The changing face of lab informatics
David Robson discovers that the lines between different informatics tools are becoming increasingly blurred, providing users with easier access to all the data they need
ABOVE: Starlims integrates with chromatography data systems and enterprise resource planning software to support laboratory processes from sample login to report generation.
There is a commonly-held theory that, from its conception, any new piece of technology will initially create a lot of hype among potential customers, followed by a period of disappointment as users realise that the product’s functionality does not meet their heightened expectations. Following this, improvements will be made to transform the system into a useful and workable tool that is widely accepted.
John Trigg, the informatics consultant from phaseFour Informatics, believes that laboratory information management systems (LIMS) are experiencing the final stage of this cycle, whereas electronic laboratory notebooks (ELNs) are still emerging from a period of disappointment after a series of false starts. ‘The majority of ELN projects are still in their pilot stage,’ he notes.
For ELNs to escape from this rut and gain widespread acceptance as a valuable tool, vendors will need to demonstrate tangible benefits from deploying their systems. It’s not just the scientists that need to be persuaded to give up their treasured paper notebooks; company lawyers also need to be sure that ELNs can provide crucial, watertight evidence in disputes over intellectual property.
One trend that will surely help to improve the perceived value of ELNs is the increasing popularity of open interfaces between e-notebooks and other informatics software, including LIMS, scientific document management systems (SDMS), and enterprise resource planning (ERP) software.
In the past, labs have faced the problem of creating, analysing and presenting data in many different programs, without the ability to transfer and share information between the different systems. Open interfaces should change this by allowing the different components to communicate and share their resources. It is hoped that scientists will then be able to manage the results from their experiments more successfully and economically.
‘There’s a battle between the open and proprietary approach,’ says Trigg. ‘The vision [of open interfaces] is to build an integrated approach – it’s driven by the idea of knowledge economy.’ The interfaces should allow programs from different vendors to work in harmony, meaning that customers will no longer be tied to one software provider, but instead will be free to choose whichever component best suits their needs.
Agilent Technologies, which provides the Kalabie ELN and the OpenLab ERP, is a company that has chosen to follow this route. ‘In the past we had a closed solution, but as we look forward it’s clear that the open solution is more popular,’ says Linda Doherty, Agilent’s worldwide informatics manager. ‘It will help us to serve a lot of different markets.’
To achieve this, Agilent provides an application programming interface (or API) for its informatics products that allows customers to program interactions between different pieces of software for themselves. In this way, customers could feasibly integrate Agilent’s products with any suitable software, independent of the vendor.
ABOVE: The Kalabie ELN from Agilent Technologies can interact with Agilent’s OpenLab enterprise resource planning software, and the EMC Documentum content management system.
Agilent has also formed strategic partnerships with other informatics suppliers to provide this connectivity ready-made, which should save some customers the bother of doing the programming themselves. Existing partners include Starlims, MDL and ChemAxon, and it has recently signed an agreement with Accelrys, which provides cheminformatics and data analysis software.
It seems clear that Starlims is also taking this strategy very seriously. ‘Integration is one of the great holy grails of any lab,’ says Simon Wood, the executive director of marketing and education at Starlims. In addition to its interface with Agilent’s software, Starlims’ LIMS solution is compatible with Waters’ Empower chromatography data system and SAP’s ERP software.
Often, data from the different programs in an informatics suite are stored in many different databases, and the efficacy of integration can sometimes be limited by an inability to find the necessary data. To solve this problem, Starlims is set to launch a content acquisition management system in the near future, ‘to bring all the data into one place, where it is stored and managed.’ This will provide a centralised repository for the data from which all of the other informatics components will be able to draw.
The system will bring together two types of data that have previously been very difficult to integrate: structured data, which comes from the QA/QC labs and is likely to be of a predefined form and stored in a LIMS or CDS; and unstructured data, which is likely to take a freer form and could include scrappy research notes stored in an ELN. In this way, all the information from a product’s inception to its production can be held together, making it easier for scientists to find the relevant data when they need it.
Informaticians frequently face the issue of data preservation – will they be able to read their data in 10, 20 or 50 years’ time? To solve this, Starlims’ system will store all files in the unified XML format – a common, open standard that can be read by many programs. It will also store the original, raw data files created by the laboratory instruments, which could prove to be important in years to come.
This should be a relief to lawyers as well as scientists. The general acceptance of ELNs has long been held back by lawyers’ fears that they do not provide a reliable store of evidence in intellectual property disputes. ‘It’s very difficult to keep scientists and lawyers happy with the same system,’ says Simon Coles, CTO of Amphora Research. He says that the way data is stored needs to be simple and transparent to withstand heavy investigation in IP courts. It must also be robust and able to withstand changes in software and possibly hardware.
Amphora’s solution to this is PatentSafe – a program that reliably stores relevant data, which can be easily searched to find the necessary evidence when it is required. PatentSafe is often integrated with ELNs from other vendors to provide this safe repository, but it has also been used to store reports written in other programs, such as Microsoft Office.
Once the correct evidence has been found, its validity typically hangs on the integrity of a signature. Lawyers need to verify that a scientist really did read and sign research papers on the day and time specified, and that the document has not been tampered with since that date. This was difficult enough with paper documents signed in ink, let alone archives stored electronically. This isn’t just an issue with IP protection; many regulatory procedures in the pharmaceutical industry also require verifiable signatures.
The Safe-BioPharma standard for e-signatures should help to solve this problem by providing a verifiable method of signing documents. To gain a Safe ‘smart badge’ (a personalised USB token that is used in place of a pen to ‘write’ your signature), users must go through a face-to-face interview to verify their identity. They must then sign a contract to abide by the rules of the standard before they are assigned a unique identifier bound in a mathematical code that is bound to each signature they make.
Each time a document is signed, a big green tick appears next to the signature, but if only one comma is removed from the text, the tick changes to a red cross and the signature needs to be verified again using the USB token.
The Safe standard is currently two years old and has recently seen a rapid rise in uptake. Mollie Shields-Uehling, the president of the Safe-BioPharma initiative, hopes that one day it will become an industry-wide standard. ‘This is the future,’ she says. ‘It’s really critical to have a strong legal framework around which transactions take place.’
It is interesting to note that neither Safe-BioPharma nor Amphora Research provide a final ELN product per se. However, both Shields-Uehling and Simon Coles claim that the ideas for their solutions arose after questioning why most companies were still using paper notebooks despite the obvious benefits of ELNs. It’s possible that this outside viewpoint is exactly what the market needs to solve the last few niggling issues before the electronic laboratory notebook becomes as widespread and popular as LIMS software.
