Electronic lab notebook

An electronic lab notebook (also known as electronic laboratory notebook, or ELN) is a computer program designed to replace paper laboratory notebooks. Lab notebooks in general are used by scientists, engineers, and technicians to document research, experiments, and procedures performed in a laboratory. A lab notebook is often maintained to be a legal document and may be used in a court of law as evidence. Similar to an inventor's notebook, the lab notebook is also often referred to in patent prosecution and intellectual property litigation.

Electronic lab notebooks are a fairly new technology and offer many benefits to the user as well as organizations. For example: electronic lab notebooks are easier to search upon, simplify data copying and backups, support collaboration amongst many users.[1] ELNs can have fine-grained access controls, and can be more secure than their paper counterparts.[2] They also allow the direct incorporation of data from instruments, replacing the practice of printing out data to be stapled into a paper notebook.[3]

Types

ELNs can be divided into two categories:

Solutions range from specialized programs designed from the ground up for use as an ELN, to modifications or direct use of more general programs. Examples of using more general software include using OpenWetWare, a MediaWiki install (running the same software that Wikipedia uses), as an ELN, or the use of general note taking software such as OneNote as an ELN.[4]

ELN's come in many different forms. They can be standalone programs, use a client-server model, or be entirely web-based. Some use a lab-notebook approach, others resemble a blog.

Objectives

A good electronic laboratory notebook should offer a secure environment to protect the integrity of both data and process, whilst also affording the flexibility to adopt new processes or changes to existing processes without recourse to further software development. The package architecture should be a modular design, so as to offer the benefit of minimizing validation costs of any subsequent changes that you may wish to make in the future as your needs change.

A good electronic laboratory notebook should be an "out of the box" solution that, as standard, has fully configurable forms to comply with the requirements of regulated analytical groups through to a sophisticated ELN for inclusion of structures, spectra, chromatograms, pictures, text, etc. where a preconfigured form is less appropriate. All data within the system should be stored in a database (e.g. MySQL, MS-SQL, Oracle) and therefore be fully searchable. The system should enable data to be collected, stored and retrieved through any combination of forms or ELN that best meets the requirements of the user.

The application should enable secure forms to be generated that accept laboratory data input via PCs and/or laptops / palmtops, and should be directly linked to electronic devices such as laboratory balances, pH meters, etc. Networked or wireless communications should be accommodated for by the package which will allow data to be interrogated, tabulated, checked, approved, stored and archived to comply with the latest regulatory guidance and legislation. A system should also include a scheduling option for routine procedures such as equipment qualification and study related timelines. It should include configurable qualification requirements to automatically verify that instruments have been cleaned and calibrated within a specified time period, that reagents have been quality-checked and have not expired, and that workers are trained and authorized to use the equipment and perform the procedures.

Regulatory and legal aspects

The laboratory accreditation criteria found in the ISO 17025 standard needs to be considered for the protection and computer backup of electronic records. These criteria can be found specifically in clause 4.13.1.4 of the standard.[5]

Electronic lab notebooks used for development or research in regulated industries, such as medical devices or pharmaceuticals, are expected to comply with FDA regulations related to software validation. The purpose of the regulations is to ensure the integrity of the entries in terms of time, authorship, and content. Unlike ELNs for patent protection, FDA is not concerned with patent interference proceedings, but is concerned with avoidance of falsification. Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et seq.)[6] and Title 21 CFR Part 11.[7] Essentially, the requirements are that the software has been designed and implemented to be suitable for its intended purposes. Evidence to show that this is the case is often provided by a Software Requirements Specification (SRS) setting forth the intended uses and the needs that the ELN will meet; one or more testing protocols that, when followed, demonstrate that the ELN meets the requirements of the specification and that the requirements are satisfied under worst-case conditions. Security, audit trails, prevention of unauthorized changes without substantial collusion of otherwise independent personnel (i.e., those having no interest in the content of the ELN such as independent quality unit personnel) and similar tests are fundamental. Finally, one or more reports demonstrating the results of the testing in accordance with the predefined protocols are required prior to release of the ELN software for use. If the reports show that the software failed to satisfy any of the SRS requirements, then corrective and preventive action ("CAPA") must be undertaken and documented. Such CAPA may extend to minor software revisions, or changes in architecture or major revisions. CAPA activities need to be documented as well.

Aside from the requirements to follow such steps for regulated industry, such an approach is generally a good practice in terms of development and release of any software to assure its quality and fitness for use. There are standards related to software development and testing that can be applied (see ref.).

See also

References

  1. ↑ Myers, James; Elena Mendoza; Bonnie Hoopes (2001). A Collaborative Electronic Notebook. Proceedings of the IASTED International Conference on Internet and Multimedia Systems and Applications.
  2. ↑ Myers, James (2003). Collaborative Electronic Notebooks as Electronic Records:Design Issues for the Secure Electronic Laboratory Notebook (ELN) (PDF). Proceedings of the 2003 International Symposium On Collaborative Technologies and Systems.
  3. ↑ Perkel, J. M. (2011). "Coding your way out of a problem". Nature Methods 8 (7): 541–543. doi:10.1038/nmeth.1631. PMID 21716280.
  4. ↑ Perkel, J. M. (2011). "Coding your way out of a problem". Nature Methods 8 (7): 541–543. doi:10.1038/nmeth.1631. PMID 21716280..
  5. ↑ "ISO/IEC 17025:2005 - General Requirements for the Competence of Testing and Calibration Laboratories." ISO - International Organization for Standardization. Web. 16 Nov. 2011. <http://www.iso.org/iso/Catalogue_detail?csnumber=39883>.
  6. ↑ United States. Food and Drug Administration. Department of Health and Human Resources. 1 Food and Drugs - Subchapter H Medical Devices - Part 820 System RegCode of Federal Regulations - Title 2ulation. FDA.gov, 7 Oct. 1996. Web. <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820>.
  7. ↑ United States. Food and Drug Administration. Department of Health and Human Resources. Code of Federal Regulations - Title 21 Part 11 Electronic Records; Electronic Signatures. FDA.gov. Authority: 21 U.S.C. 321-393; 42 U.S.C. 262., 20 Mar. 1997. Web. 16 Nov. 2011. <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11>.

Further reading

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