Creating Regulatory Guidelines

You can create regulatory guidelines if you have the files containing the guidelines on your computer for loading into the system.

Required access role: Regulatory Administrator

Before you begin: View the list of all regulatory guidelines. See Regulatory Guidelines List.
See Also
Opening a Regulatory Guideline
Regulatory Guideline Properties
  1. From the page Actions menu or toolbar, click Create Regulatory Guideline .
  2. Enter these details:

    Field NameDescription
    TypeKeep the Regulatory Guideline type. If your company defined subtypes, click to select the needed subtype.
    NameEnter a name, or select the AutoName check box to have the app automatically-generate a name for the regulatory guideline.
    TitleEnter a descriptive name for the regulatory guideline.
    DescriptionEnter descriptive text about the regulatory guideline, such as the release date and version number, and if it supersedes any other documents.

  3. Click Done. The app shows a confirmation message.
  4. Click OK. The app opens the Checkin Files dialog box.
  5. Click Browse and browse the file system to select the file. Click Open to select the file.
  6. Click Done.

The regulatory guideline is created in the Inactive state. To complete the regulatory guideline:

  1. Attach a regulatory context with a regulatory activity category. See Regulatory Contexts List. The context ensures that the correct guidelines are used in submission projects.
  2. You do not have to add a regulatory activity when you search for and select a regulatory context for a regulatory guideline, but you must select a regulatory activity for the regulatory context before you can promote the regulatory guideline to the Active state.
  3. A Regulatory Administrator must approve the regulatory guideline. See 3DEXPERIENCE Basics: Lifecycle Page.
  4. Promote the regulatory guideline to the Active state.