Enhancements to Regulatory Submissions (Med Device)
Windchill 13.1.0.0
Description
In Windchill 13.1.0.0, the Revisable Regulatory Submission process is enhanced to improve tracking, management, and efficiency. These are as follows:
• A new action, Track Regulatory Submission, is introduced for revisable regulatory submissions. This action enables the management of the tracking attributes and regulatory content that are not included in an electronic submission.
• A dedicated layout, Tracking Layout, is defined for this action to configure the tracking attributes.
• A wizard, Track Regulatory Submission which is accessible from various locations, sets the tracking attributes, streamlining the tracking process. New tracking attributes in this wizard enable central tracking and indexing for all types of revisable regulatory submissions.
• Multiple attributes are added to the existing key attributes in the Tracking Preferences.
• A new profile action Track Regulatory Submission is introduced for the action Track Regulatory Submission in the license profile PTC Regulatory Master License.
• A ready-to-use, standardized template, Regulatory Submission Manual via Change Life Cycle Version 1, incorporates industry best practices for managing revisable regulatory submissions when some or all artifacts cannot be handled through the automated submission process.
• The Regulatory Submission Manual Submitting Version 1 Workflow process manually tracks the regulatory submissions. This ensures a structured and efficient manual submission process, leveraging best practices to manage and track regulatory submissions effectively.
• A new regulatory submission team, known as the Regulatory Submission Team Version 2, enhances the submission process by clearly defining roles. This team now includes a new role called Submission Assignee, which is exclusive to revisable regulatory submissions.
• The Adverse Event Report (AER) Revisable Regulatory Submissions type now includes the following new attributes: Awareness Date, Event Description, and Event Date.
Related Information
For more information, see