The shift to remote work and decentralized global operations by life sciences companies has forever changed the regulatory market.
We have seen an increase in the speed at which the industry adapts to new methods, standards and requirements. The focus is now on how to drive better data governance and quality through a unified framework. The challenge is to create a framework that meets regulatory and labelling requirements.
To ensure local and global compliance is consistent and met, companies are turning to technology solutions. Companies are future-proofing their operations by leveraging technology that can respond quickly to any market changes, such as the type of disruption we’ve seen in the pandemic.
Looking ahead to 2022, three key areas of regulatory and labelling compliance technology, particularly automated processes, will provide greater agility for future market changes.
electronic standard
First, electronic standards will gain momentum as an accepted means of capturing and distributing information for regulatory compliance purposes.
The shift from document-centric regulatory processes to electronic-based submissions is a significant change for life sciences companies. So far, the process has been document-centric. While we’re seeing a shift to a more electronic data submission process in 2021, the industry is ready to go further.
In the future, companies will seek to use paragraphs of content stored in online databases to create reports by stitching already created paragraphs into new regulatory submissions. The value of this approach is that businesses can leverage existing information to quickly generate media for various solutions to distribute product and safety information efficiently and easily. It plays into the greater flexibility the market is looking for and allows people working from home to easily repurpose content digitally for greater efficiency.
automation
The key to a successful labeling practice is automation.
In addition to repurposing approved regulatory content, automated technology is critical to adopting the labelling process of the future. It assists in planning and tracking regulatory processes for fragmented global businesses.
If changes or updates are required, automation helps process new labels and quickly provide information at the local geographic level to meet regulatory requirements. It eliminates the manual processes associated with labeling that require a lot of time and effort today.
This year, we will see a wider embrace of automation by life sciences companies, allowing them to adapt more quickly to changing regulatory requirements. It will provide information to health agencies, websites and portals and develop new label printing processes. Thanks to the automatic generation and distribution of this controlled label, information is available before patients get their medicines.
Label
By employing technological solutions, labels minimize risks. As mentioned, label automation is an important part of the regulatory function, especially for new drugs. It ensures that all information distributed from global headquarters is thoroughly vetted and used at the local branch level.
With solutions in multiple markets, companies must be able to react quickly to changes. Ensuring that each local branch has quick access to information, understanding why and how changes are made, and then making sure that happens has always been a challenge. Technology can help businesses plan and track this process and provide greater functionality.
While machine learning plays a role at the fundamental level, natural language processing helps with the main part of the content as it helps to provide information at the local level. When natural language processing is combined with artificial intelligence techniques, it helps provide context for security implications that direct translation might miss. The use of these technology solutions will increase significantly in the coming months, leading to increased efficiency and compliance.
Focusing on technology solutions ranging from automation to AI/ML, regulatory processes and requirements will ensure the agility needed to adapt to new changes while ensuring proper compliance and information sharing. In addition, it ensures that additional risk minimization measures – sharing information with healthcare professionals and consumers in a targeted and measurable way – are also adequately addressed. Use technology solutions to reduce overall risk and improve data governance and compliance for labelling and regulatory compliance operations.
Photo: NicoElNinom, Getty Images
