laboratory informatics ➤
to QA/QC laboratories and the support of regulatory submissions, with an electronic laboratory notebook (ELN) for scientific reporting and workflows, and an out-of- the-box electronic batch record (EBR) application. ‘Te Unified Lab Management
environment eliminates paper handling, providing scientists and technicians with the ability to manage all processes and to direct workflows from their tablets. Where
STANDARDISATION IS A KEY CONCEPT FOR REGULATED INDUSTRIES
planning is traditionally a LIMS capability, the LES and ELN platforms provide execution capabilities that in combination enable a complete automation-competent workflow. Te architecture that manages these
platforms is the Biovia Foundation (formerly Accelrys Enterprise Platform), which the firm describes as a scientifically aware soſtware platform that underpins every managed process from research to manufacturing, including data management, analysis, and reporting capabilities on structured as well as unstructured data types, and integration
with third-party applications. ‘Te Biovia Foundation offers an integration capability that means every soſtware – including 3rd party systems – can be interconnected, which significantly reduces the time to implementation,’ Tetreault continues. ‘It is not a generic solution, but is very much a role-based solution that is particularly suited to regulated environments, where every step in processes must be traceable, all reagents and instrumented audited, and chain of custody must be transparent. Importantly, having a single foundation means that there is enterprise-wide standardisation, without the need to hand- craſt data models.’
Data standardisation Standardisation is a key concept for regulated as well as non-regulated industries and sectors, because no one gets value out of different labs weighing samples differently, Tetreault stresses. ‘Tis level of standardisation, even for basic operations such as weighing, mixing or diluting, is something that the industry hasn’t yet achieved, and we are working with clients including the top global pharma companies to develop. Ultimately this will aid the reuse of data and provide new insights that can be fed back into future product development and manufacturing. And with regulators increasingly requiring similar data across disparate industries, data standardisation
A contract laboratories experience
Milan-based contract testing laboratory, LabAnalysis, implemented LabWare LIMS in its pharmaceutical laboratories in 2012, and in its environmental department in 2013. LabWare LIMS was selected to replace the firm’s existing Italian commercial LIMS with a more powerful and secure solution that could meet required functionality, flexibility, data volume security and management, and facilitate meeting the high quality standards required of the contract laboratory market, explains Stefano Maggi, CEO. ‘The contract laboratory market is a highly regulated business with demanding quality requirements that must be proven, guaranteed and tracked. In today’s hugely competitive business climate, organisations everywhere are expected to do more with less and try to achieve
ever-greater efficiency, effectiveness and customer value. This is a very dynamic industry, customer’s needs are changing quickly and we have to be always ready to satisfy increasing demands and comply with the regulatory constraints and qualitative standards requirements.’ The installation of LabWare LIMS at LabAnalysis was based on LabWare’s Contract Laboratory Template, which covers all primary laboratory operations and workflows to manage samples, Maggi explains. The software in addition offers laboratory staff training management, instrument management and inventory management capabilities. ‘The biggest challenge is to achieve compliance with the requirements of the US Environmental Protection Agency (EPA) and by
8 SCIENTIFIC COMPUTING WORLD
the US Department of Defense Environmental Laboratory Accreditation Program (DoD ELAP). Compliance with these very strict standards requires a huge effort in terms of quality of the analytical and testing performances and especially requires the use of powerful management tools to secure and guarantee the work done.’ The most significant and technically relevant aspect of the LabWare LIMS implementation was the development and configuration of the Batch Manager to be able to manage the QC analytical controls and to manage within the LIMS the flag’s management on the results obtained through the QC check as required by DoD, Maggi stresses. ‘To be able to satisfy compliance for our environmental customers, we are managing within LabWare LIMS
the calibration and method detection limits studies and the generation of EDD (Electronic Data Deliverable) files and Data Package reports.’ To achieve the LabWare LIMS was interfaced with the main laboratory instruments through the LabStation module, and the platform has also been integrated with LabAnalysis’s existing ERP Sage X3 system. ‘Samples are logged into the LIMS and we get all the information regarding analysis and test lists as sale items directly from the ERP. Once the samples have been completed and review at the end of the analytical process, the data are ready to reported and sent directly to the ERP system. We are now currently running the new project to manage the air analysis within LabWare ELN (Electronic Laboratory Notebook).’
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will fit the mould of cross-sector requirements.’ Data standardisation will also allow
the regulator to use companies as data warehouses, Turston suggests. Industry will still have to generate and store the same breadth and depth of data, in specified formats, to comply with regulatory requirements, but regulators may choose to take a far more risk-based approach to inspection. ‘If a company can provide all the information required in one year, then a full inspection may be carried out less frequently, allowing the regulator concentrate on companies that are less satisfactorily compliant.’ Te volume of information generated by
multiple informatics platforms is a double- edged sword, Turston indicates. On the one hand you have to build in automation to monitor all that data, identify anomalies, and help to direct decision making. On the other hand, using soſtware to monitor all the accumulated data means that we can also now get a much more accurate picture of an overall process. ‘Using analytical soſtware to interrogate data means that we can detect trends that are indicative of a possible adverse situation developing, at an early stage. Corrective action can then be taken before they becoming relevant in terms of product quality or safety, and certainly before they reach the consumer level.’ l
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