Once your lab has adopted an informatics system (or two) and reduced the number of paper processes, you may think that your digital transformation is complete. But there is more that you could do to improve efficiencies and use your lab’s data to inform business decisions. This blog post will help you discover how LIMS integration with other systems and instruments, not only within the lab but also across the organization, can improve your workflows and boost efficiency.
A LIMS integration offers benefits beyond the lab for every organization, but here we’ll focus on life sciences, including drug manufacturing. The benefits of LIMS integration include reduced errors, better strategic decision making, increased visibility into the supply chain, and a larger data set for trending and analytics. The systems and instruments that LIMS can integrate with vary depending on the setting in which it is implemented and may include other laboratory systems like a chromatography data system (CDS) or electronic lab notebook (ELN), specific instruments, a scientific data management system (SDMS), your manufacturing execution system (MES), or enterprise resource planning (ERP) software.
There are common best practices for comprehensive, successful LIMS integrations as well as challenges you might face in the process, which we’ll describe in what follows. It’s important to take a holistic view of the data that flows through your lab and out to the broader organization when planning for LIMS integration. This approach will help you think about how you want that data to work together in the future to inform business decisions, streamline processes, and improve data accuracy.
▶ Additional Reading: Thinking Comprehensively About Your Data
Thoughtful integration of your LIMS with specific instruments and systems can improve manufacturing processes and facilitate growth. Many common processes can be automated by LIMS integration, such as logging and tracking samples for testing or creating and distributing reports. LIMS integration has the potential to improve data accuracy because it can provide a clear chain of custody, ensure data integrity, and enable access restrictions. Instrument and system integrations with the LIMS also reduce sample testing turnaround times by reducing the amount of human interaction.
LIMS integration also enhances supply chain management, by monitoring consumables and raw materials. With the right integrations, you can gain real-time visibility into your supply chain from bulk raw materials through to the packaged finished product. Many LIMS products offer some kind of inventory management capability that can let you track the use of reagents, filters, gloves, etc., with the scan of a barcode. You can set an alert to automatically reorder any of these consumables when the stock goes below a certain threshold.
A LIMS used in regulated industries like biotechnology or pharmaceuticals requires validation to comply with 21 CFR Part 11 as well as other applicable legislation. LIMS integration in these settings can optimize processes and enhance consumer safety. However, it’s important to remember that any instruments or systems that are integrated with a regulated industry LIMS will also need to be validated.
LIMS integration can streamline laboratory workflows, improve sample tracking, and get test results into the right hands faster. Integrating with your CDS allows the analysis report to transfer seamlessly to the LIMS, without someone needing to input it. Integrating with an MES keeps batches moving and allows quicker decision making on moving forward to the next manufacturing step based on the analytical testing in the LIMS. Integrating with a barcode reader system allows pinpoint-accuracy for all scanned samples and materials. Integrating with ERP software (such as SAP) lets you easily create certificates of analysis.
▶ Related Reading: Integrating the Lab and SAP QM: Decisions, Decisions, Decisions
LIMS integration with an LIS on the patient-facing end of the sample lifecycle can improve data accuracy, reduce errors, and ensure consumer safety. If you’re administering clinical trials, you can trace a drug candidate’s performance from purity and stability testing in the lab straight through to patient outcomes, while maintaining blinding and data integrity.
There are several key factors to consider for successful LIMS integrations. The skill set of the people chosen to do the integration work is one of the most important. How do you know what those skills are and whether your internal team has what is needed to be successful?
A LIMS integration requires knowledge of your business and its typical workflows, intimate knowledge of the LIMS itself, and the vision to see how your business processes could be enhanced by the integration of the selected systems or instruments. That’s in addition to the project and people management skills needed to administer what could be a disruptive process. In many cases, it does make business sense to work with a third-party consultancy such as CSols to be sure the LIMS integration goes smoothly.
Part of 21 CFR Part 11 is to ensure data security and compliance with regulatory requirements. Instrument and system integration with LIMS help with these essential tasks by providing access controls and reducing human errors. However, data security is not just a concern of the regulated industries. All businesses benefit from enhanced protection of their intellectual property. LIMS integration with other instruments and systems allows secure data transfer between systems and reduces the risk of compliance issues.
There are numerous common challenges associated with LIMS integration, which include software compatibility issues, data silos and standardization concerns, loss of productivity during the integration, and the risk of workflow disruptions or lost data. Mitigation of these challenges is another area where a third-party consultancy like CSols could be useful. Our consultants have dealt with these challenges many times and have developed efficient methods of working through or around them. Two examples are presented in what follows.
Many corporate structures have inadvertently created data silos, which makes LIMS integration more challenging. Sometimes, the underlying master data in the systems to be integrated needs to be converted or standardized before the systems will talk to one another. These kinds of compatibility issues during a LIMS integration are best handled by master data experts.
Your LIMS integration plan should identify potential risks and include the steps to mitigate them. Most integrations involve at least some system downtime, so knowing when the lab’s slow times are will help you plan for that. Although rare, the potential for data loss and integration failure should also be addressed in your planning. A backup and restore process and a robust backout plan should be in place. When the updates are underway, checks at various points will determine if you continue the integration or use the backout plan to go back to the legacy system. For example, if you have a hard deadline of bringing up the new system in 48 hours, and you get to 40 hours and know you can’t make it, you can revert to rollback and plan a new window.
What would you like a LIMS integration to do for you? Let us know how we can help.