Veeva Systems has announced Veeva Vault Submissions Publishing, a new cloud application that seamlessly incorporates publishing capabilities within Veeva Vault RIM to speed regulatory submission delivery.
The addition of Vault Submissions Publishing unifies publishing capabilities and enterprise content management to streamline end-to-end submission development. Now life sciences companies can plan, review, publish, archive and validate submissions within a single cloud platform.
Traditionally, regulatory submissions are created with disparate systems for content management and publishing. Working with separate systems requires file transfers and impedes the publishing team’s visibility into document readiness, making it difficult to effectively plan and allocate resources.
“Submission planning, registration tracking, document management and publishing are all within one end-to-end process,” said Steve Gens, Managing Partner at Gens and Associates. “Having publishing within a set of unified regulatory capabilities can reduce cycle times and improve productivity throughout the entire submission development process.”
Veeva Vault Submissions Publishing empowers publishing teams to perform activities during document authoring, formatting and reviews. This enables a continuous publishing process instead of waiting for the submission plan and documents to be finalised. With activities such as document hyperlinking and validation now moved upstream and automated, teams can complete work faster and speed submission development.
“The industry struggles with disjointed systems that force regulatory teams to duplicate data, documents and effort,” said Frank Bosley, Vice President, Global Head of Regulatory Operations at The Medicines Company. “A unified RIM approach such as Veeva’s can streamline submission preparation and enable sponsors to reduce risk and delays.”
Veeva Vault Submissions Publishing together with Vault Registrations, Vault Submissions, and Vault Submissions Archive delivers a unified RIM suite for seamless information and traceability throughout RIM processes.
“RIM transformation is gaining considerable momentum as companies seek greater visibility and global alignment across regulatory,” said John Lawrie, vice president, Veeva Vault RIM, at Veeva. “Now, with end-to-end submission development, regulatory can speed submission delivery and gain complete traceability between source documents, filed dossiers and related product registrations.”
Veeva Vault Submissions Publishing is planned for availability in early 2018.