FDA-2657 Drug Product Listing


	Prelude Computer Solutions, Inc.

Drug Product Listing

FDA-2657, FDA-2656, FDA-2658

The Drug Product Listing (DPL) Program produces the FDA 2657, FDA 2656 and FDA 2658 forms and is designed to help companies comply with the federal requirements for reporting product changes to the FDA. The Drug Product Listing eliminates the time consuming task of filling out paper forms by hand. By capturing the data electronically, users need only enter the data that has changed and must be reported. The system will generate FDA approved 2657, 2656, and 2658 forms for submission to the FDA. DPL provides ease of navigation and exceptional functionality while maintaining data integrity, in compliance with federal requirements for reporting to the FDA.

Major benefits of Drug Product Listing

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 one easy-to-navigate screen.
A complete inventory of corporate products, including sites, ingredients, and packages.
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.

The DPL Program maintains a database of product information from which to generate the DPL Report. Because the data is stored in a database, additional ad-hoc reporting is available, however, the primary function of the DPL application is to generate the following completed mandated forms in compliance with the Food and Drug Administration regulations:

FDA 2656 Registration of Drug Establishment/Labeler Code Assignment
FDA 2657 Drug Product Listing
FDA 2658 Registered Establishments? Report of Private Label Distributors

Some additional reports and features of the application are:

Imprinting Report: Imprinting of Solid Oral Dosage Form Drug Products for Human Use

Medicaid Drug Rebate Agreement Form HCFA-367 OMB no.0938: All information except the amounts are maintained and a report is created which can be used to fill out the mandated form.

Label Tracking Report: DPL tracks all packages in which a product is marketed. Each package has a related table that tracks critical information about label changes by label type (Back, Front, Insert, etc?). In addition to the written label audit history, links are provided for attaching label images or other critical electronic information.

FDA Log: DPL provides an interface for recording and logging any regulatory activity by product. The system generates the date, timestamp and user name. The user then enters who was contacted, type of contact, reason for contact, and summary of activity. Links are provided for attaching critical electronic information concerning this contact.

Audit Trail: All changes made in the DPL database are captured in an audit log which records the date, timestamp, user name, the table being changed and the contents of the data fields before and after data is changed.

Ad hoc Reports: Various other reports are provided for printing product information for example: Products and packages, Sites and products, etc? Users can also create their own custom reports.

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