Data Migration Documentation

Calyx RIM 6.2 CHF 6 Data Migration

Running the migration script results in multiple changes to the Data Administration data. The changes must be reviewed, and updated if necessary.

Changes related to JO-1-1 implementation:

  • Associates Jordan country with Jordan region in the Application Maintenance - Region Values if it is not associated already.
  • Adds the JO-1-1 assembly DTD type in the Assembly - Assembly DTD/Schema Types section in Data Administration, if it does not already exist.
  • Creates the JO - National procedure type value in Application Maintenance - Procedure Type Values, if it does not already exist.
  • Deletes any existing associations to application procedure types for each of the Jordan country and associates it to the JO - National procedure type.
  • Deletes any existing associations to application types for Jordan country and associates Jordan to the CTA and NDA application types.
  • Adds the following values to the Sequence Maintenance – Filing type Values section in Data Administration if they do not already exist:
    • ASMF Filing
    • Biological Allergen
    • Biological Bio-similar
    • Biological Blood Product
    • Biological Drug
    • Biological Vaccine
    • CEP Submission
    • Extension Filing
    • Generics
    • Generic Narcotics
    • Generic Vitamin Drug
    • Herbal Drug
    • MAA - Originator Drug
    • MAA - Originator Vitamin Drug
    • New Drug
    • New Narcotics
    • New Vitamin Drug
    • None
    • Notification with pricing
    • Notification without pricing
    • Originator Narcotics
    • Periodic Safety Update Report
    • Plasma Master File
    • PSUR single assessment procedure
    • Radiopharmaceutical Non-Radioactive Components (kits)
    • Radiopharmaceutical Ready-for-use Radioactive Product
    • Registration Department approval
    • Renewal Filing
    • Risk Management Plan Filing
    • Technical committee approval
    • Transfer MA Filing
    • USR Filing
    • Value added medicine
    • Veterinary drug
    • Withdrawal Filing
    • Periodic Benefit-Risk Evaluation Report

Changes related to Data Administration values:

  • Adds a new flag with Yes/No values, named System Process Default Flag, that indicates which status Name mapped to the same Internal System Status will be shown by default in Calyx RIM after an Event is closed manually or using a wizard. The field will be present in Registration Status Values.