Electronic Lab Notebook - Objectives

Objectives

A good electronic laboratory notebook should offer both 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.