Calyx RIM 6.2 Release Notes

Calyx RIM 6.2 CHF 7 Release Notes

This document describes a certified hotfix (CHF) provided to improve Calyx RIM 6.2.

In addition to enhanced features and functionality, Calyx RIM 6.2 CHF 7 resolves issues that were reported to Technical Support. Our hotfixes are cumulative packages applied to a named version of our software.

As a certified hotfix, these updates have undergone Quality Control regression testing, certifying the system works as expected. These changes will not create a new code branch, but will be identified by the updated build number on the existing codeline of each version affected, not a new release number.

Entity Comments

Calyx RIM 6.2 CHF 7 enables you to add comments for create/modify functions on Event - Country Status, Sequence Status Date, and Task Status Dates:
  • Event-Country Status Comments in Event- Country Attributes > Add/Modify-Country Event Status.
  • Sequence-Status Comments in View Sequence > Add/Modify Status.
  • Task Status Comments in View Task > Add/Modify Status.

Regulatory Updates

  • Support for US FDA eCTD M1 specification v.2.5, submission standards v.4.1:
    • http:// is changed to https:// in DTD reference and stylesheets.
    • US 3.3 assembly template updated to include additional folders and leafs.
    • Application Form Type Values updated to include applicable Regulatory Codes.
    • Filing Type updated with additional application types for grouped submissions.
    • Form FDA 3988 and Form FDA 3938.
    • REMS Supplement enabled for grouped submission in Data Administration.
  • Support for Taiwan eCTD Module 1 v1.1 (DTD 1.0).

BREXIT

Calyx RIM 6.2 CHF 7 includes changes and fixes necessary to support BREXIT regulatory processes.