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Building a Smart Laboratory 2015


Te main criteria are listed below: • Attributable – who acquired the data or performed an action, and when?


• Legible – can you read the data and any laboratory notebook entries?


• Contemporaneous – was it documented at the time of the activity?


• Original – is it a written printout or observation or a certified copy thereof?


• Accurate – no errors or editing without documented amendments;


• Complete – all data including any repeat or reanalysis performed on the sample;


• Consistent – do all elements of the chromatographic analysis, such as the sequence of events, follow on and are they date- or time-stamped in expected sequence?


• Enduring – they must not be recorded on the back of envelopes, cigarette packets, or the sleeves of a laboratory coat but in laboratory note books and/or electronically by the chromatography data system and LIMS; and


• Available – for review and audit or inspection over the lifetime of the record.


It is important that laboratory staff understand these criteria and apply them in their


respective analytical methods regardless of working on paper, hybrid systems or fully electronic systems. To support the human work, we also need to provide automation in the form of integrated laboratory instrumentation with data handling systems and laboratory information management systems (LIMS) as necessary. In any laboratory, this integration needs to include effective audit trails to help maintain data integrity and monitor changes to data. Supervisors and quality personnel


need to monitor these audit trails to assess the quality of data being produced in a laboratory – if necessary a key performance indicator (KPI) or measurable metric could be produced.


Chapter summary


From a broader business perspective, the introduction of computerised tools for managing laboratory information comes at a perceived higher cost, and challenges the user to consider very carefully the consequences


Beyond the laboratory


of moving from a paper-based existence to one based on technology. Te return on investment equation is critical in obtaining the initial go-ahead for an informatics


project, but the transition to digital from paper represents a major upheaval to long- established and well-understood information management processes.


“ To support the human work we also need to provide automation in the form of integrated laboratory instrumentation”


Computer systems used in regulated


environments need to be validated; the user needs to be confident that computerised systems can deliver productivity benefits, and that data integrity and data authenticity can be guaranteed in a digital world. Lawyers and patent attorneys need to be confident that electronic lab notebooks can be presented as evidence in patent submissions, interferences and litigation. n


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