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.