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Structured Content AI for CMC Test Specifications

Centralize your global test, product, and procedure specifications—and analytical methods—in one AI-powered system that saves your team time, money, and effort supporting Module 3.


Streamline CMC data and documents
with AI

Easily manage and control the entire lifecycle for all your data-driven test specifications. All while maintaining a full audit trail and keeping compliance at the core of your products’ quality and safety.

ComplianceAuthor® AI ingests your test specifications and analytical methods allowing for global product quality and compliance in one central location.

ComplianceAuthor® AI allows users to quickly draft, deploy and link methods in a compliant manner, which eliminates redundant and duplicate documents.

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 in support of your global operations. ComplianceAuthor AI supports both in-house and third-party translation service providers.

ComplianceAuthor® AI combines all various documents like test specification, methods, and validation reports to generate a specification report in a fully validated GxP system.


Easily manage & maintain accurate CMC content

CMC specifications require rigorous scientific accuracy, efficient communication, and clear workflows to ensure effective management. ComplianceAuthor® AI lets you use generative AI that’s been trained on your content to help improve each one.
Centralize CMC Documents

Centralize CMC documents

Centralize the creation and management of your CMC specifications in a single source of truth.

  • Enable cross-functional collaboration for scientists, quality assurance and control, regulatory, and more
  • Consolidate authoring, feedback and revisions across multiple stakeholders
  • Leverage standardized template for consistent structure and formatting

Streamline content authoring

Reuse components, simplify authoring, and improve collaboration across teams.

  • Break down your CMC content into modular components you can reuse
  • Facilitate timely updates across your
    specification content
  • Automate formatting and copy/paste tasks, ensuring consistency
Streamline authoring content

Maintain accuracy & compliance

Ensure accuracy and consistency by reusing analytical methods across test specifications.

  • Reduce errors through a library of standard methods and automated validation checks
  • Easily update specifications based on product and regulatory changes
  • Reuse approved methods and components to increase compliance

Built for CMC authoring needs

From test methods to specifications and beyond, ComplianceAuthor AI® helps you organize CMC submission authoring and management across all your team’s functions and needs.


All substances and methods are housed in one system, ensuring compliance.

Product specifications

Improve and sustain compliance with drug products and methods in an integrated system.



Manage and re-use methods and tests within specifications.


Tools for the whole team

ComplianceAuthor AI® ensures seamless team-based authoring and management for all your structured labeling content, dramatically reducing unnecessary rework and your reliance on manual workflows.

Life sciences capabilities (CFR Part 11, e-Signatures & more)
Modular & componentized authoring & assembly
Familiar Microsoft Word interface
Automatic XML generation
Granular authoring process integrations
Collaborative review process
Automatic feedback merging 
Integrates with other solutions (Veeva, DCTM, SP)
Pre-configured outputs & picklists

See what your CMC content looks like in ComplianceAuthor AI®