


procedure authoring – drafting SOPs and publishing them on the system – and then layer that with our Capture functionality, which allows users to capture data on a tablet, interact with pH meters and balances, and send the data directly back to the ELN.’ Out-of-specification results or instances of manual override are flagged up in real time, and channelled into a review-by-exception process for authorisation. ‘Then, on top of that, we can layer


predictive analytics, including laboratory trends so that managers can predict and schedule equipment maintenance, for example. All this functionality can then be married with inventory management capabilities, so that an inspector can view not just individual bits of data or workflows, but evaluate the lab from a more universal perspective.’ Thus it’s important not to end up with


a patchwork of software solutions that makes it difficult to find data and the contextual information that is associated with that data, suggests Julien Alvo, president of France-based SoftNLabs. ‘Companies may end up implementing possibly hundreds of different software platforms and modules, and take on


www.scientific-computing.com | @scwmagazine


foreign systems through mergers and acquisitions.’ This represents an IT headache, adds to the complexity of trying to get different systems to talk with each other, and can make finding data a game of hide and seek. ‘That’s where we need to start thinking about keeping data in standardised formats, to make sure data isn’t lost because the software used to read it becomes obsolete, or isn’t available in the lab that needs to view the data,’ Alvo points out. Standard data formats also allow users and inspectors to view data from different types of instrument or experiment in parallel, either for comparison, or because one piece of data was dependent on another.


Making use of data Organising data and setting in place an adequate archiving infrastructure are thus critical if laboratories want to ensure that their data is secure and can easily be found again, perhaps decades later. ‘Often, people will say that they can remember doing something, but can’t remember when they did it or where they put the resulting information.’ It’s a problem that will only continue to grow as big data has become part of every lab’s operation. ‘In an ideal world we would have a knowledge management solution for laboratories that is equivalent to Google,’ Alvo says, ‘and


I collaborate with an external partner and still be sure of the same quality and integrity of data that I know I can generate in-house to satisfy the regulator? Companies need to have infrastructure in place to demonstrate a chain of custody for a data record as it travels between organisations, and create a distributed audit trail that allows you to do that,’ added Schaefer. Move downstream to GMP activities and


QC workflows, and the issue becomes more one of data retention, he continues. ‘The regulator requires you to demonstrate that you have data safely archived, but more importantly, that it is retrievable for review, potentially 20 years or more,’ says Schaefer, concurring with Julien Alvo’s sentiments. This is when the topic of data formats becomes particularly interesting. ‘Archiving a proprietary data format


doesn’t make sense, because it means the laboratory will have to retain the software,


”The LIMS must be configurable to manage the laboratory operation so that capture, management and delivery of information meets the relevant compliance requirements and expectations”


August/September 2018 Scientific Computing World 13 g


Viktor Makhnov/Bearsky23/Shutterstock.com


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