Product/Service

Drug Product Listing 2000

Source: Prelude Computer Solutions, Inc.
The Drug Product Listing Program is designed to help companies comply with the federal requirements
The Drug Product Listing Program is designed to help companies comply with the federal requirements for reporting product changes to the FDA. With the advent of the Food and Drug Administration's requirements concerning electronic submissions, it is increasingly important for pharmaceutical companies to create and store the FDA-2657 form in an electronic format.

DPL's attributes provide for ease of navigation and exceptional functionality while maintaining integrity, in compliance with federal requirements for reporting to the FDA.

Major benefits of using Drug Product Listing 2000 include:

  • An automated method to track and report product changes to the FDA.
  • On-line reference tables for FDA regulations. This provides for on-line prompting as well as validation of the accuracy of the information.
  • A tabbed product entry form which presents all data on an easy-to-navigate screen.
  • A complete inventory of corporate products.
  • A complete inventory and history of label changes.
  • A historical record of all FDA-2657 forms previously submitted to the FDA.
  • A record of all imprinting on solid oral dosage forms.
  • Features of Drug Product Listing 2000
Master Tables.

Product information is entered once into master tables, which are then accessed to provide information about each product. The major master tables are:

  • Federal Tables - There tables contain all of the codes and descriptions specified by the FDA.
  • Site Master - Contains the names, addresses and codes required for submission of each manufacturing and labeling site.
  • Package Master - Contains all of the packages used by each labeler showing code, size, and type of package.
  • Ingredient Master - Contains all of the ingredients used in the company's products. Serves as a single source for entry of product data.
  • Descriptions - Contains many of the codes that are required for entry such as Product Types, Types of Business, etc.
Entry Process.

The data for the Federal and Descriptions tables is provided and ready for use. The user enters the product information for the other master tables during the initial set-up. After the master tables are populated, the data for the products can be accessed through pull-down menus.

Prelude Computer Solutions, Inc., 26 Hill Road, Parsippany, NJ 07054. Tel: 973-331-3740; Fax: 973-331-3741.