Electronic lab notebook

Lab notebooks in general are used by scientists, engineers, and technicians to document research, experiments, and procedures performed in a laboratory.

Ultimately, these types of systems all strive to do the same thing: Capture, record, centralize and protect scientific data in a way that is highly searchable, historically accurate, and legally stringent, and which also promotes secure collaboration, greater efficiency, reduced mistakes and lowered total research costs.

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.

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.

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.

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.

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.