The Electronic Scientific Document

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. 

It is useful to allow for adding additional information to a section that may not be part of a printed report, but helps the operator in organizing and searching through the document contents. The following supporting information is useful  

Metadata (data about data) Every piece of information that describes the content of a section in detail. Examples are literature references, sample number, and instrument ID. Metadata shall be searchable and are important for retrieval of experiments. 

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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... 

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

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. 

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 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. 

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. 

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

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. 

This article defines the criteria and processes for computer validation. Computer validation applies to all systems, including electronic capture systems in both the laboratory (scientific instrumentation) and field settings. Any system producing electronic records and documents, which regulators in the evaluation of product registration applications will use, needs to be validated. 

ChemText provides the wide range of special symbols and fonts for scientific documents illustrated in Fig. 1.4. These characters appear on screen and print on every supported printer. When scientists exchange electronic ChemText manuscripts they will still see the proper symbols, even on different printers. In contrast, Macintosh manuscript fonts can get switched when transferred to another Macintosh system with a different arrangement of fonts in system files. 

More complete information With electronic systems, the user can be obliged to enter certain information for notebook entries, such as additional metadata. This makes scientific documentation and workflows more consistent. No important information is missing. 

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

A specific work package (WP4) has been assigned to the creation of the web-site because the web-site is a key system to work and communicate with partners and a valid instrument for a broad and timely passive dissemination of activities. Therefore, WP4 expertise will be required to address technicalities related to scientific issues, including judgement about data structure and database organisation. Moreover, experts in WP4 advised on the best way for circulating and using forms for data collection. WP4 maintains the electronic NMS and ACC network, and support dissemination outside the project. The web-site offers a restricted area for project s participants for internal communication and circulation of documents. 

The other major source for student acquisition of PDF files is the primary literature in the form of journals. The modern electronic journal functions in much the same way as a content management system. Retrieval of individual articles has been vastly expedited by the recent introduction of the widely implemented digital-object-identifier (DOI) [4]. This provides 1-click access by means of a hyperlink embedded directly in other documents, or from e.g. the navigation tree of a HTML-based Web document. Although ostensibly introduced to provide rapid access to the published scientific literature, the DOI identifier is also the first of the technologies discussed here that has the potential to achieve the holistic and interlinked information structures implied in the title of this article. 

A discussion on the main spectroscopic techniques used in mineralogy and materials science is beyond the scope of this chapter. Several treatises and scientific papers dealing with this topic are already available. On the other hand, a thorough understanding of the local phenomena occurring when chromium is incorporated into the octahedral site of a perovskite structure, and, consequently, the know-how of deriving chromium-oxygen local distances is an essential requirement For this reason, in this section, it will be briefly explained how to obtain local bond distances by means of the electronic absorption spectroscopy (EAS), which is one of the most common and well-documented spectroscopic techniques in mineral sciences. 

Analytical scientists have welcomed ICH M4 Q—Common Technical Documentation (CTD) as a globally accepted format to provide information and scientific data in drug application submission. Recently, FDA and EU regulatory agencies have encouraged and allowed applicants for the electronic submission of the common technical documentations using ICH eCTD specification. 

The maxim "The old teaches the young" is more and more frequently reversed in modem electronic times. Someone like me who wrote his first three-line e-mail letter just a few years ago is lost without the help of informatics wizards who watch over software performance, data bases, and book formatting. The invaluable services of Alain Borel, chemistry librarian Luc Patiny, specialist of scientific documentation and Donald Zbinden, computer expert, cannot be praised enough. 

This expanded view of task automation includes new capabilities in the the traditional area of instrument automation and in the somewhat newer related field of robotics. In addition it includes a number of functions which are not new to the office and business environment but have only recently become readily available in the laboratory. These are tools such as data base management, scientific text processing, and electronic mail and document transfer. One way to improve technical productivity Is by giving the scientist more time to do science. This can be accomplished through improved efficiency In the office, communication, and information retrieval functions which must be performed as well as by allowing science to be done In new and more efficient ways through the use of computers. 

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