Tag Archives: LIMS

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

The Value of Effective LIMS

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

With the announcement of proposed rules under the Food Safety Modernization Act (or FSMA), the burden of food safety testing and record keeping placed on smaller and medium size food companies and use of contract testing labs is growing tremendously. So how do these labs manage growing requests for testing, and increasing volumes of data and demand for records? 

Here is where Laboratory Information Management Systems or LIMS play an important role, in helping labs manage the testing requests, handle all the data and records, be better prepared for audits, and comply with changing regulations, says Anthony Uzzo, President & Co-Founder of Core Informatics.

Uzzo has extensive experience in software engineering, informatics, laboratory automation, project management and science. He co-founded Core Informatics in 2006, along with Jim Gregory (Executive VP of Customer Solutions). A biomedical engineer, Uzzo started his career as a pharmaceutical lab scientist, and in that role, realized that most LIMS solutions were rigid in their scope. 

“This exposed me to different labs having different data management requirements, and gave me a profound appreciation of the impact of data management and having effective LIMS in labs. When starting Core Informatics, my goal was to provide labs with the opportunity to tailor their data management system to their needs without having to change their workflow, systems, personnel etc.,” he describes. 

We present below some excerpts from an interview with Food Safety Tech (FST).

FST: Why are LIMS so important for food and beverage companies in the current environment?

Uzzo:The food and beverage industry faces increasing regulatory scrutiny, pressures to control costs, and the challenge of maintaining quality throughout a global supply chain. A LIMS solution needs to be a solution to aid companies in the delivery and discovery of products, while complying with industry and government regulations.

The LIMS need to identify hazards, determine and monitor critical control points, and establish corrective actions and verification procedures to ensure that standards are met and the system is functioning properly. Our HACCP compliant system helps companies in the F&B industry to monitor products and make sure they do not become contaminated with chemicals or food pathogens. 

FST: How can food companies and labs choose the ideal LIMS solution?

Uzzo: According to me, the top criteria for choosing a LIMS solution would be flexibility; being web-based (able to use the LIMS with smart devices for data entry and access and no antiquated client server technology); and total cost of ownership.

There are now all sorts of novel testing methodologies being applied for food safety, and as a result, the data management requirements are constantly changing. Solutions would need to facilitate administrators to use the LIMS without writing a new code, and easily and quickly enable multi-site collaboration. For instance, there are new rapid detection technologies, such as PCR technologies for Salmonella detection, now in the market. An ideal LIMS should be able to rapidly process these results and use that data analysis, come up with efficient reports and enable lab scientists to do their job in a cost-effective manner. 

Cloud-based solutions offer great advantages in providing the ability to auto-scale, handle any amount of data, send out samples to other labs, support multi-site collaboration etc. Core Informatics, for instance, is fully embracing the power of the cloud. 

An ideal LIMS solution should address chain of custody from registration to report. The final report needs to be mentioned and be able to track who had handled that sample and every derivative of it, how it has been handled, under which condition it has been stored and for how long, and if appropriate procedures have been followed for storage and handling. Downstream, if there’s any problem, we need to be able to go back upstream and identify the correct source material.

LIMS solutions need to be prepared as new laws come into play in the next few years. Industry trends are accelerating the use of contract food testing labs. How effectively companies are able to process their data management requirements such as automatically receiving and recording test requests, preparing for their audits and complying with their food safety management programs, will all become critical.

Future Demand on Food Lab Managers

By Sangita Viswanathan
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How will food labs meet the demands of the future? What role will FSMA regulations play? And how are labs dealing with globalization of the food chain?

Food labs – both within food manufacturing companies and external contract labs – are facing a multitude of challenges: Increasing regulatory changes and compliance pressures; greater volume of testing; newer technologies and testing methods; demand for faster, and more efficient results….. How are labs and lab managers keeping track of, and apace with, all these changes? 


David White
, Chief Science Officer and Research Director at U.S. Food and Drug Administration (left, in the picture); Dave Evanson, President, EMS (middle); and Alvin Lee, Director, Center for Processing Innovation at the Institute for Food Safety and Health (IFSH), Illinois Institute of Technology (right), talked about these issues in a panel discussion moderated by Marc Carter, President of MC2, Inc. at Food Safety Tech’s Food Labs Conference organized last month in Chicago. We present some excerpts from the discussion below. 

 

What’s keeping you up at night?

Globalization of the food chain is a significant concern. FDA’s David White talked about the emphasis that FDA places on testing food products globally, increasing standards to get global labs on par with FDA’s accepted levels of testing, and using equivalent methods. 

“Southeast Asia and China, and the testing done in such regions, will be critical. This will need time and resources, but we should all collectively aim to get there,” White added. 

What keeps him up at night? White described that food labs of the future need to help companies be one step ahead of the next contamination. “Who would have thought about melamine, for instance? We need to consider which other products would be ideal for substitution and companies need to identify where their vulnerabilities lie. Everyone has a part to play in food safety – FDA doesn’t have the resources to do everything by themselves. Testing for the unknown, what’s the next melamine, that’s what keeps me up at night,” White explained. 

 

What’s the impact of FSMA regulations on the food lab market?

Getting labs to have in place specific food testing methodologies, HACCP and verification, plans to reduce contamination etc., will all improve under FSMA regulations. 

All these will take some time, says White, “but we are communicating to labs about where we stand and how the new rules can help take them to where they need to be.” 

IFSH’s Alvin Lee feels that there will be a lot more demand for documentation because of the new regulations: “Labs will have to establish certain processes or steps with a plan for preventive control, and find effective ways to control and manage data and documentation.” 

Echoing this sentiment, White said that labs need to figure out figure out how to manage databases more efficiently. “How do we create and store data, and produce it in a format that’s user-friendly? All these will be key challenges,” White described. 

 

How do food labs manage data currently?

Dave Evanson felt that there is a good history of LIMS being available and used. “Some labs have done a pretty good job of embracing that. But at the other end of the spectrum, there are some labs that still use a lot of paper. But many of these are starting to make changes. 

“There is also a lot of interest in going beyond just getting data, and learning more. And there is a push toward the producer of the data to get more information. New generation LIMS need to address this,” Evanson explained.

LIMS: Overwhelmed by Lab Data?

By Food Safety Tech Staff
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Thermo Fisher Scientific’s LIMS expert, Colin Thurston, explains how laboratory informatics can help food labs cope with large amounts of data as well as regulatory compliance.

The real challenge for food safety labs now is the amount of data that they are generating. “As analytical techniques have evolved, and instrumentation methods have become more sensitive, you can now process more and more information from a single sample. That kind of information becomes extremely difficult for a lab manager to process and to sift,” says Colin Thurston, Product Director, Informatics, for Thermo Fisher Scientific.

The big challenge for food processors is not the quality of the food but the brand. If something goes wrong with the food product, the consumer is going to remember it. So it is really critical for the lab to able to get the results to verify that the food is safe to eat, that too within a short time. 

What role does Laboratory Information Management System or LIMS play? “With the right LIMS solution, we can have the ability to automate, highlight the outliers, know which samples we have to go back and recheck, and which ones they have to reprocess because of challenges with the data. 

“Labs now are facing challenges around regulatory compliance. Regulations are changing and the food chain is becoming extended. Labs have to process a particular sample against many regulations as food companies want that product to be shipped to the U.S., consumed in Japan, Europe and so on. LIMS can store multiple sets of checks, carry out that process, and validate that product against all these requirements,” explains Thurston.