Regulatory Submissions History Software

Centralize regulatory submissions history on cloud

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.

Benefits

Global Readiness

Global readiness enabling remote team members to access authorized submissions from anywhere in the world

Faster Responses

Faster responses to Health Authorities, driven by the ability to easily locate regulatory dossiers sent by regional offices and local affiliates

Dynamic Access Control

Dynamic access control based on configured business rules, which make it easy to share the right content with the right people

Unified RIM

Connect end-to-end regulatory processes and improve efficiency with the Vault RIM Platform.

Features

Format-Agnostic Import

Import final submission packages for your records and future reference, whether they are in 510(k), PMA, STED, IMDRF, or other formats.

Integrated Viewer

Leverage an integrated, cloud-based viewer, which reduces the number of tools on the regulatory desktop.

PDF Link Navigation

Navigate PDF hyperlinks across documents within a submission and across submissions. There’s no need for separate tools, file shares or downloading files.

Health Authority Interactions and Commitments

Retain and classify all correspondence with Health Authorities. Create commitment records with related tasks and report on progress against outstanding commitments and deliverables.

Dashboards and Reports

Create self-serve reports that show historic submissions by any combination of attributes including product, submission type, country, manufacturer and more.

De-duplicated Documents

Store documents used in multiple submissions once and only once.

Smarter Navigation Display

Access a document’s complete history of lifecycle operations. See where a document is used, including direct links to each submission.

Bulk Submission Export

Quickly export multiple submissions to support product divestitures, collaboration and outsourced publishing.