Paper laboratory notebook

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 ... 

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. 

Notebook reports include all section versions as well as previously deleted sections, each with additional comments and signature information, in a similar style like in a paper laboratory notebook. 

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. 

Laboratory notebooks—It may be debatable to consider laboratory notebooks as text documents, but they should be mentioned here because of their importance in preclinical development. Laboratory notebooks are used to record experimental procedures, observations, raw data, and other important information. Although laboratory notebooks are rarely used for submission to regulatory agencies directly, they are available for inspection by the authorities in the Preapproval Inspection (PAI) and other GMP/GLP-related inspections. Currently, most of the major pharmaceutical companies still use paper-based laboratory notebooks. Electronic-based notebook systems are being developed and commercialized, which are discussed in Chapter 9. 

There are hidden gold mines under our noses—in house data becomes the new lamps for old on the tons of old clinical data from 50 years of R D— but of course, none of it is electronically accessible. It is called a library Many organizations have undertaken huge OCR (optical character recognition) projects to scan laboratory notebooks—some data even exists on microfilm and microfiche. As it is a legal requirement for a drug submission to provide provenance of scanned notebooks [38], paper, and microfilm, many businesses concentrate solely on the capture and verification of this data, rather than considering it a valuable resource to be remined. 

Chose a sturdy notebook, one that will survive your need to open and close it on innumerable occasions and one that will not burst when you have taped or pasted in chart paper tracings, scintillation counter output, chemical manufacturer s product information slips, graphs, etc. (Even superbly constructed laboratory notebooks can be damaged through normal use so protect your notebook out of respect for its archival value.)... 

Paper work that has been generated should be page numbered (with initials) and preserved, ultimately to be bound. The student s laboratory notebook should also summarize the work that has been done. The exact procedures that are used for the preservation of notes on experiments vary from institution to institution. The student should be instructed in the appropriate method what is used at the particular laboratory under consideration. 

These consist of field data sheets, sample storage records, bench sheets or laboratory notebooks, chromatograms, and shipping papers. Some of the laboratory records, in particular, can be electronic rather than paper. 

So why are there laboratories without a LIMS A laboratory without a LIMS will normally use a paper-based system such as Laboratory notebooks. Instrument logbooks. Reagent and solution logbooks. Training records, etc. The thorough manual review process can be checked only by reading the paper to see that all items have been correctly entered, and to see that all calibrations and reagents are still valid. This is a labor-intensive process. 

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 ... 

Educated in a convent since the death of her mother when Marie was 3 years old, Marie Anne Pierrette Paulze Lavoisier had talent in both art and languages. She must also have had some innate proclivity for science, because she immediately became involved in Lavoisier s scientific work translating scientific papers, working in the laboratory, keeping laboratory notebooks, and making illustrations of experimental setups. Lavoisier, now well settled, well financed, and well assisted, started on what was to be his most important work to use the principle of the conservation of mass to revolutionize chemistry. 

In this way you capture both the traditional paper records in laboratory notebooks and laboratory worksheets as well as the first recorded data in electronic form. 

Writing is the most important method chemists use to communicate their work. It begins with the record kept in a laboratory notebook. An experiment originally recorded in the laboratory notebook can become the source of information used to prepare scientific papers published in journals or presented at meetings. For the industrial chemist, these written records are critical in obtaining patent coverage for new discoveries. 

National Cataloging Unit for the Archives of Contemporary Scientists (NCUACS) http // www.bath.ac.uk/ncuacs/ (accessed October 20,2010). The (NCUACS) was established in 1973 to locate, sort, index, and catalogue the manuscript papers of distinguished contemporary British scientists and engineers. They include correspondence of all kinds, professional or technical documents, such as laboratory notebooks, experimental drawings and calculations, lecture notes, engagement diaries and journals (from NCUACS Web page). 

The validation documentation typically consists of a protocol, analytical data, and a final report. One approach to simplifying validation documentation is to focus on a thorough protocol with preapproved acceptance criteria, which are necessary to determine whether the validation results demonstrate that the method is fit for purpose. In early development, this protocol may be captured in a lab notebook which could be in either a paper or an electronic environment. There is an ever increasing trend in the use of electronic laboratory notebooks which makes it simple to execute previously developed protocols. Later in development, the protocol should be a unique document, which may have data tables to enter the test results, requiring only a short executive summary to summarize the results and a reference or attachment of raw data. A development lab will often use these well-developed and optimized master method validation protocols" " as templates for subsequent validations. A copy of the method procedure and, where available, a method development report may be appended to the validation protocol. In general, the validation protocol should contain the following ... 

Chemistry Laboratory Student Notebook, second edition, paper (ISBN 0-7167-3900-3)... 

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