NEW ONSTYLE UPDATE 3.2: MEDICAL WRITING MADE EASIER

NEW ONSTYLE UPDATE 3.2: MEDICAL WRITING MADE EASIER

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From its humble beginnings as a powerful tool, OnStyle has been developed into a refined solution, consistently evolving to meet user needs. With each update, including this release, our dedication to excellence endures. This new OnStyle 3.2 version marks a big step forward for our software, introducing many improvements, including various exciting new features designed to make it more powerful and easier to use. Let’s see what’s new in OnStyle 3.2.


New or Enchanced Authoring Features in OnStyle 3.2 

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1. Export Anonymized Document: For security reasons, this feature lets you export your document with all comments and Track Changes items anonymized. These items’ contents will be completely preserved, but their original author’s name will be erased. Instead of the original author’s name, the default username of the DocConfig (e.g., company-name-default-user) will be attached to comments and Track Changes items. Contact information is also removed for all people except for those allowed by the Tracked Change Not Anonymized or the Comment Not Anonymized module configuration. Furthermore, the module replaces the “Creator” and “Last Modified By” properties of the document with the default author name specified in the inventory.

2. Improved Convert Style Tool: In the previous software versions, when the Convert Style Tool was launched as a fix from the Results Pane to fix a Nonstandard Style issue, the tool fixed all issue instances with the same style. 

Execution is now allowed in multiple cycles, meaning the style conversion can be performed individually for each instance. Batch conversion is still available by applying the fix to the issue group.

3. Improved DocConfig Assignment: A verification process has been added to OnStyle that ensures that no DocConfig can be applied to a read only document. Upon assigning a DocConfig to a read only document, a popup dialog appears warning the user that the assignment is not possible and asking for the removal of the read only restriction. Previously, the assignment could be carried out, however, due to the restriction, no modification was made to the document. 

4. Enhanced Header/Footer Manager: Managing headers and footers is easier with the new Header and Footer Manager tool. The user interface is now a dockable pane. This allows the uninterrupted and continuous editing of the document with the header and footer manager open on the side. The functionality of the tool has also been expanded with various features. It is now possible to differentiate between the first, during the configuration. A live preview of the headers and footers has also been added. The view target can be changed using the tabs above the preview. It is now also possible to apply the header and footer settings to specific parts of the document and not only to the whole document, which was the only option in previous OnStyle versions. Specifically, it is possible to insert the configured header and footer data into either the selected section, the entire document, or from the current section to the end of the document. For extended efficiency, it is now also possible to reapply header and footer settings of one section of the document to another section, with the ability to modify it if needed.


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New inspection Modules/Correction Modules in OnStyle 3.2

  • Comment Not Anonymized inspection 

This inspection checks the document for comments and reports where the author of the comment is not anonymized.  

  • DocDefaults Present inspection 

Default settings (e.g. indentation) in the Normal template can result in unexpected layout applied in documents. Some of these default settings are stored in the DocDefaults element, which is a container for these defaults. The inspection finds and lists all entries of the DocDefaults in the document, except those listed as exceptions.

  • Document Property Value Issue inspection 

Most companies use properties in the document templates, such as Title, Subject, Keywords, etc., to identify the document’s topic or contents. In more complex cases however, custom properties might be used for document management processes. If the user changes the value of these properties, it can cause exceptions in the document management processes. The module finds and lists those document properties which do not have the required value. Required properties along with the required values and other allowed values are configured in the DocConfig based on requirements.

  • Set Document Property correction 

This correction module sets the wrong document property settings to the required value.

  • Link to Dedicated Target inspection 

Health authority guidance may require active weblinks to be placed in the labeling document with predetermined hyperlink text and target, such as www.fda.gov/medwatch for FDA, or https://www.ema.europa.eu/ for EMA documents, or other weblinks based on the requirements. The module checks if all configured hyperlinks are present in the document with their corresponding configured display text.

  • Page Number Missing inspection 

This new inspection reports all sections of the document where the header or footer does not contain a page number. Page numbers are usually required by company style guides or health authority rules. Only the title page may act as an exception for certain document types.  

  • Tracked Change Not Anonymized inspection 

This inspection checks the document for Track Changes entries and reports those where the author of the change is not anonymized.  

  • Invalid USPI Document Structure inspection 

The FDA requires US labeling documents to contain a predefined structure with the document parts: Highlights, TOC, and FPI. The module tries to find the three main parts of a USPI labeling document and reports an issue for each missing part. 

  • Boxed Warning Issue inspection 

This new module checks the existence and length of a boxed warning in the Highlights section of a USPI document. It reports if the boxed warning does not meet the USPI requirements or is missing. 

  • Column Number Issue inspection 

The inspection module checks the TOC, the Highlights and the FPI sections in the document for the number of columns. It reports an issue if any of the Highlights or the TOC section is not in the required two-column format and if the FPI is not in single-column format. 

  • Column Spacing Issue inspection 

The inspection checks the uniformity of column widths in multi-column sections such as the TOC and Highlights. It reports sections from the USPI document where the column spacing settings do not comply with the preconfigured values. 

  • Set Column Spacing correction 

This correction module adjusts the column spacing to the value specified in the configuration. 

  • RMC Issue inspection 

The inspection checks if the Recent Major Changes section is present in the Highlights section of a USPI document, starting with a preconfigured heading text and containing text-based information along with its corresponding date data in table or table-like format.


Exploring OnStyle: Present and Future

Outlined above are the main new features of OnStyle 3.2, along with several backend improvements and enhancements. For additional information, you can contact us at services@dachs.ch. We continuously strive to improve OnStyle! Expect upcoming updates to enhance your user experience.

For a detailed overview, watch our latest video demonstrating the new features of OnStyle 3.2: https://www.youtube.com/watch?v=TEDv1zzXghQ

Stay tuned for more updates and happy writing!

12/03/2024