Paperless Lab Software CONNECTS Suite | Thermo Fisher Scientific www.thermoscientific.com

Laboratories are awash in data. The two main data management packages in use today are laboratory information management systems (LIMS) for structured data such as pH values or sample weights and electronic laboratory notebooks (ELNs) for unstructured data such as images and chemical formulas. To simplify, a LIMS downloads data from a liquid chromatograph without the need to copy values manually, while an ELN replaces paper notebooks for more creative work. Together, these products represent the cornerstones of the “paperless laboratory.”

ELNs and LIMS are part of two significant trends: the desire to automate the more mundane laboratory tasks and the availability of inexpensive, massive, and distributed computing power.

The benefits of automating data handling become obvious when one considers the four to five percent error rate associated with copying by hand. A 95 percent success rate is simply not good enough for regulated industries that live and die by the guidances and standards of the EPA, ASM, ASTM, FDA, and other organizations. Tom Dolan, senior account executive at RURO (Frederick, MD), puts the data automation imperative into perspective: “If you’re dealing with a regulatory agency, my understanding is that if you don’t have an ELN or LIMS today, as appropriate, you’re behind; if you don’t have something like this five years from now, you’re in trouble.”

On the computer side, the push has not been the power of modern microprocessors as much as it has been the enabling aspects of networking. In the old days, enterprise computing relied on mainframes, but the user experience was unsatisfactory or nonexistent. “With PCs, computing became decentralized,” notes Mark Harnois, director of informatics product management at Waters (Milford, MA). “Now the technology has evolved to the point where you can bring back centralization, even globalization, but with much-improved user experience and functionality.”

The advent of LIMS and ELNs presented regulated businesses with the huge challenges of ensuring electronic document longevity and demonstrating and validating the integrity of electronically stored data. The U.S. Food and Drug Administration devoted an entire guidance, CFR Part 11, to electronic documents and signatures.

LABTrack (Lake Forest, CA) claims to be one of the first ELN vendors to tackle the legal and regulatory requirements of replacing paper with electrons. Since paper notebooks have been used to support patenting in civil and criminal cases, legal standing is no trivial matter.

CEO Richard Stember notes that lab notebooks are one of the few exceptions to the legal hearsay rule—they are admissible as evidence even if the author cannot testify. “It all goes back to a British court ruling in the nineteenth century,” he explains. “So we realized from the beginning that we would have to address this issue.”

LABTrack uses a mathematical algorithm known as hashing, a technique similar to encryption that renders the data into a unique form that is virtually tamper-proof. The algorithm is public domain and incurs no royalties or usage fees.

Longevity is paper documentation’s most notable characteristic, but according to Stember, electronic records are notoriously short-lived. File formats come and go, and updates are not always backward compatible. Proprietary file formats are the worst: if a software company goes out of business, older files become orphans in the event of an installation crash.

LABTrack’s solution is to enter data in a word processorlike environment and to store the files in HTML. “Most people already know how to use a word processor, and HTML is a long-lived data format,” Stember says. “PDFs, by contrast, enjoy a longevity of only eight years due to incompatibilities between documents and current readers.”

ELN | STARLIMS STARLIMS | www.starlims.com

The paperless lab

Laboratories are heterogeneous collections of instruments, appliances, and utilities that were acquired at different times from different vendors. Most labs still use paper to bridge among humans, instruments, and data systems. A paperless laboratory provides interoperability and data exchange regardless of the origin or destination of that data.

The notion of the paperless laboratory has been around for decades, but was only recently made possible through the emergence of enabling software and integration tools. The goals of the paperless lab are to lower costs, improve throughput, and maximize regulatory compliance by minimizing manual paperwork—objectives fully aligned with LIMS and ELN software. Staff reductions, mergers and acquisitions, and off-shoring are significant drivers toward paperless laboratories and overall operational efficiency. “There are simply fewer people around to carry out those manual tasks,” says Trish Meek, strategist for life science at Thermo Fisher Scientific (Waltham, MA). In April 2012, Thermo Scientific announced an initiative based on CONNECTS for the Paperless Lab, a vendor-neutral suite of methodology, services, and technology that creates integrated paperless environments.

Customers, Meek says, recognize the manual steps as gaps in their workflows that are rate limiting and error-prone. Understanding those gaps is the first step in a more encompassing quality initiative that covers data as well as lab operations.

Laboratories interested in going paperless first undergo an audit to identify and correct rate-limiting steps, including paper-based transactions. “It could be as simple as switching to an automated balance,” Meek tells Lab Manager Magazine. Most decades-old data systems are ripe for such a makeover.

Companies know they work inefficiently, but are often surprised when all the bottlenecks are identified and tallied. “This is the perfect time to take a holistic approach to the lab’s data systems and workflows, which probably hasn’t been done since the LIMS or ELN was first deployed,” says Meek.

Thermo Scientific’s principal laboratory data product is a LIMS, but the company also offers Integration Manager, an “enterprise bus” for transferring data, and Scientific Data Manager, an application that allows lab workers to view, in neutral format, any type of data. These advanced tools are what now make the paperless lab achievable, according to Ms. Meek.

Markets

Laboratory Information Management Systems - A Global Industry Outlook, a recent report by Global Industry Analysts (San Jose, CA), estimates that demand for LIMS will reach $1.4 billion by 2015 and that ELNs will enjoy $284 million in sales by 2017.

From the vantage point of Mike Elliott, CEO of market research firm Atrium Research (Wilton, CT), growth in ELN sales has cooled somewhat, from about 30 percent per year to about 20 percent; LIMS sales growth remains relatively flat at 1 to 2 percent per year.

ELN | ELN 6.7 | Accelrys | www.accelrys.com

Competition among LIMS and ELN vendors has been fierce, says Clive Baron, general manager for global commercial operations at STARLIMS (Hollywood, FL). A handful of vendors within both markets sell to global companies, but a much larger number of specialty firms serve smaller R&D facilities.

Sales numbers tell an incomplete story, however.

“The customer pool is in a state of flux,” Baron notes. “We’re seeing demand from odd areas, like a mattress company that uses a LIMS in their QC lab, and from general manufacturing, petrochemicals, and refining.” On the other hand, installations in more traditional industries are aging. Baron adds, “These businesses have changed, but their LIMS have not.”

ELNs are undergoing changes similar to the way in which LIMS were transformed in the 1980s and 1990s, namely a broadening of the market beyond pharma. “We’re seeing changes in the market, from the top 10 pharmas to secondtier companies, as well as diversification into chemicals, foods, and beverage industries,” Elliott observes.

Pharmaceutical industry mergers, acquisitions, and site closings, as well as the outsourcing of QA/QC, have been partly responsible for the stagnant demand for LIMS. Vendors are therefore pursuing new markets such as bioanalytical, which, while LIMS-like, also has ELN characteristics or formulations that fall more into the ELN camp but could benefit from the LIMS sample tracking.

Selecting a data system

Several factors go into the selection of a laboratory data management system beyond notions of “structured” or “unstructured” data. The first consideration, notes Earl Beutler, CEO of LabArchives (Carlsbad, CA), involves the size and type of data files the lab generates. Some facilities produce only small files such as spreadsheets, PDFs, and small images. Others regularly generate very large images or even gene sequencing data, which is measured in terabytes. “For the former, a cloud-based solution is often the best, simplest, and most cost efficient,” Beutler says. “For the latter, a locally installed server works, because transferring very large files to the cloud is prohibitive.” LabArchives provides both types of ELN product.

The type of data files, and the ability to search and view these files, may also be a significant consideration. Some systems index the contents of many file types, such as PDFs and videos, providing searchability. Related is the ability to view file contents natively, without installing proprietary third-party software.

Many file management systems also include built-in collaborative functions, including access control, for users inside and outside the laboratory. If groups are collaborating across a continent, the data system should provide easy access without the need to e-mail files and install software.

Data Management & Workflow Solution | NuGenesis® 8 Waters | www.waters.com

Bruce Pharr, a software consultant who has held executive positions with GenoLogics Life Sciences Software (LIMS) and Symyx Technologies (ELN), says that choice of data management system labs primarily depends on the organization’s “functional” applications. “These span the spectrum, from small dedicated analytical laboratories to fully integrated end-to-end biotechnology, pharmaceutical, and medical device operations.”

For example, a LIMS would benefit a genetic testing laboratory through lower costs, streamlined operations, risk mitigation, regulated sample tracking, security, and auditing. “However, this narrowly focused lab will probably not arrive at a reasonable return on investment from an ELN or other enterprise data management software,” says Pharr.

At the other end of the spectrum are chemistry or biology research labs, where the tracking of samples and reams of raw data are not top priorities and regulations are minimal. Such organizations can reap the rewards of an ELN but would not benefit from a LIMS.

Between these extremes lies a continuum of labs with varied functional applications and scales that require some combination of enterprise data management software and one or more downstream components.

Data decisions become complicated for large, fully integrated companies that conduct research, product development, and manufacturing. Almost all such organizations include service groups that generate hundreds of analyses per week (structured data) and scientific activities that are less routine and unstructured. These organizations usually adopt a “master data management” strategy and infrastructure, such as ERP, and within this supervisory system adopt ELNs and LIMS.

The hierarchy and differentiation within “big” laboratory software have created what Clive Higgins, VP of marketing for informatics at Perkin- Elmer (Waltham, MA), calls a collection of “point solutions.” These include LIMS, ELNs, and LESs (laboratory execution software). “Businesses struggle with information from different systems and have difficulty obtaining a holistic view of the lab’s overall operations to aid in decision making,” notes Higgins.

LESs are similar to LIMS in their handling of executable lab processes. But where LIMS are primarily passive, LESs walk scientists and technicians through a process, feeding them information from the LIMS or ERP system. For example, an LES provides alerts on balance calibration and can validate an instrument user’s credentials. “LESs build in checks and balances,” Higgins explains.

“For LIMS, ELNs, and integrated data management, the end user is ultimately the decision maker, but the people pushing the latest trends— the latest investments—are the executives,” explains Dominic John, Ph.D., director of product marketing at Accelrys (San Diego, CA). “When there’s a new project, there’s a tendency to throw everything in as requirements. Nobody fully understands what the system can do until they’ve implemented it. Adopt a system that immediately addresses one or two core needs, and then expand once you understand it.”

The key is immediately demonstrating benefits to the end user, whose natural instinct is to ask, “What’s in it for me?” Users will then become engaged and make their own recommendations. But managers trying to score quick wins will meet resistance, John adds.