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

Document lifecycle: share and automate

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.



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