Automatically fix & validate every PDF
that goes into your
submission package

Preparing PDF documents to meet strict health authority guidelines is
highly time-consuming and introduces risks.

DocShifter automatically validates every PDF against health authority
and other compliance guidelines and fixes them.

By automating the validation, you make sure that every PDF that goes in the submission package is fully technically compliant,
regardless of the application they were created with.

This significantly speeds up document preparation
for your regulatory submissions.

Discover more

Automated PDF Validator against health authority requirements by DocShifter | Automatically validate every PDF for inclusion in regulatory dossier

Manually identifying PDF issues

PDF is a worldwide accepted file format due to flexibility and features it provides.

In a typical submission process, pharmaceutical and biotech companies rely on manual methods to identify issues in PDF files before they go in the submission package. PDF documents from internal and external sources are checked manually, and the quality of documents are not always the same.

Given the number of PDF files, the time it takes to identify and fix issues cost these companies days and weeks; delaying the time-to-market.

Automatically check whether bookmarks are accurate or not with DocShifters automated PDF validation solution for life sciences

Are hyperlinks and bookmarks set to correct zoom level? Automatically check and fix with DocShifters automated PDF validation solution for life sciences

Automatically check if PDF file size is too large or not with DocShifters automated PDF validation solution for life sciences

Automatically validate every PDF
that goes into your submission package.
Save time and reduce the risk of non-compliance.

Check PDFs for a range of issues

Are there any misalignment or errors in the PDF that doesn’t match the regulatory guidelines?

DocShifter checks the PDF for hyperlinks, password protection, bookmarks, (blue) texts without hyperlinks, PDF version, PDF size and many more. Every technical requirement that your PDFs need to comply with, can be automatically performed.

Fix the PDFs automatically

DocShifter will fix many issues automatically and make sure the faulty PDFs are fully compliant with the HA guidelines.

This saves you time and drastically reduces the manual work required. No need to rely on manual desktop tools to fix and finalize PDFs.

No matter where your content resides

Whether you are using Veeva Vault, Opentext Documentum, Microsoft SharePoint, BOX, Generis CARA, Lorenz Docubridge or any other content repository, DocShifter connects to your systems, validates and fixes PDFs.

The fixed PDF can be returned as a new rendition, or can replace the original PDF rendition.

Automatically check if the PDF searchability is compliant or not with health authority regulatory requirements with DocShifter's automated PDF validation solution

Text searchability

PDF file size

PDF password protection

Automatically check if the PDF version is compliant or not with health authority regulatory requirements with DocShifter's automated PDF validation solution

PDF version
(1.4, 1.5, 1.6 or 1.7, etc.)

Automatically check if the fonts used in PDF are embedded or not for regulatory compliance with DocShifter's automated PDF validation solution

All fonts used have been embedded

Automatically check if your PDF magnification is compliant or not with health authority regulatory requirements with DocShifter's automated PDF validation solution

Magnification and
zoom level
is set to default

Automated checks to see if sectionsbookmarks are correct with DocShifter's automated Word formatting checker and fixer for compliance

Bookmark checks

Automated checks to see if external hyperlinks are accurate page with DocShifter's automated Word formatting checker and fixer for compliance

Hyperlink checks

Automatically check if your PDF contains comments or annotations for regulatory compliance with DocShifter's automated PDF validation solution

Annotation and
comment checks

Automatically check if the hyperlinks and bookmark zoom levels in PDF are compliant with health authority regulatory requirements with DocShifter's automated PDF validation solution

Hyperlink & bookmark
zoom level check

Plan a demo

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Benefits of automated PDF validation

Easily meet the technical PDF requirements for regulatory submissions
Ensure all PDF files are ready to be submitted to health authorities, no matter which tool they were created with
Centrally check and validate all PDF documents and fix errors automatically with 1 click

Reduce the risk of non-compliance and last minute stress in submissions
Provide submission ready documents to your publishers quicker than ever
Save valuable time and thanks to fully automated PDF validation checks

Improve and speed up the typical document lifecycle

You do not have to wait until draft publish stage to validate the technical compliance of PDFs.

DocShifter generates submission-ready PDF renditions from your source content at rendering stage.

For individual health authorities or simultaneously for multiple health authorities.

Faster time-to-market. Reduced risk of non-compliance. Saving you a lot of time and money in your submission process.

Improve document lifecycle and start validating PDFs earlier in your regulatory content preparation process with DocShifter's automated PDF validation software

Access the webinar recording

How to auto check and fix Word and PDF documents for compliance

You want to make sure that Microsoft Word & PDF documents meet compliance guidelines. And that they are fixed automatically if they don’t.

In this 30-minute webinar on 24 February, Paul Ireland talked about how you can easily:

Automate the formatting checks and fixes of your Microsoft Word documents for compliance (both regulatory and corporate compliance)
Automate the validation of PDF files against Health Authority (FDA, EMA, PMDA, etc.) guidelines
Incorporate the Word and PDF checks and fixes into your rendering process
Save valuable time and reduce the risk of non-compliance in your submission process

Frequently Asked Questions

What is PDF validation? What does PDF validation mean?

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.

PS: You can find the full FDA PDF formatting specifications in our free checklist.

How does PDF validation work within DocShifter?

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.

Can I also validate and fix PDFs that are initially not created by DocShifter? (created by other tools)

Absolutely. DocShifter can check, validate and fix PDF files regardless of the tool they were created with.

Which systems can DocShifter connect 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 above, please drop us a note at info@docshifter.com. We will be happy to investigate your question.

Can I deploy DocShifter in a cloud environment?

DocShifter can be deployed anywhere: in a private, hybrid or public cloud.

Furthermore, deploying DocShifter on Docker/Kubernetes allows for infinite scalability to handle peak loads.

How about pricing?

DocShifter subscription pricing is server, volume and functionality based. To find out more about pricing, please drop us a note at info@docshifter.com

Your peers found these interesting

How do you reduce regulatory content issues in your submission content preparation process?

4 tips: How to reduce regulatory content creation issues?

A fear for many: huge quantities of documents that must meet stringent guidelines.

Of course, these guidelines provide some flexibility, but you still need a rock-solid authoring process to simplify compliance with these technical and content specifications set by the Health Authorities.

What are some ways you can improve your content creation processes?

PDF requirements for US FDA submissions (Free checklist) - What are the FDA PDF specifications for FDA submissions? FDA submission requirements. US FDA PDF formatting specifications guideline.

Free checklist: FDA PDF formatting specifications

Do your documents meet the PDF format specifications of FDA?

With this free checklist, you will be able to check what specifications your PDF documents need to meet to be FDA compliant.

You can also see how easy it is to create FDA-compliant PDF renditions in DocShifter in our product video.

3 tips to save time and reduce risk in regulatory submissions

Compiling regulatory submissions is never easy. Fighting against deadlines and stringent guidelines, while your time-to-market is held hostage by the regulatory landscape.

What can pharmaceutical and biotech companies do to further simplify and streamline the regulatory submission content preparation process?

We have compiled 3 actionable tips for you. Enjoy the read.

Positively impacting document conversion

“We are using DocShifter integrated within our document management system. The solution offers the possibility to create document conversion workflows in a user-friendly (non-IT) way. It also allows possibilities for seamlessly integrations into existing solutions.

Very powerful tool for document conversion and generation. From my point of view quite unique in the industry.”

Kris VHEuropean biotechnology company – Read more on Capterra

“We are using DocShifter in conjunction with Documentum software. Best part is its performance. The PDF conversion performance that is observed so far is more than 4000 documents per hour (on 1 single DS instance).

The output is compliant to HA and is configurable for different countries. The services are also extended to DS team, which has helped us crack sever use cases those we had been struggling with the previous software.”

Piyush J. Multinational Pharmaceutical Company – Read more on Capterra

“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 BellgardPeopleScout Technology - Recruitment Process Outsourcing – Discover this use case

“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 Submission SpecialistMultinational Pharma 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 Kelleher CEO – Compliant PDF within CARA by DocShifter

“We are so excited about working together with DocShifter. The advanced content transformation solution implemented by DocShifter is extremely efficient, reliable and well designed. The partnership between DocShifter and DACHS is a perfect fit. Together, we have a strong product presence enabling us to enter into potential new markets.”

Ede FaludiCEO – See the official press release

“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 – See the press release

“Thanks to its extensible architecture, we chose to work with DocShifter as our solution to automate our document management process. DocShifter’s integration with OpenText Documentum© makes it very easy for us to configure our document layouts and the multi-target output allows us to deploy the document to any digital store or environment we’d like to. DocShifter fully responds to our need for a content conversion solution.”

Document Management Operation SpecialistTurkish Aerospace Industries

“Back in 2006 we created DocShifter because of the increasing demand for automated and large scale any-to-PDF conversions. Today, DocShifter supports over +300 formats and we are using its functionalities in our digital transformation solutions as a real business advantage. We do understand the full potential and power of the content conversion platform for companies in different sectors and are always looking forward to discover even more use cases.“

Frederik RosseelCEO – Docbyte

DocShifter team - the world's fastest document conversion sofftware - Schedule a live demo or contact us.

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Automated PDF Validation

Automatically fix & validate every PDF that goes into your submission package