6 Analytical Instrumentation
How LIMS Enable LNG Laboratory Agility in the Face of Changing Standards
Colin Thurston, Director of Product Strategy, Process Industries, Thermo Fisher Scientific Altrincham, United Kingdom
Email:
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thermofisher.com • Web:
www.thermoscientific.com/LIMS
When laboratory professionals discuss the vision of the true paperless laboratory – a lab that contains zero paper, where processes are automated and data is virtually mistake-free – simplified compliance is usually one of the first advantages mentioned. In LNG sampling labs, however, automating compliance is much easier said than done. In addition to regulations enforced by local, national and international agencies, LNG customers require suppliers to comply with standards that are usually stricter than the law. And if manufacturers cannot meet these stringent requirements, they risk being displaced by companies that will.
Compliance would be one thing if standards for testing such as those recommended by ISO and ASTM were a static set of guidelines, but standards are in constant flux as methods and technologies evolve. Running a paperless LNG laboratory that complies with moving targets and completes audits efficiently would be an impossible task without major automation capabilities.
Fortunately for quality managers, there is a solution: a laboratory information management system (LIMS). A LIMS not only enables an LNG laboratory to collect, store and analyse data more accurately and efficiently in a paperless environment, it also ensures compliance in an environment of constant change. How? This article will explore how a LIMS enables integration with enterprise systems and automation of processes to transform compliance with industry standards from a burdensome source of worry to a business differentiator.
Compliance in the Paperless Lab Twenty years ago, when nothing in the lab was automated and the idea of a paperless lab would have seemed farfetched, compliance revolved around frequent referrals to hard copy manuals kept in the lab. Standards organisations issued new testing definitions through subscription, and each time a standard was created or revised, the lab would update an operating procedure and retire the old one. Lab technicians unfamiliar with updated procedures were obligated to refer to the newest manual constantly to ensure that their day-to-day activities would not violate the new standard. Control of the correct versions of operating procedures required a manual control system to ensure that everyone was using the right version at the right time. Under this system, unintended violations were difficult, if not impossible, to spot and audits were slow and inefficient.
Today’s successful LNG enterprise relies heavily on the integration and automation capabilities of a LIMS to enable compliance in an environment where standards are more accessible, but also updated more frequently. Instead of having to familiarise personnel with perpetually outdated hard copy manuals, labs now have LIMS that automatically link directly to the revised standards and update records accordingly. Some advanced LIMS, such as Thermo Scientific SampleManager 11,
Enhanced traceability features in SampleManager, including the ability to track aliquots and composites, enable finer control over samples and more reliable data for decision making and compliance.
can even store standards as attached documents on relevant workflows. That way, if a user wants to double check for compliance midway through a procedure, he or she needn’t track down the correct section in an enormous paper document. A simple point and click will open up the relevant parts of the standard for the technician to review.
With automation, however, even point and click navigation is often unnecessary. New standards aren’t just downloaded automatically; the LIMS also adjusts laboratory management workflows to conform to new requirements. This includes necessary user training requirements, equipment calibration, instrument timelines and more. If, for instance, an ASTM standard is revised to require instrument inspection for accuracy monthly instead of bimonthly, the LIMS will automatically revise inspection scheduling and issue reminders to lab managers so that the company doesn’t miss a beat.
So which standards are most onerous for LNG companies? Let’s consider two of the most important standards organisations: ASTM and ISO.
Managing to ASTM Standards
An enterprise level LIMS such as SampleManager can help bridge the islands of data generated in the lab and transform that data into information that can be used across the enterprise.
ASTM International, formerly the American Society for Testing and Materials, is an internationally- recognised organisation that issues standards “to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence.” ASTM creates standards on everything from 3D imaging, nuclear technology and quality control to, most relevantly, laboratory testing. LNG customers worldwide require suppliers to comply with ASTM standards that, if followed correctly, will ensure that tests done to assess product composition and quality are performed correctly and are comparable wherever they have been carried out across a global industry.
Unlike some other standards, which are revised on a schedule basis, ASTM’s recommendations are
OCTOBER / NOVEMBER 2013 •
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