Building the Future’s Structured Content Solutions… Today!

SPL Server™

The 1st 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. Whether they use a Macintosh or PC, 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

Ready for the SPL Physician Labeling Rule (PLR) Challenge
Bound by federal mandate, the United States Food and Drug Administration (FDA) has required that all NDAs, BLAs, and Efficacy Supplements submitted after June 30, 2006 conform to the SPL-PLR rule. In addition, all NDAs, BLAs, and Efficacy Supplements approved since June 30, 2001 must be converted to the SPL-PLR format in the course of a 7-year implementation window. The addition of the Physician Labeling Rule (PLR) requirements to the SPL submission represents the first major change in the insert labeling in 25 years. All of the ThinSpring Team software and services are designed for complete compliance with the new SPL-PLR requirements. In addition, we’ve partnered with specialists QeL to create the technically sophisticated Highlight Text section with Custom SOW Definition, FPI creation and verification, highlight codes, and FDA support through the examination and approval process.

Key Features:

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All labels ready for the Physician Labeling Rule (PLR)

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Real-time labeling content negotiation

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Fully web-based, no browser plug-in or add-on is required

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Easy to use, Word-like interface

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Auto email notification, alerts, and status tracking

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Advanced search and reporting functionality

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Drug listing and medical terminology code look ups

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Automatic version status accounting

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Advanced link and dependency management

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Electronic signatures for approval

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"What You See Is What You Get"
(WYSIWIG) direct content editing and review via the web

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Full support of the PhRMA working group standard style sheet

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Role based security for editing, reviewing, approving and submitting labeling content

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Enterprise-wide visibility through your existing Intranet and/or the Internet

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Built-in annotation and comments

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21 CFR compliant version control and
audit trails

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21 CFR compliant electronic signatures including X.509 encryption

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Integration with existing document management systems and authoring tools

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Tier one (HL7) and tier two (FDA)
Structured Product Labeling (SPL) file
type validation

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Section 508 compliant

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. If the document does not pass the tier one validation, the SPL will be rejected by the FDA before any review is even performed. We validate the SPL document against the HL7 standard SPL schema to verify the document will pass all schema validations when submitted to the ELIPS system. We also perform a tier two validation which enables you to see what the FDA will see once the label is submitted, therefore reducing the risk of a lengthy review process.

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 Microsoft® “Word-like” 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