Regulatory Submission Processor Interface

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The Regulatory Submission Processor Interface is an interface that provides the ability to customize the behavior of regulatory submissions and implement specific formats for the regulatory agencies. For example, you can customize the attributes while creating or revising regulatory submissions. You can also customize regulatory submissions to open the default or an alternate editing user interface.

Scope, Applicability, or Assumptions

• Assumes that you have general knowledge of Java classes and concepts such as a class extension

• Assumes that you have general knowledge of the xconf mechanism to register service classes

Prerequisites

To apply this best practice, you need to understand the following:

• Java class extension

• Xconfmanager

Solution Elements

The next table describes the various solution elements.

Element	Type	Description
com.ptc.qualitymanagement.regmstr.impl.SimpleRegulatorySubmissionProcessor	Java Class	Out-of-the-box processor interface that is registered for a non-revisable regulatory submission.
com.ptc.qualitymanagement.regmstr.impl.AERSubmissionProcessor	Java Class	Out-of-the-box processor interface that is registered for an Adverse Event Regulatory Submission.
com.ptc.qualitymanagement.regmstr.impl.ERSubmissionProcessor	Java Class	Out-of-the-box processor interface that is registered for an Establishment Registration Submission.
com.ptc.qualitymanagement.regmstr.impl.RPSSubmissionProcessor	Java Class	Out-of-the-box processor interface that is registered for a Regulatory Product Submission.
com.ptc.qualitymanagement.regmstr.impl.UDISubmissionProcessor	Java Class	Out-of-the-box processor interface that is registered for a Unique Device Identifier Regulatory Submission.

Default Behavior

When searching for a regulatory submission processor, Windchill searches the Type tree until a processor is found. For example, if a subtype of Adverse Event Regulatory Submission does not have a processor that is registered using xconf, the AERSubmissionProcessor is used.

Creating xconf Entries

To register custom populators relative to specific regulatory submission types and subtypes, create entries in a custom service.properties.xconf file.

An example of an xconf entry to register against a non-revisable regulatory submission subtype is given below:

An example of an xconf entry to register against a revisable regulatory submission subtype is given below:

An example of an xconf entry to register against a non-revisable regulatory submission subtype is given below:

An example of an xconf entry to register against a revisable regulatory submission subtype is given below.

If a service class does not exist for a subtype, the parent types of the subtype are checked until a service class is found. If a service class is not found, a trace log entry reports on the class and type with no service class defined. Turn on TRACE logging for com.ptc.qualitymanagement.qms.util.helper.QMSServiceClassHelper to display the log entry.

The following sections describe the areas of customization for regulatory submissions.

• Attribute Populators for New Regulatory Submissions

• Attribute Populators for New Revisions of Regulatory Submissions

• Developing an Alternate Editing User Interface

• Developing a Report

• Developing a Clean Transmission Content Processor

• Developing a Payload

• Developing a Submission Processor

• Developing an Acknowledgement Interpreter

• Developing a Completion Processor

• Developing an Expiration Processor

• Developing a Cancellation Processor

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