LEADERS ROUNDTABLE
based equivalents. Information that remains on paper is potentially at risk and so we consider it is our job to provide laboratory software that allows customers to capture the widest range of data, in the most efficient manner, and to ensure the solution is affordable, secure and viable for the long-term. In our view, customers that implement integrated laboratory solutions will enjoy competitive advantage over those that operate with paper or hybrid solutions consisting of non- integrated software products.”
Pierre Rodrigues: “The first-to-file method will bring a much less constraining procedure to obtain patents. It will reduce the complexity and costly fights to determine anteriority in discoveries. Therefore, eLN usage could also be turned less complex and integrated patent-proof digital signatures almost obsolete. The date of invent marked on digital signatures will therefore not affect patent issuing procedure and may be rendered almost useless.”
Thomas Schmidt: “This decision should lower the resistance of the customers to deploy an eLN. Until now, there was still an uncertainty if the electronic submission of a file was bullet proof enough to serve as an evidence for the time of invention. As a result, you can find a lot of hybrid systems where customers deployed an eLN for collaboration and efficiency purposes but still kept paper records in parallel. Now the challenge is to keep the time between the invention and the submission as short as possible. The eLN can take a decisive role since accurate and efficient documentation is crucial. The advantage of being able to retrieve the relevant data for the submission with a few mouse-clicks rather than having to compile the printed reports from the paper archive is obvious.”
Michael Elliott: “A number of departments, particularly those in late- stage development, require functionality that traditionally exists in discrete solutions like LIMS for sample management, eLN for experiment documentation, and SDMS for data archiving. What is your product vision to address the requirements of these potential clients?”
Francois Beiullouin: “Our vision is to let customers choose systems that best fit their needs and to provide ‘a la carte’ options from our
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European Pharmaceutical Review Volume 16 | Issue 4 | 2011
OpenLAB portfolio. The solution is a combination of components from our portfolio (eLN, SDMS or CDS), standard interfaces with external systems (LIMS) or tailored integration into the customer existing Information System. Customers can start with any set of modules and turn on others later based on their needs. This ability to scale – both on functionalities and on volume – is key in our strategy.”
Dominic John: “Our focus is to drive improved collaboration and productivity in the electronic lab and extend scientific expertise across the enterprise by efficiently connecting scientists, information, instruments and applications and fully leveraging existing methodologies, processes and results. Our goal is to avoid disruptions and unnecessary costs by integrating with existing LIMS and SDMS solutions wherever possible. Integration rather than replacement creates the greatest value for our customers. Longer term, we see great value in better use of standards for managing data and transferring data between systems. For example, utilising S88 and S95 ISA standards within the eLN will improve the capture of analytical methods and recipes in development and streamline the transfer of experimental processes and data between existing LIMS, SDMS and ERP systems. Improved standards will also enhance scientists’ ability to mine, analyse and report information across LIMS, SDMS and eLN systems to better meet Quality by Design objectives.”
Thomas Schmidt: “Customers are nowadays looking not only for specialised solutions for isolated tasks or areas but they want to optimise the overall lab operation. This includes workflow management, data management and sample management requirements. An integrated platform as a solution has many advantages over an environment that needs to rely on interfaces. Waters has already been providing such an integrated platform for data management and eLN capabilities. To address the need for covering the entire lab process with one single solution, Waters added comprehensive sample management and sample tracking capabilities to the Waters NuGenesis SDMS platform.”
Glyn Williams: “Our vision is simple – to provide scientists with access to the high context data they need to do their jobs. An eLN won’t replace
every system in an organisation but a data-centric system will provide value through integration with other systems and multiple disciplines, the ‘glue’ if you like that binds systems together. Providing a comprehensive API and extension points in the right places is critical to provide integration with external applications. These integrations should be as seamless as possible, to exchange the right level of data, and sensitive to the workflows they are used in so that they can genuinely streamline the processes rather than just add extra steps. Thoughtful LIMS, SDMS and CDS integrations also delivers lower cost, rapid deployments. We are actively working with a wide range of major vendors in all of these sectors and delivering E-WorkBook with an increasingly large portfolio of ‘out of the box’ components for these key systems.”
Nick Townsend: “We agree that the overall trend is to implement a comprehensive laboratory software solution that includes LIMS and eLN functionality, and a tool for managing raw data, although this may not always be termed ‘SDMS’. LIMS is of course well established technology although its application is often perceived, rightly or wrongly to be more successful in manufacturing than in R&D. Previously, it has not been uncommon for R&D customers to purchase an eLN or SDMS and then try and ‘stretch’ the product boundaries without implementing a LIMS. These strategies have had limited degrees of success and from what we can see, it’s becoming increasingly apparent that a comprehensive laboratory solution requires all three areas of functionality, in both R&D and manufacturing. Few would argue that the trend in pharmaceutical and other industries is to implement fewer, rather than more software products, and LabWare believes that the business case for a single laboratory product platform, providing these three types of functionality (and others) in a seamlessly integrated, modular, unified database environment is overwhelmingly compelling.”
Pierre Rodrigues: “At AgileBio, we have developed our solution offering around LabCollector, an inventory/LIMS/LIS system. Its versatility makes it the central repository for all data, samples and information generated by the lab. The eLN is therefore a natural extension addressing only scientific reporting like one would do on a paper notebook. Everything has
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