SPL

SPL: Structured Product Labeling Software

SPL software is an easy-to-use, content authoring tool which manages SPL/PLR/Drug listing lifecycle and validates the output as per USFDA regulatory guidelines. Creation of SPL document is as simple as uploading the word document directly into the application without the need for cut and paste operations from a source document. The complex content structures, including tables, images, lists, and nested sub sections are easily created by the tool.

How It Works

The software simplifies label creation by automating structure, content formatting, and data mapping. Complex elements like tables, images, lists, and nested sections are easily managed, ensuring every submission meets USFDA validation criteria. It supports multi-user collaboration, audit tracking, and complete lifecycle control—from creation to submission and updates.

Major Features

• Life cycle Management – SPL/ Drug listing / PLR (Including Kit Products)
• NDC Labeler management.
• Establishment Registration management.
• Facility self-identification management.
• Blanket No-Change Notification.
• Provision to import SPL using existing SPL xml (RLD xml) or from Word document.
• In-built verification module as per latest validation criteria.
• Multi-user system: Supports multiple users for parallel work with secure access control.
• Comprehensible & effortless flow
• Menu & Drug Level Security: Ensures controlled user access for safety and compliance.
• Plugged in HELP module
• Data Reuse: Copy or Inherit SPL data from one drug to another with ease.
• Audit Trails: Tracks every change for full visibility.

Why Choose SPL Software?

This software offers a faster, error-free, and compliant way to manage SPL/ Drug listing / PLR submissions. Whether you’re a small manufacturer or a large enterprise, this solution ensures your documentation process is reliable, accurate, and aligned with health Canada requirements.

For organizations seeking SPL/ Drug listing / PLR services or complete labeling solutions, this software brings together compliance, convenience, and control—all in one intuitive platform.