Creating and Managing Regulatory Submission
As a Quality System Manager, you can create, edit and view regulatory submissions for a part, a regulatory decision, or a place and submit it to the regulatory agencies configured in the application. You can also create follow-up tasks or revisions on a regulatory submission and execute all the life cycle states in the submission workflow.
Types of Regulatory Submissions:
• Non-revisable Regulatory Submissions
• Revisable Regulatory Submissions
Prerequisite
• Administrator should create subtypes of Regulatory Submission in Type and Attribute Management at site level for non- revisable and revisable regulatory submissions. The subtypes of revisable regulatory submissions are Adverse Event Regulatory Submission, Establishment Registration Submission, Regulatory Product Submission, and Unique Device Identifier Submission. For more information see, Working with the Type and Attribute Management Utility.
To configure custom rules in cascading attributes, refer to Cascading Attributes Tab.
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You can create change objects (Change Notice, Change Request, Problem Report, Variance, and Review) using right-click action only for the revisable regulatory submissions and its subtypes.
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• Add regulatory agency records in People and Places. For more information, see Creating People and Places.