laboratory informatics ➤
but that doesn’t clash with or make their existing informatics solutions obsolete.’
Addressing each client’s pain points It’s about finding the client’s pain points, Mullen continues. Customers may be looking to reduce paper-heavy processes, such as maintaining logbooks, or issues with sample registry or management. ‘Sometimes they have a problem with just finding information, for an FDA audit, for example, or they may need a bidirectional link between laboratory instrumentation and an SAP system.’ In addition to the Sample Management and ELN solutions that are part of the NuGenesis platform, Waters offers solutions, such as the Paradigm Scientific Search Soſtware, which can integrate with NuGenesis SDMS to allow scientific data searching, or the NuGenesis Connectors, which act as configurable bidirectional links between the NuGenesis Lab Management System and business system applications such as SAP.
Similar basic needs and issues Te primary client base for the NuGenesis platform is the pharmaceutical sector, and many clients do present with similar basic needs and issues, he admits. ‘We generally start by looking at how data is managed, which is where NuGenesis SDMS can have a major impact on data organisation and issues such as sample naming conventions, which can differ between laboratories or departments even within the same organisation. Once information is captured and organised in a standardised fashion, we can move on to more complex tasks, such as setting up an ELN, or implementing laboratory inventories. And then look at capturing results data in a standard format, integrating these solutions with inventory systems, training records or instrument calibration, and move on to exporting parts of or all of that information to SAP prior to batch release.’
Reducing complexity Waters is also looking to develop preconfigured soſtware packages tailored to standardised pharmacopeial methods. Many LIMS (laboratory information management system) solutions are highly configurable and customisable, and whereas that ability to fine tune can be a real benefit, it can also present clients with a daunting task of setting up and configuring a whole informatics system from scratch, Mullen
6 SCIENTIFIC COMPUTING WORLD
points out. ‘We’ve developed great tools for capturing data, for documenting the activities that happen in laboratories, and for doing calculations and integrating soſtware solutions. What we are looking at for the future is offering more lightweight, point specific and off-the-shelf solutions, so that we can provide easily installed tools that do what the client asks, but with a minimum of effort. ‘We already offer a solution for creating
stability studies, which guides the user through the process and through the calculations. Our plan is to continue along this path, and offer additional standardised, plug-and-play soſtware, such as inventory or instrument management tools, which don’t require customisation, and which ease the burden of validation. Tese tools may, for example, come with preconfigured tables that have many of the metadata fields labelled.’
Origins of a lab management system Te appreciation that laboratories need standardised solutions that reduce complexity and make communication more seamless brings today’s NuGenesis back to its origins, Mullen comments. NuGenesis has its roots in Mantra Soſtware, which in 1998 was tasked by a pharmaceutical client
a product called Archive, which could effectively sweep the network of PCs around a company and identify and copy newly created data files. Archive was combined with the print capture technology and the platform was then named NuGenesis, matching the company name. Waters acquired NuGenesis in 2004, shortly aſter it acquired Creon Lab Control, a Germany- based firm that offered boutique-type LIMS functionality, ELN, and workflow tools.’
Advanced LIMS capabilities And from that combination of capabilities NuGenesis was evolved into the first iteration of the NuGenesis Lab Management System platform, Mullen comments. Over the subsequent decade Waters added functionality including data capture enhancements that allowed integration with other Waters applications, such as its Empower chromatography data soſtware, and data capture from instrumentation, including balances, titration equipment, pH meters and other serial devices, which assisted in the consistent capture of data showing the correct units of measurement, and significant numbers directly to ELN. ‘Te latest version of NuGenesis,
launched in March 2015, provides advanced LIMS functionality that marries sample registration and management tools with
WHAT WE ARE LOOKING AT FOR THE FUTURE IS OFFERING MORE LIGHTWEIGHT, POINT SPECIFIC AND OFF-THE-SHELF SOLUTIONS
to solve the problem of accessing highly specialised data from multiple, specialised soſtware – including individual vendor instrument soſtware – without breaking compliance or creating a security risk. ‘Mantra solved the problem by first asking what all these soſtware solutions had in common,’ Mullen explains. ‘Realising that they all had the capacity to print reports, the company developed a patented process for capturing that print output from each one of those systems as a Windows- enhanced metafile, and the resulting data aggregation tool was the very first iteration of NuGenesis. Mantra also changed its name to
NuGenesis in 1998. Within a couple of years, however, and the introduction of FDA’s 21 CFR part 11 regulation for electronic records and signatures, came the need for a method to capture the data files that were the source of those printed documents. ‘Tis expertise was found in
reagent and instrument inventories, and additional tools to facilitate regulatory compliance, including enhanced workflows and the ability to create protocols and test sequences.’ All this has been built on a platform
that was originally designed for data aggregation and harmonisation, Mullen admits. ‘Although now highly evolved, NuGenesis is still differentiated by this ability to capture data from any instrument in the laboratory, in a very unobtrusive way, and with no custom coding. It requires the simple installation of a printer driver, and uses a graphical interface to map a document and extract content. And as we move forwards, we are driving to continue to minimise complexity, and deliver capabilities spanning sample registration to calibration and metrology, through off- the-shelf configurations that will reduce our customers burden of installation, integration and validation.’l
@scwmagazine l
www.scientific-computing.com
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