Vendor Column: Two approaches to multi-vendor instrument support when standardizing your CDS Operations

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  • Published: Aug 16, 2016
  • Author: Chris Stumpf
  • Channels: Laboratory Informatics / Chemometrics & Informatics
thumbnail image: Vendor Column: Two approaches to multi-vendor instrument support when standardizing your CDS Operations

The cost of training and maintaining multiple Chromatography Data Systems are driving many organizations to standardize on a single chromatography data platform. In this article and the next, I will discuss things to think about when standardizing your chromatography data system (CDS) operations. In two of last year’s columns (here and here), I discussed the topic of laboratory informatics standardization covered from a laboratory wide perspective.

Laboratories usually determine what type of analytical instrument to purchase based on the particular analytical problem they are trying to solve. For example, if the sample consists of a mixture of analytes then a separations technique such as liquid chromatography (LC), gas chromatography (GC), supercritical fluid chromatography (SFC), or capillary electrophoresis (CE) is chosen. Once a laboratory chooses a suitable separation technique for a given sample type, it then compares commercially-available analytical instruments that are evaluated on the basis of speed of analysis, sensitivity, etc. and price. For a laboratory growing organically from the bottom up (based on the problem-at-hand), little thought is often given to the accompanying instrument control software as long as the software is easy enough to use, can control the instrument, process the data, and generate a report. Although regulatory compliance and operation efficiency concerns have led to greater scrutiny of the instrument control software in recent years, the fact remains that many laboratories are a hodge-podge of hardware (and by extension software) from a wide variety of vendors. So any discussion regarding CDS standardization begins with a simple question, “If I standardize onto one CDS brand, can it control my existing hardware?”.

There are two ways to approach multi-vendor instrument support under a single CDS brand.

(a) Direct instrument control by the CDS
(b) Import and conversion of legacy data into the single CDS format

Direct instrument control is ideal because data management, data processing, regulatory compliance (21CFRPart11 technical controls), and reporting are all managed within the same system for all current and future experiments – this eases searching for historical data and reduces the cost of ownership and maintenance. A separations based laboratory generally supports LC, GC (with LC and GC being the most common), SFC, and CE, so direct instrument control should cover at least these techniques. In addition, these techniques are combined with auto-samplers and detectors (e.g., tunable ultraviolet (TUV), photodiode array (PDA), mass spectrometry (MS), evaporative light scattering detection (ELSD), etc.) therefore the CDS should support these components in order to provide comprehensive system control.

For a CDS to control an instrument, it must have a suitable “instrument driver” (similar to a printer driver used by your personal computer) to control and communicate with the instrument. The effectiveness of an instrument driver depends on two key factors (1) an interfacing technology that operates separately from the main CDS “code” and (2) an established business relationship between the instrument manufacturer that is writing the driver and the CDS software provider. Most laboratory managers prefer the instrument driver approach for controlling mismatched instruments under one CDS brand for a number of reasons. For one, the instrument manufacturer has the expertise to develop and support drivers for their instruments – ensuring it will run properly under your chosen CDS brand. Architecturally speaking, this approach saves time and expense since adding a new driver/instrument does not require the reinstallation, and subsequent revalidation, of the entire CDS software whenever a new instrument and its corresponding driver software is added

And there’s the human factor: a close-knit business relationship between the instrument manufacturer and the software provider is also paramount since they need to collaborate effectively in order to develop a properly functioning instrument driver. Most of the major LC and GC instrument manufacturers now support the instrument driver approach pioneered by Waters Corporation and either write drivers for other CDS solutions or facilitate instrument drivers to be run under their own CDS.

Which leaves laboratories with the issue of wrestling with what to do about legacy business-critical data acquired with legacy CDS formats that a laboratory no longer uses? Marooning legacy data is not generally an option due to product life-cycle and regulatory compliance concerns. Hence, the best approach is to convert legacy data and migrate it into the standardized CDS data format. This data, which might include common separation and detection techniques such as LC, GC, LC/MS, GC/MS, UV DAD, TUV, and ELSD, also carries with it meta-data or meta-tags which aid in locating the legacy data once it has been ported over to the new CDS and allows you to further interrogate the data, reprocess it and generate reports from it. (Note: reprocessing the data acquired with one CDS brand and porting it into another may cause slight variations in result values because of differences in peak detection algorithms; however, from a regulatory compliance perspective this is easily explainable and therefore does not represent a significant hurdle.)

If you have decided to standardize on a single CDS and plan to follow the two standardization methodologies outlined here (instrument control and data conversion), what benefits might you expect after you have completed your project? Most organizations have two primary goals that they try to achieve: (1) regulatory compliance and (2) improving operational efficiency. Standardizing onto a single CDS brand addresses these goals by making exchange of information easier between colleagues (efficiency), reducing time for review & signoff (compliance & efficiency); reducing the training effort (compliance & efficiency), and making it easier to locate data since it’s all in one place (compliance & efficiency). There are other benefits as well, but these give you a flavor for what is possible.

In the next column, I will discuss other things to keep in mind if you are looking to standardize your CDS operations on a single CDS brand.

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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