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.