We added a new module to our range, called the Hi-Fidelity module. This module functions as an overall regulatory compliance solution. This module allows the rendition of quality documents in compliance with ICH-, ISO– and FDA–guidelines. DocShifter takes any input format (Word, Excel, PowerPoint, PDF…) and transforms them into compliant documents. With this module it is possible to add: headers, footers, logos, bookmarks and paging to your documents.
DocShifter is able to process large volumes of documents and compile different (parts of) documents into one document. It automatically assigns the files to a folder or CMS and it has an optional sign-off for those who want a more secure approval flow.
Below you can find a sample of items from our compliancy checklist:
For your convenience, we have also added some extra features to the Hi-Fidelity module:
- Customization of bookmarks by outline-level and style
- Support for non-English Office versions
- Support creation of tagged PDF’s
- Settings for track changes
- Settings for rendering comments into the PDF
- Settings for underlining and coloring table-links
- Process macro-enabled documents and password protected PDF files
Screenshot of ICH module configurations
Regulatory Compliance Solution
If your organization needs to generate quality documents that have to comply to certain regulations, you should certainly look into the modular DocShifter platform. We would be happy to inform you more about our three editions and the Compliant Rendering Solution in general, to help you establish a more secure quality management system. We can even add certain features upon request, which are tailor-made to your organization’s needs.