What are the key elements of a LIMS for Food and Beverage?

Question

Accepted Answer

Base LIMS requirements for food and beverage labs

The use of LIMS in food and beverage R&D, production, and quality labs is not a new concept ^[1], though many such labs today find themselves still using manual, paper-based methods. Given the regulatory demands for providing rapid proof of traceable product movement and relevant quality control data, a LIMS or other informatics solution appears to be increasingly critical to eliminating such manual processes, while improving sample management, increasing productivity, and improving regulatory conformance.^[2] However, in most cases, a generic LIMS won’t do; it’s imperative the lab find a solution that meets all or most of its workflow requirements. This more often than not requires a configurable solution that enables trained users to quickly make the changes they need, if those changes make sense within the overall data structure of the LIMS. What follows is a list of system functionality important to most any food and beverage laboratory, with a majority of that functionality found in many vendor software solutions.^{[3][4][5][6][7][8][13]}

Note : Any citation leading to a software vendor’s site is not to be considered a recommendation for that vendor. The citation should however still stand as a representational example of what vendors are implementing in their systems.

Test, sample and result management

food safety lab

Sample log-in and management, with support for unique IDs
Sample batching
Barcode and RFID support
End-to-end sample and inventory tracking
Pre-defined and configurable industry-specific test and method management, including for bacteria (i.e., microbiology), heavy metals (i.e., chemistry), drug residues (i.e., pharmaceutical chemistry), and other substances
Pre-defined and configurable industry-specific workflows
Configurable screens and data fields
Specification management
Test, sampling, instrument, etc. scheduling and assignment
Test requesting
Data import and export
Robust query tools
Analytical tools, including data visualization, statistical analysis, and data mining tools
Document and image management
Version control
Project management
Method and protocol management
Investigation management
Facility and sampling site management
Storage management and monitoring

Quality, security, and compliance

Quality assurance / quality control mechanisms
Mechanisms for compliance with ISO 17025 and HACCP, including support for critical control point (CCP) specifications and limits
Result, method, protocol, batch, and material validation, review, and release
Data validation
Trend and control charting for statistical analysis and measurement of uncertainty
User qualification, performance, and training management
Audit trails and chain of custody support
Configurable and granular role-based security
Configurable system access and use (i.e., authentication requirements, account usage rules, account locking, etc.)
Electronic signature support
Data encryption and secure communication protocols
Archiving and retention of data and information
Configurable data backups
Status updates and alerts
Environmental monitoring support
Incident and non-conformance notification, tracking, and management

Operations management and reporting

Configurable dashboards for monitoring, by product, process, facility, etc.
Customizable rich-text reporting, with multiple supported output formats
Custom and industry-specific reporting, including certificates of analysis (CoAs)
Industry-compliant labeling
Email integration
Instrument interfacing and data management
Third-party software interfacing (e.g., LES, scientific data management system [SDMS], other database)
Data import, export, and archiving
Instrument calibration and maintenance tracking
Inventory and material management
Supplier/vendor/customer management
Integrated (or online) system help

Specialty LIMS requirements

As noted previously, some software vendors are addressing food and beverage processor needs beyond the basic laboratory through their food safety software. A standard LIMS tailored for the food and beverage industry may already contribute to some of these wider organizational functions, as well as more advanced laboratory workflow requirements, but many may not, or may vary in what additional functionality they provide. In that regard, a food and beverage LIMS vendor may also include specialized functionality that helps the food and beverage producer and its laboratory^{[8][9][10][11][12][13][14][15][16][17][18][19]}:

Manage stability studies: Just as with the pharmaceutical industry, stability studies play an important role in food and beverage safety. These studies require careful statistical analysis, predictive modelling, sensory analysis, quantitative descriptive testing, discrimination testing, microbiology testing, and more. This translates to a need for a wide variety of analytical and visualization tools, as well as LIMS support for a wide variety of test methods and limits. A robust LIMS should have these abilities, but not all do.
Manage recipes, as well as master and batch production records: This functionality is more in the domain of the LES or manufacturing execution system (MES). However, a few LIMS vendors may extend their LIMS to provide these features. Given that the HACCP rules, in particular, mandate the creation and management of batch production and in-process manufacturing material records, some food and beverage facilities testing batches and manufacturing materials may appreciate support in this regard.
Support molecular biology workflows: Molecular biology is an important tool in the research of improving foods, beverages, and their ingredients. However, not all LIMS are ideally equipped to handle related workflow aspects such as nucleic acid extraction, protein and cell isolation, and genotyping. A lab using such techniques may have to do extra due diligence in finding a food and beverage LIMS that also supports these workflow tasks.
Take advantage of ELN functionality: Given the level of R&D to be found in a food and beverage facility, the ELN is a familiar companion to other informatics systems. A few LIMS vendors may have a built-in ELN with their LIMS or offer an ELN that comes readily integrated with the LIMS. Some elements of ELN functionality may even be found in a few solutions. At a minimum—and nodded to in the base functionality above—the LIMS should support ELN functionality through its ability to effectively connect to a third-party ELN.
Develop regulatory-driven safety plans: The Hazard Analysis and Critical Control Points (HACCP) quality control method is recommended or required for food and testing labs (and is an influence on ISO 17025). Some LIMS vendors have recognized this and integrated support for building HACCP steps into laboratory workflows. In some cases this may be as sophisticated as allowing the user to diagram HACCP in their lab or facility as a visualization tool.
Generate schedules for environmental testing: While a LIMS can help assign and schedule a variety of laboratory tasks, broader organizational goals of testing the production environment on a scheduled, reportable basis may not be so straightforward, particularly without facility and sampling site management functionality that allows for highlighting specific test points in the facility. Even offsite or randomized testing may not be fully supported by a generic LIMS, requiring a LIMS flexible enough to compensate for the need for broader scheduled and randomized testing and retesting.
Improve reaction time to non-conformances: Many LIMS will have some basic form of non-conformance and incident management tools, but the robustness and extensibility of that functionality may be lacking. Can it send an SMS or email to the appropriate supplier in real-time when a pre-defined set of circumstances concerning that supplier’s ingredients occurs? Can it re-prioritize or pause other related activities that are scheduled due to the identified non-conformance or incident? This is a useful area of functionality for the potential LIMS buyer to confirm with a vendor.
Improve audit readiness and reporting: A LIMS worth its weight will have a robust audit trail, to be sure. But can your LIMS help you audit your suppliers? Can it capture internal audit data on-demand and directly from the facility floor via mobile-friendly forms? Can HACCP- and audit-related data be flagged as such to make retrieval more efficient for audit purposes? These and other considerations may be important to a food and beverage facility, and not all food and beverage LIMS can provide.

References

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