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As the life sciences migrate towards a paperless work flow, electronic notebooks are becoming a popular option. Electronic lab notebooks (ELNs) have all of the capabilities of a paper notebook, but the electronic format provides an opportunity to integrate the notebook with other tasks in the laboratory. An electronic notebook can integrate with instruments, collect and manage data, manage work flows, and be used as a tool for GMP/GLP compliance and process optimization. Best of all, a laboratory notebook is a searchable document. When researching intellectual property, a few keystrokes can replace hundreds of hours looking through paper notebooks.
Scrapbooking your science?
In transitioning to an ELN system, it is tempting to think of a laboratory notebook as a straight substitute for paper—a kind of scrapbook approach where text files, data spreadsheets, and graphics are pasted in to each entry. However, that kind of approach can actually be worse than paper, because of the risk of data loss and the lack of legal integrity of files that can be changed or deleted without a trace. Even at its best, an electronic “scrapbook” can not offer its user the universe of potential that a well-designed ELN can offer.
“Electronic notebooks are about a lot more than IP retention and paper replacement,” said Chris Molloy, Vice President of business development at ID Business Solutions (IDBS) of Surrey, U.K. IDBS developed E-WorkBook for biology to meet experimental design, organization, and data management needs in life science discovery and pharmaceutical research and development. They have worked extensively with client companies making the transition to paperless workflows.
Physically, the experience of using the ELN is intended to be as similar to using a paper notebook as possible. The user can carry a notebook or tablet PC from station to station, collecting data and taking notes. However, unlike a paper notebook, the ELN acquires the data and zaps it into the network database, bypassing many opportunities to insert human error, and imposing GMP-compliant structures and methods on the work flow.
“I hesitate to call what we have an ELN,” said John Helfrich, vice president at VelQuest Corporation (Hopkinton, Mass.). “I refer to what we do as a procedure execution system.” VelQuest’s SmartLab GMP Lab Execution System manages every aspect of the laboratory work flow to comply with rigorous GMP requirements.
Signature solutions
One of the most important fundamental hurdles that had to be overcome when introducing electronic laboratory notebooks was a method of applying a signature in electronic format that would be viable for long-term archiving and meet legal and regulatory requirements. Digital signatures are a form of electronic signatures that carry the added security of encryption; they are the preferred method of signing electronic lab notebook entries. A number of options are now available for digitally signing documents.
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However, in corporate research and development, ELN systems must be able to support the company’s intellectual property requirements and be retained for long periods of time. There is a need for a standard in digital signatures to make sure everyone is on the same page.
The SAFE-BioPharma Association (Fort Lee, N.J.) is a consortium of biopharmaceutical and related companies that manages a standard for digital signatures that is gaining traction in the life sciences. The U.S. Food and Drug Administration (FDA) and European Medicines Agency also contributed to the development of the standard.
U.S. legislation—Electronic Signatures in Global and National Commerce Act (E-SIGN) and Uniform Electronic Transactions Act (UETA)—created the concept of a valid electronic signature, but did not specify any particular technology or method for creating one. SAFE-BioPharma’s standard uses public key infrastructure (PKI) technology to encrypt data that is signed. The SAFE-BioPharma standard also securely establishes the identity of the signer and links the two together. The signing certificate can be carried on a USB token, which is issued to the user after a process of identity verification.
Abbott Laboratories, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, and Sanofi-aventis have all joined the association and adopted the SAFE-BioPharma standard. Software and PKI vendors supporting the standard include Adobe, Aladdin, Arcot, IDBS, Symyx, Waters, Intralinks, Microsoft, Gemini Security, IBM, and others. The SAFE-BioPharma standard can be implemented with most other products that support digital signatures.
According to Kay Bross, program director for SAFE-BioPharma, the digital signature standard “tells you that not only can you trust the document has been signed by a valid digital SAFE-BioPharma certificate ... it also tells you that you can trust the identity of the signer’s name that appears there.”
A shared vocabulary
Any electronic document can be made searchable by individual words or combinations of words. However, the choice of words used may vary between individuals or groups. For example, one scientist may write “antibody” and another might use “peptide.” Within the conventions of English language composition, the use of precisely consistent terms is perceived as redundant and displeasing to the ear, so even one individual being as precise and as consistent as possible is likely to confuse a machine using a basic search string. By constructing an ontology—a dictionary system that creates a standardized vocabulary for a database—a search can become much “smarter”.
An ontology presents itself to the user through drop-down menus and other interactions with software. Once established, it can also be transferred to other systems to facilitate interoperability. In that way, an electronic notebook system can be quickly adapted to systems from other units of the company, new equipment being put into use in the laboratory, customer or vendor systems, and so forth.
Ontologies support shared workflows between scientists, which is an important part of what elevates the electronic notebook above the level of a paper notebook.
Workflow for all
The ELN “does not just support one individual scientist’s work flow,” says John McCarthy, vice president of product management strategy at Accelrys Inc. (San Diego, Calif.) “It supports how scientists work together.” As an example, he explains, in pharmaceutical drug development the process chemist needs to be able to hand a drug candidate to a formulator. If the candidate comes with a list of ELN files detailing materials and excipients and all properties of the compound, the formulator can avoid “sixteen phone calls to five different people.”
Ultimately, one of the most important workflow improvements with an ELN system is opening up information and methods in shared work environments. Paper notebooks encourage a balkanization of workflow, where each scientist owns a kingdom of data, access to which is mediated by a dance of courteous inquiries. With the use of ELN, an organization can better access and review information that is created and stored within notebooks that it rightly and legally owns.
“Suddenly the organizations get control over the records. The bound book is perceived through the centuries as private. You, the scientist, carry it around, while it really belongs to the organization,” says Mats Kihlen, informatics specialist at Contur Software AB (Stockholm, Sweden).
Although a painful cultural shift for some scientists, an ELN system can remove barriers between scientists and departments, allowing information to move freely, encouraging teamwork and peer review, and boost the status of the scientist’s notebook from a record of experiments to a research tool in its own right.
About the Author
Catherine Shaffer is a freelance science writer specializing in biotechnology and related disciplines with a background in laboratory research in the pharmaceutical industry.
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