What life sciences companies stand to gain from integrating regulatory content management and publishing

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By Sadia Ahmed

Life sciences companies are increasingly looking for better integration and interoperability across their various content management systems and improved oversight of regulatory content to address both compliance and efficiency demands. This is particularly important for regulatory publishing amid a push to improve both data quality and processes.

While a content management system on its own offers many benefits, such as version control, access control, metadata control, and a centralized repository across the organization, integration between content management and publishing gives companies another level of control and oversight.

When the solutions are integrated, publishing teams are able to bind to specific versions, regardless of whether that version exists in the content management system, or to the current version of the document for publishing. Another benefit is being able to use the rendition of the document whenever it is available in the content management system, for example to run a function to update a selected part of a document where rendition is available.

Given the global nature of regulatory submissions, being able to maintain a relationship between the source file and the published file or, in other words, to keep track of everywhere a particular content document was used, is a huge benefit. Without integration between content management and publishing, this is difficult to achieve.

Simplifying the archiving process

Archiving is another priority for the regulatory publishing team. Companies are required to archive submissions so regulatory authorities can see the archived submission at any point. The benefit of a regulatory content management system that is integrated with publishing is that it makes it easier to store that archived submission and can be used to make content available on demand.

Without that integration, companies typically have to manually go into the content management system and upload submissions to the archive location. Embedding the archive function within the publishing system is both more secure and less labor-intensive.

As regulatory teams and other functions look for more efficient ways to manage processes, automation has become an increasingly hot topic. When documents are stored in a regulatory content management system, the solution also stores metadata that defines that content. If the publishing tool the company has adopted has tight integration with a content management system, it can pull that document metadata along with the content into the submission, which opens the door for automation.

For example, it might be possible to pull metadata from the content management system and – knowing exactly what version is involved – populate some of the information automatically to build the submission. This not only saves time but also improves compliance because the publishing team doesn’t have to duplicate the data.

Having better oversight of the entire regulatory process is an important benefit of regulatory content management. With well-integrated tools, the publishing team can keep track of where a document is being used, and if changes are made to the content it’s much easier to identify what submissions may be impacted by those changes. For example, if the content is being used in multiple applications, publishing can run a report that notes exactly what the document is used for.

Without this level of integration, the only way companies can track the way content is used would be by using a basic spreadsheet, and very often those changes are made in each instance without any tracking.

Companies are not only looking for better integration within their publishing tools, but also looking for publishing systems that can accommodate multiple content management solutions. For example, many companies use one tool, such as Documentum, as the content management system for their regulatory/CMC/ Quality data, and another, such as Veeva’s Vault PromoMats, for promotional materials with the move to eCTD submissions. As a result, there is a growing expectation of cross-platform integration, allowing companies to use solutions interchangeably.

The move toward greater integration with content management is creating opportunities for companies to realize greater efficiencies, improved compliance and – potentially – automation across all aspects of document creation and regulatory submission. It’s the direction companies should expect to move to as they deal with greater demands on their time and resources.


Sadia Ahmed has over 18 years of experience in IT and the life sciences Industry working in research and development and global management functions. She has extensive global knowledge of regulations and guidance for electronic submissions. She currently works as product manager for DXC’s Publishing Suite for regulatory publishing.

 

Comments

  1. Interesting article Sadia. I’d also suggest a need for life sciences companies to be integrating other content that is shared publicly via print and electronic media, including regulatory, product and marketing content required for labelling.

    Like

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