The Gap Between LIMS Capabilities and Environmental Monitoring Needs
The Gap Between LIMS Capabilities and Environmental Monitoring Needs
Abstract
While laboratory tests are an important part of Environmental Monitoring (EM) operations, the EM workflow is complex and the EM workplace presents a unique set of challenges. Commercial Off-The-Shelf (COTS) LIMS products bring a wide range of functions to help automate the analytical laboratory, but struggle to meet the unique challenges of the EM operation.
This paper reviews the workflow typically found in EM operations to identify the needs of the EM organization. It matches the capabilities of commercial LIMS to these needs, and discusses the LIMS customizations that would be required to close these gaps. It also discusses two alternative approaches to building an interface between an EM-specific product, such as MODA-EM, and a commercial LIMS.
The Environmental Monitoring Workflow
Figure 1 describes the EM workflow in six stages.
Figure 1. Environmental Monitoring Workflow
The following table briefly describes each of these stages and discusses the LIMS product capabilities that could be used to support the stage. It identifies the limitations of the LIMS and lists the customizations that would have to be performed.
In summary, most LIMS products do not provide specific capabilities and features that are required to support Environmental Monitoring:
· Not paperless. LIMS products are not designed to eliminate paperwork, but rely on lists of tasks printed in advance for sample collection. Process deviations and unscheduled events not anticipated by LIMS require even more paperwork.
· Inadequate workflow. LIMS products are not designed to support the location, routine and event-based scheduling functions that are essential to support EM SOPs for clean rooms.
· No clean room platform. LIMS products are not designed to operate on sanitized, mobile, touch-screen PCs with limited network connectivity. They typically use fixed workstations.
· Inadequate reports. LIMS products do not include the analysis tools to study the trending, perform the investigations and produce the reports to meet core EM needs.
And once the extensive customizations for EM are complete, the standard functions may no longer work for the routine, non-EM storage and scheduling functions of the lab.
Alternative Approaches
Environmental Monitoring is usually performed by a Microbiology group that is part of a Quality Control (QC) department within the manufacturing organization. The LIMS product under consideration for EM may have already been adopted by the QC or Quality Assurance (QA) department to control other laboratory functions, such as analytical chemistry.
Even though the LIMS may not be a natural solution for the EM process, it is possible to extend LIMS functionality to meet the EM requirements. This whitepaper will describe two viable, alternative approaches:
· Deliver results – Choose an EM-specific product, such as MODA-EM, that meets the needs of the Microbiology group and integrate with the LIMS only to report the results of the EM process for compliance activities such as product release.
· Tight integration – Choose the same EM-specific product and “tightly connect” it to the LIMS product.
The following sections describe these approaches.
Deliver Results
This approach leaves the entire EM workflow in the EM-specific product. The EM system communicates with the LIMS at two points in the process:
· For the EM system to obtain batch/lot information from the LIMS. The EM system associates this information with each sample so that later EM reporting can be done on the batch/lot.
· The EM system delivers approved results to the LIMS product. This places all QC information in a single system of record – the LIMS.
This flow of control and information is depicted in Figure 3.
Figure 3. Deliver results from EM to LIMS
Advantages of Deliver Results Approach |
· The LIMS system eventually receives all completed EM results; there is a single repository for all QC data. · The EM workflow is supported by an EM-specific product. · LIMS customizations are not necessary for EM. · Common LIMS platform provided for both QA and QC data. · Ability to report from LIMS on combined QA and QC data for product/batch release. |
Tight Integration
This approach describes an example of how an EM-specific product can be tightly integrated to a LIMS product. It divides the EM workflow between the two systems:
· A Microbiology Supervisor schedules sampling using the LIMS Scheduling function, which builds a list of the planned samples to be collected.
· This schedule is exported to the EM system, where it becomes one or more Assignment Lists to be performed by microbiologists.
· The EM system, operating in the Clean Room, supports the Microbiologists as they process the Assignment Lists and collect samples.
· When the samples arrive at the Microbiology Lab, the EM system exports information about them to the LIMS, matching samples to the original LIMS schedule.
· The LIMS supports processing of samples, including incubation and results entry.
· The LIMS supports review and approve of the results.
· The EM system accesses the LIMS database to produce EM-specific reports.
This flow of control and information is depicted in Figure 2.
Figure 2. Example of Tight Integration Between LIMS and EM
Advantages of Tight Integration Approach |
· The LIMS holds all EM results; there is a single repository for all QC data. · The LIMS is able to track all scheduled, in-progress EM work. · The mobile capabilities of the EM Collect Samples function are employed. · The workflow capabilities of the LIMS Process Samples and Review Results functions are employed. This is consistent with the processing of non-EM tests elsewhere in the QC organization. · Common LIMS platform provided for both QA and QC data. · Ability to report from LIMS on combined QA and QC data for product/batch release. |
Conclusion
By itself, a LIMS is not a viable solution for support of an EM workflow. The LIMS is designed for an environment in which production-based samples are brought to fixed instruments in a lab. The EM process involves complex planning of sample collection at sites whose physical location is essential information – simply a different problem. As a result, a LIMS would require extensive customization to effectively support the EM workflow.
The Deliver Results option is very straightforward and can quickly enable an organization to effectively address their EM-specific requirements for sample scheduling and collection via an automated, paperless EM solution like MODA-EM; while leveraging a LIMS for viewing, management and additional reporting of all completed QC records.
The Tight Integration option between a LIMS and an EM-specific product is more complex, but also feasible. A key additional advantage of this option is the establishment of single, common repository for all QA and QC data, including the work in progress. Tighter integration wrapped in a product offering along with a single line of product support provides even more value to the Information Technology (IT) groups responsible for maintaining the solution. A leading commercial LIMS vendor has recently established a formal partnership with MODA Technology Partners to provide a tight integration with MODA-EM as a commercial-off-the shelf (COTS) hardware and software extension to their LIMS product line. The integrated solution has been fielded in production biopharmaceutical manufacturing environments and is receiving very favorable market interest, thus providing real-world field validation to the concepts raised in this whitepaper.
About MODA Technology Partners
MODA Technology Partners is a commercial software company focused on automating paper-based quality functions in process manufacturing. With the market’s first integrated, workflow-driven, mobile data acquisition platform, MODA offers a flexible, industry proven means for paperless, automated processing in environmental monitoring, utility testing and product testing. Our solutions help improve our customers’ operating performance and ensure overall product quality while minimizing the risk of regulatory non-compliance. Additional information is available on the web at www.modatp.com .
Contact Information:
Robert Toal
Director, Marketing and Business Development
MODA Technology Partners
Tel +1 484 253 1000 ext. 133
Fax +1 484 253 4054