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Complete history of regulatory submissions

Regulatory teams often use a patchwork of systems to track historical submissions, creating confusion and slowing responses to health authorities.

³Ô¹Ï±¬ÁÏ Submissions Archive makes it easy to find the right information in a validated cloud environment. Regulatory teams can link health authority correspondence to related submissions for a complete view of regulatory communications. Affiliates can download submissions or submission components for reuse in local markets and upload submissions already sent to various health authorities.

³Ô¹Ï±¬ÁÏ Submissions Archive enables companies to import submissions directly from file shares while preserving the file structure, folder structure, and inter-document hyperlinks. Users can navigate documents exactly as they were submitted to regulatory agencies and directly from the repository without needing to download files. An integrated viewer provides current, sequential, cumulative, and regulatory action views so users can quickly see a submission’s full lifecycle.

Business Benefits

• Increased visibility.
  Comprehensive view reduces time and effort to find and access submission information.

• Faster decision-making.
  Advanced search capabilities help users easily locate information, accelerating timelines.

• Improved access.
  Spend less time maintaining compliance and reallocate time to more strategic tasks.

• Unified RIM.
  Connect end-to-end regulatory processes and improve efficiency as part of the ³Ô¹Ï±¬ÁÏ RIM Platform.

Features

• Format-Agnostic Import
  Import final submission packages for records and future reference, whether they are in STED, IMDRF, 510(k), 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
  Retain and classify all correspondence with health authorities. View correspondence documents in the context of the application and associated submission.

• Dynamic Access Control
  Use rule-based access control to dynamically calculate permissions that ensure people can see only what they need and nothing else.

• De-duplicate 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.

³Ô¹Ï±¬ÁÏ RIM

³Ô¹Ï±¬ÁÏ Submissions Archive is part of ³Ô¹Ï±¬ÁÏ RIM, which streamlines global regulatory processes on a single, cloud-based platform. This enables medtech companies to:

• Ensure teams are developing reliable regulatory content with high data integrity
• Coordinate regulatory efforts across headquarters, affiliates, and partners
• Respond faster to changing regulations
• Increase end-to-end process efficiency from submission planning to publishing