Quark SPL Accelerator

Meet SPL Requirements through Easy XML Authoring

The Quark SPL Accelerator for Quark XML Author is a commercial, out-of-the-box solution based on Microsoft® Word that helps pharmaceutical companies, over-the-counter manufacturers, animal medicine manufacturers, and biologic manufacturers easily meet the U.S. Food and Drug Administration's latest SPL requirements.

You can use Word as you normally do, while the Quark® SPL Accelerator converts Word content to create valid and compliant SPL files.

Benefits

  • Meets all SPL authoring needs through a single solution
  • Supports creating XML documents with Microsoft Word – the primary business tool for millions of knowledge workers worldwide
  • Requires little training and no understanding of the technical aspects of XML
  • Automatically updates R3 documents to R4 compliance
  • Easily transfers content from existing Word documents to the SPL XML format
  • Validates document content prior to FDA submission through a rules engine
  • Reduces business disruption normally associated with adoption of new technology
  • Provides a user-friendly interface for managing Product Listing Data

Quark's SPL solution supports all submission types and requirements, including the following:

  • Bulk Ingredient
  • Establishment Registration
  • Human OTC Drug Label
  • Human Prescription Drug Label
  • License Blood Intermediates/Paste Label
  • Licensed Vaccine Bulk Intermediate Label
  • No Change Notification
  • Non-Standardized Allergenic Label
  • NDC Labeler Code Request
  • OTC Animal Drug Label
  • OTC Type A Medicated Article Animal Drug Label
  • OTC Type B Medicated Feed Animal Drug Label
  • OTC Type C Medicated Feed Animal Drug Label
  • Out Of Business Notification
  • Prescription Animal Drug Label
  • Vaccine Label
  • VFD Type A Medicated Article Animal Drug Label
  • VFD Type B Medicated Feed Animal Drug Label
  • VFD Type C Medicated Feed Animal Drug Label

In addition, because the Quark SPL Accelerator provides a flexible foundation built on Microsoft Word, it reduces the amount of effort required to implement subsequent changes necessary to meet evolving FDA requirements.


Case Study


PAR PHARMACEUTICAL EMBRACES XML FOR SPL AND DYNAMIC PUBLISHING
A Strong XML Strategy Built on Quark® XML Author™ Allows Anyone on Par’s Team to Create FDA-compliant SPL Submissions using Microsoft Word®

Download PDF: English