One solution for all your regulatory and other content transformation needs.
Supporting every step of your
submission content preparation.
Solving your compliant
content preparation challenges.
1 software solution to go from source documents to creating and validating compliant PDF documents for multiple HAs
DocShifter automatically recognizes documents, emails, images, audio, and video files and converts them to the output format and specification required. In fully submission-ready, technically-compliant PDF or any other standardized format. Lightning fast. Once converted, these documents can be stored in a controlled Document Management System and included in any dossier needed, or archived as PDF/A.
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DocShifter can also convert individual documents into multiple output files, meeting the specifications of each regulator needed in one go, first checking the input document for issues and fixing many common problems it finds. Once converted, it can even automatically check and generate reports to demonstrate the converted files meet the requirements set out by each of the health authorities.
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Output can be enriched in many ways. OCR, automated table of content creation, headers and footers, bookmarks, watermarks and many more.Â
Centralize. Automate. Reduce risks.
One source document to multiple submission-ready PDF renditions
Create separate renditions for each Health Authority from the same source file. Simplify your global submission preparation. Save time. Reduce risk of missing deadlines.
Automated file format recognition
All supported file formats are automatically recognized and processed based on your workflow settings. Be setup and ready to render any format in minutes.
Process content wherever it is located
Simplify and speed up your document conversion from any repository (OpenText Documentum, Veeva Vault, SharePoint, Box, CARA, Lorenz, File Shares, etc.)
Reduce software and other IT costs
Drastically reduce the need for desktop tools and other decentralized solutions to prepare and validate your submission-ready PDFs.
Consistent look for all track changes and comments in PDF
No matter who reviews, edits and comments on your content, ensure the PDF renditions consistantly look the way you need them to.
Move technical compliance earlier in content preparation
Achieve full technical content compliance at the rendering stage. Identify issues well before you even begin publishing.
Merge multiple files automatically
Merge ZIP files, folders, Virtual Documents from OpenText Documentum or Binders from Veeva Vaults. Reduce effort required at the publishing stage.
Convert images and scans to searchable text-based PDFs
Create fully searchable, text selectable PDFs with integrated OCR (Optical Character Recognition). Fully integrated and automated.
Automatically generate Tables of Contents (ToC)
Automatically add a ToC to your source document or just to the rendition. Update any existing ToC's content and ToC page numbers in the rendition created.
Sets correct zoom level for all hyperlinks and bookmarks
Ensure compliance by setting all hyperlinks and bookmarks to inherit zoom. Other zoom settings can be set for other purposes.
Optimize for fast web view
Create PDFs that are optimized for fast web view, as required by most regulators. Allow you PDFs to be viewed more efficiently in web browsers.
Receive notifications when a rendition fails
Quickly identify issues with individual documents. Inform users and administrators of problems.
Compliant, fast, automated and scalable
file format conversion for the regulated enterprise.
PharmaLex reduces manual work, and the associated costs & risks to accelerate compliant PDF conversion of submission content
“DocShifter will save us over 750 hours of manual work per year. And we expect the time savings to increase as we continue to expand our use of DocShifter.
This is significant for our clients who need the eCTD sequences to be published quickly, accurately and efficiently.
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“The quality and reliability of DocShifter is very good. The integration with our submission management system makes it seamless to generate submission-ready PDFs, and the volume of PDF features eliminates most of our manual work.”
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Jennie May – Director, Regulatory Operations
PharmaLexÂ
5 minutes saved per document
PharmaLex saves 5 minutes per document, across thousands of documents they process every month.
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With DocShifter, PharmaLex is able to publish eCTD leaflets a lot quicker, while maintaining essential quality and compliance.Â
Centralizing PDF conversion
PharmaLex was previously using licensed PDF plug-in tools to prepare content for inclusion in submissions. The process of converting the original source documents to fully compliant submission-ready documents was complex, manual and extremely time-consuming.
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With DocShifter, PharmaLex is saving time and money while being able to automate most of the dull and repetitive tasks they used to have.
Accelerating submission publishing
Thanks to DocShifter’s wide range of PDF features, PharmaLex’s expert submission-publishing team is able to process more documents in a shorter amount of time.Â
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PharmaLex is no longer manually editing PDFs for submission readiness. Hyperlinks, bookmarks, zoom levels, fonts, table of contents and many other compliance elements are handled automatically by DocShifter.
"They listen, and make it happen. Very quickly."
PharmaLex has had some specific requirements for creating submission-ready PDF renditions.
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Due to the architecture, it is very easy to implement changes in DocShifter. We have listened to PharmaLex’s needs and suggestions, and have incorporated them in DocShifter in a short amount of time.Â
Case Study
"How does document conversion impact regulatory operations?"
“We have documentation in different languages, but when converting everything to PDF for submissions, things got complicated really fast. Our rendition engine couldn’t cope with all those fonts, and we lost a lot of time fixing problems that weren’t supposed to be there in the first place.
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We decided to make a switch to DocShifter.
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Scalability during our peak times, ability to deal with multiple fonts, automation (conversion of source documents to simultaneous submission-ready PDFs for multiple health authorities) and performance.
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These are just some of the things that make DocShifter such a powerful rendering engine.”
