Vendor Column: Do I need SDMS and LIMS together?

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  • Published: Aug 13, 2013
  • Author: Chris Stumpf
  • Channels: Laboratory Informatics / Chemometrics & Informatics
thumbnail image: Vendor Column: Do I need SDMS and LIMS together?

I recently led a workshop on laboratory data management and regulatory compliance where the topic of SDMS (Scientific Data Management System) versus LIMS (Laboratory Information Management System) for data management came up. Most people think SDMS and LIMS are pretty much the same thing. So in this article, I will describe how they differ and why they are complementary.

Before I talk about the key characteristics of SDMS and LIMS, allow me to first discuss why data management is important from a regulatory compliance perspective. Specifically, the FDA requires under the predicate rules (21 CFR 211.68 and 21 CFR 211.180(d)) (see full reference here) that for High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) (and other computerized systems involving user inputs, outputs, audit trails, etc.) the electronic records (as defined by 21 CFR Part 11) themselves must be retained and maintained. Hence, according to Level 2 Guidance and the predicate rules, a paper chromatogram would not be considered a “true copy” of the entire electronic raw data because it lacks information describing the injection sequence, instrument method, integration method, and audit trail that can be used to establish the validity of the records. So for drug manufacturing, the FDA requires that electronic records created by computerized systems must be retained under the requirements of 21 CFR Part 211.

Now that I’ve described the data management requirements from a compliance perspective, how does SDMS or LIMS address them? Allow me to first briefly describe what a LIMS and SDMS solution does. First the LIMS – a LIMS solution offers a broad range of capabilities including management of samples, instruments, laboratory users, standards, workflow automation, invoicing, and stability testing. For example, in the product manufacturing process, the product batch undergoes a number of processing steps and may require analytical testing during processing before the batch can continue to the next step. In this scenario, a sample is taken from the batch (at some stage in manufacturing), given a sample identification number by the LIMS and sent off to the analytical laboratory. Once in the laboratory, the sample is received, split into a number of sample aliquots, and tested by one or more various analytical techniques such as LC/MS, GC/MS, NMR, IR, etc. The LIMS tracks the analytical testing for each of these samples as they undergo testing within the analytical laboratory and ensures that laboratory staff has appropriate training to perform specific tests. Once testing is finished, the results are manually put back into the LIMS and associated with the sample identification numbers. At this point, the sample results may be collated into a certificate of analysis (if this is the final step in the batch manufacturing). When a LIMS is used in a Quality Control environment (as in the example just described), it will also likely provide FDA 21 CFR Part 11 / EMA Annex 11 technical controls (unique login & password, audit trails, etc.) to ensure that information stored in the LIMS is trustworthy and reliable.

By contrast, an SDMS solution serves as an analytical data repository for the laboratory. In the analytical testing workflow described above, while the LIMS was keeping track of sample identification numbers, scheduling tests, and compiling results, the SDMS solution was busy collecting analytical raw data from the LC/MS, GC/MS, NMR, IR, etc. at the analytical instrument. This raw data includes the computerized data format that the analytical instrument used to write and store all of the specifics about the analytical test, including the chromatogram/spectra, sample queue, method details, analyst I.D., etc. Additionally, the SDMS solution captures any printed report generated by the analyst after data processing at the analytical instrument. By using a direct network connection to the analytical instrument’s PC workstation, the SDMS solution can automatically capture and catalog analytical data as it appears on the workstation hard drive. After capturing and cataloging the analytical data, the SDMS solution ensures trustworthy and reliable data archival by providing FDA 21 CFR Part 11 / EMA Annex 11 technical controls. Because the SDMS solution centrally captures all analytical data originating in the laboratory, analysts and managers can locate, review, and approve analytical results in one location before sending results on to the LIMS. Through the use of software interfacing, it is also possible to connect a LIMS and SDMS together so that manual transfer of test methods and results information into the LIMS isn’t necessary. Hence, directly connecting the LIMS and SDMS together allows the LIMS to make use of the “raw data” stored in the SDMS so that creating a certificate of analysis in the LIMS can be automated and paperless. To see how one organization implemented a SDMS together with a LIMS, see the article entitled, “Move from Paper to Electronic Documentation”, here.

To summarize the sample testing workflow:

  • The LIMS solution schedules and tracks sample tests coming into the laboratory
  • The LIMS supports the user in making decisions for a batch disposition and creation of a certificate of analysis
  • The SDMS captures and creates a catalog of the raw and printed analytical data originating at individual instruments—thus storing a complete electronic record of data and result
  • When used together, the LIMS assists laboratory users in managing the “text information” associated with sample testing while the SDMS supports compliance with FDA predicate rules 21 CFR 211.68 and 21 CFR 211.180(d) for analytical raw data management.

Finally, although both LIMS and SDMS have been around for decades, a lot of confusion about them still persists. Separately, they perform different functions very well. Together (as complementary solutions), they can bring real benefits to the laboratory by improving workplace efficiency and supporting regulatory compliance data management requirements – to accelerate product development and release to market.

The views represented in this article are solely those of the author and do not necessarily represent those of John Wiley and Sons, Ltd.

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