GE Healthcare Streamlines Global Regulatory Processes with Veeva Vault RIM

In early 2019, GE Healthcare’s pharmaceutical diagnostics division launched Vault Registrations, Vault Submissions, and Vault Submissions Archive to improve visibility and confidence in their regulatory data. They saw several initial improvements including automated task hand-offs, fewer emails, and faster information access. Even more impressive, they cut down the time required to create records for a regulatory activity across 130 markets from several hours to just five minutes.

Uncovering Additional Regulatory Benefits

These efficiency gains were just the start, and in the time since implementing Vault RIM, GE Healthcare further streamlined their regulatory processes including:

• Publishing: New personalized schedules and the ability to filter submissions by product, region, and in-house or outsourced work give publishers greater flexibility and control. They can now track dossier content on the submission record rather than in an emailed spreadsheet, which reduces versioning issues and publishing rework.
• Regulatory approvals: Previously, regulatory operations spent about 20 minutes creating and emailing memos for each approval, and they had to repeat the process several times a week. Now, they generate a single weekly report in just 10 minutes. This speeds communication and saves the team about 200+ hours annually.
• Performance measurement: The GE team leverages Vault RIM KPI data to uncover and resolve process issues. For example, they identify affiliates that are slow to update health authority approvals and assign them targeted training and reminders. They also plan to monitor submission rejections to increase the likelihood of regulatory approval.