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A4L Professional - The Complete SPL Solution

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SPL Authoring Using Microsoft® Word

A4L Professional leverages x4o, i4i’s industry leading Microsoft® Word-based structured authoring platform, allowing users of all levels to easily manage the entire SPL authoring and collaboration process.

A4L simplifies the SPL authoring process by presenting the user with the familiar Word interface, as A4L works behind the scenes to create valid SPL submissions.

Comprehensive Regulatory Support

A4L supports the SPL Release 4 (R4) and Release 5 (R5) standards, and allows for the management of the complete Authoring, Review, Validation, and Submission process. Guided templates for creating and maintaining your SPLs, for all product types listed below, make SPL compliance easy:

  • Human Prescription Drugs
  • Over-The-Counter (OTC)
  • Cosmetics
  • Dietary Supplements
  • Biological Products
  • Veterinary Medicines & Medicated Feeds
  • Bulk Ingredients/APIs
  • Medical Foods
  • Homeopathic Drugs
  • Medical Devices
  • Lot Distribution Report
  • Risk Evaluation and Mitigation Strategies(REMS)
  • Blanket No Changes Certification for Product Listing

  • Establishment Registration
  • Labeler Code Request
  • Generic Drug Facility Identification Submission
  • Identification Of CBER-Regulated Generic Drug Facility
    Coming soon...
  • Salvaged Animal Drug
  • Blood Establishment Registration & Product Listing
  • Blood Establishment Registration & Product Listing Change in Information
  • Human Cell and Tissue Establishemnt Registration & Product Listing
  • Human Cell and Tissue Establishemnt Registration & Product Listing Change in Information

A4L's familiar Word authoring environment greatly aids user adoption & productivity.


Ease of Content Migration

Migration of existing content is fast and easy. Content can be authored directly in the SPL templates, imported (Word .docx or XML files) into A4L, or copied and pasted from other sources. Even the most complex content, such as tables and graphics, are copied with ease into A4L.

The Physician’s Labeling Rule

A Physician’s Labeling Rule (PLR) format SPL can be easily created from scratch, or upgraded from an existing non-PLR document. Standardized sections and boiler-plate text are automatically generated, and Highlights are uniquely arranged to ensure content compliance with the related section's text. When converting a non-PLR label to the PLR format, A4L automatically reorders sections and guides the user in the necessary content revisions to ensure compliance.

Automated Code Management

A4L automatically handles everything involving the management of the GUIDs (Globally Unique Identifiers), XML attributes, Ingredient Codes (UNIIs), and coding associated with the FDA's controlled vocabulary. A4L takes all technical complexities out of the SPL process, allowing authors to focus on the content while easily creating valid and compliant submissions.

Compliant Drug Listing

A4L features user-friendly forms that guide the user through the definition and population of all required drug listing information. Its unique FDA Resource Updater ensures the extensive lists of FDA-controlled vocabulary, within the A4L interface, remain current as changes are made by the FDA.

Forms integrated into Word let users easily complete all required listing information.


Extensive Validation

A4L features a comprehensive, built-in validation engine that ensures the content is complete, consistent, and compliant with the most current regulations. The validation in A4L incorporates all of the rules outlined in the FDA's Implementation Guide, the latest Validation Procedures, and the XML Schema, including:

  • OTC Monograph/CFR Rules
  • Medication Guide Validation
  • Required Sections per Label
  • UNII Code and Moiety

Validation ensures compliance during the authoring process.


Collaborative Content Management

To learn how A4L Professional can be extended to provide fully-integrated, collaborative content process and lifecycle control and tracking, see ALiCE for Labeling - US SPL Edition.