DocShifter powers the document conversion solution in Generis new CARA cloud offering

We are happy to announce our DocShifter software will be the default enterprise document conversion solution in Generis’ new CARA cloud offering. The integration will further strengthen the bond between organizations and allows the new CARA to serve a larger range of clients with expanded document conversion functionalities.

New CARA cloud offering provides an enterprise content and information platform, able to store and manage data both in CARA as well as that stored in a range of other repositories.  While the integration has been available for classic CARA for some time, it will now be the default option for the New CARA Cloud platform for customers requiring rendering meeting a range of complex requirements of regulated industries. 

DocShifter solution automates any-to-any conversions with support for 300 input and output formats. The speed, scalability and connectivity with all DMS & RIM systems make DocShifter technology an essential for Life Sciences organizations that deal with complex content and document conversion requirements. 

 “With the integration of DocShifter as the default document conversion solution into the new CARA, we are able deliver our promise even better: drastically speeding up and simplifying the complex process of content and document conversion. DocShifter’s document conversion capabilities, combined with new CARA, are able to answer the complex requirements of highly regulated industries,” states Geert van Peteghem, CEO of DocShifter. 

“We already support many joint customers who have advanced document conversion requirements met by the integration of DocShifter with CARA,” said James Kelleher CEO of Generis. “We are now happy to be able to offer this on a pre-built package with New CARA on our cloud for such customers.”

About DocShifter

DocShifter

DocShifter was created in 2007 to respond to the need for easy and fast content conversion in highly regulated environments. Customers can be found worldwide in Life Sciences, Public Sector, Engineering, Banking & Insurance. The company is headquartered in Ghent, Belgium.

At DocShifter, we believe that relevant digital content should never become obsolete. Unstructured information needs to be kept in a readable and searchable format, for generations to come. In our fast-paced digital world, standards appear and disappear. Transforming all this digital content, in whatever shape or form is our goal. To ensure your information continues to provide value.

About Generis 

Generis is a global leader in content and information management systems, specialising in proven solutions for regulated industries. Established in 1997 as a consultancy group, Generis has since grown and developed alongside its flagship product CARA. Our mission is to provide a platform which is highly configurable and user friendly; a dedicated team works hard to guarantee customer satisfaction. Currently counting over 450,000 users across numerous industries worldwide, including 8 of the 10 largest Life Science companies, CARA continues to progress to become the answer for end-to-end data management. 

To find out more visit: www.generiscorp.com

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.

Free 30 min webinar. Be sure to join us.

Successful eCTD Implementation in China: 3 Lessons Learned

China is the most populous country on the planet accounting for more than 18% of the world’s population. Following the focus placed on biopharmaceutical development by the Chinese government in the last decade, the country’s global industry ranking rose from 9th largest in 2007 to 2nd in 2017. 

To help expedite the review and approval of new medicines, China will soon join other Asia Pacific countries in accepting submissions in a fully electronic eCTD format. The implementation of eCTD in Japan and Thailand highlighted many hurdles for both domestic and international biopharmaceutical companies, some of which can be avoided.

CFDA eCTD Adoption

After joining the ICH (International Conference on Harmonization) in June 2017, China’s draft eCTD guidance has now been provided by the CFDA (China Food & Drug Administration). It is time for any organisation looking to gain approval for their products in the Chinese market to prepare to take advantage of this regulatory change.

  • eCTD approach.
    • The CFDA is adopting the ICH specification 3.2.2. This means it will more closely follow the US FDA’s submission process rather than the European EMA’s implementation (or the Japanese PMDA with its unique approach to lifecycle).
    • Clinical trial datasets and Study Tagging Files (STF) will be required and node extensions will not for example.
  • Chinese language usage.
    • Documents will be required in Chinese with English versions as reference.
    • eCTD leaf titles will also be required in Chinese.
  • Review and validation.
    • Submissions are expected via CD/DVD delivery initially with an electronic gateway in the future.
    • A link is expected from the CDE (Centre for Drug Evaluation) website which will allow for free submission validation (they will be using LORENZ (member of the Alliance of Experts) technology for their own validation, review and management).

Top 3 considerations when implementing eCTD in China.

  1. Thoroughly review all supporting technology required.
    • Review whether a new publishing solution is required to deal with the specific Chinese eCTD needs. A solution that was ideal for EU and US submissions may no longer be the preferred platform once Chinese conditions are added. As an example, companies often used different tools for Japanese submissions, because of their unique requirements. Consolidating on common tools, however, provides huge efficiencies and savings across global regulatory teams.
    • Ensure a rendering platform that can convert all required original source content into fully technically ICH-compliant PDF files is in place, and that multi-byte Chinese character sets are well handled. Many companies un-necessarily continue to struggle to implement a single consistent platform that handles the needs of both Asian and Western character sets. Most often, local tools are used to ensure the converted content meets the local technical submission guidelines.
    • Ensure all supporting content creation, management, manipulation, publishing and validation technologies support the multi-byte Chinese documents which will be used.
    • Thoroughly test all solutions in as close to real world conditions as possible (use pilots where possible).
  2. Understand the cultural requirements as well as the technical requirements.
    • Flexibility is required to account for different interpretations of ‘recommendations’ in any guidelines. While Japanese companies, for example, typically strictly adhere to all rules including any recommendations, companies in the US might choose not to follow some recommendations where particular efficiencies might be gained by not doing so. A similar understanding of the Chinese approach in these situations is essential to a successful implementation of eCTD.
    • Having a partner based in China or with a very deep understanding of the Chinese regulatory culture is critical to success. As with any region, historical and cultural knowledge when dealing with the local authority can be critical in ensuring a timely submission process.
  3. Ensure teams affected are thoroughly trained.
    • eCTD provides significant benefits, but the tools and processes require a great deal more training than most companies allow for.
    • Start training early. Training should begin well before the first submission in eCTD to China is planned.
    • Get involved with any pilots should there be any. This provides the best way to test your systems and internal processes prior to a live submission. Ensure you test lifecycle updates as well as the initial 0000 submission. You will receive invaluable feedback no matter how well organised you are.

Conclusion

With such a huge quantity of applications being received, the implementation of eCTD will certainly help provide a timelier review process and continue to help alleviate the backlog of work for the CDE. 

REVIEW RESULTS                                       .
APPLICATION TYPE APPROVED REFUSED OTHER TOTAL
IND 554 12 37 603
Confirmatory clinical trial 130 14 96 240
NDA 132 9 65 206
ANDA 1038 115 1200 2353
Supplementary application 1776 127 511 2414
Import re-registration 395 27 60 482
Generic drug QCE / 238
Re-review / 88
TOTALS 4,025 304 1,969 6,624
Chemical drugs reviewed by CDE in 2018

 

Since the initial release will not mandate the use of eCTD, this transition period provides biopharmaceutical companies with the opportunity to avoid some of the headaches they faced when adjusting their processes for other regions. Supporting technologies have also evolved since eCTD was first introduced to the global stage and harnessing some of these can further ease this evolution in China.

DocShifter supports the transformation of content into formats required by the CFDA and other regulatory health authorities.

You can download the PDF version of this article via the link below.

Download the PDF

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.

Free 30 min webinar. Be sure to join us.

6 Valuable Tips: Why should you convert to PDF?

Most companies are not demanding when it comes to the file formats they use. They just use the most common file formats as the logical extension of their software tools. The best example is the Microsoft Office package. Although Word is a good program for word processing, text editing and file formatting, a Word-file (.docx) is not the best suited file format for storage, archiving, sending sensitive and private data, and internet sharing purposes. Read more

How Docker puts your rendering farm on steroids

Infinite scalability in document conversion through container technology

Container technology* has been around for a while now. The benefits are clear: scalability, rapid deployment, cost savings, simplicity. In 2020, 71% of all companies have moved workloads to containers, according to a study by DivvyCloud.

Containerization has now come to the advanced rendering space. In this blog post, we focus on the use cases and advantages of running advanced rendering on Docker. 

*Container technology is a method to package an application so it can be run, with its dependencies, isolated from other processes. A container is a package that includes everything to run an application. Containers rely less on external hardware and software and can run on any environment (Microsoft, Linux, Mac etc.)DocShifter and Container (Docker) technology for infinite scalability and easier deployment

Why should you investigate running your rendering farm on Docker?

Document conversion is a resource intensive process. Moreover, the workload is highly unpredictable in most cases. And there is typically considerable time pressure. 

Think of thousands:

– of ICH compliant PDF files that need to be generated at submission time in Life Sciences. 

– of payslips that need to be sent at the end of the month. 

– of documents that are flowing into the organization, that need standardization/harmonization before being added to a content repository.

Today, most companies have architected their solution for peak loads. They have built huge rendering farms for doomsday. And these sit idle most of the time. Resulting in an IT architecture that is largely overscaled, expensive and inefficient.

DocShifter on Docker - Ultra scalability at lower cost

With DocShifter implemented on Docker, you can scale when you need to. When your business requires it. It gives you the ability to spread your workload over as many resources as needed.

Scalability taken to the next level. Effiency²

When we designed DocShifter years ago, it was already designed with maximum scalability in mind. Our customers can scale, by adding additional transformation engines, or receivers.

DocShifter on Docker takes this scalability to the next level.

With DocShifter implemented on Docker, you can scale when you need to. When your business requires it. It gives you the ability to spread your workload over as many resources as needed. Eliminating the costs related to setting up and maintaining an oversized rendering farm

DocShifter architecture automatically starts as many transformation engines as necessary to support your business. And it is the transformation engines, or receivers, that takes care of the heavy lifting. 

Combining the speed of DocShifter with the efficiency of Docker puts your rendering farm on steroids. Effiency². Thanks to the nature of Docker, fewer hardware and software resources are needed to run the same application. DocShifter on Docker allows organizations to save big.

This setup allows for true transversal services for content transformation – serving multiple departments within your organization. Centrally.

Automate deployment

You decide where you run your content transformation operations: on-site, in a private cloud, a hybrid cloud or in a public cloud. If it runs on your system, it runs everywhere. 

With DocShifter on Docker, combined with Kubernetes – you can automate your deployment, scaling and operations of content transformation containers across clusters of hosts. With DocShifter, you get all the benefits from running Infrastructure as Code: time saving, cost saving – and reduced risk!

Discover More     Plan a demo

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.

Last update: 08/01/2021

Free 30 min webinar. Be sure to join us.

What to do with Legacy Data?

Many companies sit on a big pile of old data (information or old file formats, such as Excel 2.0 from 1987 or Excel 5.0 from 1993 for example) or use outdated systems to manage valuable company information. These legacy data and applications are still valuable to the organization, but their inefficiency, poor usability and high maintenance cost do not weigh up against the benefits. To get the most out of your legacy data you should convert these files to new file formats to keep them accessible, readable and searchable in the long term. Read more

5-Step Automation: Reduce Risks in Correspondence Tracking and your incoming e-mail conversion

Life Sciences organizations deal with external parties and health authorities on a regular basis. Given the amount of information, tracking all that communication is very challenging and burdensome. 

“An essential part of any complete RIM platform
is the ability to plan and track all day to day
regulatory
activities that an organization needs to undertake.”

These activities are often initiated by a request from a health authority for more information, It is critical that these requests are traceable alongside the tracked regulatory activities in the RIM platform. 

Can you keep track of all those incoming and outgoing correspondence?

Information and requests are shared in various formats, by various means and from various locations. Manually keeping track of all this correspondence is a huge burden on time and resources. Organizations still rely on manual processes. Manual processes lead to miscommunication and therefore delays in activities and even fines for missed deadlines.

Central repositories and systems (enterprise content management or document management) to track correspondence are essential elements of the information flow within and outside of life sciences organizations. When information is received from a health authority or external partner (such as a CRO or a medical writing team) it needs to be:

    – Processed to uncover what type of correspondence it is.

    – Converted into a consumable format based (PDF, Word etc.) on the type of correspondence and who the consumers/responsible parties will be.

    – Stored in the appropriate content repositories for the type of correspondence it is.

    – Distributed to the appropriate individuals.

Once this has been accomplished, an entry needs to be made in a correspondence tracking system. The company-critical content can then easily be found in the future alongside other information relating to the new regulatory activity. Correspondence is often a catalyst for some form of regulatory activity (such as creating a new submission to provide more information to a health authority for a particular drug).

“Being able to trace the activity from the initial request
provides a fuller picture of the entire
regulatory history of a product.”

Correspondence Tracking - Manual Steps

Correspondence Tracking – Manual Steps. Manual steps introduce risks and delays and may result in fines for missed deadlines.

Currently the initial steps in the processes for any correspondence tracking are performed completely manually. Individuals involved are required to:

    – Monitor incoming emails to identify incoming correspondence that relates to ongoing or future regulatory activities. Examples of this might be letters of approval, requests for more information, etc.

    – Convert the identified emails and any attachments (supporting information in many different formats) identified into a useful, future proof and standard format (such as PDF).

    – Store the email and converted attachments in an appropriate location of a central repository (such as an electronic Document Management System).

    – Create entries in the correspondence tracking system (if it exists, and if not in a tracking spreadsheet) to monitor the information received and any activities that are required to be completed due to the request.

Time to reduce risks from your incoming mail conversion process

The risks associated with manually tracking correspondence can be reduced. By automation and simplification.

DocShifter can help streamline the process and reduce the risks associated with correspondence tracking by automatically:

    1. Monitoring email systems (or specific folders or other content storage repositories) for correspondence that needs to be processed.

    2. Transforming the correspondence into a consumable format (such as fully compliant industry standard PDF) along with any attachments.

    3. Storing the transformed content and/or original correspondence into the right repository.

    4. Emailing individuals with the content or to alert them of the arrival of the correspondence.

    5. Kicking off a task through the DocShifter API to start the entries in the correspondence tracking system.

Correspondence Tracking - Automated Steps

Desired Correspondence Tracking. Fully automated from the identification of mails to file transformation and storing these in content repositories.

Whether a true correspondence tracking system or spreadsheets alone are used for this purpose, DocShifter can be an integral part of this mission critical process.

The historic pain points of correspondence tracking can be drastically reduced. In the meantime, read more about the correspondence tracking solution here.

Learn More  Plan a demo

 

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.

Free 30 min webinar. Be sure to join us.

 

Part III: The Switzerland of Modern Rendering: Centralize document conversion in one platform

The present read has explained why modern rendering is more than just having the right technology in place. We have also described how our three guiding principles can improve your existing document conversion processes.

To make all of the above happen, there are a few criteria that your technology systems in place need to be able to cope with: scalability, speed, connectivity, and easy deployment.

We will now focus on those technical features that a rendering system needs to have in order to be truly modern.

Enter DocShifter.Accelerate your rendition results

Why wait for a document to be rendered? With the rendering process typically being one of the final steps just before the submission, ensuring a fast time to market is crucial at this point. So, you want the document rendering speed to be lightning fast.

That is exactly what we can assist you with. Render more than 150 10-page-documents to technically compliant PDF in less than a minute. Delight your customers with an improved conversion speed by up to 10x compared to other existing solutions on the market.

No memory leaks or other manual interventions to slow you down or increase the risk of non-compliance. Faster performance translates into faster renditions. Automated and risk-free.

Increase your enterprise scalability

To deal with growing workloads, it is essential to have an infrastructure that scales up and down as needed. A system that can run on any platform (Linux, Windows) and aims for maximum scalability using a Docker container. You need a system that grows with your needs during peak loads.

GIF explaining docshifter scalability thanks to document container platforms

To deal with growing workloads, you need a system that is built to scale. A system that can run on any platform (Linux, Windows) – or even virtual (in a Docker container). You need a system that grows with your needs during peak loads.

Moreover, DocShifter easily connects to all your existing document repositories, either via a native integration, or a web API. We enhance the capabilities of your RIM or document management platform. We are neutral and integrate with the systems that are in place. That’s why we are often called “the Switzerland of modern rendering”. 

Using this architecture type, you can ensure that multiple business units and departments share the same platform while solving any inconsistency issues. Scale your IT infrastructure only when you need it. Automated and risk-free.

Benefit from an easy-to-use system

DocShifter recognizes the incoming file formats automatically and no user intervention is required. The administrator uses an intuitive web interface to create workflows for your documents. This workflow is tailored to your needs and follows three major guidelines: 

  • where do the documents reside (Input); 
  • what do we want to do with them (Transformation); and 
  • where do they go after transformation (Output). 

Once you define an automated workflow, you can store these configurations and reuse them later on for maximum efficiency. 

In addition, DocShifter comes with predefined configurations that are set up to ensure technical compliance with the specifications of the various HAs (FDA, PMDA, EMA, etc.). Reduce manual labor and minimize the risk of human error. 

Aim for the lowest total cost of ownership possible

By design, DocShifter does not require any native applications to create the rendition. This means that you don’t need to worry about any risks or licensing costs associated with setting up and maintaining any rendering platforms. No need to have individual tools on every desktop. Through centralization, we have seen customers saving up to $500.000 per year, in licensing costs alone.

Additionally, DocShifter can help you to drastically reduce your current IT infrastructure and related costs. Most of our customers handle the same workload with only a third of the servers they previously needed. Doing more with less resources. 

Capterra testimonial from Piyush J. - Large pharmaceutical company

And there is a lot more than just PDF

DocShifter can handle +300 incoming and outgoing file formats. This opens endless document conversion scenarios.

  • Have you recently acquired another company, and now you need to migrate hundreds of thousands of files? Or maybe you are actively collaborating with partner organizations? Why not standardize all of these external incoming files and update them to the latest file format? Generate thumbnails on the fly.
  • Email is a growing source of incoming information. Do you need to keep track of all your conversations with the regulatory authorities? Automatically convert your incoming emails and their attachments to a standard format and store these centrally.
  • Are you building an enterprise archive and want to reduce your dependence on native applications? Convert your critical business information to future proof formats like PDF/A or TIFF to guarantee long-term access to your company’s intellectual property.

Modern rendering allows you to enrich your documents, add watermarks, and pagination where needed. You can automatically merge or split documents from multiple sources as needed. You get the guarantee that all of your hyperlinks and table of contents will be correctly colored and styled.

DocShifter is an all-in-one document conversion solution that can automatically generate technically compliant, submission-ready PDFs. Save time and money. Eliminate manual intervention. Reduce the risks of non-compliance and of receiving an RTF.

Plan a demo

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.

Free 30 min webinar. Be sure to join us.

DocShifter is Moving to Grow

Move To Grow

Exciting times ahead for the DocShifter team, with the upcoming move to our new office! 

Some people have asked us: ‘Why are you moving?’. On one side reasons are purely practical, on the other they are related to our growth, so now is a great time to share these with you.

Read more

Part II: How to go beyond technology? 3 guiding principles to power your regulatory operations

The first step is to make an inventory throughout the enterprise of all your existing rendering processes. Before implementing any changes, it is crucial to evaluate the as-is-situation and have a complete overview of your current challenges. Next, we are going to share with you three of our guiding principles to help you improve your existing processes and aim for enhanced efficiencies.

1. Think about the entire document life cycle

Modern rendering is a lot more than just generating a technically compliant PDF right before the submission. It covers the entire document lifecycle: from cradle to the grave. There is room for improvement at every stage. The typical document lifecycle is shown below. 

Document Creation

Documents are created internally. But this is not always the case. For example, you may have external digital files entering your organization through an acquisition, or a collaboration with a partner, through CRO’s, or in many other ways. 

To be able to reuse the external documents, you should first update them in the company’s templates before sending the files to your content repositories. By standardizing all incoming documents to a unified file format or rendition compliant with your company’s internal requirements, you minimize the risk of having content and styling inconsistencies  down the road in the document lifecycle.

Document Active Lifecycle

Why wait until the publishing stage to create fully compliant PDFs? Why not do that right after the authoring stage? Begin technical review months earlier and reduce the last-minute stress right before the submission. 

Address any existing content issues directly at the source, and fix any problems very early in the document lifecycle. This will save you more time and manual labor while drastically reducing the risks of non-compliance and receiving an RTF (‘Refusal-to-File’). Populate document properties available in your content management system automatically.

Merge documents together into a single file for Veeva binders, ZIP files, OpenText Documentum virtual documents. Automatically split documents. Set maximum file size limits. Move compliance earlier in your submission processes through modern rendering. Save valuable time and money. Simple, fast, and risk-free.

Document Archive 

When medicinal product-related documents reach the end of their active lifecycle (i.e., the medicinal product is removed from  the market), you must ensure they are all compliant with the regulators’ requirements in terms of long-term digital archiving. Converting these documents to a future proof format such as PDF/A and TIFF preserves critical business information by making it searchable, accessible, and readable for digital archives. 

2. Connect all your systems and document management platforms

From our conversations with both large and small organizations worldwide, we have learned that one of their most challenging issues with rendering documents is that the process itself is not centralized. Company employees use different desktop tools, different Microsoft Word settings, causing inconsistent output and leading to significant associated licensing costs. Why not try a different approach? Why not move the rendering process away from the individual user and centralize it? This will significantly reduce the volume of manually-intensive tasks while minimizing the risk of human errors.  

Additionally, by centralizing the rendering service,  you can ensure that more departments will be served across different business units and ervention. Not to mention the potential cost savings. We have seen many situations where our clients managed to reduce their infrastructure costs by up to 70. 

As you can observe in the visual below,  the centralized service will allow connection with many document management systems (DMS), regulatory information management (RIM) platforms, or other specific platforms within your organization. This way you can also ensure integration with every system that needs document conversion at some point. 

Centralizing and sharing is more than just a practical step. It increases consistency and eliminates risks of non-compliance. 

3. Automate your document rendering (conversion) process 

Reach high levels of automation through the implementation of shared document rendering service. For the supporting centralized systems, you only need to set them up once and the rendering will automatically run in the background. 

Creating technically compliant PDF renditions from a single source file is only one click away. Be efficient and save time in the case of simultaneous submissions with multiple HAs. Repurpose the rendition created for one HA to be compliant with as many HAs as you need. Automated, simple, and time-efficient. We spoke to 50+ companies, both large and small, and all agreed that the impact of such a setup would take a huge burden away.

Below is a simple example of an automated workflow: pick up the file, and then use the automated tool to render it to the requirements of FDA, PMDA, EMA, and ROW. All in one go.

Rendering to the requirements of FDA, PMDA, EMA and ROW. All in one go.

Rendering to the requirements of FDA, PMDA, EMA and ROW. All in one go.

Use automation to speed up the document conversion process. Get faster renditions for large volumes, in a highly scalable way, and ensure that  the system will easily cope with peak workloads when you need it most.

There’s more to the story. Read the final part here.

Final Part

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.

Free 30 min webinar. Be sure to join us.

 

Part I: How does modern rendering improve your overall document management approach?

Modern rendering. Compliant rendering. High fidelity or hi-fi document rendering. There are many terms on the Life Sciences market related to document conversion. What do they mean? How can such processes have a positive impact on regulatory operations in the industry? To these questions and more, you are going to find answers in this white paper.

When working in a highly regulated industry like Life Sciences, compliance comes first. At the same time, business needs are growing, and there is huge pressure to get to market fast. Streamlining your existing processes is vital to ensure success, and modern rendering can help you achieve your goals.  

Modern rendering is more than just excellent technology.
It is looking at how we do things today, and evaluate as is vs. to be.

 

What is modern rendering?

Document rendering is no longer an innovation in the Life Sciences environment. However, its continuous improvement and development has never stopped. For many years, experts have been looking for new ways to visualize, print, and share documents in a standardized way. Most organizations have integrated rendering with the implementation of an enterprise content management or document management solution. 

Regulatory pressure has caused Life Sciences organizations to become very risk-averse when adopting new technology, for understandable reasons. However, there is always room for improvement in the old way of doing things. Modern rendering allows you to aim for enhanced efficiency gains in regulatory while easing the ability to ensure technical compliance.

How can modern rendering streamline your compliant document conversion?

Modern rendering is much more than (the process of) transforming a relevant source document to a PDF file. It starts with challenging how you do things today. Identify those departments in your organization that are actually rendering documents. No surprise, that is not just your regulatory operations team. Marketing, labeling, HR – each has its impact on document conversion at a specific moment in the lifecycle. 

  1. Additionally, you need to ensure that all external incoming documents from a third party (e.g., partner organizations, CROs, etc.)  are compliant with the company’s internal templates to ensure consistency. 
  2. At all times, you should have a close look at your authoring guidelines. Implement small changes early in the process to save valuable time further down the road. Pay attention to regional software settings as they may cause the creation of incorrect renditions. Japan’s PMDA vs. US’ FDA: very different technical requirements for compliant PDFs. 

Modern rendering is also about rethinking the entire process, as well as the solutions in place today. One of the processes we’d like to mention here is the submission publishing process. 

Why leave the creation of technically compliant PDFs to the last minute?
Why not move this step earlier in the document life cycle?

 

If publishers are already provided with compliant PDFs before the publishing stage, this saves down valuable time and reduces risks. 

Modern rendering is about increasing efficiency and ensuring compliance by setting the right output parameters to the different Health Authorities’ (HAs’) requirements. One time. Centrally. And not leave this decision in the hands of an individual document author. Or not letting multiple manual PDF manipulations for different HA requirements. Modern rendering is about drastically reducing IT infrastructure and indirect licensing costs and, at the same time, being able to deal with peak loads. It can deal with these increased periods of high activity. How? Through massive scalability. So that when you need it, you can meet any tight deadlines. In highly regulated industries, regulatory pressure can slow down innovation. Modern rendering can pick up the pace and win valuable time back during your submissions and beyond. 

Curious to find out more ? Here’s the second part. 

Part II