Registratrion Database Intranet Application

Registration Database Application
For Drug Regulatory Affairs

Introduction

The Registration Database is an Intra- or Internet based application that allows worldwide recording, planning, managing and reporting Pharmaceutical Product Registrations in accordance to Drug Regulatory Affair needs:

Define Master Data such as Manufacturers, Products, SPC, Strengths, Packaging Materials, Storage Conditions and Shelf Lives.
Keep track of your Product Registrations by country, store defined product characteristics such as Ingredients, Filling Sizes and Package Sizes.
Link Product Registrations to MA-Holder information, MOP, PIL, SPC, Packaging and other documents.
Plan, submit and document Product Registration requests to authorities .
Plan, submit and document Variations of Product Registrations.
Document and Report Product Registration Status worldwide.
Easily Create XEVPRM Product Messages for electronic submission to European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No 726/2004.

Application Overview

With Registration Database following data can be easily managed and maintained:

Product, PMF Registrations and its Variations/ Change Control
Master Data such as Products, Suppliers, Packaging Materials and many more
Search, Report and automated Info Mailing
User Management & Security
Audit Trail and Access Logging
XEVPRM Product Messages for electronic submission to European Medicines Agency in accordance with Article 57(2)

Registration Database Model

Product Registrations and Change Control
Product Registration Status	Registration Status of a Product including registered Manufactures, Marketing authorization Holders, Filling Sizes, Package Sizes, Intermediates etc.
PMF Registration Status	Plasma Master File Registration Status
Product and PMF Registration Status Variation	Product and PMF relevant Variation Data
Change Control	Change Control Numbers and Descriptions for selection in Variations

Master Data
Products	Root Data for Products: Code, Name, Filling Size, Package Size, Strength, Country, Blood Group, Master MOP, link to file System etc.
Intermediates	Intermediates Master Table: A Product is build by Intermediates e.g. Plasma, Basic Substances manufactured by third parties
Companies/ Suppliers	Root Company Data: Name, Address, Contact Data: Manufacturers, MA-Holders and Suppliers delivering Materials (e.g. Plasma Centres, Basic Component Manufacturers etc) Laboratories
Packaging Materials and Medical Devices	Label, Carton, Leaflet, Syringe etc.
Tests	Holds root data of possible Tests including approved Test Kits to be made on a Product and/or Intermediate e.g. Nucleic Acid Tests (NAT)
Bags	Holds Root Data for Blood Bags
SPC	Summary of Product Characteristics
Epidemiological Data	Holds Epidemiological Statistical Data for Donors/Donations in Plasma Centres over several years and several Viruses
Countries	Country Root Data: Data can be loaded from this Table when needed
PSUR	Periodic Safety Update Report

Search, Report and automated Info Mailing
Search & Report	Custom Search Functionality (Plugins) to amplify the Application Functionality based on Company needs
Email Settings	Table defining on which Email Addresses change Information has to be sent. To be configurable by System Owner

User Management & Security
Application Users	Personnel Data: Personal Information, Contact Information and Application Access Permission
Access Control and Data Access Rules	Access Control Data defines the Security Matrix for Data access by Persons

Audit Trail and Access Logging
AuditTrail	Audit Trail of Changes in the Registration Database
Search Log	Log Table for Usage of Search And Report Functions