14 ANALYTICAL AND LABORATORY EQUIPMENT
ANALYTICAL AND LABORATORY EQUIPMENT 9 SECTION NAME 3
workflows, retrieve and archive any kind of raw laboratory data and export those results across the organisation to ERP systems, for example, all in whatever format is required by recipients.
Te ability to manage the entire process in a tightly integrated solution, one that functions as a single piece of software, dramatically streamlines laboratory operations while minimising the cost of ownership, implementation, validation and ongoing maintenance.
Seamless integration An example of this is SampleManager LIMS, which includes built-in functionality for LIMS, LES and SDMS as well as integration technologies. What’s more, when labs plan for such seamless integration it enables lab managers to codify a “do it right every time” process approach, which is in alignment with QbD processes, providing the transparency necessary to identify and remove non value- add steps, while lowering the cost of training new staff.
With LES functionality available as part of a LIMS implementation, SOPs and methods are automatically established electronically so that for any lab personnel, new or seasoned, the LIMS acts as their workflow, manual and constant guide.
It’s easy to see the LIMS, LES, SDMS ‘stack’ as a lab-centric view of pharmaceutical business, but that would be a mistake. Te ability to run efficient labs and protect the brand by safeguarding product quality are both enterprise-level concerns.
As such, the LIMS needs to be fully integrated with ERP systems: in fact, many work requests coming into QA/QC laboratories are actually initiated in a manufacturers’ ERP system,
which for many companies is the bridge between its manufacturing execution system (MES) and other systems such as the LIMS.
Conclusion In many organisations, a LIMS is a standalone investment, managing workflow and sample testing and generating appropriate reports. If the lab needs additional software, such as an ELN or SDMS, those systems are then implemented and sometimes, but not always, integrated with the LIMS so that lab operations are more streamlined and data is easier to manage.
In a QA/QC lab, however, a LIMS that is pre-built with LES and SDMS functionality, delivers end-to-end workflow and data capture that is literally designed
for quality. Te benefits of having all these capabilities resident in a single system are myriad, starting with lower total cost of ownership, ease of training and administration, streamlined compliance and better overall quality control. And all of this is possible across vast geographies or contractual partnerships, all of which can be managed holistically.
Organisations, that haven’t done so already, need to make this year a major inflection point for laboratory technology, especially within the QA/QC function. After all, the evidence is stacking up that the costs of inaction clearly outweigh the investment that is required for change.
Trish Meek, Director of Product Strategy, Thermo Fisher Scientific.
www.thermofisher.com
www.scientistlive.com
QA/QC laboratories need a tightly controlled process and well managed laboratory to drive predictive analytics.
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