Overview

Structured Product Labeling (SPL) is the mandatory document markup standard for Regulatory submission of label content, product and facility information, and any subsequent changes to an existing label information in an electronic format. SPL format defines the structure and content of label information as required by the United States Food and Drug Administration (US FDA), Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). The FDA has mandated SPL requirements for over 50 types of documents and for various types of products including human prescription drugs (labeling of pharmaceutical products, biological and generic drugs), over-the-counter (OTC) products, veterinary medicine, homeopathic products, bulk ingredients etc. Some of the common document types that are supported by FDA SPL standard are listed below:

  • Blanket No Changes Certification of Product List
  • Establishment Registration
  • National Drug Code (NDC) Labeler Code
  • Lot Distribution Data SPL
  • Drug Listing SPL
  • SPL / Content of Labeling (CoL)

To submit drug labels through an SPL compliantly, applicants must have a deep understanding about the compilation of submissions in XML format to avoid errors that causes reworks viz., incomplete data, section misalignment, improper hyperlinking etc. To overcome such procedural complexities, Freyr Structured Product Labeling (SPL) software – compliant with 21 CFR Part 11 criteria and Health Level Seven (HL7) standard – offers a robust platform to create validate, store, and submit complex content structures, SPL Standard data elements and company and product information.

Freyr SPL software is stacked with enhanced features such as electronic records, electronic signatures, etc. making it secure and reliable. Being offered both on cloud and on-premise models, Freyr SPL Software reduces time taken for implementation and will sure be a cost-effective solution, for your SPL submissions. 

 

Freyr SPL Expertise

  • Dashboards and Reports
  • SPL Request Status Track
  • SPL Request Initiation
  • Authoring SPL
  • SPL Validation
  • Reviewing SPL
  • Version the SPLs
  • Approve SPL
 

Freyr SPL Features

  • Structured Product Labeling (SPL) supporting document repository
  • SPL version management
  • Multiview availability: SPL, XML, content editing, pdf
  • Workflow management and parallel review
  • Administration of users, roles, FDA SPL data elements, company and products information
  • Robust and user-friendly web interface
  • Email notifications to task owners and annual updates’ notifications
  • Open architecture integrated with leading document management system (DMS)
  • On-premise and cloud hosting deployment of Structured Product Labeling software
  • Text comparison
  • Revision of the existing SPLs
  • Bulk SPL data migration at the time of client site hosting
  • Supports 21 CFR Part 11 compliance (eSignature, audit trails, etc.)
  • Compliant with HL7 SPL specifications
  • Reduces manual effort of editing in XML  

To Know More about Freyr SPL software and to take a feature-specific comprehensive product tour.

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