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  • Industries
      • Life Sciences
      • Banking & Insurance
      • Other Industries
  • Solutions

      Life Sciences

      • Submission ready PDF

      Create compliant PDFs for your regulators all around the world.

      • Automated Word Checker and Fixer

      Automatically check and fix Microsoft Word documents for styling and formatting errors.

      • Automated PDF validation

      Check and fix your PDFs to make sure they meet internal and external guidelines.

      • Automated Report Level Publishing

      Create navigation-rich, searchable PDF reports by merging documents into single or multiple PDFs. 

      • PDF/A & TIFF conversion for archiving

      Mass convert all your enterprise files to future-proof file formats such as PDF/A or TIFF.

      • Incoming e-mail converter

      Monitor e-mail inboxes and automatically convert e-mail & attachments to PDF or other formats for correspondence tracking or other purposes.

      • Audio & Video conversion

      Convert your audio and video files to the format of your choice.

      Finance and Other Regulated Industries

      • Enterprise PDF converter

      Centralize the conversion to PDF for your entire organization.

      • PDF/A & TIFF conversion for archiving

      Mass convert all your enterprise files to future-proof file formats such as PDF/A or TIFF.

      • Incoming e-mail converter

      Monitor email inboxes and automatically convert mails and attachments to PDF or other formats.

      • Automated document generation

      Generate repeatable documents by bringing templates and data together. At scale.

      • Legacy document transformation

      Convert old file formats to the latest standard to ensure accessibility and readability of your valuable content.

      • Audio & video conversion

      Convert your audio and video files to the format of your choice.

      • Document conversion services

      A team of experts to help you convert thousands of digital files to another file format. 

  • Platform
      • How does the platform work?
      The basics. Connect all your systems, convert and enrich documents.
      • Maximum scalability
      How we scale to your fluctuating demands.
      • Speed

      Discover what makes DocShifter 10x faster than comparable solutions.

      • Integrations

      See how easy it is to connect to all your enterprise systems.

      • Automated file format recognition

      Discover how DocShifter can save you time with ‘set and forget’. 

      • Supported file formats

      Discover how DocShifter helps reduce dependency on desktop tools by supporting multiple file formats.

      • OCR

      Create searchable, extractable PDFs using our built-in OCR engine.

      • Deployment

      Windows, Linux, Docker. On-premise or in the cloud. You choose.

      • High-availability

      Keep your conversion services up and running at all times.

      • Insights

      See how rendering is used within your organization. Make smarter decisions based on data.

  • Resources
      • Blog & Whitepapers

      Tips & tricks, blogs, checklists or whitepapers on document conversion, digital archiving, eCTD, regulatory submissions and many more. 

      • Product Videos

      See DocShifter in action: animation videos, product explainers, and how-to videos. 

      • Events & Webinars

      Discover our past and future webinars; and see at which events you can meet us virtually, or in person. 

      • Customer Stories

      How are our customers using DocShifter, what benefits do they see, and what do they see about working with us? 

  • Pricing
  • About Us
      • Company & Our History
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Contact Us

Create
navigation-rich, searchable
PDF reports

fda

Discover how you can use DocShifter for
fully automated report level publishing

Create PDF reports to include in
your regulatory submissions

Clinical Study Reports (CSR), Investigational Medicinal Product Dossiers (IMPD), 510k submissions, etc.

PDF collation for submission documents

You can use DocShifter to merge documents into single or multiple PDFs that are used either as standalone reports or for inclusion later in your regulatory submissions.

Create other non-regulatory PDF reports

Standard Operating Procedures (SOP), training guides, annual reports, and many more.

PDF collation for other reports

DocShifter can automate the creation of complex reports by merging multiple documents of any format into 1 or more PDF documents.
  • Creating reports by merging documents manually?

    The process of creating reports requires full time employees, decentralized tools and a lot of manual effort. 

    Leveraging automation for report creation saves you valuable time and money. It ensures you get high-quality, navigation-rich, consistent reports with the minimum manual work. By reducing manual steps, you also reduce the risks from human errors.

  • Merge multiple documents into 1 or more PDF reports

    Cover pages with logos, graphics, text; table of contents (ToC), optional table of tables (ToT) or table of figures (ToF), consistent headers, footers and pagination across the entire report, watermarks and hyperlinks.

    These are some of the things you might need to include in your reports. 

  • Science takes time, all the rest should not

    Creating single reports from multiple individual source documents can be an un-necessarily complex and expensive process to manage. 

    Bringing a new drug to market already takes many years, so why complicate the generation of simpler reports, such as IMPDs, Clinical Study Reports, etc?

    Fully automate all your
    report level publishing with
    a centralized solution

    DocShifter has the ability to generate reports by merging multiple documents into 1 or more health authority compliant PDFs; including cover pages, ToC, ToT or ToF, bookmarking, adding pagination, headers, footers and much more.

    Fully automated, with no manual steps involved.

    Automate everything your reports need

    From creating cover pages, table of contents/tables/figures, merging or splitting documents, pagination, watermarks, headers & footers, DocShifter automates everything for you.

    Drastically reduce the risk of non-compliance

    Reduce the need for manual tools and steps in your report generation process.

    Integrate with your existing systems

    Whether your documents reside in folders on your network, in your controlled Document Management Systems, or in other solutions that contain content, DocShifter can connect directly to them via direct or web service modules.

    Move away from manual, decentralized methods

    Reduce the dependency on manual tools, plug-ins or complex solutions designed for submission compilation.

    Save time and money through automation

    Ensure consistency in the reports you create by removing manual steps. Once setup, DocShifter will create high-quality, navigation-rich and technically compliant reports.

    10x faster PDF conversion with reduced costs

    DocShifter doesn't need authoring applications (MS Office, Adobe technology, etc.) to perform document-to-PDF conversion. This speeds up the report creation process, and reduces the required licensing and infrastructure costs.

    Automated report level publishing illustration - merge documents into PDF and generate navigation-rich PDF reports

    Free FDA PDF format specifications checklist

    To help you out in your submissions to US FDA, we prepared a free checklist. This free FDA PDF specifications checklist can help you reduce risk of non-compliance in your submission content preparation for FDA.

    Download the free checklist

    Simplify and speed up
    report generation

    Define the content required for inclusion in your reports in ZIP files, folder structures, Documentum Virtual Documents (VDs), or Veeva binders for automated report-level publishing.

    Specify the contents required

    Define the content required for inclusion in your reports in ZIP files, folder structures, Documentum Virtual Documents (VDs), or Veeva binders. The order within the report can also easily be specified regardless of the source.

    Automatically merge multiple documents into 1 or more PDFs

    Whether you need to create clinical study reports (CSR), standard operating procedures (SOP), training guides, annual reports, or any other type of report, DocShifter can automatically merge multiple documents; add the required table of contents, bookmarks, cover pages, watermarks, consistent header and footers and more.

    This reduces the manual burden of having to collate and finalize reports manually.

    Automated PDF enrichment and compliance features to accelerate your report creation processes.

    Cover Pages

    Automatically add cover pages at the beginning or end of your reports. Leverage the metadata in your DMS to include dynamic titles, add visuals such as company logos, graphics or other text, etc. All designed in the tools you already know (MS Word).

    Table of Contents

    Automatically create an overall table of contents that covers the sections for the entire report.

    Table of Tables & Table of Figures

    If needed, also include separate Tables of Tables, Tables of Figures, etc.

    Merge multiple documents

    Merge as few or as many documents together as needed for the report type needed. Whether just a few, or hundreds of documents, DocShifter will merge documents no matter what the original format.

    Consistent headers & footers

    Automatically add consistent headers and footers to your report. Leverage attributes from your DMS to further automate the process.

    Pagination across all documents

    Automatically add consistent pagination across your final report.

    Split reports into multiple output files

    If you need to create the report in multiple output files, DocShifter can automatically split the final report based on page count, or file size.

    Hyperlinks & bookmarks

    Ensure your hyperlinks and bookmarks continue to function correctly, and are styled appropriately throughout your reports.

    Meet all your compliance needs

    The final report can meet all the same technical specifications as any individual document rendition created by DocShifter. Optimized for fast web view, correct PDF version, fonts embedded, initial page view settings defined, etc.

    Frequently Asked Questions on Automated Report Level Publishing

    How are DocShifter's automated report-level publishing capabilities complementary with Lorenz's publishing capabilities?

    DocShifter’s automated report level publishing capabilities generate navigation-rich, searchable PDF reports.

     

    For inclusion in regulatory submissions, these reports must comply with the right submission structure. Compiling, publishing and reviewing needs to be done by a publishing tool, like Lorenz Docubridge.

    Can DocShifter automatically bookmark PDFs and create Table of Contents (ToC)?

    Yes to both questions. DocShifter can automatically create bookmarks in many different ways. DocShifter can create bookmarks from custom heading styles, as well as from Word’s default headings.

    For Table of Contents (ToC), you can define whether you would like to create it at Word level, or PDF level. You can set limits, and skip generating a ToC if the page contains less than 5 pages, for example. You can also automatically define rules to automatically create a ToC if the page exceeds 10 pages. 

    For more questions, please drop us a note. 

    What is a clinical study report (CSR)?

    A clinical study report is an extensive report; including statistical descriptions, presentations and analyses of a clinical study. A CSR usually utilizes tables and figures to present the data. 

     

    A CSR provides an overview of how and why the trial was chosen; gives information on the plan; methodology and the conclusion of the study.  

     

    A clinical study report’s format and content are defined by ICH. A CSR must contain study objectives, investigational plan, study patients, efficacy and safety evaluations, and overall conclusions. 

    What do you mean by 'fully automated' report level publishing?

    By ‘fully automated’, we mean that report level publishing doesn’t have to include any manual work. Today; companies use complex publishing tools (typically designed for submission publishing) that require lots of manual configuration to generate reports. And this manual configuration is required for every report. 

    DocShifter, once configured, will fully automate your report publishing needs. Without any manual intervention, it will merge documents; add ToC, bookmarks, headers and footers; and generate 1 or more PDF outputs. 

    Can we try DocShifter?

    Yes of course. We thought you were never going to ask.

     

    There are multiple options:

     

    • Hand-held demos with your own content.
    • A dedicated environment that you can use to upload files to. Where you can configure your own workflows.
    • On-premise trial installations, so you can test quality and performance within your own infrastructure.

    Contact us to try for yourself.

    What is document level publishing?

    Document level publishing is the process of creating bookmarks, hyperlinks and other required PDF elements for the document. The goal of document level publishing is to make navigation easier; and therefore simplifying the review process. 

    Which systems can I connect DocShifter to?

    DocShifter has native integrations with OpenText Documentum, Veeva Vault, Microsoft SharePoint Cloud, Generis CARA, Lorenz Docubridge, File Systems, Dropbox and FTP.

    It also supports any other system that allows Web Services API connections, such as IBM Filenet, Box, Alfresco, etc.

    If your content repository isn’t represented on the Integrations page, please use the Contact Us options to ask. We will be happy to investigate your question.

    How about pricing & licensing? How much does DocShifter cost?

    DocShifter subscription pricing is server, volume and functionality based. 

     

    To find out more about pricing, please visit our Pricing page and request a quote. 

    What is DocShifter?

    DocShifter is the world’s fastest any to any conversion software. Speed, quality, scalability and configurability are the reasons why leading companies use our software to convert their documents into high quality, navigation-rich, searchable content.

    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

    PharmaLex - confidence beyond compliance

    “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.

     

    “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.”

     

    Jennie May – Director, Regulatory Operations
    PharmaLex 

    Read more on pharmalex's benefıts

    5 minutes saved per document

    PharmaLex saves 5 minutes per document, across thousands of documents they process every month.

     

    With DocShifter, PharmaLex is able to publish eCTD leaflets a lot quicker, while maintaining essential quality and compliance. 

    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.

     

    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. 

     

    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.

     

    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. 

    See what our beloved customers have to say about us:

    "DocShifter is converting 36.000 documents per day, coming from all over our company (and external). We have no control over what is coming in. And still the failure rate is below 1%.

    And what really sets it apart from what we were doing before, DocShifter tells us what went wrong, so we can act upon the documents that did not convert".
    Operations Manager Large European Bank
    "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. "
    Jennie MayDirector, Regulatory Operations - PharmaLex
    "Very powerful tool for document conversion and generation. The DocShifter software goes further than our current needs, and from my point of view quite unique in the industry. Quick adaption due to user-friendly workflow creation functionalities. Possibility to create workflows in a user-friendly (non-IT) way. Possibilities for seamlessly integrations into existing solutions."
    Kris V.ITS Business Partner, Clinical Development
    "We are using DocShifter in conjunction with Documentum software. The rendition performance that is observed so far is more than 4000 documents per hour (on 1 single instance). The output provided is fully compliant to health authority specifications (FDA, EMA, PMDA, HC, SwissHealth, etc.) and is configurable for different countries. A true enterprise document conversion solution.”
    Piyush J. Solution Manager
    "We use DocShifter to prepare compliant, submission-ready PDF renditions for all regulatory content.

    The product is reliable, extremely fast and produces output that is compliant with multiple Health Authorities."
    Large US biotechnology companyRegulatory Information Systems Manager
    "We implemented DocShifter into production and have converted over 35.000 documents. Our failure rate has dropped from over 10% to well under 0.1%. We have seen an astronomical improvement in our document conversion processes thanks to how easy DocShifter was to implement and to use. In the course of 12 months, we are going to convert more than 100.000 documents with DocShifter. Fantastic document conversion solution!”
    Chris B. IT System Administrator - PeopleScout Technology
    "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. We decided to make a switch to DocShifter. 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. These are just some of the things that make DocShifter such a powerful rendering engine."
    Jade O. Document Management Professional
    "We selected DocShifter for the incredible ease-of-use, the simple configuration and implementation, the high-quality ICH compliant output, and the huge number of formats supported. Performance is excellent, and we reduced the number of rendition servers by a factor of 3. All of this, plus the company’s responsiveness made it an easy choice."
    Regulatory Operations & Global Submissions SpecialistLarge pharmaceutical company
    "DocShifter powers the document conversion solution in Generis’ new CARA cloud offering. “We already support many joint customers who have advanced document conversion requirements met by the integration of DocShifter with CARA. We are now happy to be able to offer this on a pre-built package with New CARA on our cloud for such customers.”
    James KelleherCEO - Generis
    "As we are in the middle of a paradigm shift from analogue to digital in Japan, I have been looking for the right solution to support this for many years. In DocShifter we have found a company with solutions that have been selected by organizations of all sizes because of their responsiveness, cost-effectiveness, class-leading performance and unique capabilities that rise above the competition.”
    Kosuke OmodaPresident - eSA Japan
    "One of the things we love about DocShifter is the graphic interface to configure file transformation flows. The user interface is very simple to use and rare to find within other similar document conversion products. Wide selection of connectors to different solutions (EIM & DMS systems) make DocShifter a great choice for our company as well. We also are very happy with the customer support we receive: extremely friendly and prompt.”
    Nikita L.Information Management Consultant
    "With DocShifter, we are seeing better performance with even less resources, compared to our previous solution. The deployment is very easy, and the utilization of hardware/software resources are extremely efficient. Thanks to DocShifter's architecture and not needing Office applications, we were able to save a lot of money and resources by the switch.”
    Istvan V.Solution Architect
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    15 years of experience in automating, simplifying and speeding up document conversion.
    For all regulated industries. 

     

     

    Rated 5 stars on Gartner’s Capterra platform.

    DocShifter document conversion solution is rated 5 starts by our customers on Gartner's Capterra platform.

    Contact us

    • hello@docshifter.com
    • +32 (0)9 242 87 39
    • Address
      Eedverbondkaai 242/003
      B-9000 Gent
      Belgium
    • VAT (BTW) Number
      BE0544.961.044

    Schedule an intro call

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