Tag Archives: laboratory information management systems

Tim Daniels, Autoscribe Informatics
In the Food Lab

Using LIMS to Get In Shape for FDA’s Visit

By Tim Daniels
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Tim Daniels, Autoscribe Informatics

FSMA is a major reform of the U.S. food safety laws. It shifts the emphasis for food safety to preventing contamination during manufacture instead of just responding to it. As part of the implementation process, the FDA will enforce these new rules during routine random inspections at food manufacturing sites. With such a significant change in emphasis, Shawn K. Stevens of Food Industry Counsel LLC, released an FDA Inspection Checklist. The checklist is designed to help food and beverage manufacturers to prepare for an agency inspection and to ensure they have the required controls and checks in place. Before we look in more detail at the checklist, it is worth reviewing some of the underlying requirements.

Some Basic Requirements

One of the fundamental requirements of FSMA is the establishment of an environmental monitoring program at each facility. It defines the testing protocols for appropriate microorganisms and verifies that the preventative measures undertaken are effective. Clear procedures and systems are required to identify the test microorganisms most suited to the risks in their systems. They need procedures to identify the locations from which samples will be collected and the number of sites to be sampled, since the number and location must be adequate to determine whether the preventative controls are effective. They also need to identify the timing and frequency for collecting and testing samples. The tests to be conducted must be specified, including the analytical methods used and the corrective action procedures in the event that testing detects an environmental pathogen or an indicating organism. Just as importantly, all of the data associated with this testing program needs to both be recorded and accessible for audit purposes.

Acquiring and Managing Environmental Monitoring Data

Any environmental monitoring program will come at a cost to the food manufacturer. While the program itself will need to be set up by experts in the field, much of the implementation can be carried out by lesser-qualified technicians. So a key aspect is having the tools to implement a program where the most effective use is made of each resource available, as this keeps costs down. In principle, one such tool is a Laboratory Information Management System (LIMS).  The use of a LIMS is commonplace in QA Labs to record and monitor laboratory samples, tests and results in order to simplify and automate processes and procedures. There is a variety of ways in which a LIMS could facilitate the environmental monitoring process to enable best practice even by non-specialist staff. For example, analysis can be simplified if each set of test results can be automatically linked to respective sampling points in the facility. Out-of-specification test results could be linked to corrective and preventive actions (CAPA). Test failures at a particular sampling point could be used to trigger more frequent testing at that point according to pre-set criteria.

  • The data management capabilities within a LIMS make it possible to:
  • Implement data management strategies that increase security and availability of data
  • Eliminate manual assembly of data for analysis and audit
  • Make data more useful with easy retrieval/visibility

Perhaps most importantly, a properly configured LIMS can provide a suitable framework for set-up and adjustment by the environmental monitoring expert, while reducing the expertise required to operate it on a daily basis.

Laboratory Information Management Systems
The Matrix Gemini Environmental monitoring solution is an example of an information management system that uses the capabilities of a LIMS to record and monitor laboratory samples, tests and results to simplify and automate environmental monitoring in QA Labs. Image courtesy of Autoscribe Informatics

FDA Inspection Checklist

This comprehensive document highlights the steps that companies need to take to prepare for the inspection process, navigate the inspection itself and respond to any criticisms arising from the inspection.

There are three main areas in the checklist where a LIMS could help satisfy FSMA requirements:

  1. Finalizing written food safety systems and making sure certain employees know the plans. LIMS provides the framework to set up documented food safety sampling requirements and track microbial test results over time. This facilitates recall and more detailed investigation should a sample fail.
  2. Well organized and maintained data, and ease of records access. LIMS should be capable of date and time stamping every entry and since it will contain all the test data over time, this can be easily recalled should the need arise. Typically a standard operating procedure would be developed, which will increase testing and start “out-of-specification” actions if abnormal microbial contamination is detected. LIMS can provide a full audit trail for all test data and produce reports showing result trends over time, highlighting variance and peaks in data.
  3. Proper documentation of corrective actions. In the event of failures, investigators will want to focus on the particular sample points and the “out-of-specification” actions that were initiated to investigate and resolve these failures. Typically three months of data is requested around these sample points, although up to two years’ worth of data could be requested. LIMS should allow data to be instantly pulled from the database as a report for further investigation.

FDA investigators will be most interested in what happens in the event of a failure and what learning gets incorporated into your regular regime. What happens when an out-of-specification result is obtained is the crux of preventive testing regimes. Actions might include changing sanitation methods, increasing test frequency or locations in areas of concern, segregating traffic patterns, re-training staff and so forth. Some of these actions, such as increasing test frequency, can be automated. All actions must be clearly documented, which can be done by adding appropriate records directly into the LIMS. This captures the actions that each quality improvement cycle needs in order to discover the likely root cause of any problems and how they may be avoided in the future.

All corrective actions should identify the root cause of the deviation, actions taken to prevent recurrence and, if product safety is not affected, a written conclusion (supported by factual and scientific data) that the deviation “does not create an immediate food safety issue.”

The emphasis should always be on preventive actions to remove potential points of failure before issues get into the final delivered products causing stock loss and costly recalls.

Configuring a LIMS for Environmental Monitoring

While most LIMS in principle provide the capability to handle the requirements of environmental monitoring, the system will need to be configured to do so, and this may not be a trivial exercise. The software will need to be configured to represent user requirements in terms of workflows, screen designs, menu designs, terminology, numbering schemes, report designs and much more. For many LIMS, full configuration for specific applications requires custom coding, which will require re-validation.

Once configured, LIMS can offer a practical way for food and beverage companies to document their sanitation/safety programs and instantly show written evidence of both testing and corrective actions when the FDA comes knocking.

Why LIMS Is a Necessity, Not a Nicety

By Dr. Christine Paszko
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How a laboratory information management system can facilitate safety testing and regulatory compliance within a food processor’s lab.

The food industry is under pressure to produce high-quality products while adhering to stringent microbiological testing standards controlling costs and meeting regulatory compliance goals. Food companies face a number of regulations and requirements, including those related to Good Manufacturing Practices, nutritional labeling, HACCP (Hazard Analysis and Critical Control Points), public health security, the Bioterrorism Preparedness and Response Act of 2002, and FSMA. For laboratories that offer products globally, the Global Food Safety Initiative focuses on continuous improvement of food safety management systems to ensure confidence in the delivery of safe food to consumers. Many companies face these regulatory challenges armed with a stable and secure laboratory information management system (LIMS) and laboratory automation solutions. LIMS solutions can provide a cost-effective means to ensure that product standards are met, product is delivered as quickly as possible, and managers and staff have the tools to effectively do their jobs. While there are many commercially available LIMS solutions, it is critical that laboratory managers perform due diligence to ensure that the system they select will be successful in the lab. Some ways in which an LIMS vendor can differentiate itself includes: having ISO 9001 certification offering a qualified staff, being a certified Microsoft Gold Partner, and offering software solutions based on the latest technology that allows users to leverage the Internet, tablets and smartphones.

Implementing an LIMS: The problem and the solution

A microbiology laboratory of a meat processor was looking for ways to eliminate transcription errors, and shorten its analysis turnaround time and reporting time through automation. The company was experiencing increasing sample volume, which would require hiring additional resources that had to be trained and deployed. However, taking on more personnel was not an option. To manage its growing sample volume, the company was seeking an LIMS that could also interface with its laboratory instruments and manage plant samples from multiple remote sites. An evaluation of current processes revealed multiple opportunities to automate data entry, reporting, and eliminate dual and triple entry while accelerating and automating data handling and test scheduling.

Samples, including raw materials, finished products and plant samples, were sent from multiple plants to the laboratory daily for environmental monitoring. The current manual system was labor intensive and required that all processes be manually checked and re-checked for accuracy prior to data release. Data was entered into the manual systems multiple times. Instrument data was not integrated with the reporting and the lab was increasing its sample volume for the instruments alone by up to 900 samples per day. Primary reasons for investing in LIMS automation included:

•    Having the ability to do more work with the same resources (removing manual tasks)
•    Enhancing data management into a single, secure data base
•    Meeting regulatory compliance goals
•    Operating under enhanced efficiency and data quality
•    Facilitation of standards and increased communication across their operations
•    Cost savings

Automation reduces transcription errors, increases productivity, enhances data quality and accelerates result delivery. Faster turnaround translates into faster product release, longer shelf-life and ultimately, cost savings.

Then: Prior to implementing the LIMS, samples would arrive at the food processor’s laboratory each morning. From there, they were manually sorted, paperwork was organized, and checks were conducted to verify receipt of samples.

Now: LIMS has significantly streamlined the process. Each morning, a work list is printed from the LIMS, identifying which samples will be received from the plants. The samples are organized and prepared for analysis and placed on the instruments with barcoded work lists for rapid and accurate set up.

The microbiology laboratory leveraged an automated food pathogen detection system to test for Listeria spp., Salmonella spp. and E.coli:0157:H7 on various sample types. Prior to automation, the manual steps of loading the sample IDs, scanning the print outs from the instruments, and then entering the data into reports with secondary review required 40 to 45 minutes per batch of 60 samples.

 Two of the four instruments interfaced with a LIMS.

Implementation of the LIMS has reduced report review time to five minutes. The data is received by the LIMS, and the email is automatically parsed and ready to receive the samples. The emailed worksheets, which are also automatically imported into the LIMS, eliminate several manual steps, including the time in which the laboratory team spent cross-checking samples with the paperwork and calling for missing samples. In this case, the automation has reduced the amount of paperwork and significantly streamlined the process. Now the laboratory knows which samples it will be receiving each day and can quickly match the samples to previously imported work lists.

Once the samples are loaded on the pathogen detection instrument to match the work list from the LIMS, the screening is conducted and the data is sent back to the LIMS, with the final analysis report completed automatically.

 
 An example of a final report automatically generated from the system, which is also automatically emailed.

 

Conclusion

Primary enhancements to implementing an LIMS include higher data quality and significant time savings (a conservative estimate: LIMS typically saves customers between 25-45% of time on their operations). On the instrument integration alone, the automation saved 35 to 40 minutes of work per batch (a batch contains 60 samples), and a typical day includes 10 to12 batches, or up to 720 test results per day. Conservatively, if we allot 35 minutes per batch and 10 batches per day, the time savings are nearly six     hours daily, and this is only from interfacing four instruments. Additional time savings are also realized as a result of reducing data errors.

An alternative solution to hiring additional staff to work in the lab involved examining the benefits of automation to leverage existing resources and allowing them to be more productive. This path eliminated mundane tasks and allowed existing lab staff to focus on the LIMS  (managing, tracking and organizing data) and automation (barcoding, scanning, instrument integration, automated email imports and automated reporting). Laboratory staff was trained on-site and received follow-up training at the LIMS Boot Camp. As a result, workflows were streamlined, sample throughput was accelerated, and the lab experienced faster turnaround times.

Other benefits of deploying a new LIMS in the laboratory include increasing data security, having an audit trail if any approved and validated results required a change, full traceability, facilitating standardization across the organization, reducing the amount of paper forms, and automating the release and reporting process.


About the Author

Dr. Christine Paszko has extensive expertise in LIMS, laboratory automation and food safety testing. She is currently the VP of Sales and Marketing at Accelerated Technology Laboratories, Inc., (ATL). Prior to joining ATL, she worked at Applied Biosystems. She was responsible for the creation, marketing and sales of molecular test kits that leveraged the TaqMan technology to detect major foodborne pathogens such as Salmonella, Listeria, and E. coli 0157.

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.