Most laboratories can readily see the value in the deployment of Laboratory Information Management System (LIMS) or a Chromatography Data System (CDS), but what about a Scientific Data Management System (SDMS)? Many companies feel confident that instrument data from the laboratory is protected in each instrument system (CDS, UV, IR, Mass Spec., etc.) and then is successfully transferred into a LIMS manually or via a system linkage. They believe that is enough control of the raw data, and no further action is necessary.
In the current compliance arena, that may not be true. Have you ever reprocessed data on the system of record? Did you ever re-report that data? Have you ever had a version mismatch of processed data and the reported data? If so, an SDMS may be a solution for your laboratory. In this blog, we plan to give a few reasons as to why an SDMS is valuable to your laboratory.
All laboratory instruments with a connected computer (systems) generate raw data and reported data. The reported data typically lives in the LIMS but the raw data nearly always lives in the initial capturing instruments system. Any time a user goes into the instrument system to view that data, you run the risk of reprocessing the data and not having accurate reported results. An SDMS would not be able to limit the amount of reprocessing, because that is an IT or business process activity, but it can perform the following tasks:
As the raw data from native systems fill hard drives, many companies archive that data—a labor-intensive process that makes data difficult to retrieve. An SDMS in this case would:
Sometimes, companies want to archive data for all systems on a single platform. Performing this task internally can be difficult because it needs a lot of custom setup from your IT teams. An SDMS is designed to sweep known directories for either an electronic version of changed files, a human-readable version (Print Capture) of the files, or both. This method can serve as an appropriate archive. The only issue with the SDMS serving as an accurate archive is that the native software must be kept running on one machine within the company to access the electronic files for reprocessing. If your company never intends to reprocess data, this may be a viable solution.
Without an SDMS, you may not have sufficient control over the data collected in stand-alone pieces of laboratory equipment. As the laboratory uses these stand-alone computers, more data is collected that may not be sufficiently backed up, due to the volume produced by non-networked benchtop equipment. This can put the data at risk of loss or corruption. Traceability to the raw data may be compromised. An SDMS can capture all versions of the same file or different versions of the same sample automatically once these systems are networked. This can be done for future comparisons of data from a particular instrument or of certain types of samples collected from many instruments.
Data integrity is one of the hottest topics in the regulated space for laboratory data today because the FDA has been looking into many of these laboratory systems. Data integrity includes raw data, reported data, and metadata. Regulatory bodies are looking into how this data is managed, including the processing of the data. They are checking the audit trails and how systems are interfaced to transmit data from one system to another. An SDMS can collect all the data, including multiple versions. The audit trail can also be backed up by this system, providing a backup of metadata.
Although the need for an SDMS may not be as apparent as for a LIMS or a CDS, it can be critical to maintaining raw data integrity in your laboratory. Once in place, a laboratory through IT network controls can secure raw data, secure the access, and limit the ability to reprocess. Furthermore, an SDMS can provide the appropriate traceability to the systems that collected the data and identify the files that were used to report the data.
Does your laboratory have issues around version control of processed data? Do you have sufficient backup of all your laboratory systems? Do you have a platform to compare data from different instruments? If you’re not confident in the answers to these questions, maybe an SDMS is right for your laboratory.
Comment below if your lab has successfully adopted an SDMS, or if you’ve got additional questions not addressed here.