Many labs and Biobanks choose to implement a Laboratory Information Management System (LIMS) to help them meet regulatory compliance. When you’re frantically preparing for the auditor’s visit it’s difficult to remember that the purpose of regulation and compliance is to ensure quality and safety.
When using spreadsheets to track your samples and lab processes, it’s often impossible to record everything. And what you do capture may not be consistently recorded. Without accurate and complete data, you may lack confidence in your samples, processes and results. It might also take you longer to find the samples you need to carry out your work.
Likewise, if you’re using several separate systems with information diluted or, even worse, duplicated across your labs.
A LIMS system is designed to centralise your data, improving its integrity and quality. Plus, it helps instil consistency by enforcing your processes. All this helps you to meet regulatory compliance and manage quality in your lab.
The importance of data
You rely on your data to help make important decisions and assess the performance of your lab or Biobank.
One of the main benefits of a LIMS is improving the way you capture and store data. As you add data, most systems prompt you to enter mandatory information, automatically format data and present you with predefined lists to choose from. These all help to make sure that everyone is recording information in the same way. Let’s be honest it will probably take you slightly longer to record information. But it will be a lot easier and quicker to find, query and use it.
Some advanced systems also offer integration with instruments and other applications as well as bulk data import tools. Both of these remove the need for duplicate data entry which can help reduce manual data entry errors and save you time.
Another core LIMS feature is an audit trail. This gives you traceability of who created and updated information and when. Enhanced auditing at field-level may also be available so you can see the previous value of a specific field and who changed it. Plus, some systems audit processes such as sample check-in and creation of aliquots.
More than data quality control
But laboratory information management systems offer more than data quality control. These systems can also help you manage and monitor the quality of your products and processes.
Sample quality control
Comprehensive sample management, profiling and auditing can tell you where a sample came from, how it was collected, where it’s stored and under what conditions and who has used it, when and how. This can help you assess the quality of a sample and whether it’s suitable for use.
Process quality control
A LIMS can guide you through your processes, prompting you to enter information and preventing you moving to the next step until previous steps have been successfully completed. This makes sure each process is carried out consistently while the audit trail automatically records each step taken.
Equipment quality control
Whether it’s carrying out equipment calibration checks or recording temperatures against freezers a lab information management system can help you make sure your equipment is performing optimally.
Staff quality control
In some advanced LIMS you can track which team member has completed which activities in the lab. This helps you to identify any potential bottlenecks or performance issues as well as training requirements.
The role of analytics in quality control
Because you’re recording data consistently it becomes much easier to query and use.
Whether it’s in the form of dashboards, reports or queries, being able to analyse and get a high-level of view of your information enables you to spot inconsistencies and problems more easily.
Real-time, dashboards displaying average times to fulfil requests or complete a process can highlight potential bottlenecks. Reports identifying samples that have been in storage for more than 12 months might compel you to assess their condition and suitability for use. While oversight dashboards can highlight where ethics or consent documentation is pending, missing or expired.
And with some problems the quicker you can find them the better. So, if you can spot where there’s a problem you can try to find out its root cause and resolve it before it becomes serious. Saving you time, money, resources and possibly even your reputation.
Tracking quality issues and corrective actions
Some systems, such as Achiever Medical LIMS, enable you to track issues and any instances of non-compliance. This could, for example, be a problem with a shipment you sent or samples you’ve received. It might even include something found during an internal audit or a sample request from a researcher.
For each issue you can capture details of any corrective actions, attach any associated documentation and importantly follow the issue through to completion.
You can even analyse the number, status and progress of these on interactive dashboards.
Plus, Achiever Medical provides an Audit and Quality Control module so you can randomly select storage and samples to audit. You can then record and manage any issues and non-compliance. Its real-time, graphical dashboards display audits completed and associated outcomes that can help you better manage your lab operations. It helps you improve quality across your lab. What’s more it also provides you with valuable evidence for any external audits.
A final thought about how a LIMS can help you manage quality control
Compliance isn’t just for compliance sake – it’s to ensure quality in your lab or Biobank.
You may be considering a Quality Management system to monitor your quality control and assurance activities. But don’t forget how a LIMS naturally plays an important role in quality control. Not just in terms of improving your data but also in how it monitors your samples, processes, staff and equipment.
And importantly, because your LIMS is an essential part of your lab work it can help make quality part of your everyday.