Electronic scientific documents

Since documenting work is a major aspect, an ELN should provide at least a documentation capability similar to conventional word processing software. We will refer to this functionality as electronic scientific document to distinguish this functionality from other features of an ELN. 

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 ... 

If we want to take a scientific workflow into account, we can organize an electronic scientific document into sections, each of which represents the notes for a work step. Each section in the electronic scientific document requires then at least a status and a version and may have additional information attached. Sections may have different states ... 

In the ideal case, a section will disappear if it is deleted or if a new version is created. However, a page cannot be removed or content erased beyond recognition in paper laboratory notebooks. Consequently, the electronic scientific document should provide a special view showing all versions of sections as well as the deleted ones. In this view, the status of a section has to be clearly indicated. 

In addition to the template functionality, ELN users should have a way to reuse previously created electronic scientific documents or sections when starting with a new laboratory experiment. This kind of clone-functionality should optionally include all supporting information described above. 

Reports from electronic scientific documents may be created in different formats, and two of them are particularly important ... 

Reports from electronic scientific documents require predefined headers and footers to be included that show the same administrative data (e.g., author, date, time, project) and signature information as with hardbound paper notebooks. If document reports are required for submission to regulative authorities like the FDA, these headers and footers are predefined in the system and are automatically included in a report without user interaction a scientist is then also not allowed to change this information. 

In the ideal case, conventional word processing software can be embedded into a scientific workspace to directly edit and report information in the same software package. Creating a report document in a scientific workspace also allows the transfer of the preview of any file entry to be included, for instance via drag and drop from the file tree to the document. Workspace reports may optionally include placeholders for administrative data, similar to the electronic scientific document. However, in contrast to the latter, this information may be changed or edited. 

By providing the features just described, we covered the most important requirements for the electronic scientific document. There is another aspect of scientific... 

A scientific workspace editor is a tool that allows scientists to keep their work data supporting the ELN in a separate secure database area. It allows users to create, upload, organize, and share data in a usually less regulated manner than with electronic scientific documents. The principle intention of this tool is to allow the user to enter, work on, and share data in an intermediate secure repository. The user can enter data and keep them private until explicit release and does not need to keep data on paper or on a local file system. In summary, a scientific workspace editor allows the following ... 

Direct transfer of documents to electronic scientific documents in the ELN. 

Electronic scientific documents and scientific workspaces are primarily independent from each other but are used in the same environment. Consequently, they share several common resources, such as user, laboratory and project data, metadata, and pick list. Both concepts use a similar technology for predefined templates and file type, respectively. 

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. 

Zoom or select a particular area, annotate the peaks, and drag it to the electronic scientific document. 

The reviewing and signing process for electronic scientific documents can be considerably improved when keeping these requirements in mind. 

The results of a structure or reaction query are displayed in a hit list, ideally within an ELN software. The user can then create a new section in the electronic scientific document using any structure from the hit list, including metadata delivered by the database. By transferring the structure, an additional unique identifier from the external database needs to be kept that is, the created section has a hyperlink to the external system that allows opening the default structure viewer directly from the section. 

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. 

Scientific Workspaces are a specialized concept of electronic laboratory notebook software underlying less restrictive regulations than electronic scientific documents. They are containers designed for personal preparation of data as well as for effective organization, sharing, and publishing of information within a team. 

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