ANALYTICAL AND LABORATORY EQUIPMENT 2
SECTION NAME 13
QA/QC laboratories need a tightly controlled process and well managed laboratory to drive predictive analytics and to prevent substandard products before they occur. An end-to-end informatics solution warns the organisation before nonconformances occur by monitoring critical product attributes creating a proactive versus reactive environment. Laboratories address these needs through the use of several systems: Lab Execution Systems (LES), Scientific Data Management Systems (SMDS), and Laboratory Information Management Systems (LIMS).
LES has become a critical component of today’s paperless lab ensuring that quality processes are followed in the laboratory and that the methods built on QbD principles are followed in day to day laboratory operations.
LES drives users through any laboratory procedure in a stepwise fashion. Tis provides technicians with the direction they need to execute processes safely, and in a consistent manner. It also assures laboratory management that good laboratory practices are used and that SOPs are being followed by experienced and newly trained laboratory personnel.
Maintaining a consistent approach to activities like sample preparation, instrument calibration and maintenance and analytical testing is critical to a good scientific process. Lab managers can then be certain that all of their results are a true assessment of final product quality.
An SDMS lets you integrate instruments across the lab and centralise data capture, allowing for long-term data archiving but more importantly, data visualisation from the archive – all accessed from the LIMS.
An SDMS archives the original raw data files from the instrument along with a normalised representation in XML, without the need to restore the data to the original instrument workstation or install the instrument software on every computer. Te real scientific data and the results gleaned from it are a critical part of QbD.
Paperless lab Te final product specification is determined by comparing the analytical results to determine which formulation and process parameters yield the best product. As part of a paperless lab environment, an SDMS integrated with the LIMS reduces paperwork, manual review time and data transcription, which improves efficiency, productivity, consistency and quality while reducing costs dramatically. SDMS also provides secure access to archived files for as long as necessary, and enables more efficient and defensible reporting to regulatory authorities.
LIMS remains a critical part of any pharmaceutical manufacturing organisation’s infrastructure. Today’s LIMS goes far beyond just the management of samples, tests, and results. It also provides resource management allowing organisations to forecast fewer sample volume and resource needs. It provides dashboard views that allow organisations to see how their lab is operating and identify any data that is trending towards warning or failure limits. Tese lab management activities are essential, but organisations also need to be able to drive the day to day operations of the laboratory as well.
Having a smart infrastructure built on a state-of-the-art informatics solution at its core enables another critical benefit in the lab: automation. Even smart instruments must undergo regular performance
verification. And how often this is done depends on many factors, including the frequency of use. Because instrument failure – or having a system go out of specification – can negatively impact quality, production or compliance down the road, any risk is unacceptable. A LIMS can save considerable time helping labs adhere to precise rules and requirements, automating critical procedures on pre-defined schedules.
When all systems are aligned, the convergence of people, processes and technology is transformative. Problems arise when these systems aren’t fully integrated and these disparate systems become out of synch.
At a macro level, breakdowns occur at three key points: data capture, data transcription and data management. Put another way, the key to an efficient lab that delivers uncompromising quality is having smart instruments within a smart infrastructure. Tis starts with SOPs for highly standardised methods and processes, which are handled by the LES, and includes raw instrument data generated by the analytical instruments used in those experiments, all of which is handled capably by the SDMS.
What lab managers really want is a truly connected system that provides lab management, drives lab operations and integrates all of the data-generating sources and ties all that data together in one centralised location. A modern LIMS needs to be a complete informatics infrastructure by providing a LIMS, SDMS, and LES in one.
Going beyond paperless Today’s paperless lab can more aptly be called an integrated lab. Te trinity of LIMS/LES/SDMS enables lab managers to achieve full instrument integration, manage their methods and
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“What lab managers really want is a truly connected system that provides lab management, drives lab operations and integrates all of the data-generating sources and ties all that data together in one centralised location.”
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