The new application, Veeva Vault Submissions Publishing, was released at the Drug Information Association’s (DIA) RSDIM event in Bethesda, MD, yesterday.
“Today, publishing regulatory submissions is an inefficient, time-consuming process. Documents must move from a document management system to a publishing tool, then out to a file share, and finally to an archive, which may or may not be the content management system used for authoring,” John Lawrie, Vice President, Vault RIM Strategy Veeva Systems, told us.
Due to the gaps between systems, he said there is no traceability between source documents and the documents on-file with the regulatory authorities.
“Veeva Vault Submissions Publishing speeds the submission publishing process by performing publishing activities earlier, during the content development process rather than waiting until the end after documents are fully approved,” explained Lawrie.
Additionally, offering speeds the publishing process by automating activities that are currently triggered or performed manually.
Lawrie added, “Veeva is able to automate more of the steps because publishing within Veeva Vault RIM is unified with the upstream content management and the downstream dossier archive.”
Vault Submissions Publishing is expected to be available in early 2018 as part of the company’s unified suite of regulatory applications.
“Technology innovations can motivate process change. Look at how dramatically continuous manufacturing improves the speed and quality of drug production. In the regulatory space, continuous publishing can speed submission delivery. Companies will be able to automate more of the publishing activities and perform them in tandem with content creation,” Lawrie said.
"As companies shift to unified RIM suites, process improvements like continuous publishing become possible."