Posting your name (signature) as an Author or as a Witness to a page.
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To complete the process of authoring a page, click on the Post Author Legal command. This will prevent any further modifications to the page and is essential for 21 CFR Chapter 11 compliance.
The legal section of the page, located in the footer, depicts the personnel taking responsibility for the current page, the author of the page and the individual that reviews the work. When the researcher creates a new page, their name and picture as well as the date and time get recorded and displayed in the bottom left of the page. When the author has completed the page and "posted" their name, no alterations are allowed. The document will show a date and time stamp in the posted field. This signifies that the page is complete and cannot be modified or adulterated under any circumstances. This security feature is an essential part of 21 CFR Part 11. These fields are still searchable, however they cannot be changed. When the supervisor logs in to
NoteBookMaker®, using their own name and password, they can review the authors page for completeness and accuracy. When satisfied, they perform the legal function "Post Witness". The time and date stamps are set as well as their name and picture, all transferred from the library card. The page has now been authored, posted, and witnessed. These features are all essential for legally defensible data.
The main body of the page, (the white section), is formatted to print on 8 1/2 x 11 paper. Since this is the typical paper size scientist currently use, the transition is easy. Also, this is the format that auditors are comfortable with. Spending valuable time and money training an assessor to use your notebook is counterproductive not to mention frustrating to all associated parties. System administrators must consider audit friendliness when choosing an electronic authoring tool.