Enhancements to Regulatory Submissions (Med Device)
Windchill 13.1.0.0
Description
In Windchill 13.1.0.0, the Revisable Regulatory Submission process has been enhanced to improve tracking, management, and efficiency. Key updates include:
• New action — Track Regulatory Submission for managing tracking attributes and regulatory content not included in electronic submissions.
• Dedicated layout — Tracking Layout for configuring tracking attributes.
• Wizard — Track Regulatory Submission, accessible from multiple locations, streamlines the tracking process, and enables centralized tracking and indexing.
• License update — New profile action, Track Regulatory Submission, added to the license profile PTC Regulatory Master License.
• Manual process support —
◦ Ready-to-use template, Regulatory Submission Manual via Change Life Cycle Version 1, for cases where automation is not possible.
◦ Workflow Regulatory Submission Manual Submitting Version 1 Workflow ensures structured manual tracking.
• New team — Regulatory Submission Team Version 2 introduced to enhance submission processes with clearly defined roles, including a new role Submission Assignee exclusive to revisable regulatory submissions.
• New attributes — Adverse Event Report (AER) Revisable Regulatory Submissions type now includes Awareness Date, Event Description, and Event Date.
• Tracking preferences — Additional attributes added to existing key attributes in Tracking Preferences.
Related Information
For more information, see