Regulatory Information Management – traditional vs. modern ways of working

By 15. June 2015Blog

During many customer meetings we experienced a wow effect with a modern and light software user interface. But customer also challenged us, whether software that appears to be light and easy to use, can handle regulatory complexities. Let me share some thoughts about this:

Managing regulatory complexity – yesterday

Preparing an eCTD submission with hundreds of compliance requirements that need to be fulfilled, is a complex topic, correct? Managing and updating multiple submissions in multiple countries for multiple products is complex as well. Therefore a complex technology is needed to handle these complexities. That’s why regulatory software needs to be complex. And that’s why it is accepted that regulatory software users struggle on a daily base with complex configurations and tons of clicks that have to be conducted to fulfil a process step. Because of that reason it also is accepted to allocate tons of money and yearly budgets to maintain complex regulatory software implementations.

Managing regulatory complexity – today

Naturally we tend to solve complex problems with complex technologies. But once we understood the complexity, technology should handle the complexity and automate process steps rather than keeping the complexity on users shoulders. Let’s look at the Blackberry example: Blackberry was used in enterprises for quite a period of time due to it’s complex configuration options, that allowed a user or enterprise to personalize its settings for individual complex purposes. Setting up a new Blackberry always took half a day for a user and the organization, before it was operationally able to synchronize emails? I am sure many of us remember these painful hours. What percentage of the costly complex features was actually used by the end users? When the iPhone came out, it was perceived as a toy, due to its simplicity and ease of use….. Where are we today with those two technology approaches?

And is it really necessary to maintain a “SAP-type“ of implementation for my regulatory problems, or are there more lean and cost effective alternatives available that automate process steps?

Yes there are. In reality this can be achieved via re-engineering an established complex process such as the eCTD compilation process. Older eCTD software technologies had to be complex, because the complexity was not understood in its entirety. This has changed. Today we understand the entire process. Thousands of eCTD’s have been submitted and we have learned from it. But changing existing technology architecture is almost impossible. It would require complete new software architecture to reduce complexity. Each software vendor should critically question their approach on how to manage complex regulatory processes today. Each software vendor should re-invent their architecture every 3-5 years and come up with enhancements such as process step automation.

Let’s look at some regulatory submission related examples: Automatic meta data tagging and meta data management as well as meta data re-use sounds complex. But it is something that modern software can do, without the user realizing that it is happening. The result in a situation at which modern regulatory software automates redundant process steps such as manual eCTD tree manipulations. And it allows to auto-compile eCTD documents into a complex eCTD tree via one mouse click. Furthermore it facilitates a re-use of submission data for pharmacovigilance purposes automatically. And it enables me to get an automatic notification about when to prepare a PSUR. It automatically creates the draft PSUR for me and it enables me to share regulatory documents with my external partners.

Another example of automating manual steps is the handling of PDF operations for publishing purposes. PDF validation is an important eCTD compliance criterion. Specific errors and warnings defined by the eCTD validation guidelines can be automated such as PDF version conversion and fast web view enable. This allows the eCTD publisher to focus on validation areas that are critical for submissions and reduce the time spent to make sure the submission output matches the agencies expectations as well as the internal specifications in terms of quality. These are just a few examples among many more.

It might sound futuristic or artificial intelligence but many more benefits should come with modern regulatory software, today! Modern ways of working bring value, are widely embraced by employees and give a positive image of your company. Get prepared. Allow yourself to analyse a potential paradigm shift. Challenge your existing regulatory software vendors. Be open to look into alternatives and new ways of managing regulatory processes from newer vendors. By doing so, increase your productivity and reduce your operating costs.

Rainer Schwarz

Author Rainer Schwarz

Cunesoft CEO - He has over 15 years of experience with compliant software solutions for regulated processes. He worked in senior management positions at CDC Solutions, Liquent and NextDocs. He has a master degree of Social Sciences from the University of Innsbruck and Hong Kong University

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