Administration Roadmap

To implement Market Registration, you must configure the project settings, regulatory activity categories, market authorizations, and submission process and classification properties.

To implement Market Registration on-premises, you must first install the 3DEXPERIENCE platform as described in Installation and Administration: 3DEXPERIENCE platform. Collaboration and Approvals is part of 3DSpace, which is installed as part of the 3DEXPERIENCE platform.

The following table lists the supporting components that need to be installed and configured. It includes references to information to help you do so. For Market Registration, the table provides cross references to topics that describe those configuration steps and options.

Software ComponentSetup or Configuration OptionFor More Information
Collaboration and Approvals Configure checkin and checkout using properties and URL parameters. Collaboration and Approvals Administration Guide: Common Document Model
Determine vaulting strategy and set up company vaults using MQL. MQL Concepts: Building the System Basics
Add companies, assign vaults, and add at least one administrative user per company using Collaboration and Approvals. Collaboration and Approvals Administration Guide: Configuring People and Organizations
Collaborative Services Install third-party apps and products, such as search engines and 2D and 3D viewer software and connectors. Documentation for the third-party software and 3DEXPERIENCE Open apps.
Register viewers, define formats, and set up viewer preference choices. Collaboration and Approvals Administration Guide: Configuring BPS Functions: Setting Up 2D and 3D Viewers
Market Registration

Install or upgrade Market Registration and these required or optionalapps in the following order:

  1. Change Management
  2. Quality-based Document Control (Optional)
  3. Device Identification (Optional)
  4. Complaints and Nonconformance (Optional)
  5. Adverse Event Reporting (Optional)
  6. Engineering BOM Management (Optional, but required for Device Master Record Management)
  7. Manufacturing BOM Management (Optional, but required for Device Master Record Management)
  8. Device Master Record Management (Optional)
  9. Project Management
  10. Market Registration
  11. Project and DHF Management (Optional)
  12. CAPA and Audit Management (Optional)
Installation and Setup: Install: 3DEXPERIENCE Platform: Installing 3DEXPERIENCE Platform Services: Installing 3DEXPERIENCE Platform Services One-by-One: Web Apps Installation: Installing and Upgrading Web Apps
Perform the necessary data migrations after upgrading to a new release of Market Registration.See Migration > Data Migration in the Program Directory.
Configure Market Registration to reflect your business processes.

Configuring Action Tasks

Configuring ATC Classifications

Configuring eCopy Submissions

Configuring How Manufacturing Plants Are Added to Market Authorizations

Configuring Mandatory Milestones

Configuring Market Authorization Results Value

Configuring Market Authorization Notification Intervals

Configuring PDF and ZIP Package Export

Configuring Regulatory Activity Categories

Configuring Regulatory Notifications

Configuring Regulatory Request Queue Dates

Configuring Submissions

Configuring the Timer Servlet

If necessary, configure triggers for Market Registration to reflect your business processes:
  • Turn off triggers that you do not want.
  • Change parameters passed to trigger programs, as needed.
Collaboration and Approvals Administration Guide: Activating and Deactivating Triggers and Studio Modeling Customization Guide: Triggers
If necessary, change the on-screen text for Market Registration, including internationalized text.

Collaboration and Approvals Administration Guide: Changing Onscreen Text

Collaboration and Approvals Administration Guide: About Internationalizing