Implementing a LIMS has emerged as a key strategy in ensuring quality in high throughput environmental monitoring labs. These facilities include applications ranging from pharmaceutical manufacturing to food and beverage production. From sampling detail, sample storage documentation through testing, as well as reporting and trending, LIMS facilitates a level of automation and detail that cannot be achieved through manual efforts. These benefits are amplified with the increased sample volumes that come with high throughput labs.
The top LIMS features ensure quality in environmental monitoring lab facilities include planning, scheduling, sampling, testing, and reporting. Let's take a closer look at each of these features, and see how they positively impact the daily operations of environmental monitoring labs.
Controlling quality requires deliberate action and planning. For environmental monitoring programs, this involves building a plan that outlines and dictates the precise schedule of required sampling points, sample types, when they will be sampled, and assignment of lab(s) responsible for testing.
Constructing such a plan is far more complicated and dynamic than a static spreadsheet. This sort of plan sets the foundation for a successful environmental monitoring (EM) program that can be controlled, approved, monitored, and even audited. This, in turn, allows all personnel and stakeholders to trust in the reliability and validity of these control processes. After all, any changes within the environment may be immediately visible, controlled, and systematically audited.
Having one view from one solution enterprise-wide makes it easier to understand and communicate quality control efforts and their results, thus opening up transparency to extend throughout the entire organization. High visibility into the plan opens the door for internal communications that can improve the plan. Additionally, when a consensus has been reached on a particular EM program, the plan can then be locked into place so that it is consistently performed in exactly the same fashion over any time period.
Scheduling in environmental monitoring is an essential way to maintain quality and consistency over time. Instead of a manual process that is inherently limited and which must be scheduled around personnel availability and locations, EM scheduling capabilities can be automated in LIMS and deployed to the enterprise. Each sample is automatically logged at the appropriate time with generated barcode labels and prepared sample schedules for execution.
The plan and schedule need not be limited to one particular physical location. There can be different routes for samples incorporated into this plan, and scheduling may be implemented based on factors that include geography or physical location. Full process control may be retained with scheduling. Because scheduling ensures the consistent timing of testing, the sampling that is performed is a more reliable descriptor of the environment’s quality. This also means that any issues in quality may be intercepted when they emerge because the window between tests is controlled as part of scheduling.
Consistent, automated sampling documentation is vital to ensuring quality. All information required to document the sampling event and the sample record are defined in LIMS. Barcoding the sample label automates information gathering and sample processing as well as ensures the sample and sampling event are fully traceable with a close eye kept on the precise chain of sample custody. Samples may be tested in another location (such as a company or contract testing lab). Each sample needs to be tracked with documentation that also includes shipping and storage information for processing at contract labs.
LIMS also provides a solution for managing a central lab workflow, regardless of how many processing points there exist for each sample. Monitoring the physical movement of these samples—from multiple locations and potentially thousands of sampling points, correlating tracking numbers and tracing the journey of these samples through their final receipt at their target destination can be complex; automation is the way to simplify this shipping and handling process.
The configuration capabilities behind LIMS automation also provides for another feature: the support of randomization in sampling. Ideally, different testers should be chosen at random in order to avoid sampling bias in the quality control and environmental monitoring results.
The quality processes in which testing is performed will drive the validity of the results and the level of quality that can be attributed to the samples.
Automatic testing of workflows is a key part of LIMS because it produces a consistent record with minimal demand from personnel. Testing and retesting can be handled with automated management which includes the automatic triggering of investigations when a suspect or out of specification test is detected. Specific actions may be taken based on the type of undesirable result. For example, if an environmental monitoring lab were to detect the presence of objectionable organisms, specific sample/test flagging and testing workflows are initiated.
LIMS also provides the ability to integrate various instruments onto one platform so that the management of different types of testing may be centrally controlled and processed. Instruments may receive sample sequences from LIMS and import result data for automated processing.
Incubation management provides the ability to align sample and control batches and the timing required for each incubation stage. Media used in the batch, its generation, storage, and ongoing suitability may be continuously monitored, with the capacity to flag and isolate any suspect or contaminated batches.
Testing can also qualify the media prior to use. The media and other critical test materials will have all required information defined in their record such as expiration, lot number, vendor, and history. Once activated through qualification testing, the media inventory is decremented as consumed and critical re-order levels managed.
Reporting and Trending
Whether for internal quality assurance or to prepare for future audits, ongoing EM reporting is critical. LIMS allows for the precise graphical and data representations needed to align with the exact and unique needs of your quality program. Rapid reporting of test results and sample trending means that both short- and long-term timescales can be viewed and operationally managed. Trending provides the ability to anticipate a future alert or out of control event and react to it before it occurs. LIMS includes the ability to manage your high volume lab operations with capabilities such as a KPI dashboard.
These operational views provide the ability to manage operational capacity and address bottlenecks based on both human and instrument capacity.Reports may be scheduled for regular production or when flagged by certain events. When combined with its automatic sample/test lifecycle management, a LIMS allows for far more detailed and consistent monitoring of sample trends. If any problems should ever arise, each aspect of the sample and its storage conditions may be viewed throughout its history and lifecycle, including the precise moment when negative changes were first detected. Equipment issues may be identified before they become full-blown problems. Trending and instrument qualification workflows may shed light on where defects are beginning to emerge before they elicit conditions beyond the acceptable range.
A LIMS implementation is a cost-effective way to ensure maximum quality in operations that require high throughput environmental monitoring. The opportunity to replace manual actions with automated sampling, sample processing, testing, recording, and reporting means that team members can focus on other efforts without compromising quality. Higher quality EM programs lower risk both for reduced business or concerns like failing audits. Leveraging the power of LIMS is an ideal way to facilitate the long-term success of environmental monitoring labs.