Janet González, senior product manager at Abbott Informatics, notes that while manual systems can struggle to document and follow procedures a LIMS system is ideally suited to this functionality.
“Data integrity and transparency can be verified through the use of secure audit trails, which track every activity in the lab, record who carried out which function, and when, using which instrument,” commented González. “All this makes it much easier to satisfy requests for data during an audit, and to use analytics to identify what, in the process, may have led to out of specification results, or adverse trending.”
Informatics platforms can similarly prevent the time and cost associated with rework due to the use of unqualified equipment, for example. “In a paper-based lab it may be possible to miss if your equipment is due for maintenance or calibration.
If you carried out tests using this equipment you would have to go back and validate the data that was generated, or perform additional tests to justify that the system was suitable, not to mention that you will have to document the event in an investigation and determine corrective and preventive actions” González notes.
“It is time-consuming and costly. A LIMS solution can prevent that, by ensuring that samples are only sent or assigned to instruments that have been correctly calibrated and maintained, and also by managing maintenance scheduling. Similarly, LIMS platforms can be configured to assign work only to those analysts who are qualified to do that work,” González added.
Implementing a solid informatics infrastructure will help ensure that all current regulations are met at each point in the workflow, as well as facilitating automation and integration, states Ionut Mihai-Jitariuc, head of LIMS research and development at Abbott Informatics.
Mihai-Jitariuc continues: “The bottom line is compliance, and data integrity. Your lab needs to have a quality management system as well as a laboratory management system in place, down to equipment maintenance, quality control limits studies and calibration records. What are the reagents and standards you have used in the process, and how do they link to the performed analytical methods?” All this has to be documented.
Informatics platforms are inherently good at flagging up deficiencies that must be addressed, and in particular by guiding scientists to follow procedures to the letter, González states. Using an ELN, for example, makes it possible enforce the execution of methods, as prescribed, step-by-step, and capture all procedural and results data and metadata through the LIMS. Effectively we can enforce the consistency of what is documented, and how it is documented.
Instrument integration is also critical, comments González, concurring with Randall. “Instrument integration reduces the need for manual recording, or transferring data from one system to another, which negates the potential for errors, gives back operator time, and reduces data redundancy.”
The bottom line is the ability to verify that the product you are manufacturing meets quality standards, and has been manufactured according to all regulatory requirements. “And all your data must be defensible,” Mihai-Jitariuc states. “This is critical for any laboratory operating in a regulated environment, regardless of the industry. To do this you have to ensure that your data comply with ALCOA principles laid out in the FDA guidance. Whether recorded manually or electronically, it must be attributable, legible, contemporaneous, original and accurate. These principles should underpin all data and its life cycle.”
Working with paper-based systems in principle is still possible, but for the QA/QC lab it is no longer cost- or time-effective, suggests Gabi Koberg, country manager D-A-CH, at Abbott Informatics. “Today’s informatics platforms also allow us to look at results with a greater depth of business intelligence. Using analytics software, you can look at results trending, and mine historical data to understand how issues arise, so that protective measures can be put in place. But these kinds of retrospective and predictive analytical approaches can only be carried out when you have all your data and metadata available in context.”
Abbott’s STARLIMS platform offers advanced analytics capabilities that can add an extra layer of business intelligence over and above that of a day-to-day sample and test management system, González states. “In contrast with most ‘static’ analytics capabilities offered with some platforms, the advanced analytics packaged within STARLIMS looks at data in real time, in combination with historical data. And in addition to these advanced analytics capabilities, STARLIMS offers integrated ELN and SDMS functionality, and mobile features.”
The STARLIMS LIMS platform is architected on segregated business logic and technology layers, being highly flexible, versatile. This enables the STARLIMS solutions to evolve together with organisations, allowing them to take advantage of the technological advancements and to tailor the LIMS to their organisational configuration, business model or changes driven by regulations and procedures, Mihai-Jitariuc notes. “STARLIMS continuously evolves, and technology upgrades can be implemented with minimum or no impact to the business logic layer and master business static data.”