Scientific Documentation — Electronic Laboratory Notebooks ELNs

9 SCIENTIFIC DOCUMENTATION — ELECTRONIC LABORATORY NOTEBOOKS (ELNs) 

But what does appropriate mean for scientific documentation Obviously, simple documentation is not enough there are additional requirements for a scientific notebook. Some companies sell preprinted paper notebooks, usually containing 100 to 150 pages, square grid or horizontal ruled, serially numbered in the upper outside corner, and bound at the left margin. Loose-leaf or spiral notebooks are not acceptable, because pages can be intentionally inserted or removed or accidentally ripped out. Any such action opens up the possibility that someone will question the authenticity of the data. Here is a summary of the most important laboratory notebook rules  

The notebook has to provide a complete record of activities in a manner that allows coworkers to exactly repeat work and be able to obtain the same results without having the original author around. 

Errors should not be erased or obliterated beyond recognition. They should be crossed out and replaced by new entries. All errors and mistakes should be explained and signed as they occur. 

An electronic solution has to cover these requirements but can bring significant advantages to some of these points  

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Electronic Laboratory Notebook (ELN) is a laboratory software for authoring, managing, and sharing electronic information for the purpose of scientific documentation. 

In the ELN, the electronic scientific document serves the role of a conventional laboratory paper notebook It is a container for laboratory data bound by regulatory guidelines. As an electronic regulatory vehicle, the electronic scientific document must meet GxP and 21 CFR Part 11 requirements mentioned earlier as well as the requirements governing paper laboratory notebooks. As a result, it must do the following ... 

The inbox concept is particularly interesting for documentation systems, like ELNs. According to paper laboratory notebook rules, a scientist is not permitted to write to another notebook besides his own. The same applies to ELN software An external system like an agent will not be able to insert data into an electronic scientific document without user interaction. The inbox plays here the role of a database cache in between an external system and the secured notebook database. The scientist can take a look at the inbox items and can decide which item he wants to insert into his document. 

Electronic Scientific Document is a concept of ELN software that serves the role of a container for documented laboratory data underlying the regulatory guidelines for paper laboratory notebooks. 

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