Tag Archives: LIMS

Getting Ready for FSMA: How a Laboratory Information Management System Can Help

Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required by FSMA.

Do you know where your food comes from? How sure are you that it was grown, processed or produced with your safety as the priority? Increasingly this issue is headline news as we struggle with managing the outbreak of food-borne illnesses caused by the very stuff of our daily lives: salmonella contaminated peanut butter; e-coli contaminated beef and pork; contaminated spinach, lettuce and strawberries; melamine in milk.

In each instance, the grower or producer had inadequate methods in place to trace the original source of the contamination. The Mexican tomato business was devastated in 2009 when tomatoes were wrongly blamed for an outbreak of salmonella that was actually caused by tainted jalapeño peppers. Without proper systems in place to provide traceability, there was no way to know the contamination source. Several people died, many more became ill and a major business was destroyed for lack of information. The ultimate price for those food producers is that not only have they lost revenue due to product recalls, but, more importantly, they have also lost the trust of the buying public – and governments around the world have taken notice.

In the United States, the oversight of food had fallen under a fractured network of agencies responsible for different parts of the production process, from site inspections and safe processing methods, to the documentation of calorie counts and ingredient listings. Some grown and produced foods fell under the auspices of the U.S. Food and Drug Administration (FDA), while food groups that contained a combination of meat, dairy and produce fell under the oversight of the Department of Agriculture. Compound this regulatory environment with the fact that staffing for food inspections had been low compared to the volume of inspection needed to manage safe production. This lack of manpower and the separation of responsibilities exacerbated the ineffectiveness of the regulatory agencies and caused confusion among the consuming public.

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The result of this legislation for consumers should be greater safety of their grown and produced foods. The impact for food producers will be mandates for upgraded business and operations plans, investments in instrumentation, software and manpower, and a safer food supply chain. This white paper discusses how to respond to FSMA, the role that traceability plays in it, and how leading food producers have implemented best practice solutions.

Employing a LIMS to meet the demanding FSMA requirements

The most important common thread throughout the FSMA is traceability. Laboratory Information Management Systems (LIMS) play a critical role in the traceability of quality in the production process from farm to fork, providing such capabilities as:

  • Automated data collection from testing and delivering the records of proof that are required for regulatory compliance;
  • A secure environment for monitoring batch relationships between raw materials, processed materials and packaged goods;
  • A centralized system that collects, stores, processes and reports all the data generated within food laboratories, allowing a complete overview of the quality of any product;
  • Automated checks for out-of-specification results and identification of suspect products to prevent release pending investigation; and
  • Assurance that all (standard, fast turnaround and condition sensitive) samples are handled and processed correctly.

Furthermore, a LIMS provides the producer with the knowledge that the quality of the product meets the standards set by the regulator, while recording that data for any subsequent inspection. Auditors can review uniform compliance reports and the certificates of inspection stored within the LIMS whenever required to confirm consumer safety.

Ultimately, a LIMS plays a key role in the integration of the laboratory environment with critical enterprise systems to facilitate faster, more informed decisions. This makes laboratory data available to process control systems, giving managers immediate accessibility to results, as well as cascading any release data through to enterprise resource planning systems.

For some food testing laboratories, commercial LIMS have been too costly for the business to absorb and support, forcing them to rely on inefficient manual and error-prone home-grown systems, spreadsheets or paper-based methods. The new legislation will put enormous strain on these labs to remain compliant. Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required of the FSMA.

Case Studies: LIMS providing traceability for food worldwide

Chr. Hansen is one of the world’s top food ingredient companies. The company standardized on Thermo Scientific LIMS across all of its six culture production sites in the United States, Denmark, France and Germany to ensure optimum quality control in starter culture production. The LIMS implementation has delivered considerable benefits, including real-time, automated entry and processing of laboratory data, and fast extraction of results, leading to increased laboratory productivity and accelerated sample turnaround. Chr. Hansen has also integrated the LIMS with its existing ERP system, so that test results authorized in the LIMS by lab personnel can be immediately available for the processing facilities technicians and laboratory administrators.

Molkerei Alois Müller produces more than a third of all yogurt eaten in the UK from the Market Drayton factory. The Müller UK labs focus mainly on production Quality Control. Every step in the process undergoes quality checks, which are managed and stored with the LIMS. Müller UK selected Thermo Scientific LIMS to manage their QC data for raw materials, in -process, and finished dairy desserts. The LIMS reduced the amount of error-prone manual paperwork processes and expedited testing, while providing the necessary reports and documentation for a complete audit trail during regulatory inspections. By using a LIMS, Müller is able to trend all data and make quality and safety decisions, as well as any necessary improvements, much faster and more reliably.

Sino Analytica in Qingdao City, China is a world-class food analysis laboratory that provides contract analytical services to a wide range of food suppliers, trading companies, and retailers from China and all over the world. Sino Analytica historically managed data manually in the laboratory with a monthly load of over 1,200 samples. The company chose Thermo Scientific LIMS to support its food safety contract laboratory and meet the internal quality standards and accreditation requirements for food exports to countries including the United States. The LIMS has helped laboratory managers achieve faster assembly, collation, and review of information and data relating to QA/QC activities. The LIMS also demonstrates that the company meets the requirements of auditors and provides documentation for processing internal QC data.

This article has been adapted from a white paper presented by Thermo Fisher Scientific. Click here to access the white paper. For More Information about Thermo Scientific informatics solutions for the food and beverage industry, visit: www.thermoscientific.com/foodsafetyresources.

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.