Software vendors naturally look to find out from potential clients what they want in a laboratory management informatics system. Sometimes, however, it can be just as valuable to ask them what they don’t want.
Top of the list of ‘not required’ is a platform that duplicates existing capabilities and just adds complexity, suggests Garrett Mullen, senior product manager for Waters’ NuGenesis Lab Management System. ‘Clients also want to avoid platforms that require time-consuming and tricky custom coding whenever new instrumentation needs to be installed, or when functionality is added or software systems are upgraded.
Neither do laboratories want software that cannot sit alongside and communicate with their existing informatics infrastructure. What customers do want is an evolutionary solution that allows them to implement specific, or point capabilities as required, but to which new and expanded functionality can be added with minimal fuss.’
Linking the laboratory to business
This is the ideal around which the Waters’ NuGenesis platform has been built, Mullen suggests. NuGenesis encompasses an integrated suite of solutions; NuGenesis SDMS (scientific data management system), NuGenesis ELN (electronic laboratory notebook), and NuGenesis Sample Management. The combined platform has the capability to link every activity in the laboratory – from sample submission to laboratory execution methods, results review, software integration, laboratory inventories, and stability testing – to business operations.
But what sets NuGenesis apart is its flexibility, Mullen states. ‘The platform hinges on three basic principles: easy to install; easy to configure; and easy to validate. We don’t insist that the client installs the whole NuGenesis platform from the start. Each customer may only need some functionality to bridge gaps in their existing informatics infrastructure. When we first meet with a client we ask what their specific bottlenecks and goals are. We can then look at providing an informatics solution that meets their requirements 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 Software, 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
The 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 software 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 points out. ‘We’ve developed great tools for capturing data, for documenting the activities that happen in laboratories, and for doing calculations and integrating software 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 software, such as inventory or instrument management tools, which don’t require customisation, and which ease the burden of validation. These tools may, for example, come with preconfigured tables that have many of the metadata fields labelled.’
Origins of a lab management system
The 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 Software, which in 1998 was tasked by a pharmaceutical client to solve the problem of accessing highly specialised data from multiple, specialised software – including individual vendor instrument software – without breaking compliance or creating a security risk. ‘Mantra solved the problem by first asking what all these software 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. ‘This expertise was found in 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 after 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 software, 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.
‘The latest version of NuGenesis, launched in March 2015, provides advanced LIMS functionality that marries sample registration and management tools with 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.’
