by Caitlin Smith
Despite the technology strides of recent decades, most laboratories today still use some form of paper-based documentation system. Paper systems have been fruitful historically, but are now outdated, considering the available—yet underused—electronic alternatives. Current high-throughput methods are crying out for documentation options that are less susceptible to human-generated errors. Is it possible to go from the inception of an idea to the completion of a successful experiment with nary a sheet of paper: the entirely paperless lab? Yes, it is—but perhaps not easily at first.
One of the hurdles in going paperless involves changing people’s attitudes about paper usage in the tried and true methods of data recording and analysis. For example, a piece of paper with results on it is irrefutably real, tangible evidence. However, to make the transition to a paperless lab, lab members must learn to think of paper as temporary, and the information on the paper as real, hard evidence. For some people, this change alone is sufficiently difficult to prevent acceptance of new methods. Indeed, our reliance on computers may seem to have taken us further from—not closer to—the paperless lab, by producing reams of printed material to document our work.
Add to this the fact that it can take several years for a lab to switch over to being completely paperless, and the question remains: why go paperless?
The benefits of going paperless
Going paperless will probably save money and time; if not right away, then in the future. It accomplishes this by enabling “facile distribution, sharing, and ‘gelling’ of group efforts,” says Ray Dessy, professor emeritus of chemistry at Virginia Tech, “and legal protection of intellectual property is made easier.” Paperless labs save time because the electronic acquisition and analysis of data is simply faster than equivalent processes based on paper. They are also more efficient, because data in electronic form can be shared more quickly with all members of the research group, which speeds up the decision-making processes for the next steps in the experiment.
Another benefit is that most electronic notebook systems have built-in regulatory compliance features, regardless of how many lab members are using the system (particularly useful, for example, in pharmaceutical research where US Food and Drug Administration regulations must be adhered to stringently). The software typically keeps track of who made changes to the experimental parameters, made notes, or executed any analysis functions, for example. This makes it possible to trace experimental changes, duplications, and errors easily and efficiently. And finally, the paperless lab enjoys faster sample throughput due to the electronic data acquisition and automatic sample manipulation—all boons for high throughput work.
How do paperless labs work?
How does going paperless actually work? There are many available software packages—sometimes called electronic notebook notebooks—on the market today that are designed to put the paperless lab into effect. One example of this is VelQuest’s SmartLab GMP Electronic Notebook System. John Helfrich, director of GMP Lab Automation Programs at VelQuest, says that SmartLab is designed to eliminate the paper-based processes that create productivity and compliance bottlenecks in pharmaceutical and biotech labs, especially those for doing quality control (QC) and quality assurance (QA) operations. “Since it is “purpose-built” we included key capabilities that a cGMP compliant operation requires, such as data capture that is direct to a database from remote PCs,” says Helfrich. “This allows mobility for the analyst, yet compliant data management per cGMP requirements.” Also, the SmartLab system is method-based, which means that the test method being executed by the researcher is shown “under glass,” or only visible to authorized lab members. The system also verifies whether data are compliant before data capture, ensuring that all data are captured compliantly, and it alerts researchers when the data fall outside of an expected window. “This assures “right first time” execution,” says Helfrich, “saving huge costs in rework and/or compliance audit issues.”
Like other paperless software packages, SmartLab integrates with instruments in the lab (including balances, pH meters, titrators, spectrophotometers, HPLCs and CDS systems, particle size analyzers, and dissolution baths), captures data from them, and sends data directly to the database. But not all electronic notebooks subserve the compliance functions emphasized by Helfrich: “The critical issues are ensuring compliant data capture and system checks on the ‘compliance state’ of instruments, supplies and people. This, plus the ability to place expected data value windows into the QC method, assures only quality data is captured.” In addition, SmartLab has a dashboard function that automatically flags anything that is out of compliance according to the data review process.
It is increasingly common for labs to have laboratory information management system (LIMS) software that acquires data from each instrument and stores them in a central database that all lab members can access. Paperless lab software packages go beyond this basic level of networking, though some labs still hold on to both types of software. Helfrich thinks using a system like SmartLab exclusively will lead to greater efficiency: “The trend for many companies is to integrate the SmartLab GMP Electronic Notebook System into a tiered IT architecture including LIMS and the SmartLab System. In fact, many labs that have LIMS initiatives to attempt to integrate with lab instruments are using the off the shelf SmartLab system to complete their LIMS into the lab operations. This process will save more than 50% of the time and costs of trying to accomplish this with custom LIMS programming methods.”
But going paperless isn’t painless
As mentioned above, changing people’s ideas about how they work in the lab is challenging and time consuming. One possible reason for this is noted by Dessy: “For thousands of years scientists have drawn diagrams of their work using some form of stylus, employing various media in order to record and share their work.” By contrast, most electronic lab notebooks are heavily, if not completely, based on data entry using a keyboard and mouse. “Until simple, robust, convenient, and unambiguous graphic, holographic and symbolic entry tools are available, the hand-written lab notebook will be quicker and easier for the scientist to create,” says Dessy.
Security is still a sore spot, as well. It is not likely that someone will break into your lab and swipe your notebooks. In contrast, as security issues rapidly increase for computers (especially those connected to the internet), it will become more challenging to archive electronic notebooks safely. “An individual's intellectual property is more easily usurped, and flawed data is more readily distributed,” says Dessy. Small labs will inevitably have a more difficult time making their paperless lab a safe place for data, because the ratio of cost to benefit will be higher with costs of hardware, software, and personnel.
The future sees making paperless labs more secure, and more accessible to those with security clearance. For example, says Dessy, in the future, “wireless tablet PCs, voice plus handwriting recognition software, symbolic entry learning programs, and biorecognition controlled entry is the logical direction.”
