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Validate your PDF files are submission ready.

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  • Identifying issues in
    PDF files
    is time-consuming.

    In a typical submission process, pharmaceutical and biotech companies rely on manual methods and decentralized desktop tools to identify issues in PDF files before they are included in the submission package.

    Checking that the PDF output meets the detailed HA requirements is highly time-consuming and as with any manual process includes risks.

  • Risk of non-compliance is a major problem.

    Health Authorities' standards include correctly embedding fonts, fast web view optimization, correct bookmarking, accurate hyperlinks, table of contents inclusion and much more.

    In a typical submission, where large numbers of PDF files must be verified manually, issues can easily slip through the cracks.

    Automating these validation checks earlier in your process allows you to identify issues earlier and significantly reduce the risk of non-compliance.

    Automatically validate every PDF is submission-ready.

    DocShifter automatically validates every PDF against health authority and other compliance guidelines. This automation ensures that every PDF that will be included in a submission is fully technically compliant, regardless of the application it was created with.

    This significantly speeds up document preparation for your regulatory submissions. 

    Easily meet the technical PDF requirements

    Even if the PDF files you receive from external parties, CROs, etc. do not meet the PDF guidelines, DocShifter will check and fix these for you.

    Integrate with your existing systems

    Either through native connectors or Rest API, pull documents from your systems and create perfect PDF renditions.

    Reduce risk of non-compliance

    Don't wait until you are publishing to validate your PDFs. Validate early and provide truly submission-ready content to your publishers.

    Reduce risks and strengthen compliance

    Using manual tools to validate the stringent PDF specifications introduces a lot of risks. Avoid these risks by automating PDF validation.

    Check and fix PDFs, no matter how they were created

    Whether created by your document management system, desktop tools or publishing tools, DocShifter can check and fix from any source.

    Centralize PDF validation

    Centrally and automatically check and validate all PDF documents and fix errors. Without the need for desktop tools.

    Automatically validate and fix your PDF files against Health Authority guidelines with DocShifter
    Start a live chat. Ask questions, or book a demo

    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

    Some of the PDF checks that can be automatically performed.

    Text searchability

    Check if your PDFs are text searchable

    Password protection

    Check if your PDFs are not password protected

    PDF file size

    Check if your PDF file size exceeds the required limit

    PDF version

    Check if the PDF document version is correct

    Check if all fonts are embedded

    Make sure that all the used fonts are embedded in the PDF files

    Magnification and zoom level

    Check if the magnification and zoom levels are correct

    Bookmarks

    Check the correct number of levels of bookmarks have been created and shown is accurate. Check for broken bookmarks and zoom level set properly.

    Hyperlinks

    Check if internal hyperlinks have the right color, all the hyperlinks work (no broken links) and hyperlink magnification is set to inherit zoom

    Annotations and comments

    Check if the document does not contain any comments or annotations

    Optimized for fast web view

    Check if the PDF documents are optimized for fast web view

    Save huge amounts of time in your regulatory submissions: Begin PDF validation earlier.

    Reduce the risk of non-compliance by moving technical content compliance earlier (the moment you first generate or receive your PDF) and reduce last-minute stress during publishing (well some of it anyway).

    How does automated PDF validation work?

    01

    Connect your systems

    Connect DocShifter to all the systems where your content is stored. Either through native connectors, or using the Web Services API. For more information on the integrations, please visit our integrations page.

    02

    Convert to PDF if necessary

    Convert your source documents (MS Word, Excel, PowerPoint, OpenOffice formats, e-mails and attachments, scanned images, audio and video files, etc.) into high-quality, navigation-rich PDF documents if not already done.

    03

    Validate the PDF meets HA guidelines

    Check and validate the PDF document for annotations, bookmarks and hyperlinks, PDF properties, formatting, headers and footers, page format, pagination, initial view settings, magnification settings, JavaScript, security and many more against the specifications defined by Health Authorities.

    04

    Output and report

    The results are then stored directly in the desired DMS, RIM system, EIM platform, folder or other systems via web services.

    You will receive a clear report of the identified and/or fixed issues, as well as any outstanding non-compliant elements.

    Frequently Asked Questions

    PDF validation is the process of checking and PDFs against a set of rules. These rules or guidelines are defined by the health authorities where the products will be marketed. FDA, for example, demands that PDF can not contain security settings such as passwords and all the fonts in the PDF documents should be between 9 – 12 only.

     

    As different health authorities set out different guidelines for compliance, PDF validation is a core process in submissions. Organizations must be sure that the documents they send out comply with the HA guidelines.

    DocShifter is able to automatically check PDF files against a set of rules defined by users. If you wish to, for example, check every document against FDA guidelines, DocShifter will compare the PDF properties and a range of issues with the defined FDA guidelines.

     

    In case your PDF files fully comply with the FDA requirements, DocShifter will return a report to inform you of it.

     

    In case some of your PDF files do not comply with the FDA requirements, you can either tell DocShifter to fix them or simply report and communicate this with internal/external stakeholders.

     

    PDF validation rules can easily be defined and updated in case there are any changes to what health authorities/other regulators demand.

    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.

    DocShifter subscription pricing is server, volume and functionality based. 

    To find out more about pricing, please visit our Pricing page and request your estimate. 

    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 Platform -> Integrations page, please drop us a note at info@docshifter.com.

    We will be happy to investigate your question.

    Compliant, fast, automated and scalable
    file format conversion for the regulated enterprise.

    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.

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