Enhancements to Regulatory Submissions (Med Device)
Windchill 13.1.1.0
Description
In Windchill 13.1.1.0, the regulatory submission process has been enhanced to improve traceability, and user experience. The following improvements have been made:
• A new Drives Regulatory Submissions table has been introduced to provide additional traceability for Regulatory Submissions from Driver objects. This table is accessible on various objects that serve as a Driver to a regulatory submission.
• A new profile action View Drives Regulatory Submissions is introduced for the Drives Regulatory Submissions table in the following license profiles:
◦ PTC View and Print Only License
◦ PTC Contributor License
◦ PTC Author License
◦ PTC Windchill Base License
◦ PTC Windchill Advanced License
◦ PTC Windchill Premium license
• A new tab named Regulatory has been added across multiple entities involved in the regulatory submission process. These entities include:
◦ Customer Experience
◦ Part
◦ People and Places
• A new action, Validate, has been introduced allowing users to evaluate both Non-Revisable or Revision-Controlled Regulatory Submissions and is accessible from various locations.
• A new profile action Validate Regulatory Submission is introduced for the action Validate in the license profile PTC Regulatory Master License.
• The Regulatory Submission Manual Submitting Version 1 Workflow is updated with a Check Out validation step for the Manual Tracking assignment.
Related Information
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