One of the most critical areas addressed by Lab Informatics is ensuring the integrity of data obtained in the research, manufacturing, or quality control processes of pharmaceuticals and medical products. In the simplest terms, it’s about proving and documenting that all data and information obtained in these processes are true, unaltered, and accurately reflect what has been investigated. Lab Informatics helps automate laboratory processes and eliminate errors and inaccuracies in documentation, ultimately ensuring patient medication safety.
Laboratory procedures – labour-intensive and error-prone
Working in a pharmaceutical or biotechnological laboratory involves not only conducting research but also generating a substantial amount of documentation and reports. This documentation not only concerns the ongoing activities but also the detailed processes, equipment, and reagents used. Ensuring the quality of a drug, for example, requires conducting various tests to demonstrate that all related parameters are correct, within the standards, and in accordance with pharmaceutical laws or regulations for a given market. One of the main challenges in this process is the actual analysis and documentation preparation.
Creating a reagent, for instance, necessitates a detailed description of the entire process, including entering the serial numbers of the chemicals used, certificates for glassware and laboratory tools used in reagent preparation. A newly created chemical reagent must also be tested for compliance with standards and registered. Furthermore, a variety of other information needs to be included, such as instrument certificates (e.g., scales, chromatographs, spectrophotometers), evidence of their qualification or calibration, reports from tests, adjustments, or calibrations of equipment before conducting tests. All this documentation is maintained in various registers or computer systems, utilizing numerous disconnected sources. And all of this is for a single analysis!
This manual process significantly impacts data integrity because human errors can occur when manually entering and transcribing results. Inaccuracies can also result from improper equipment handling, selecting an inappropriate procedure for a given task, poor execution, or even researcher negligence. If an error is detected by the person conducting the study or the reviewer, the documentation can be corrected following the appropriate procedures. However, if the problem is not identified early on, it can be hazardous and costly. Each device has an “audit trail,” which automatically records the results in the device’s registry. Consequently, during a thorough audit by authorities like the Main Pharmaceutical Inspectorate in Poland or the Food and Drug Administration in the USA, the source of the problem will be identified, leading to significant legal and financial consequences. Ultimately, patients’ health can be jeopardized if such a situation arises.
Lab Informatics: Automation of laboratory processes safeguarding data integrity
The described laboratory procedures and activities are highly complex, labour-intensive, and susceptible to deliberate or accidental errors affecting data integrity. The process of preparing and later archiving documentation, as well as the negative consequences of mistakes, can be costly. The way to eliminate such issues is through digitising and automating documentation, which is precisely what Lab Informatics is focused on. In many areas which are commonly automated, especially in the pharmaceutical and Life Science sectors, specialized expertise and experience are required to execute this process. Pure programming knowledge is insufficient – familiarity with laboratory procedures and activities, an understanding of how the equipment operates, and the specific nuances of the field are essential. This is precisely the specialization of Lab Informatics teams. Their task is to create solutions that eliminate the possibility of error in research methodology, manipulation of results, and simplification of the process.
The result is the digitalization of documentation and the automation of processes that occur during sample testing. Such an electronic journal integrates all measuring devices in the laboratory within the IT system and all data sources about these devices and reagents. Additionally, laboratory staff receives precise descriptions of the procedure for conducting a particular research method in a workflow format within the system. This essentially eliminates the possibility of selecting an inappropriate procedure or performing it incorrectly, significantly easing and expediting the work. All data is recorded digitally, and the entire sequence of an activity can be reproduced at any time; metadata can be checked, results can be verified, and an audit trail can be conducted. If an analyst conducts research using a specific measuring tool, there’s no need to manually transcribe data into a journal or provide data from calibration or certification. All information is automatically or semi-automatically completed in the digital registry, ensuring reliable results.
The issues described above pertain to ensuring data integrity within organizations, particularly in R&D departments and quality control, within systems like LES (Laboratory Execution System). However, these aren’t the only activities supported by Lab Informatics. Another aspect is creating connections (interfaces) with external systems of the LIMS class (Laboratory Information Management System). This is done to report and monitor results from research and processes, which are compared to standards for a specific substance and statistically analyzed for deviations. The scope of reporting varies widely depending on the specific institution or the type of data transmitted to a particular system, encompassing issues related to the subject of research, equipment, research progress, and information on the frequency of occurrences.
Collaborate with Lab Informatics Experts
Within Billennium’s Lab Informatics department, we focus on ensuring data integrity in laboratory processes in the life science and pharmaceutical sectors. Our team actively participates in implementing systems such as LES, ELN, LIMS, and other systems used in this environment. We also conduct audits and validations of existing IT systems to assess their configuration, security, user access management, and compliance with standards and regulations for a given market. Our team comprises business analysts, electronic versions of laboratory method programmers, bioinformaticians, and biostatisticians, all with experience in the Life Science field, particularly in quality control, quality assurance, and research and development departments in pharmaceutical facilities. Thus, we have practical experience in creating electronic laboratory work records from the drug manufacturers’ perspective.