Cham Williams

Everything is faster in the 21st century. We travel on bullet trains and jets. Technology allows us to do more in less time, and the COVID-19 pandemic sped up the adoption of digital healthcare by several years. This is particularly evident in the regulatory submissions sphere, where a move from detailed, paper documentation to remote, electronic solutions is quickening its pace.

This shift to electronically stored information allows life science companies of all sizes to process regulatory applications remotely, as effectively as if they were in office. And with the remote model having now been proven, it is unlikely the industry will continue with the current traditional, document-centric methods.

Despite all the advantages associated with the electronic storage of regulatory information, several challenges remain. The “garbage in, garbage out” conundrum still exists in any setting where human operators carry responsibility for capturing or processing data. This creates the need for increased circumspection across the teams and departments that deal with regulatory submissions. Still, the use of robust data governance protocols and a structured content approach can help ensure successful regulatory compliance.

For decades, regulatory submissions were created in programs like Microsoft Word, with data manually entered into the relevant sections. Approved content is then “cloned” as submission copies to be formatted and deemed submission ready. This practice was labor-intensive and left plenty of room for human error. With structured content, components of information can be generated automatically for use in multiple document formats.

content developed outside of specific interface

 formats and delivery methods. The information is broken down into components that can be pulled into any content management system. This allows information to be authored just once and subsequently reused across multiple channels.

Content components are easier to iterate, and authors can use artificial intelligence (AI) and natural language processing (NLP) to create documentation. Instead of duplicating the work involved in each individual submission, users can store the components in a data silo. Submission teams can then pull approved sections of information they need and combine them to create the required output format.

By taking pre-emptive actions that incorporate verified data into regulatory and labeling operations, firms can avoid having to recapture flawed information. This method also enables them to repurpose material into new formats, minimize data loss, and improve data integrity. It streamlines regulatory submission processes and labeling, adds greater operational efficiency, and ultimately changes how the data is captured, used, and managed from end to end.

By adopting componentization, companies can take their content management a step further than merely shifting to digital submissions. They can increase patient safety while setting the stage for greater agility in future responses to industry shifts.

Generating advantages for life sciences companies

Pharmaceutical, medical device, and healthcare companies count on data to shape their commercial strategy and tactics and to deliver several advantages. For example, data allows firms to track their performance and ensures compliance with regulatory requirements.

Using electronically stored information and digital processes for regulatory filing makes it easier to distribute knowledge rapidly to different audiences. The filing process for regulatory and labeling compliance is also sped up by employing digital forms.

Health agencies have begun implementing programs focused more on application data than content accrual. Labeling, which has to date often been viewed as an ad hoc aspect of the process, also comes to the fore because component authoring supports faster label filing and compliance.

This scenario is a welcome change for life sciences companies, especially those operating globally. It results in better alignment in how data is captured and the way it is reported in readily consumable formats. Comprehensive information can be quickly generated and distributed to multiple audiences. When all stakeholders follow similar data entry protocols and distribution methods, everyone benefits from the improved efficiency of the compliance submissions.

As health agencies prioritize programs that focus on data through applications and electronic forms, the filing process for regulatory and labeling compliance will become faster. Life science companies will turn their attention to ensuring greater data integrity. Better governance and less human processing will guarantee the gathering of high-quality information, as well as accurate formatting and entry into databases for use.

These actions will enable companies to optimize their electronic regulatory submissions and future-proof their processes to meet the needs of current and new regulations. Ultimately, this will set them up for success in the high-tech, post-pandemic environment.

Cham Williams is Associate Director of Business Systems at IQVIA.

Articles

How taking steps to incorporate data into all regulatory and labeling operations helps firms avoid retroactively planning to recapture information
