Frequently Asked Questions (FAQ)


How do I add a new user to NoteBookMaker®? 
You must contact the Librarian, (The Librarian is the individual that is in charge of administering all of the electronic notebooks). Only the Librarian can create a library card. Your Library card contains your individual information; Note Book ID, User Name, Employee ID, Password, Witness, Security Clearance, Picture, etc. In the demo version of NoteBookMaker®, open the Librarian from the cover page. Press the “New Card” button and fill in all the appropriate parameters. There is a secure method for opening the Librarian file. The password for its access can be and should be changed from the default. Contact tech@NoteBookMaker.com for more information. 



How do I create a New Page (record)? 
After opening your notebook with your personal password, hit the “New Page” button in the legal commands section.



Why can’t I delete a record? 
One of the primary requirements of a legal notebook is that modifications cannot take place after the author has “Posted” his/her signature. This property is one of the main security features of NoteBookMaker®. If deletion were allowed there would be no way to determine if records were accidentally or purposely eliminated. 



Why Can’t I edit a Posted file? 
One of the primary objectives of a Laboratory Notebook is Security. Once the author of the page has finished a particular page and declared it finished or “posted” then no more editing of that page is allowed. This ensures that the information entered on a page was performed by and only by the author. There is no possibility of information being added after the author has left the computer. 



What does “Posted” mean? 
Posted means that the author has completed work on a particular page or record. They have reviewed their work and are ready to create a permanent, non-editable, legal record. Essentially, they are committing to the data and the date and time are recorded. 



What does “Post Witness” mean? 
Post Witness means that the witness has completed reviewing what an author enters on a particular page or record. They have reviewed the author’s work and are ready to sign off on the information. By definition, a witness is someone who actually was present when the Author performed the work. After both the author and the witness have posted their names to a record no more editing is allowed. Essentially, they are committing to the data. 



What does “Post Validator” mean? 
Post Validator means that the Validator has completed reviewing what an author enters on a particular page or record. They have reviewed the author’s work and are ready to sign off on the information. A validator should be checking the quality of the page with respect to correctness. They are typically not present when the work is created as with the witness. Essentially, they are committing to the data.



Why can’t I Witness my own pages? 
An author can’t witness his or her own work. This is a violation of CFR21 Section 11. CFR21 Section 11 is the Code of Federal Registry that establishes the guidelines that an electronic notebook must operate under. Allowing a person to be both the author and the witness for a particular record is forbidden. 



Why can’t I Validate my own pages? 
Authors can’t validate their own work. This is a violation of CFR21 Section 11. CFR21 Section 11 is the Code of Federal Registry that establishes the guidelines that an electronic notebook must operate under. Allowing a person to be both the author and the witness for a particular record is forbidden. 



Do I need to have my pages Witnessed or Validated? 
It is a good idea, but in fact the process of posting your pages locks each record and thus creates a very strong case for authenticity. If you have someone who can witness and validate, then the case becomes even stronger and more defensible. 



How do I change the Witness (typically a supervisor)? 
You must contact the Librarian. Only the Librarian can alter your library card that contains each individual’s personal information. The witness is typically a supervisor and has a different security level. In the demo version of NoteBookMaker®, open the Librarian from the cover page. Change the reference in the Witness (Group Leader) field. 



What happens if I forget my password? 
NoteBookMaker® is a totally secure electronic notebook. You will not be able to open or alter your notebook in any way without your password. If you do forget your password you must contact your System Librarian. This person is responsible for maintaining the entire electronic system including password generation. 



What are the security clearances in the librarian? 
Security clearance, located on the library card enables a particular user access to only areas of the network were they are assigned. Different ratings allow access based on their role within the company. On the demo version of NoteBookMaker®, everybody has the ability to alter their personal library card. In the full version of the program, only the system administrator, or the Librarian, has the ability to create and edit library cards. 



Why can’t I access my notebook over a network? 
You are probably running the standalone version. You must contact NoteBookMaker, LLC. and obtain a multi-user license. If you already have a multi-user license, then consult the FileMaker user manual to learn how to setup FileMaker Pro as a multi-user environment. 
Can I search somebody else’s work? 
Yes, if you have the proper security clearance to open their file. Contact your system Librarian to determine if you have that security clearance. 



How do I perform a search? 
To perform a search, you must first enter the “find mode”. To do this hit the search button under the Search menu, type a keyword or phrase in any of the fields, and press the continue button. This will find any occurrences of your search string within your notebook. To search different notebooks you must have the appropriate security clearance. Contact your librarian for additional security levels. 



Can I add text to a picture? 
No, you can import only one picture to a page. If you desire to add text to a picture or alter the image, you must perform these actions in a third party program like; Photoshop, Microsoft Excel, or Corel Draw and others. 



Can I search on a picture/movie? 
You cannot search the actual image or movie file. However, if you type a description or title above the image, you will be able to perform a search based on the text. 



How do I capture a query? 
Capturing a query is an obsolete term. With NoteBookMaker® there is no need to maintain a library of different search queries. You simply search on the field or text that you are looking for. See the Search help file field for more detailed options. You can also use “Open ScriptMaker” under the scripts menu to save search routines this is much more flexible and powerful than using a typical query builder. 



Why are some of the toolbars “grayed out” or not available? 
The program that NoteBookMaker® uses for lower level function calls is FileMaker Pro. FileMaker Pro uses a different menu scheme. These commands are not available as to satisfy several different security issues and to maintain compliance to 21CFR11. 



What are the major features in version 8.5? 
Building on the new release of FileMaker® Pro 8.5, NoteBookMaker® 8.5 is able to export directly to Excel and create a PDF. Tool tips and custom menus have also been implemented. Searching now shows the criteria, as it is located on a record. The logic used in the correction routines is now more obvious. For completeness version 7 features are listed here. Version 7 allowed for attachment of complete files, such as graphics, spreadsheets, other databases, operating systems and just about any file. This allows the native file format to be maintained in a fully locked mode. The notebook file size has grown from 2 GB to 8 TB. This allows for extremely large notebooks and is very handy when attaching video files. Version 7.1 adds a 3rd signature line for a Validator. Validation creates a very strong and defensible process to protect your intellectual property. An additional authentication step has been added to each of the post routines to better comply with legal electronic signature rules. In version 8.0 expanded TOC routines were added which allow you to break your work into very logical relations. Building on version 8.0, version 8.5 now has the ability to directly view pages from a detailed TOC report. Version 8.0 provided routines to allow better correction tracking for pages that may have errors on them and that need to be referenced by a correction page. Most notably, 8.5 has a new login script that makes it much simpler to view the list of available notebooks while securing all data and authentication fields. The administrator of the librarian can easily switch from being a host or a user with a simple Re-Login script. Over all, the system is more efficient, user and audit friendly. We received very good comment from our users and look forward to even more for the next versions. 



How do I get a database with no records? 
You must contact NoteBookMaker®, Inc. Our trial version contains several records to show examples of the many different aspects of the program. To receive a copy without demo data, then contact us via email at tech@NoteBookMaker.com. 



Do I need FileMaker® to run NoteBookMaker? 
NoteBookMaker® is a FileMaker Pro solution. The standalone single user version does not require any other application. However, the multi-user version does require the FileMaker Pro application running in the background. FileMaker is a very robust easy to use database system that allows several users with different passwords to interact seamlessly. 



Where do I find more help? 
You can find more help in several different places. First, from the cover page of the notebook, there is a red Help button in the top right hand corner. Second, by clicking on any of the light purple section headers. These fields will describe all of the button characteristics within that area.