Vault Submissions Archive provides a centralized place for regulatory submissions history, making access to published submissions secure, quick, and easy. The software stores all electronic submissions in a validated cloud environment and links Health Authority correspondence to related submissions, enabling medtech regulatory teams to navigate and review all document history directly from the repository.
Global readiness enabling remote team members to access authorized submissions from anywhere in the world
Faster responses to Health Authorities, driven by the ability to easily locate regulatory dossiers sent by regional offices and local affiliates
Dynamic access control based on configured business rules, which make it easy to share the right content with the right people
Connect end-to-end regulatory processes and improve efficiency with the Vault RIM Suite.
Import final submission packages for your records and future reference, whether they are in 510(k), PMA, STED, IMDRF, or other formats.
Leverage an integrated, cloud-based viewer, which reduces the number of tools on the regulatory desktop.
Navigate PDF hyperlinks across documents within a submission and across submissions. There’s no need for separate tools, file shares or downloading files.
Retain and classify all correspondence with Health Authorities. Create commitment records with related tasks and report on progress against outstanding commitments and deliverables.
Create self-serve reports that show historic submissions by any combination of attributes including product, submission type, country, manufacturer and more.
Store documents used in multiple submissions once and only once.
Access a document’s complete history of lifecycle operations. See where a document is used, including direct links to each submission.
Quickly export multiple submissions to support product divestitures, collaboration and outsourced publishing.
Complete history of archived dossiers and correspondence
How Epredia transformed quality and regulatory operations with Veeva MedTech
Lori Holder shares how Vault RIM provides a single system to automate Alcon’s regulatory processes
Modernizing Regulatory Affairs: 2021 Regulatory Benchmark Report