The Evolving LIMS, and What It Means for the Pharmaceutical Lab

The Laboratory Information Management Systems (LIMS) of yesterday are being extended to fully integrate with other critical information systems (such as Electronic Lab Notebooks) and may have on-demand components that can benefit big and small companies alike. We talked with Thermo Fisher Scientific’s Kim Shah, VP of Marketing and Business Development, about why and how LIMS are evolving, and what these changes mean to pharmaceutical lab professionals.PhM: It’s been said that ELNs and LIMS systems are merging. Is it correct to say that this signals a paradigm shift in the way that lab professionals are working? K.S.: For today’s pharmaceutical R&D laboratories, informatics solutions have evolved from being instrumental in improving laboratory productivity to now playing a key strategic role in the laboratory process. There is increasing pressure on the laboratory to connect systems in order to harmonize processes and make use of all the data being generated. The way labs operate today is quite different compared to earlier years when instruments and databases were primarily standalone installations with their own distinct purposes and workflows, and where each process or result had a paper counterpart.Today, the LIMS and ELN are two primary electronic data management tools. Each of these solutions has a place in the modern laboratory, improving on their paper counterparts of twenty-five years ago, and that are still in use in many labs today. However, labs stand to gain the most value from a LIMS and an ELN if they are fully integrated with each other, and with the other enterprise systems and instrumentation bringing real-time information to management at all levels of the organization.    PhM: What’s driving this trend and what opportunities does it present for pharma labs? K.S.: The increased role of laboratory informatics in achieving strategic corporate objectives (such as decreasing product time to market and ensuring regulatory compliance) is an indicator of how integral the lab has become to the overall operations of the business. Since the introduction of LIMS, lab staff have shifted their expertise from manual and time-consuming activities to more sophisticated data analyses. Likewise, instrument software like Chromatography Data Systems (CDS) have helped eliminate the manual processes formerly used to record instrument data. Scientific Data Management Systems (SDMS) and Document Management Systems (DMS) have helped secure the exchange of data and documents, and have reduced a lab’s reliance on storage rooms filled with filing cabinets and boxes.  To bring us full circle, today’s sophisticated ELNs provide the electronic answer to the scientists’ historical companion—the paper laboratory notebook. One of the most important areas of change can be illustrated in the way people work with each other, whether it involves scientists in the same laboratory or in remote parts of the world. The evolution of collaborative methods has been enhanced by the technologies available, giving the field of informatics a new role to play in bringing scientists together. But as instrumentation has become more sophisticated, the amount of data has grown tremendously, giving today’s scientist a new challenge—the managing all that data from various systems to make faster, more informed decisions.PhM: Are pharma R&D or QA/QC labs ready for this integration? K.S.: Many laboratories still use a paper notebook to document the unstructured context and observations that accompany daily work. The signed paper notebook still serves as the legal record of their scientific discoveries and the company’s intellectual property. Company policy and accepted laboratory practices outline the information that must be included into the experimental record. Researchers generate their data in several disconnected heterogeneous systems, then create reports or use spreadsheets to merge and transform the data into a sensible presentation – then print, cut and tape. The end result is that electronic information is then manually transferred back to paper format. This paper record is then copied and then scanned in to create a final electronic copy.This is obviously not an efficient system. By replacing paper notebooks with an ELN, researchers can electronically capture their experimental record including from initial experimental design and hypothesis to conclusion. By connecting an ELN to a LIMS, the researcher gains a complete picture of the experiment and its results.Lab professionals are already being pushed to change. In the QC lab, for example, efficiency is about aligning resources to execute the procedure in a timeframe that minimizes any delay in reporting on the results—and thus product output costs are reduced. A batch release form that combines the validated method, approved release parameters, along with access to the lab records or other required references speeds processes and gives QA departments the certainty that procedures and specifications have been met. This requires the connection of instruments, ELNs, and LIMS. The integration of Symyx Notebook and Thermo Scientific LIMS and CDS, for example, enables these laboratory efficiency gains by providing access to the necessary data, no matter which system is accessed by a researcher.PhM: Tell us a little more about what’s behind the partnership between Thermo Fisher and Symyx.K.S.: The collaboration with Symyx is a key component of the company's recent launch of Thermo Scientific CONNECTS, and demonstrates our ongoing commitment to provide customers comprehensive informatics solutions to meet the changing needs of businesses around the world.Now, in addition to our LIMS, CDS (Chromatography Data Systems) and Document Management Systems (DMS), by providing an Electronic Laboratory Notebook (ELN) as part of our end-to-end solutions, we can provide our customers with secure and efficient methods of managing what has formerly been a manual and time-consuming process of recording research, documents and procedures in the laboratory. The integration of an ELN into out portfolio allows more efficient use of laboratory resources and information, as well as consistent compliance with various regulatory requirements for documented processes, such as those defined by ISO, FDA or GLP.In the mix of mission-critical systems, ELNs are playing an increasingly important role. Our customers are using ELNs to drive knowledge sharing and provide a central, consistent, and secure environment for real-time IP capture, storage, retrieval, and reuse of unstructured data. The value of our partnership with Symyx is clear. Coupling ELN, LIMS and CDS provides that holistic view of laboratory information that research organizations have sought. PhM: I assume you’ll also be partnering with other ELN providers? K.S.: Absolutely—in fact, we already have! We understand that our customers’ environments are heterogeneous and we will support them no matter what ELN solution they have or are looking at implementing. Thermo Fisher Scientific is teaming with ELN vendors to help solve customer needs and integrate their ELN solutions with our products. While ~20% of laboratory data is structured—that is, captured, stored, and retrievable in software applications like Thermo Scientific LIMS and CDS—the other 80% is unstructured data, which can include experimental protocols and results, research notes, reference information, documents, spreadsheets, etc. The significant growth of these types of data has driven the need to integrate our solutions with ELN providers such as Symyx, Velquest, IDBS and CambridgeSoft.PhM: Companies are moving towards hosted software solutions, and coincidentally you have just introduced a LIMS-on-Demand product. Which labs at which companies would benefit most from a web-based LIMS hosted by Thermo Fisher? That is correct. We have just launched Thermo Scientific LIMS-on-Demand (www.limsondemand.com), a lab management solution allowing small labs to have the benefits of a full-featured LIMS without the expense and hassle of installing and maintaining an enterprise client server application.I expect that small- to medium-sized laboratories doing routine testing, with 3-5 scientists and typically no IT resources, will benefit most from this solution. Laboratories involved in research and development, nutraceuticals, cosmetic manufacturing, food and beverage testing, environmental monitoring, pathology, water safety and biobanking will be taking a good look at LIMS-on-Demand.
PhM: What are the limitations of on-demand LIMS? Certainly, it can’t be as robust as a LIMS on a manufacturers’ own server, correct? K.S.: LIMS-on-Demand is every bit as robust as an enterprise class LIMS. Working with a SAS 70 certified hosting partner, we ensure that our clients will have reliable access to their application and that their data will be secure. That said, LIMS-on-Demand is not for everyone. Pharmaceutical and Life Science companies that need to customize a LIMS solution to fit their own workflows or conform to some regulatory requirements may not be able to use this approach. Thermo Scientific Darwin LIMS has been designed specifically with these companies in mind with built-in functionality like stability testing, environmental monitoring and batch processing.  PhM: Hybrid LIMS solutions with partial on-demand features are also possible—what’s the market potential for this, and who would take advantage of it?K.S.: By hybrid solutions, I assume you mean implementing a LIMS solution in a typical enterprise client server model, but with Thermo Fisher Scientific managing the server aspect of the solution. In other words, we would manage the database software, the hardware and network technologies, the security of the data, and maintaining and upgrading the software from time to time. For a variety of reasons, many large companies are outsourcing various aspects of their business processes, especially the IT processes. For these companies, a hybrid solution is an attractive alternate that we can provide. Big pharmaceutical companies have been especially aggressive at outsourcing non-strategic aspects of their businesses—I believe many of these companies will explore whether a hybrid solution works for them.