In light of CUSTOpharm’s regulatory endeavors, a need developed for publishing software to perform a final ‘submission functionality’ check prior to validation and subsequent submission to the regulatory agency. Pub-Assist is the publishing tool that works as an Adobe Acrobat® plug-in developed by CUSTOpharm Regulatory Professionals for Regulatory Professionals, which allows our clients and customers to perform four common batch processing tasks required for all PDF documents. Pub-Assist can perform the following operations:
¨ Checking Hyperlinks and Bookmarks
Checking for invalid Hyperlinks and Bookmarks using Pub-Assist allows you to make sure all destinations associated with Bookmarks and Hyperlinks within one document or within multiple documents in a directory (or file folder) are valid. Using this functionality, Pub-Assist will verify that all paths associated with Hyperlinks and Bookmarks have a valid destination. Validity of the destination is defined as a functional destination—a location that exists. Pub-Assist will not be able to verify that the destination is the correct destination (i.e., content); Pub-Assist will verify that the destination does exist. This functionality will reduce or eliminate the number of error messages users receive. This feature may also allow you to recognize global problems with Hyperlinks and Bookmarks within a file or within multiple files (including an entire directory and sub-folders). Invalid Hyperlinks and Bookmarks are noted in a report file and highlighted in red/boxed when present in the PDF document aiding in identification. The red color/boxes can be changed back to the original color during the correction process or by using another option included with Pub-Assist.
¨ Setting the Zoom Level for Bookmarks and Hyperlinks to Inherit Zoom
Changing the Zoom Level of PDF documents using Pub-Assist allows you to standardize the way pages look when a Bookmark is selected by a user. PDF document bookmarks have several Zoom Level options including ‘Fit Visible,’ ‘Fit Width,’ ‘Fit Page,’ ‘Actual Size,’ and ‘Inherit Zoom’. Bookmarks that are generated from source programs can sometimes be set to default to one of these options; however, bookmarks that are created using Adobe® Acrobat® programs are not set to default with ‘Inherit Zoom’. Standardizing the Zoom Level on bookmarks is required and/or suggested by some agencies or corporations for PDF documents to be deemed acceptable. (Changing Zoom Levels while reviewing or reading documents can be distracting and hindering to the user.) Adobe® Acrobat® programs will allow you to change the Bookmark property for Zoom Level to ‘Inherit Zoom’ and allow this change to be saved, but this function will need to be performed on each individual Bookmark. Adobe® Acrobat® does not allow batch processing where this setting can be changed to several Bookmarks or documents at one time. Pub-Assist allows you to change the Zoom Level on all Bookmarks to ‘Inherit Zoom’ within one or more documents at one time (batch processing).
¨ Setting the Initial View of Documents to Page and Bookmark View if required
Changing the Initial View of PDF documents using Pub-Assist allows you to standardize the way the document looks when it is first opened by any user. When documents are scanned or converted from another authoring program, only the page is viewable in Adobe® Acrobat® unless the setting is changed in the PDF document. Some regulaqtory agencies or corporations have requested the ’Page and Bookmark’ view for documents that contain bookmarks to facilitate the review process and allow easier identification of particular sections of a document. Adobe® Acrobat® programs will allow this change to be saved, but this function will need to be performed on each individual document. Adobe® Acrobat® does not allow batch processing where this setting can be changed to several documents at one time. Pub-Assist allows you to change the Initial View on one or more documents at one time (batch processing) to see both the Bookmark Navigation Panel and the Page in each document to ease users in navigating the document.
¨ Setting the PDF Version to PDF Version 1.4 as required by the FDA.
Reducing the File Size of PDF documents using Pub-Assist allows you to save the file to be compatible with older versions of Adobe® Acrobat®. The PDF version associated with a converted document is a function of the Adobe® Acrobat® program version (i.e., 4.0, 5.0, 6.0, etc.) that was used to create the PDF document. Some agencies or companies require that the document property of PDF version be 1.4 to ensure that the document can be opened on computers that have older versions of Adobe® Acrobat® running. Adobe® Acrobat® programs will allow this change to be made and saved, but this function will need to be performed on each individual document. Adobe® Acrobat® does not allow batch processing where this setting can be changed to several documents at one time. Pub-Assist allows you to reduce the file size of PDF documents to be compatible with PDF Version 1.4 on one or more documents at one time (batch processing).
Using Pub-Assist can decrease the time associated with the Quality Control (QC) review for submissions and eliminate errors experienced by those viewing the submissions. Pub-Assist can be used regardless of how the submission is prepared or created. Pub-Assist is used in submissions prepared by CUSTOpharm and is available as purchasable software for customers. Technical support and validation assistance is also available.
Pub-Assist can perform any one or any combination of the above-mentioned tasks on a single document or multiple documents (including files and sub-folders within a directory). Pub-Assist does not change content/text within documents; Pub-Assist only standardizes the view of documents and the ability of the documents to be opened with older versions of Adobe® Acrobat® programs. The Bookmark and Hyperlink verification operation produces a separate file indicating which documents have been checked for invalid Hyperlinks and Bookmarks and where invalid hyperlinks and bookmarks are located. Invalid Bookmarks and Hyperlinks within the text are also outlined or changed to red font so detection is made simple. Pub-Assist also has a feature that can remove the red color for document finalization.
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