Validate your PDF files are submission ready.
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 puiblishing to validate your PDFs. Vadliate 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.
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.
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
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?
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.
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.
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.
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.
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.
