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How to design or implement an enterprise file conversion platform?

Enterprises deal with a lot of documents, in multiple formats. Word, Excel, PowerPoint, PDF, PDF/A, scanned images, JPEG, TIFF, audio and video files, XML, HTML, e-mail files and many more.

All these files need to be converted for many reasons: standardization, digital archiving, customer communication, regulatory compliance, internal requirements, etc.

It is also possible that the systems in-place have difficulties working with older formats. Think of old versions of Microsoft Word. Not every format supports backwards compatibility.

Some file formats have become de facto standards: PDF for outgoing documents, and PDF/A or TIFF for digital archiving.

Of course, enterprises have to take other criteria into account as well when looking to simplify and speed up their document-related processes.

We have prepared a free guideline for you. This document will help when selecting the right file conversion platform for your needs.

What are some key requirements you should consider for all your enterprise transformation needs?

To ensure the platform meets all your enterprise transformation needs, it must:

  • Connect with your existing enterprise content systems to allow transformations: OpenText Documentum, Microsoft SharePoint, IBM FileNet, Alfresco, Veeva Vault and e-mail systems such as POP, IMAP, Exchange or Office 365.
  • Support flexible deployment: On-premise or in the cloud of your choice: Amazon Web Services (AWS), Google Cloud, Microsoft Azure, etc.
  • Have multi-support platform: Linux, Windows or Docker.
  • Scale and grow to your needs. And ideally, support Docker & Kubernetes to allow maximum scalability during peak loads.
  • Easily be implemented by an expert team. Are there sufficient skills in the market to do the implementation? Are there companies specialized in doing the implementation?
  • Reduce your costs, in many different ways. Not needing authoring applications (Microsoft Office, Adobe technology, AutoCAD, etc.) will for example reduce your licensing costs.
  • Support all the formats your enterprise uses: from Microsoft Office formats to image files, Photoshop documents, e-mail files and many more.
  • Generate output that is compliant with your industry regulations.
  • Help centralize document conversion throughout the enterprise: marketing, sales, HR, delivery, operations, development. All should use 1 centralized conversion platform for consistent output.

These are just some of the key requirements you should keep in mind when selecting your enterprise file conversion platform. You can find all the key requirements in our free guideline.

How to know if your enterprise file conversion platform is the right one?

File conversion throughout the enterprise is a very resource intensive process. Not only resource intensive in terms of computer power, no. It also requires a lot of manual work.

Do you recognize any of these? Does your existing file format transformation software allow less and less automation? Because it is outdated? Out of support perhaps?

How can you cope with new file formats? Do you have to purchase extra tools and software to be able to convert those new file formats?

How about regulatory compliance? Do you manually make sure that your documents meet the specified guidelines? Or is there an automated validation mechanism?

How do you design an enterprise file conversion platform? What are key requirements to look at? UI, conversion options and connectivity. How do you design an enterprise file conversion platform? What are key requirements to look at? Supported file formats, regulatory compliance and reporting capabilities.

Every enterprise needs an efficient, fast enterprise file conversion platform

Many companies in different industries (insurance, banking, HR, automotive, aviation, life sciences and healthcare, IT integrators) use DocShifter to speed up and simplify their document conversion and enrichment. 

DocShifter software is 10x faster than comparable solutions, easier to use and doesn’t need authoring applications (MS Office, Adobe technology, AutoCAD etc.) to run. Saving you valuable time. Reducing your IT and infrastructure costs. Speeding up your operations. 

Looking for an automated document conversion software that can convert and enrich your 100.000s of documents at lightning speed? 

Contact us today or schedule a demo

 

How to reduce regulatory content creation issues? 4 tips.

Life Sciences organisations are required to create huge quantities of documentation to support the marketing of their products around the world. Industry standards have been put in place to ensure that Global Health Authorities receive content in a manner that simplifies the review and approval process of new medicines or devices. These guidelines do provide the sponsor organisations with some flexibility, but good authoring processes are essential to ensure the content is presented in both the format and to the technical specifications required by the agencies.

Most health authorities base their specific submission content requirements on guidelines set out by the International Council for Harmonisation (ICH). The final documents being submitted will mostly be in PDF format, but the content will be created and edited using traditional authoring tools such as Microsoft Word. To ensure the PDF is compliant, the Word document needs to be prepared in a specific way. If done correctly, and with the correct tools in place for content conversion, the process of generating the final PDF files for inclusion in regulatory submissions can be much simplified.

Typical regulatory content creation process - How do you simplify regulatory submission content preparation?

Typical regulatory content creation cycle – Author a document, review and render, prepare the PDF manually for inclusion in the dossier. Draft publish and validate at the last minute to identify errors.

 

 

 

 

 

 

The guidelines for content cover many aspects of how the document will look and also how it can most easily be navigated through when being reviewed. 

What do some rules regulatory guidance cover? Here are some examples. 

  • Font Specification
    • Recommended fonts
    • Permissible font sizes
    • When fonts should be embedded
  • Use of Images
    • Acceptable image compression methods (specific for colour, black & white, greyscale)
    • When images should have Optical Character Recognition (OCR) applied
    • How the text should flow around images
  • Headings
    • Section numbering formats
    • The sequencing of numbering
    • How many heading levels to use
  • Linking
    • What style should be applied to hyperlinked text
    • Allowable target types for links
  • General Formatting
    • Track changes & comments usage
    • Empty pages and other spacing
    • Table formatting
    • Use of embedded objects

Ensuring these rules are followed on every single document used is very difficult, and often extremely time-consuming for those involved in authoring and preparing the content for use in submissions. It also becomes significantly more difficult to control once content is authored by external contributors. Typically, much of the work to ensure these guidelines are met is still performed manually or using multiple tools to check and rectify specific issues.

How to simplify regulatory content creation issues? 4 Tips to Ease the Burden

1. Correctly implement a good set of document templates.

This sounds logical, but often templates are purchased as a package and not configured in a way to suit the needs of both the company itself and the Health Authorities. Often this means that many formatting and other changes still need to be performed manually once the content has been created.

If purchasing ready-made templates, ensure that the vendor can help configure the templates fully to maximize your investment, otherwise you will not be getting the value you should expect.

While templates can help keep authors on track with the guidance, it is always possible for changes to be made that would mean the document no longer complies with the rules.

How to reduce regulatory content creation issues for regulatory submissions? 4 tips.

Document templates can help ease the burden in regulatory content creation processes. However, keep in mind that the templates need to be kept up to date and need to remain compliant.

2. Use a standard authoring tool that can help identify and resolve formatting issues.

Implementing a number of different tools or macros to help identify issues with the content is very complex and becomes expensive to maintain and manage. If developed in house, the functionality needs to be kept up-to-date, or you have to deal with multiple vendors if sourced externally. Choose a single tool that can more easily be distributed to your authoring community that best meets your specific needs. Tools exist that:

  • Can check your content for both internal and external compliance issues,
  • Identify where the document deviates from the rules set out in the template,
  • Provide the ability to fix the issues individually or in batch,
  • Extend the capabilities in Word to ensure compliance is more easily maintained in the first place.
  • Are maintained by the vendor to comply with any evolving requirements.
Using a standard authoring tool can help identify and resolve formatting issues in your regulatory content creation process.

Make sure to use an automated tool that can check and fix Microsoft Word documents for formatting issues. This saves time and reduces the risk of non-compliance.

3. Implement a new rendering solution.

Rendering solutions are often put in place alongside the Document Management System and little thought is put into what capabilities they offer other than their ability to convert content to PDF. Modern rendering technology can provide many benefits to the authoring process:

  • Ensure the PDFs created are fully compliant with the Health Authority specifications (legacy rendering tools typically create standard PDFs which are not suitable for inclusion in a submission without further manipulation).
  • Fonts are embedded correctly.
  • Hyperlinks are coloured correctly, even if not correctly set in the original source document.

What can a rendering solution mean for regulatory content creation? Font handling, hyperlink handling and many other options to become Health Authority compliant.

  • The appropriate Headings are converted into PDF bookmarks, even if too many heading levels have been created

Rendering solution should also be able to handle bookmarks, to make sure that the PDF generated is submission-ready to different Health authorities across the globe.

  • Track changes have a consistent look in the PDF output regardless of differing authoring and Word settings.

These are just examples of how a modern rendering software can automatically adjust elements to account for issues in the original source document. Ideally of course the original document will be authored in a way that minimizes the need for adjustments at the rendering stage, but the rendering platform is a critical part of the content creation process that is often overlooked.

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

Modern rendering solution allows you to generate technically compliant, submission-ready renditions earlier in your submission content preparation process. This way, you don’t have to wait until the last minute to validate the PDFs. This approach drastically reduces the risk of non-compliance and speeds up time-to-market.

4. Fully automate many of the checks and fixes in the source documents.

The manual and batch methods typically used to perform updates on the documents are highly effective, but do still require an element of human interaction. With any human interaction, a degree of risk is always introduced. It is now also possible to fully automate many of the checks that need to be performed on all documents, as well as fix many of the errors that occur. Without any human interaction.

Preparing content for regulatory submissions can be manual, batch or automated. They are all being used today by pharmaceutical and biotech companies, and have their advantages and disadvantages.

This automation can be fully integrated into your document lifecycles, whether using a Content Management System or not. Automated workflows will check and fix the documents at the required points in the content’s lifecycle without any involvement from the content creators. This allows your authors and others involved in preparing the content for use in a submission to focus on the content, knowing that many of the formatting and technical issues can be discovered and resolved automatically. It will likely never be possible to fully automate the content preparation process, as there will always be issues that require human interaction. These fully automated tools can at least ensure any issues are automatically identified to be resolved by someone with the correct knowledge later.

Example DocShifter workflow to check and validate the content before inclusion in regulatory submission.

DocShifter is able to check and fix many formatting and styling errors in Microsoft Word documents before converting these to submission-ready PDF files.

Conclusion

Many hours of time is lost by a large number of people to ensure content is prepared with the right formatting and to the right specifications for its intended use. While each check might seem minor on its own, when you multiply the number of checks performed in each document by the number of documents being authored, by the number of versions created through its lifespan, this becomes an enormous issue for any size Life Sciences organisation. Luckily, technology has evolved to ease this burden.

Any automation to these processes can reap huge rewards for any company and ultimately further reduce the risks associated with any manual task. It makes the entire authoring and review process more efficient and ensures the limited time available can be focused- as it should be- on the content and delivering fully compliant content on time.

About DocShifter

Speed, quality, scalability, and configurability are reasons why biotech, pharma and medical devices companies choose DocShifter to automate and simplify all their document conversion processes. From automatically checking and fixing Word and PDF documents to generating compliant, submission-ready PDF renditions, DocShifter software offers a unique and proven approach to speed up time-to-market.

High volume, high-quality document conversion, on-premise, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs. Rated 5 stars on Gartner’s Capterra platform.

Bonus: We created an FDA PDF format specifications checklist for you, so that you can identify content-related issues as soon as possible to reduce the risk of RTF.

You can download the checklist here.

Free checklist for PDF format specifications for FDA submissions

Pharmaceutical and biotechnology companies spend a lot of effort in the R&D process of a new medicine or a product. As every stage must be properly documented, a typical R&D process generates a lot of documents. And in a lot of different formats: Word, Excel, PowerPoint, text files, image files and many more.

Why is it important to comply with the US FDA PDF submission requirements?

Health authorities base their specific submission content requirements on guidelines. Not complying with these guidelines will increase the risk of refusal to file (RTF) and loss of revenue. The documents must be reformatted again afterwards, which also increases the amount of manual work. 

Even though FDA provides some flexibility, these guidelines should be followed in most business cases.

What are the FDA submission requirements for PDF files? (What are the FDA PDF specifications?)

To ensure the PDF is compliant, the original source documents must be prepared in a specific way. The PDF file must be: 

  • Including all content from the original source. 
  • Readable by Adobe Acrobat X. 
  • The correct PDF version (1.4 – 1.7 or PDF/A-1, PDF/A-2)
  • Free from JavaScript or any other dynamic content
  • Free from password or other restrictions. 
  • Embedding all non-standard fonts. 
  • Using font sizes from 9 to 12. 
  • Free from PDF annotations
  • Text searchable if they are scanned. 
  • Optimized for fast web view
  • Including table of contents if they are 5 pages or larger. 

These are just some of the PDF file format specifications for electronic submissions to the FDA. You can find all the FDA PDF formatting specifications in our free checklist. 

What is the easiest way to comply with the PDF requirements for US FDA eCTD submissions?

The stringent PDF requirements make US FDA eCTD submissions very complex. Many source documents need to be formatted in a specific way. Hyperlinks, bookmarks, navigation options, table of contents, page margins, PDF versions, annotations, PDF security options, fonts and many more. Manipulating and finalizing all these documents remains a challenging task.

Many pharma and biotech companies either do these in-house, or have outsourced it. Yet, finalizing PDFs for submissions is still done manually, using desktop tools.  

To save you time and simplify submission-ready PDF generation from source content, we developed the DocShifter software. DocShifter is able to generate fully compliant, submission-ready PDF renditions from your source content. Simultaneously, for FDA, EMA, PMDA or any other health authority. Reducing risk of non-compliance and speeding up time to market. 

Please take a look the video to see how you can simplify FDA submission content preparation with DocShifter.

Would you like to schedule a demo with your own (anonymized) content? Happy to arrange that as well. Please pick a day & hour that works for you.

Document conversion software for enterprises: which solution should I choose?

What is enterprise document conversion and how does a document conversion software impact your business?

Enterprise document conversion is the process of converting different digital file formats into other formats so that they can be used in various business processes (standardization, customer communication, digital archiving,  sharing and collaboration, etc.) and applications (CRM, ERP systems, etc.). The whole idea is to make file formats accessible, readable and shareable internally and externally: with stakeholders, other departments, etc.

Document conversion software is the software that is responsible for the file format conversion. File format conversion, depending on the number of documents, can be a background process. Converting just a few documents to PDFs for example, is easy and can be done via desktop tools. Just open Microsoft Word and save the document as a PDF. And repeat this for your 100 documents. 

But when talking about enterprise document conversion, the number of documents grows immensely.

When you have 100.000s of documents to convert to PDF or PDF/A, choosing the right document conversion software for your business is crucial. We’ll explain the three most important features of a true document conversion software that add value to your business.

1. A true document conversion software should be fast(er)

Most organizations, without even realizing it, are not directly converting documents to PDF. Instead, they first have to open the source file in the application where the original document was created. This ‘authoring application’ can be a Microsoft Office application (Word, Excel, PowerPoint) or Adobe technology, for example. And then a PDF is created from those applications. This indirect process is significantly slowing down the whole document conversion. An ideal software that doesn’t need this intermediate step will work much quicker and is definitely the right choice for organizations with large volumes to convert.

The speed of your document conversion software is also impacted by its speed of enriching documents: adding headers, footers, bookmarks, table of content (TOC), hyperlinks, security, watermarks, … All these enrichments may be legal requirements, so you can’t go without them. 

Classically, the PDF document created will be uploaded to different tools in order to add all necessary elements. This manual work is not only increasing the risk of errors, but it’s also slowing you down. A conversion software that offers both conversion and enrichment capabilities, is clearly a lot faster and reduces your dependence on having other tools to enrich the documents. 

What is an enterprise document conversion software How does it speed up your document conversion

A document conversion software that provides both conversion and enrichment capabilities, will speed up your document-related operations drastically.

2. A true conversion software should help reduce costs

All authoring applications (such as MS Office or Adobe technology or AutoCAD etc.) require licenses. And these licenses come at a cost. Plus, the software also needs maintenance. If you can convert your documents directly without needing the original application, this will result in huge cost savings.

The same goes for OCR: extra tools, plug-ins and add-ons you might need to perform OCR on the converted documents. They also come with licensing costs. An all-in-one document conversion solution is not only much faster, but will work great for your budget.

Have we mentioned the manual work? Document enrichment is very labor-intensive. Converting a Word document to PDF via Adobe takes no more than 5 seconds, but enriching (managing hyperlinks, adjusting zoom levels, adding headers & footers, watermarks, bookmarks, merging documents, creating searchable documents etc.) and re-routing it to the right repositories is the most time-consuming task of the document conversion process. If this has to be done for thousands of documents, you or your employees will spend lots of time (days or weeks probably) doing repetitive manual work that can be automated by an efficient document conversion software.

How does Word to PDF conversion work with authoring applications? How does that impact document conversion? Blogpost by DocShifter - enterprise document conversion software

The most common of converting a Word document into PDF. For this process, you need both Microsoft Word and Adobe technology, which slows your conversion speed down.

3. A true conversion software should help reduce manual work

Avoiding manual work as much as you can: that’s where an ideal conversion software should add value. Downloading content manually to the computer desktop, for example from email repositories or document management systems, and then uploading it to the conversion tool? The right document conversion software can do much better: it will automatically take content from any location(s), convert it to desired formats and send it back to the right location(s)

Other manual steps can be eliminated too, such as the use of optical character recognition technology (OCR). Rather than having to use a separate OCR tool, the perfect document conversion software should have built-in OCR as part of the document conversion process. Saving you valuable time, while reducing your dependence on manual tools. 

This maximum automation in one platform will give you the greatest ease of use. You don’t need to check what the document will look like in Microsoft Word versus Adobe. No more wondering whether colors, titles and other settings will appear in the same way. You just control everything from one platform before converting documents. 

How does automated document conversion work? How does it speed up document conversion? Blogpost by DocShifter - enterprise document conversion software.

The cost of manually converting and enriching documents is just too high. And the risk of non-compliance in regulated industries. A true document conversion software should solve these problems.

Every company needs an efficient document conversion solution

Many companies in different industries (insurance, banking, HR, automotive, aviation, life sciences and healthcare, IT integrators) use DocShifter to speed up and simplify their document conversion and enrichment. 

DocShifter software is 10x faster than comparable solutions, easier to use and doesn’t need authoring applications (MS Office, Adobe technology, AutoCAD etc.) to run. Saving you valuable time. Reducing your IT and infrastructure costs. Speeding up your operations. 

Looking for an automated document conversion software that can convert and enrich your 100.000s of documents at lightning speed? 

Contact us today or schedule a demo

6 Rocking Reasons to Rethink Document Rendering

We have been rendering various documents into a unified format such as PDF for many years now. For many reasons: ease of use, accessibility, a wide range of functionalities and many more. 

In knowledge-driven industries, the need for standardization is often forced by regulators. For example, in Life Sciences, the introduction of the electronic Common Technical Document (eCTD) has accelerated the move from paper to electronic formats; mainly to PDF.

In other industries, the need to archive documents has led to massive content transformation as well. Transformation to de facto standards such as PDF/A ensures that documents are secure for the long term. Read more

3 tips to save time and reduce risk in regulatory submissions

How can you speed up the process of getting your medicinal products approved by health authorities? At the same time, how can you reduce the risk of submitting PDFs that are not complying with technical requirements in your regulatory submissions? Our tips will help you streamline the whole regulatory submission process.

For Life Sciences companies, time is scarce when preparing to launch a new product. Anything that slows down your submission process and introduces a risk of a delay in gaining approval is hugely frustrating. Having your submission rejected by the health authorities because your PDFs don’t meet their technical requirements is time-consuming, financially expensive and negatively affects the company’s image. So here are a few tips on how to tackle this challenge, save time and reduce the risk of non-compliance.

Tip 1: Move compliance earlier in your regulatory submissions (don’t wait until submission time)

When creating PDFs manually or with many rendering tools, you typically need to edit them afterwards in order to meet each of the health authorities’ technical requirements where the content will be used. A regular PDF will not be compliant by default, so additional tools and steps are required to modify each and every PDF created to make it compliant, or wait until the very end of the submission process and let the publishing tool make those adjustments. This approach is time-consuming, means that technical issues are only discovered very late in the process, and increases the risk of making mistakes.

The solution to this problem is to ensure compliance is achieved at an earlier stage in your submission content preparation process. Compliance should actually be reached automatically when you render your content to PDF; not require any additional tools or manual steps, including for multiple Health Authorities if necessary. This enables a shift in focus on quality control, and reduces the number of issues being resolved after the publishing stage. 

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

Waiting until the last minute to generate compliant PDFs will only increase the risk of non-compliance in your regulatory submissions. A regulatory submission process can be further streamlined if you move the technical PDF compliance earlier down the line.

Tip 2: Automate (reduce the necessity of manually editing PDFs for regulatory submission compliance)

Enhanced efficiency and built-in compliance can only be achieved by using an automated PDF rendering system. Some of these systems can automatically render multiple versions of your PDFs, each meeting the technical requirements of a specific health authority such as the FDA (US), PMDA (Japan), EMA (Europe), Health Canada and Swiss Health. Differences can include the PDF version used, whether the PDFs are optimized for fast web viewing, the number of bookmark levels created and visible on opening, the colour of hyperlinks, whether bookmarks for tables and figures should be grouped together, and if documents exceeding a specific number of pages should automatically have a table of content added.

Many Life Sciences companies are still using desktop tools, such as Adobe Acrobat or DXCToolbox (formerly known as ISIToolbox), to manually edit thousands of PDFs for compliance. This manual editing is extremely time-consuming, repetitive and increases the risk of making mistakes. Automating compliant rendering can help whether you work in a specific market only or if you have a global portfolio of products.

How to simplify and streamline the regulatory submission process? How can I reduce risk of non-compliance in regulatory submissions?

Compiling regulatory submissions is not an easy task. Racing against the time, while keeping an eye on the stringent health authority guidelines. Making sure that your documents meet the technical requirements set out by the regulators.

Tip 3: Centralize all your (compliant) PDF conversion/rendering

For a smooth approval process by health authorities, it is necessary to submit PDFs that are consistent technically and visually. This is difficult to achieve when using multiple technologies to create and manipulate your files. Each application can introduce inconsistencies, in particular when they can be configured differently by each user involved. 

A powerful system for automated compliant rendering will solve this problem. The PDF rendering engine retrieves the files from all your different controlled content repositories such as OpenText Documentum, Veeva Vault and Microsoft SharePoint, but also from file shares, web services and email repositories, and converts them to consistent and compliant PDFs, ready to be submitted to any health authority worldwide.

DocShifter can help you to reduce the risks of non-compliance, automate and centralize compliant document and PDF conversion.

Submission-ready PDF conversion software for regulatory submissions for Life Sciences & Pharma. Create submission ready, compliant PDF for FDA, EMA, PMDA, HC and many more.

About DocShifter

Speed, quality, scalability, and configurability are reasons why Life Sciences organizations choose DocShifter to generate technically compliant, submission-ready PDF. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs. Rated 5 starts on Gartner’s Capterra platform. 

Bonus: We created an FDA PDF format specifications checklist for you, so that you can identify content-related issues as soon as possible to reduce the risk of RTF. 

You can download the checklist here.

 

Track changes and comments don’t look consistent when you convert Microsoft Word documents to PDF?

Are you having trouble converting Microsoft Word documents containing track changes and comments to PDF?

Creating consistent output when converting MS Word documents containing track changes into PDF is a big challenge. With multiple reviewers and authors working on the same document, each with their styling, getting this consistency is almost an impossible mission

Do you continually have to edit the PDF to achieve the desired results?

The only way organizations can tackle this right now is manual: changing how the track changes should look like, once authors and reviewers finish editing the document. Considering the large volumes, this is extremely inefficient, slow, and time-consuming. 

It is a manually-intensive process that requires multiple edits in Microsoft Word to get the desired results. 

Force the track changes and comments to look a certain way, when creating PDFs. 

Why not automate this manual PDF editing process and fix inconsistencies much earlier? Why wait to make all these manual manipulations in the PDF document, one by one? Use an automated document conversion solution that can easily ensure consistency in your track changes and comments already from the Word documents. 

Did you know that DocShifter is able to guarantee all track changes and comments appear with a completely consistent look, no matter how the authors and reviewers added them in the original Word document? 

Different options for different scenarios. Do you want the comments to be shown or not? If yes, what style would you prefer: inline changes or in bubbles? All options will be centrally applied when rendering a Microsoft Word document that contains track changes and comments to PDF. Automated, fast, and risk-free.

This consistency ensures you can save valuable time and reduce manual work when sharing content both internally and externally.

Would you like to see how it works? Schedule a demo or write to us and we will be happy to help!

About DocShifter

Speed, quality, scalability, and configurability are reasons why biotech, pharma and medical devices companies choose DocShifter to automate and simplify all their document conversion processes. From automatically checking and fixing Word and PDF documents to generating compliant, submission-ready PDF renditions, DocShifter software offers a unique and proven approach to speed up time-to-market.

High volume, high-quality document conversion, on-premise, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs. Rated 5 stars on Gartner’s Capterra platform.

Bonus: We created an FDA PDF format specifications checklist for you, so that you can identify content-related issues as soon as possible to reduce the risk of RTF.

You can download the checklist here.

Is data taking over the role of PDF in eCTD submissions?

The Life Sciences industry is dedicated to protecting the health of millions of individuals worldwide. The industry is also looking to improve their lives with affordable and easily accessible medicinal products. Patient and patient safety always comes first, which is why the process of bringing a drug to the market takes many years (from 8 to 14 years). 

To be able to launch a product, Life Sciences companies must comply with many regulatory requirements, starting from the first stage of research and product development through initial product commercialization.

Migration from paper-based submissions to e-dossiers

The process of submitting documents to regulatory authorities to receive approval for launching a new medicine dates back to the 1940s. Initially, these submissions were all on paper and consisted of small single-volume dossiers containing fewer than 100 pages. Over time, paper dossiers increased considerably both in complexity and size, making paper-format submissions no longer an appealing option.

The accessibility to information technology and the fast broadband Internet connection changed the way documentation and data were submitted. First introduced in 2003, the eCTD (electronic Common Technical Document) became the expected format for electronic submissions to Health Authorities (HAs) worldwide. 

However, the implementation process of the electronic submissions (both eCTD and NeeS – non-eCTD electronic submissions) by the global HAs took many years and was met with reluctance from the industry. In 2020, there are still 80 countries worldwide that file their submissions on paper. Even China, one of the most technologically advanced countries in the world, is only now implementing the eCTD submission format. Currently, the following countries accept eCTD submissions: the US, EU, Canada, Gulf Cooperation Council (Saudi Arabia, Oman, UAE, Bahrain), Jordan, Australia, Switzerland, South Africa, Thailand, and Japan.

Status of eCTD submission implementation worldwide

PDF vs. Data : The upcoming battle in eCTD submission format

Many other countries like China are just now implementing eCTD. To justify all that investment and effort, it will take them years before looking into alternatives to document and PDF submissions. The many regulations make the Life Sciences industry slow moving and understandably risk-averse. Every new process has to be approved, then validated, and finally implemented and this takes up many years.

However, some general discussions about the ongoing implementation process of IDMP (the European regulations on Identification of Medicinal Products) revealed a possible future alternative to the unstructured PDF format. IDMP is an initiative for patient safety and heavily focuses on structured data. Even though it has nothing to do with launching a new product, many companies hope that IDMP will be the beginning of a new era and allow electronic submissions to evolve into data submissions

While there is excellent potential to embrace data submissions, the Life Sciences industry is not ready for such a radical change in today’s reality. Just consider that not long ago, companies used to deliver hard-drives and laptops to the HA where the electronic submissions were stored. This process has evolved gradually over a long period of time, and nowadays, any type of electronic submissions is mostly filed in a PDF format. Given the slow adoption speed and the unrealized potential of eCTD & documents, we believe that PDF will be there for many years to come.

Today’s reality in eCTD submission: PDF

There are many reasons why PDF documents are critical for electronic submissions. Let’s take a moment to see what the eCTD stands for: electronic Common Technical Document. This means that in today’s reality, the worldwide expected format for digital submissions is a document, and not data. While that may change in the future, the creation of a new and improved version for the eCTD, namely eCTD 4.0 only comes to support the idea that documents are not going away and that PDF is here to stay.

Another reason why PDF documents are still crucial for electronic submissions is closely related to the huge volumes of documents that are piled up, especially in the first stages of research, development and testing of a new medicinal product. Imagine how many documents a company has after 14 years of research.

When filing for marketing authorization of a new drug, the company must ensure that each and every one of those documents that will be submitted, is technically compliant with the HA requirements. While that is not an impossible task, it is  extremely time-consuming to do it manually and let’s not overlook the increased risk of human error. This is where a solution like DocShifter comes in: automatically converting all those documents into submission ready PDFs for any health authority in the world.

How are the current eCTD submission formats expected to evolve in the future?

Let’s consider the countries that are currently accepting eCTD submissions. As we mentioned before, the Life Sciences industry, due to the risks involved, is very reluctant to change. Therefore, it took decades to move to the electronic PDF format. Additionally, making this change into electronic submissions took a lot of effort and time from both HAs and companies. 

  • On one hand, there are companies that must be able to create the documents in the required eCTD format while being compliant with any additional requirements imposed by each national HA. 
  • On the other hand, there are the HAs that had to implement the technology needed to be able to review the electronic submissions and also train their employees on using the new technology.

Just consider the financial investments of companies and HAs currently accepting the eCTD submissions or are in the early implementation stages. They would have to cover all costs if they were to move to a new, uncertain and not tested format like data submissions.

It is always good to think about new possibilities, and data submissions can become a reality in the future. However, the era of PDF submissions is still here and is not going anywhere for many years to come. There is still a lot of room for improvement in existing submission processes, starting from how compliant PDFs are generated for submissions. 

This is why the Life Sciences industry should focus on the present and search for better ways to optimize their PDF creation processes for electronic submissions. The creation of fully compliant, submission ready PDFs can be much easier, quicker and with less-risk. Multiple compliant PDFs can be generated simultaneously from 1 source document, simplifying the process of submitting the dossier to multiple HAs. 

Even if parts of what is submitted in PDF will become data gradually, it is still years away from becoming the norm.

 

About the author – Paul Ireland 

Paul Ireland - VP Life Sciences - DocShifter

20+ years in helping to provide regulatory software and service solutions to Life Sciences organisations globally. Industry and commercial experience in delivering Content Rendering, Regulatory Information Management, Submission and Report-level Publishing, and Electronic Document Management solutions. 

About DocShifter

Speed, quality, scalability, and configurability are reasons why Life Sciences organizations choose DocShifter to generate technically compliant, submission-ready PDF. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs. Rated 5 starts on Gartner’s Capterra platform. 

Bonus: We created a FDA PDF format specifications checklist for you, so that you can identify content-related issues as soon as possible to reduce the risk of RTF. 

You can download the checklist here.

Last update: 08/01/2021

Refusal to File (RTF) and how modern rendering can reduce non-compliance risk

Bringing a new medicine or a product to the market is a complex process that typically takes from 8 to 14 years. Although this process may vary from one Health Authority (HA) to another, there are some general stages that the medicine must go through before it can be safely distributed to patients. It starts with research and development (R&D), then slowly moves into the next steps, including assessment and evaluation through non-clinical and clinical trials, filing for marketing authorization to the HA and getting regulatory approval. The final stage is the post-market safety monitoring after the product is launched to the market.

the diffrent steps of bringing a medicine on the market and in which step a refusal to file can be found

Patient safety is crucial in the Life Sciences industry

There are high risks of taking any shortcuts in this long process. In fact, a study conducted by the Tulane University back in 2003 showed that each 10-month reduction in the US Food and Drugs Administration (FDA) review time period for a new drug can lead to an 18% increase in serious adverse reactions, an 11% increase in drug-related hospitalizations, and a 7.2% increase in drug-related deaths.

Patient safety is the reason why the process of bringing a new drug to the market takes so much time. And since it is the main focus of the entire Life Sciences industry, the new drug can be rejected even before filing for marketing authorization to the HAs if it isn’t considered safe for public use. For example, during the clinical trials, the first phase sees approximately 70% of drugs move to the next step. Phase III trials see only 25-30% of those remaining drugs enter the final stage leading to HA review.

Filing for marketing authorization – is success guaranteed?

Once the drug passes the testing phase, pharmaceutical companies finally reach the stage of submitting a request for authorization to the HA where the drug is going to be marketed. However, there is always a risk of getting a rejection from the HAs.

What is refusal to file (RTF)?

Refusal to file is an official letter issued by the health authority to inform a sponsor that their application doesn’t comply with the compliance needs of the agency. In other words, refusal to file is the agencies way of saying that they will not be reviewing the sponsor’s submission application.

Research shows that 25% of the marketing applications for drug authorization submitted in the past to the European Medicines Agency (EMA) were rejected. Additionally, looking at the statistics published by the FDA, a total number of 73 refusal-to-file (RTF) letters were issued to non-compliant pharmaceutical companies over a period of 7 years.

However, some companies were able to turn it around and had their applications reviewed after receiving an RTF initially. Some even got approvals, after meeting FDA’s demands. 

How can I avoid a refusal to file from FDA?

One of the main reasons of Refusal to file is the inability to comply with the technical HA requirements.

As explained in one of our previous articles, it takes many years for a new drug to be approved. When the pharmaceutical company is finally able to file for marketing authorization, it must ensure that each document from the millions collected over so many years of research respects all the specific technical requirements from each national HA. This is where an automated document conversion solution like DocShifter can help companies: automatically convert all those documents into submission ready PDFs for any HA in the world and reduce the risk of receiving a Refusal to file.

What are the consequences of receiving a Refusal to file from the FDA?

When a Life Sciences organization’s marketing authorization for a new drug is rejected by the HA for non-compliance, the negative impact can be translated into significant financial losses and damages to the company’s image and reputation. To give you a better understanding of the importance of compliance in the Life Sciences industry, let’s focus on the consequences of receiving an RTF from the FDA.

Rejected FDA submissions could cost a life sciences company between $660,000 to $8,000,000 for every day the drug is delayed.

  1. Fines imposed by the FDA. Under the Prescription Drug User Fee Act (PDUFA), when applying for the approval of a new drug, the pharmaceutical company must pay an application fee (for 2020, the current rates are: $1,471,483 – if no clinical data is required, and $2,942,965 – if clinical data is required). If a drug application is refused for filing, the pharma organization can receive back only 75% of the application fee, incurring financial penalties of $367,871 up to $735,741.
  2. Loss of R&D financial investments. Statistics in the industry show that pharmaceutical companies spend, on average, 17% of their revenue on developing a new drug. This amount translates into an average of $4 billion, and an RTF letter delays (months) in getting the product to market and causing loss of revenue. Even when the company takes actions to become fully compliant with the FDA’s requirements, it will still lose significant amounts of money every day that it doesn’t bring the new drug to the market.
  3. Stock price drops. This is another negative impact that contributes to the significant financial losses incurred after receiving an RTF from the FDA. For example, there was the case with a pharmaceutical company that filed for marketing authorization of its new drug with the FDA in December 2015. Two months later, in February 2016, the company announced that it received an RTF letter from the FDA. Soon after this announcement, the stock prices plummeted by 37.3% in a single day.what can an Refusal to file (RTF) letter lead to in life sciences? What are the consequences of technical non-compliance? DocShifter
  4. Negative press. Ensuring patient safety is vital in the Life Sciences industry. This means that patients also should be confident in the pharmaceutical company’s ability to bring a new drug to the market that may help improve their lives. If the press discovers that the pharma company’s drug application was refused by the FDA, all that negative buzz can end into losing the customers’ confidence. And when that happens, the consequences can be truly catastrophic and it can really be the end of the new drug, long before being launched to the market.

How can DocShifter help pharmaceutical companies achieve technical document compliance?

Pharmaceutical companies can get an RTF for two main reasons: the inability to comply with content requirements (missing information or summaries, appendixes not submitted, etc.) or with technical PDF formatting requirements of health authorities. 

Even though there are some tools that can create compliant submission ready PDF documents in multiple steps, they are costly, time-consuming, and have to be manually configured. The DocShifter document conversion software makes sure that your electronic submission documents are fully technically compliant with any HA. Simple, automated, and fast. 

To ease compliance and reduce the risk of Refusal to file, DocShifter software provides technical PDF configurations, that are predefined to the technical requirements of each national HA like the FDA (in the US), EMA (in the EU), PMDA (in Japan), HC (in Canada) and many more. With this, every PDF you generate with DocShifter will exactly match what the HAs demand. 

Compliant, pre-defined PDF configurations to create fully technically PDFs for FDA, EMA, PMDA, HC and many more. Save time, reduce risk of an refusal to file (RTF) with DocShifter

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Speed up time to market, reduce risk of non-compliance and save big. 

Submission-ready PDF conversion software for regulatory submissions for Life Sciences & Pharma. Create submission ready, compliant PDF for FDA, EMA, PMDA, HC and many more.

Convert your source content simultaneously into multiple submission-ready PDF documents for multiple health authorities. Using one centralized document conversion platform. Without needing any desktop PDF editing tools.

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About DocShifter

Speed, quality, scalability, and configurability are reasons why biotech, pharma and medical devices companies choose DocShifter to automate and simplify all their document conversion processes. From automatically checking and fixing Word and PDF documents to generating compliant, submission-ready PDF renditions, DocShifter software offers a unique and proven approach to speed up time-to-market.

High volume, high-quality document conversion, on-premise, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs. Rated 5 stars on Gartner’s Capterra platform.

Bonus: We created an FDA PDF format specifications checklist for you, so that you can identify content-related issues as soon as possible to reduce the risk of RTF.

You can download the checklist here.

Last update: 08/05/2021

How to speed up PDF conversion by 10X in 2021

Introduction

Enterprises work with a lot of digital formats: Microsoft Word, Excel, PowerPoint, JPEG, TIFF, PDF, PDF/A, video and audio files. All these digital files need to be converted at some point; for various reasons: standardization, regulatory compliance, digital archiving, customer communication and many more.

Not an easy task, as documents live in different systems, versions, digital file formats etc. And that is where standardization comes in. The transformation to a neutral, generally recognized file format such as PDF plays a big role here.

For many reasons, PDF files (amongst other formats) are created. PDF ensures consistency, helps standardize across different departments and platforms. Thus, it helps increase efficiency in document centric processes. Almost like a one-fits-all file format. 

What is document rendering? What does document rendering mean?

The conversion of different file formats to PDF is often also referred to as ‘document rendering’. Converting documents is generally handled by very specific applications & systems, the so-called ‘rendition engines’. This ensures the transformation of one digital file format into another, f.e. PDF.

Document rendering can be done in different ways. The most common approaches are:

  1. By making use of the ‘authoring’ application that was used to author the original document (Microsoft Word, OpenOffice, Microsoft Excel, etc.)
  2. Standalone document rendering, without using the authoring application(s).

Both approaches are very different, and vary greatly in terms of speed, quality, configurability. This article further explains the inherent differences of both. 

Rendering through the use of the authoring applications (f.e. Office, Adobe, …)

This approach is being used today by most organizations and is the most common way of creating a PDF. As an example, this is what happens during a Word to PDF conversion with this approach.

  1. The first step is to retrieve the Word file from where it resides. Within large organizations, content can be stored in multiple places: Document Management Systems (DMS) such as: OpenText Documentum, Veeva, Microsoft SharePoint, Box, Alfresco, Generis CARA, Hyland etc. 
  2. The rendering engine connects to the existing Document Management System(s) and pulls the original Word file from there. Or the file is being sent over.
  3. The rendering engine then calls the authoring application (for a Word file, the authoring application is Microsoft Word. For PowerPoint, is Microsoft PowerPoint etc.) to open the original source file.
  4. Subsequently, it performs a Print to Postscript action using an Adobe Distiller or other printer driver. 
  5. The rendering server then starts Adobe Distiller or equivalent and the Postscript file loaded, which is then converted to PDF. 
  6. All authoring and Adobe applications are finally closed, and the PDF is sent back to the Document Management System(s). 
  7. The PDF file is stored as a rendition to the original Word document or as a new object. 
  8. The process then repeats for the next Word file.

Why should you not convert to PDF using authoring and native applications?

So far, so good. The conversion of a Word file to PDF through the authoring application. But, what happens in reality?

” Rendering by using the authoring application
introduces risks.”

Based on the conversations with industry experts, and our customers, this PDF rendering approach has drawbacks:

  1. The authoring applications (Office and Adobe tools and everything else) need licenses. And these come at a price. The number of documents to be converted and the organization size impacts licensing cost. All these authoring applications must also be upgraded, patched and validated. All in all, this brings big (and often overlooked) costs for most organizations. Especially when you consider how many different formats should be converted to PDF. (PowerPoint, Excel, Word etc.)
  2. Rendering through the use of the authoring applications introduces risks. A simple version difference (Word version installed on the desktop vs. Word version installed on the rendition server) can cause all PDF conversions to fail, potentially bringing the entire process to a stop. In some cases, Word documents containing specific settings, have caused the rendition server to inherit these settings, causing incorrect renditions.
  3. Rendering through the use of the authoring applications is slow and burdensome: For every PDF conversion request, the authoring application opens the source file(s). This process, multiplied by thousands of documents for each submission package, can add up to weeks or longer.

Document conversion is being used by many departments (marketing, HR, labelling, regulatory etc.) throughout a large organization. A slow or failed conversion process quickly becomes very costly

Time to market is critical, so coming up with solutions to the above challenges is key.  PDF conversion should be easy, automated and as cost-efficient as possible.

‘’Rendering through the authoring applications is risky, expensive and slow. Is there a more efficient way?’’

What can significantly improve the PDF rendering speed?

Standalone document rendering

DocShifter doesn’t need any authoring applications to perform PDF or any other conversions. Thanks to this architecture, our customers see a 66% cost reduction in IT infrastructure. (licensing, number of servers etc.) Risks associated with authoring applications (slow conversions, extra costs, manual interventions etc.) are simply eliminated. 

Convert word to PDF with authoring applications. Fast, simple, automated document and content conversion with DocShifter

Moreover, DocShifter doesn’t need any authoring applications to run. This significantly improves the conversion speed: 10x faster than comparable solutions.

Docker container technology further empowers the document conversion capabilities of DocShifter. When organizations have the pressure to convert thousands or millions of documents in a very short amount of time, peak loads are easily dealt with.

DocShifter’s standard configurations for FDA, PMDA, EMA and other health authorities allow consistent and automated submission-ready PDF creation. In one go. 

Thanks to native integrations and open API’s, DocShifter connects with any DMS or RIM system. This open connectivity greatly reduces the risk and increases the efficiency, as content is stored in multiple repositories. Document conversion is centralized in 1 platform, for all departments. 

About DocShifter

Speed, quality, scalability, and configurability are reasons why organizations all around the world choose DocShifter. High volume, high-quality document conversion, on-premises, or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs.