eCTD Submission Preparation Optimized
Everyone who works in regulatory affairs is always under constant pressure to get submissions out as soon as possible. No matter which eCTD preparation software or EDMS system you utilize; the process always begins with Microsoft Word documents. Everyone is familiar with the basic functions of Word. Everyone has opened or created a document and started typing. However, the more effectively one utilizes Word's more advanced features the more effective and efficient you can be in preparing your submissions. Actually this goes beyond just submission preparation but extends itself into any word processing requirements.
Some of the key tasks that can speed up your work are automating processes, selecting text and repetitive text entry. We will describe some simple way you can use Word more efficiently. At Custopharm, we use these and many others to speed up our submission preparation to ensure timely delivery of our work product. The instructions provided below are for Word 2007 but similar procedures have been utilized for previous versions.
- Automating Processes - The most common form of process automation we use is through the use of cross references and numbering.
- Cross References are a link to a particular paragraph, figure, table, etc. The main benefit using cross references is that if section numbers, tables or figures are modified due to changes in the document; the cross reference will update automatically. For example, if you have a cross reference to Table 2 in a file and you add another table to your document which changes Table 2 to Table 3. The cross reference will automatically updates the reference to list the table as Table 3. To add a cross reference, place your cursor where you want the cross reference placed, click on insert on the ribbon and then in the link section select Cross Reference. Select the desired reference type (figure, table, numbered item) and what you want to reference (i.e. page number, paragraph number, etc.). Then click on your desired target and click insert. The cross reference will be added at your cursor position.
- Numbering or Outline Numbering plays an integral part in submission or any complex document formatting. To utilize this feature in the home tab of the ribbon click on Numbering or Multilevel List in the Paragraph Section. Many clients that we work with manually enter numbers and then when creating a table of contents or adding sections the numbers also get out of order. Both types of numbering allow you to define what your number looks like. You can precede all the numbers with the module number followed by the section number. To customize you layout click on the "Define New ..." which is displayed when you click on the drop down arrow. In this section you can define the numbering style (font, font size, bold, etc), you can design how the numbers and associated text are formatted within word including fonts, paragraph spacing, layout, etc. Custopharm's typical practice is to utilize the multilevel List and associate the various levels with headings 1, 2 , 3. etc. This facilitates the preparation of the table of contents when the document is completed, which is another process that can be easily optimized once style sheets are properly used.
- Selecting text is frequently utilized in all sorts of document editing. Most people will use their mouse to select text by clicking on the first letter and dragging through the last word. This is by far the most inefficient method of selecting text. It may not seem like much time can be saved by selecting text more efficiently but with the frequency of this activity saving a few seconds each time will really come to be a significant time, especially for complicated selections. We will describe the easy ways to perform selection of various items.
- To select a word: double click on the word.
- To select a line: single click in the white space next to the line.
- To select a sentence: hold down "Control" and click on any word in the sentence.
- To select a paragraph: triple click on a word in the paragraph.
- To select a table: hold down "Alt" and double click on any cell in the table. Alternately, click on the little box with two arrows that is displayed on the upper left corner of the table when your cursor is in the table. (Single clicking on a word with "Alt" brings up the research tab)
- Repetitive Text Entry is useful for repeated entry of the same set of text. This is especially helpful for drug names, manufacturing facilities or any block of text that needs to be entered frequently within a document. For this we utilize Words' Quick Parts. This is located in the Insert tab of the ribbon under the text section. To add a selection to Quick Parts, simply select your text, press the drop down arrow of the Quick Parts Section and click "Save Selection to Quick Part Gallery." Another way to easily add repetitive words is to use the auto correct feature in word. To do this go to Word Options, go to the proofing tab and click on "AutoCorrect Options..." Here you can define a combination of letters to be replaced with your complete text. This is how word converts (r) to the registered symbol. The only thing to keep in mind for this is to not use letters that will be normally in sequence. This feature has created numerous problems for analytical chemists trying to abbreviate acetonitrile as ACN only to have it change to CAN automatically.
We welcome comments for any other tips or trick for Word you may have.