Connectivity and data standards – a precondition for successful digitalisation 

 

This paid-for whitepaper by The SiLA (Standardization in Lab Automation) consortium appeared in DDW Volume 22, Issue 4 – Fall 2021 

R&D, manufacturing and contract research laboratories across many industries are investing in efforts to digitalise their processes and operations, with the goal of achieving end-to-end connectivity and automation. A common aim is to reduce manual work, reduce the risk of errors, shorten time to result, and deliver greater insight from valuable data. Realising this vision hinges on the ability to connect hardware and software seamlessly across an enterprise, as well as communicate with partners and service providers. And there is a role for laboratory software suppliers to provide the tools and solutions that will help labs achieve that end goal.   

It seems reasonable that for their part, labs looking to acquire new software – say, a laboratory information management system (LIMS) or electronic laboratory notebook (ELN) – will select a package that satisfies a shopping list of must-have features. But while a particular software solution may seem ideal at face value, in practice, realising its full worth might be challenging if it can’t easily be integrated into the ecosystem of instrumentation and other digital packages that are already in place.  

Software typically interacts both with data producers, and data consumers, and at ground level, software integration can be a major, and expensive headache with respect to resources, time, and money. “And for the customer, the potential hurdles associated with integrating software into an existing lab environment can have a very real impact on purchasing decisions,” suggested Burkhard Schaefer, head of partner management at the non-profit SiLA (Standardisation in Lab Automation) consortium.  

That last mile

A large part of that integration issue is down to communication between systems. As Schaefer noted, when standard protocols for communication are not used, “It’s that last mile to the instrument that becomes the real hurdle. At the level of the scientists and other end users, integration issues can result in punctuated workflows, and impact on data quality, management and utility. So when software and instruments can’t communicate, the workflow essentially stalls, resulting in the need for manual data entry, retrieval and transfer, to bridge the gap.”  

Data integrity  

Human data input and handling then introduces the risk of unintentional errors. “The very fact of manual data entry – and the errors that will at some stage inevitably occur – can undermine experimental or test processes, leading to lengthy delays, skewing results and analyses, and potentially compromising data integrity,” Schaefer suggested. For regulated industries, a serious breach of data integrity may ultimately result in hefty fines, and potentially even close a facility until the issues are corrected.1,2

One workaround for implementing software that can’t naturally communicate with the existing infrastructure is to build a custom interface between the software and the rest of the laboratory environment. However, having to tailor an integration fix or generate new drivers/interfaces can result in missed revenue opportunities for software vendors. “Its not uncommon that software vendors may find a potential purchase of their platform sidelined because of connectivity hurdles,” Schaefer stated. “A software vendor wants to sell licenses. That’s what brings money into the bank. But if they have to deliver a hefty level of professional services together with that license, then what might start out as a seemingly profitable cash cow will slow them down.” Such integration issues may tie up resources to the point that it ultimately caps revenues and growth. 

A fundamental tool 

Integration issues can be addressed by supporting a standard protocol for software and hardware communication. SiLA has been developed as a fundamental tool that will make it possible to realise seamless lab- and enterprise-scale software and instrument connectivity, on a vendor-agnostic basis, both within labs and across an enterprise. Daniel Juchli, chief technology officer for the SiLA consortium, explained, “SiLA is an open communication standard that allows software and instruments to talk to each other and deliver instructions and commands, using a common language, and without the need to configure custom drivers, or punctuate that workflow with manual data input.”  

SiLA thus represents a key – though not the only – piece of the overall lab integration solution. “Enabling end-to-end lab interconnectivity and hands-off data management requires the marriage of a proven communication standard – such as SiLA – with support for a similarly open, robust data standard, such as AnIML [Analytical Information Markup Language],” Juchli continued. “So while SiLA is a standard protocol for instruments and software to talk to each other, AnIML has been developed as an open, XML-based human-readable data standard for managing all experimental data, results, and measurements, generated by these instruments and software.” 

SiLA in the real world 

For some software vendors the adoption of one standard has highlighted the need for and benefits of adopting the other. “LabWare first embraced support for the AnIML data standard two years ago,” explained Jim Brennan, technical sales specialist at LabWare. “We quickly realised that AnIML represents a fantastic mechanism for handling and archiving data, and simplifying the lab’s interaction with instruments and the data that comes out of that instrumentation. But labs are increasingly focused on interoperability, as well as on interconnectivity. So while AnIML represents a great file format for data, it’s not the whole solution. Adopting SiLA in parallel with AnIML means we now also have a robust communication protocol for a standardised, automated, data-driven lab.” 

“SiLA can be thought of as a key enabler for future-focused ‘internet of laboratory things,’” Brennan noted. “It will ultimately facilitate digital transformation through a standard communication platform between remote Bluetooth- WiFi and cloud-connected systems, software and instrumentation.” 

SiLA in the cloud 

Mike Groezinger, CEO at Constance, Germany-based Siobra, expanded further,  “Siobra develops enabling integration solutions for organisations in multiple industries, and our partnership with SiLA and collaborators within the SiLA initiative has resulted in the release of a cloud extension for SiLA 2, which gives labs the freedom to connect software and instrumentation that previously may have been locked into a closed lab environment, with remote or cloud services. SiLA 2 support for standardised cloud connectivity means organisations can collaborate, and embrace the power and opportunities of cloud services, IoT connectivity, and that Lab 4.0 vision.”  

A key benefit of cloud connectivity is the facilitation of secure working with partners and service providers off-site. And as Brennan stated, “Standard communication protocols enabled through SiLA, and standard data formats enabled through AnIML, mean that remote collaboration can be achieved more seamlessly, and securely, through fileless data communication.”   

Supporting SiLA 2 in the cloud has effectively opened up avenues for maximising the utility of data and applying new methods of data analysis, from specialist providers. Groezinger further noted, “We have, for example, together with KNIME, developed the tools that enable data communicated via the SiLA standard in the cloud to be analysed through the KNIME analytics platform.”  

Focus on features 

It is important to understand why and how standards can benefit both software vendors and customers, but in practice, standards should really just be a means to an end, and work quietly, and efficiently in the background. Juchli pointed out, “When I buy a printer, I don’t have to ask which printer protocol I’ll need for the printer to communicate with my operating system, or my model of laptop, desktop and tablet. I just expect it to plug and play. This means that I can focus on choosing a machine based on its features, and not on how to connect it to my home computing equipment.”  

Consider that same level of freedom of choice for a lab environment, by removing locked and proprietary communication formats, and it’s easier to visualise the benefits for the end user, but also for the software vendor, who can then focus their expertise on developing products with the features that labs are looking for. “And if the software developer is good at what they do, then that will be what attracts the customers,” Schaefer commented. 

Extending equipment lifespan  

Supporting SiLA as a standard communication protocol in parallel with AnIML as a standard for data management means that end-users can also more easily project on the future use of their software investments as the lab evolves or expands. “If the need to support dated, proprietary and locked languages is no longer an issue, and you can connect easily with other hardware and software investments going forwards, then you can extend your equipment and software lifespan,” Juchli suggested.  

And this is aided by achieving that fileless connectivity that Brennan already touched on. Schaefer pointed out, “Typically, when you write a file, then that file is sent ‘to’ someone, who imports it. But that file transfer exposes a risk. Files may get lost or tampered with. At that point you then lose control of the life cycle of that file and its data. Labs connecting software through fileless SiLA protocols can effectively be more confident of transparent, traceable and secure data and information flow.” 

Greater insight and intelligence 

Importantly, combining standards – SiLA and AnIML – can generate a greater completeness of data, Schaefer continued. “So, for example, when you retrieve a simple weight or pH measurement, you don’t just get a numerical reading, you can evaluate that reading as part of a more complete dataset that describes the experiment itself, as well as the instrument configuration, along with a record of who carried out what function, and whether the experiment was run according to a standard operating procedure (SOP) or method.”  

The benefits of supporting communication and data standards have prompted many of the major, international software vendors to build in support for SiLA and AnIML. “Software vendors are more understanding of the manifold advantages, both for their customers, and for their own business, of supporting interfaces and drivers for standard communication and data management protocols,” Juchli said. “This is especially helpful for smaller platform companies or providers of niche products, who can rely on proven, validated protocols and offer simple, integration tools to connect their software to the labs through the SiLA interface.”  

And it makes obvious sense for a software vendor to tap into established libraries of tools that enable connection to equipment that supports SiLA. “In other words, why reinvent the wheel?” Groezinger added. The capacity to connect seamlessly to other systems in the lab environment, and to cloud-hosted solutions, data lakes, and remote partners or service providers, is a major development that will open up huge opportunities for business, R&D, and collaboration. 

References 

  1. https://www.fda.gov/media/97005/download  
  2. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-efforts-improve-drug-quality-through-vigilantSIL 

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