Structured Content AI for Global Labeling

Reduce global product label generation time from months to days with an easy and cost-effective system your whole team will love.

HOW IT WORKS

Enhance global labeling workflow
with generative AI

ComplianceAuthor AI^® simplifies your internal processes around authoring, reusing, translating, and managing product labels.

ComplianceAuthor AI^® uses natural language processing specifically designed for pharmaceutical companies to index your existing clinical information into one controlled system.

ComplianceAuthor AI^® allows users easy and fast authoring through MS-Word. This provides companies with a powerful xml system in a simple Word interface.

ComplianceAuthor AI^® helps users, health authorities and authorized third parties easily collaborate. Harmonize internal and external comments, edits, and tracked changes automatically in one document.

ComplianceAuthor AI^® manages technical translations out of the box. ComplianceAuthor AI supports both in-house and third-party translation service providers.

ComplianceAuthor AI^® leverages state of the art omni-channel publishing capabilities to automatically generate regulatory submissions like QRD, SPL, and FHIR formats.

KEY BENEFITS

Safely reduce label authoring timelines by up to 50%

Pharmaceutical labeling is a complex process involving multiple teams, all of them collaborating for months at a time on a single product. With ComplianceAuthor AI^®, you can dramatically reduce the typical product label timeline while optimizing your processes and procedures.

Streamlined label authoring

Create and deploy structured content components across the globe. Make a change once, and gain insights to determine the next best action.

Cut your labeling process by up to 50%
Manage change control with tracking and compliance reporting
Facilitate instant feedback across teams

Outputs for every health authority

Experience seamless compatibility with all health authority outputs, ensuring your labels are ready for every market.

Generate traditional outputs like QRD and SPL
Supports emerging standards for data exchange like FHIR
Reuse components & translations across multiple labels

Works with your tech stack

ComplianceAuthor AI^® integrates easily with your current systems in a way amplifies your capabilities.

Flexible system infrastructure designed to scale as your organization evolves
Leverage a secure cloud to organize and optimize your data supply chain
Minimize IT costs to support and maintain the system through the line of business

USE CASES

Built for component-based pharma content

ComplianceAuthor AI^® enables the authoring, collaboration, and management of all your content at the component level for simple reuse and automatic impact analysis across your workflows.

Content analytics and change control

Search, find and index and monitor content. Manage change control across your enterprise, leveraging machine learning.

Structured product labeling

Design your product labels with regulated and compliant components at every stage of the drug’s lifecycle.

AI automated content generation

Use generative AI to transform internal data sheets into approved health authority labels, with a human in the loop.

TOP FEATURES

Tools for the whole team

ComplianceAuthor AI^® enables the authoring, collaboration, and management of all your content at the component level for simple reuse and automatic impact analysis across your workflows.

Structured Content AI for Global Labeling

HOW IT WORKS

Enhance global labeling workflowwith generative AI

KEY BENEFITS

Safely reduce label authoring timelines by up to 50%

Streamlined label authoring

Outputs for every health authority

Works with your tech stack

USE CASES

Built for component-based pharma content

Content analytics and change control

Structured product labeling

AI automated content generation

TOP FEATURES

Tools for the whole team

Familiar Microsoft Word interface

unstructured to structured data conversion

Life sciences capabilities (CFR Part 11, e-Signatures & more)

Automatic XML generation

Direct metadata tagging

Granular authoring process integrations

Collaborative review process

Automatic feedback merging

CLOUD-BASED COMPONENT CONTENT MANAGEMENT SYSTEM

impact analysis for tracking changes to components

Integrates with other solutions (Veeva, Documentum, Sharepoint)

Pre-configured outputs & picklists

See how your labeling process can be improved with ComplianceAuthor AI®

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Enhance global labeling workflow
with generative AI

See how your labeling process can be improved with ComplianceAuthor AI^®