SPL Server™

 

The first Fully Web-Based, Turn Key SPL Labeling Compliance Solution

Create SPL using our Native Structured Content Authoring Tool

Allow your regulatory operations staff, graphics designers and scientists to collaborate in real time when creating and maintaining labeling content. No new software is required on the end user’s work station. Only a browser is required to access all features and functions including native structured content authoring and document management.

SPL Labeling Process

Designed for Ease of Use
Regardless of your role in the labeling life cycle, SPL Server allows you to access the most important labeling information and tasks with the fewest number of mouse clicks possible. You can easily view and manage multiple “in-process” new submissions, supplements and changes in real time. Automatic notifications and alerts identify critical path items and help you stay on top of your regulatory operations work load.

Tier One and Tier Two Validations Are Key
No SPL document will be submitted to the National Library of Medicine (NLM) if it does not pass the tier one and tier two validations. Tier one validation checks the SPL document against the latest HL7 SPL schema. We also perform a "tier two" validation to ensure compliance with the "Structured Product Labeling (SPL) Implementation Guide with Validation Procedures" document published by the FDA, which enables you to significantly reduce the risk of a lengthy review process.

 
 
  Key Features:
 
  • All major label types are supported including Human Prescription and OTC drugs, Medical Devices and Cosmetics  
 
  • Built-in support for ordering according to the Physician Labeling Rule (PLR) including Highlights  
 
  • Real-time labeling content negotiation  
 
  • Easy to use interface, fully web-based, no browser plug-in or add-on is required  
 
  • Auto email notification, alerts, and status tracking  
 
  • Advanced search and reporting functionality  
 
  • Drug listing and medical terminology code look ups  
 
  • Automatic version status accounting  
 
  • Electronic signatures for approval  
 
  • "What You See Is What You Get"
(WYSIWIG) direct content editing and review via the web 		 
 
  • Role based security for editing, reviewing, approving and submitting labeling content  
 
  • Enterprise-wide visibility through your existing Intranet and/or the Internet  
 
  • Built-in annotation and comments  
 
  • 21 CFR compliant version control and
audit trails 		 
 
  • 21 CFR compliant electronic signatures including X.509 encryption  
 
  • Tier one (HL7) and tier two (FDA)
Structured Product Labeling (SPL) file
type validation 		 
 
  • Section 508 compliant  
 


SPL Editor

Get real-time validation results with "What You See Is What You Get" (WYSIWYG) editing functionality. Add and delete main sections, sub-sections, paragraphs, tables, ordered lists, unordered lists, and notes all from one easy to use menu. See how your label will be displayed to the public by viewing the SPL using the HL7 standard style sheet.

  
SPL Editor Screen and Menus

Update SPL

No need to train employees on XML with our Rich Text Editor editing functionality. SPL Server makes generating XML simple and seamless. Use standard shortcut keys to make text bold, italic, and underlined or use the SPL Server menu buttons. When you have completed your edits, hit the “Check Spelling” button to check for spelling mistakes.

  
Update SPL Screen

View Source

Want to view or edit the SPL source code? Simply check the “View SPL Source” box and let our system convert the text to HL7 schema valid XML.

  
View Source Screen

Compare SPL Versions

SPL Server takes the guess work out of labeling changes. With our compare functionality you can view differences in any two versions of a label.

  
Compare Screen