Although all laboratories must comply with industry standards in order to produce valid results, the pharmaceutical laboratory’s quality control (QC) team must adhere to some of the most stringent standards. This team is responsible for ensuring the quality and purity of pharmaceutical ingredients and products, where there is no room for error.
Ensuring that the lab staff is properly trained, actively maintaining the appropriate procedures, and documenting lab activity in an audit-compliant manner can be an overwhelming list for a QC lab manager. To some extent, these professionals have to rely on the rest of the laboratory to meticulously follow best practices, but even in the best-case scenario, the lab is still vulnerable to human error.
The implementation of a laboratory information management system (LIMS) can make all the difference for laboratory operations, primarily through its capacity for automation and documentation. A LIMS is optimized and is validated out-of-the-box to address quality issues that commonly arise in laboratories.
10 Ways that QC Lab Managers Can Use LIMS
Accountability is a key component of running an effective, compliant lab. This includes making note of any sample handling that occurs along the way.
The right systems need to be in place to track the samples being tested, the assignments of those samples to scientists, and the specific attributes to be tested. It is also important to make sure that automatic systems are implemented to maintain sample testing timelines and ensure that the right testing is performed and completed on time. Ideally, the results of any tests are stored alongside the samples.
These details need to be documented in a manner that can be easily presented during an audit to demonstrate laboratory compliance.
Chain of Custody
Another aspect of running a compliant lab is the maintenance of detailed records around sample storage; unfortunately this information can be easily lost, be highly distributed or kept disorganized if manually documented. The process can also be susceptible to human error if staff are responsible for remembering to document samples, following defined procedures for how to keep track and the details to record.
A LIMS solution can track where the sample is, how stable its storage is, and monitor any work that has begun on it. If the sample moves from one lab to another, automatic tracking through the LIMS can help keep documentation smooth and simple. When working with higher-risk samples, such as toxic chemicals or biohazards, LIMS can keep track of whether they have been properly disposed of and how the disposal occurred.
Quality control is a critical part of a larger chain of pharmaceutical production. As such, it is vital that what leaves the door doesn't fail specifications. Testing results need to be tied to each sample and documentation must be readily available, all of which can be handled through your LIMS.
Sometimes things go awry in pharmaceutical production and the final end product fails to meet specifications, resulting in quality investigations — or worse, product recalls. Having the ability to trace product history through production, storage, and handling can pinpoint problems—or support the need to look elsewhere to find the issue. Because LIMS automatically tracks these properties of samples, traceability is intrinsic to the laboratory workflow.
Investigations into Atypical Results
It's not only laboratory audits that benefit from the documentation afforded by the quality control capabilities of a LIMS. If the results generated from testing include something atypical, the LIMS can help investigate into why that particular result occurred, perform additional testing to determine if it's a singular batch issue or a larger laboratory issue.
The investigation efforts can be documented and stored as part of the sample's history for future reference, whether for applications or for audits. Capturing issues that are atypical allows a QC lab manager to take action and address issues prior to batches failing specification.
LIMS implementations can track and analyze the historical data stored in the system, which helps lab managers identify trends over time.
If there are any recurring issues involving samples, having access to these time trends can help pinpoint the source of problems. Problems can range from supplier issues, human error, instrument malfunctions, or inconsistencies in hardware. Tracking data over time does not just improve quality in the moment, but it also allows access to trends that can anticipate future issues. QC lab managers can respond by taking more holistic corrective actions to positively influence laboratory quality.
For example, consider any quality issues your laboratory had this last quarter and focus on the problems from lapses where procedures could have been tightened up to reduce manual error, instrument failure, or other similar problems. If a UV detector keeps failing, you might repeatedly change the bulb; with a LIMS implementation that tracks trend lines, you may realize that you are constantly changing bulbs that are produced by a particular manufacturer.
Instead of simply chalking the situation up to an instrument fix, you may realize a pattern with the instrument manufacturer and actually opt to change the equipment source. This, in turn, could save you time and resources in the long run while also keeping your equipment run time up.
The sample data that a LIMS records is immediately compared against the expected specifications. This immediately highlights if unexpected or undesirable results have emerged. In turn, the laboratory can leverage this built-in LIMS quality control to immediately respond to the problem.
Due diligence and investigations on samples are easier to carry out effectively when they happen practically in real time, as opposed to the several week lag that can result in a best-case scenario with manual documentation. Each LIMS allows you to enter in the ranges of acceptable values for testing results, so that any intolerances around the specifications or warning limits can flag potential issues as soon as you input the sample result.
Data on Instrumentation
The fact that a LIMS automatically captures data electronically from laboratory instruments allows for more timely data entry at regular timepoints, and to greater levels of detail as opposed to manual documentation. By eliminating human transcription, errors are avoided, additional checks are reduced, and associated metadata can be captured immediately.
A LIMS implementation removes much of the potential for error. When your staff need to examine the record later, the human error associated with it can be eliminated. Instead, the manager or lab member tracking down any issues, errors, or deviations can focus on instrument calibration or other characteristics of instrument operations and laboratory protocols to identify the source of the problems.
LIMS quality control features can even empower a laboratory to develop a managed process for monitoring calibrations and ensuring laboratory-wide precision. This also incorporates a checkpoint where instruments cannot be used until they are calibrated in the system. An uncalibrated machine can introduce extensive errors downstream or disqualify results that have been generated.
Assists Overburdened Lab Staff
Not using LIMS quality control features leaves documentation and tracking in the hands of humans who are prone to error, even in the best laboratories. Every lab member will experience stress at some point, which negatively impacts their work overall. Under stress, people tend to be more forgetful, prone to mistakes, and may even deliberately cut corners even if they know they technically should not. The last thing you want is to fail an audit, particularly for something that’s easily preventable through automation and built-in controls.
Another aspect to how LIMS quality control interacts with an overburdened lab staff is through monitoring for problems. If major or consistent sample issues are detected, you may effectively end up with a direct measurement of your laboratory’s capacity. Without a measurement, it can be difficult to understand their scope or see how overworked they are. You may just think your lab is very busy when some of your staff are actually overworked. Looking at the sample trends automatically documented in LIMS can shed light on this.
LIMS quality control capabilities leverage the automatic processes and thorough documentation that a LIMS implementation offers, and allows for maximum diligence and accountability within a laboratory. Not only does this make for high quality laboratory products, but it also keeps laboratory operations compliant and stable even through the most rigorous of audits.