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

Regulatory Pressure and Document Conversion

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

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