Structured Content AI

Simplify Structured Content with ComplianceAuthor® AI

Streamline the way you draft and manage regulatory documents with structured content authoring software for pharma.

Documents to Data

Transition from
Documents to

Generate Any Output or Document Type

Any Output or
Document Type

Get Improved Time to Market with End-to-End Ecosystem Support

Get Improved Time to Market with End-to-End Ecosystem Support

Perpetually Sustain Compliance with Audit Trail & e-Signature Capabilities

Perpetually Sustain Compliance with Audit Trail & e-Signature Capabilities


The AI-Powered Authoring Assistant

ComplianceAuthor® AI is a GxP-compliant, structured content AI that leverages natural language processing and generation models trained on your data to streamline your authoring process. All in a familiar, Word-based format.

  • Harmonize agency-neutral, component-based content with metadata / attributes / properties

  • Generate any health authority output or regulatory document type

  • Access 30+ pre-configured document types with industry relationships mapped, populated picklists, available drop-down menus

  • Support ecosystem of health authorities and local operation business interactions for improved time-to-market

  • Sustain CFR Part 11 & EU Annex 11 compliance with audit trail and e-Signature capabilities out-of-the-box
Compliance Author AI

Streamline Component Authoring
for Any Document

Automate the rote, time-intensive steps in your authoring workflow – from cutting and pasting component content, to rewriting approved language, to XML conversion.

  • Structured component management processes for tracking, managing, and reusing components

  • Centralized component content management system (CCMS) cloud repository

  • Word-based interface

Automatically Convert into Any Health Authority Output

As you generate, review, and approve your content, ComplianceAuthor AI maintains everything in its appropriate health authority output format. No coding necessary.

  • Automatic XML generation

  • Life sciences extensions (CFR Part 11, EU Annex 11, e-Signatures, etc.)

  • Direct metadata tagging
Healthcare Compliance

Collaborate Easier & Shorten
the Document Lifecycle

Using ComplianceAuthor AI, authoring teams can significantly reduce the amount of time spent on the creation and management of regulatory documents.

  • Modular, componentized authoring & assembly

  • Granular integrations of authoring processes & data sources

  • Collaborative, parallel review processes from inside MS Word with automatic merging of feedback

Add AI to Any Regulatory Document
Authoring Workflow

ComplianceAuthor AI can be used to enhance authoring workflows for any kind of regulatory documentation or structured content process, including global drug labels and product and test specifications.
Global Labeling Content

Say goodbye to unmanageable version control. Access, update and collaborate on structured components for global labels in real-time and keep all your content organized, unified and efficient.

Clinical Labeling Content

Add immense value to clinical labeling processes by expediting the creation of precise and compliant labels, adapting to evolving trial requirements and enhancing patient safety and regulatory compliance.

Cannabis Labeling Content

Revolutionize cannabis labeling by rapidly generating accurate labels, mitigating errors and maintaining consistency across diverse product lines, ultimately heightening the labeling process while ensuring consumer safety.

Test Specifications for CMC

Maintain a comprehensive audit trail of specification changes for ultimate traceability and compliance, and ensure your product meets the highest safety standards throughout its lifecycle.

What Users Say About ComplianceAuthor® AI

“This software is amazing. It saves my team so much time. We no longer need to copy and paste everything and the XML process is so much simpler.”

Job Title, Company

Frequently Asked Questions

ComplianceAuthor® is a cloud-based SaaS solution that leverages micro-services architecture.

We offer a simple and quick implementation of our out-of-the-box solution that includes 30+ preconfigured document types. Custom configurations are available for more complex workflows and specific client requirements.

Yes. ComplianceAuthor™ ingests documents, harmonizes data, and stores it at the component level in an agency-neutral format. ComplianceAuthor™ stores content with assigned metadata, attributes, and properties to support component-based authoring to generate component-driven outputs or documents of any kind.

Clients are using ComplianceAuthor® for use cases across Clinical labeling, Global Labeling, Safety, Regulatory, and CMC, Clinical Study Reports, Medical / Scientific Writing. Supported with your artwork and any additional content management.
ComplianceAuthor AI® uses artificial intelligence and machine learning to find, index, and provide context to your data, thereby sustaining compliance. These tools are pre-configured and trained for life sciences with the knowledge needed to provide valuable insights into your data.
ComplianceAuthor® is hosted on either your organization’s private cloud or a third-party private cloud (AWS, Azure, etc.) and it includes controls (like Firewalls, security groups, and ACLs) configured to best practices.

Glemser leverages an easy-to-use Microsoft Word plug-in that allows the end-user to interact with structured content in the familiar MS Word format. The plug-in guides the users through the authoring process while hiding the complexity of the structured backbone. This allows all comments and edits made in MS Word to be carried back to the SCM system. This easy-to-adopt approach reduces the volume of change for end-users and allows for an easy implementation.

Yes. Glemser has a globally integrated team across the US, EU, and India. All resources are trained to support and implement ComplianceAuthor™, a commercial off the shelf software. We have successfully passed 100% of our clients’ quality audits.

Glemser’s approach is different from our competitors for two reasons. First, we do not require that you decommission, retire, or replace any of your existing systems. Our clients, market research, and special interest group participation (Navitas, Gartner, Forrester) showed that our clients wanted to maintain their existing systems, but add enhanced functionality, capabilities, and speed to their existing process. We have a life sciences specific applied artificial intelligence and machine learning tool that, out-of-the-box, crawls our clients’ existing RIM systems and data repositories to harmonize data. We can scan data of any filetype (PDF, word, artwork, video, spreadsheet, etc.) in any data repository (Veeva, SAP, Oracle, SharePoint, Documentum, etc.). This allows our clients to maximize the value of their data, providing a centralized search function, analytics, and insights that no number of manhours would be able to replicate. Second, our approach to content management starts with the end in mind. Whether it is global labeling, clinical labeling, CMC, medical / scientific writing, or almost any other use case, we know our clients needs to store data as components for use and re-use. We structure, store and assemble content at the component level with agency-neutral tags that can be rendered into Word, XML, PDF, HTML, and JSON formats and combined with graphics and illustrations on a page layout. This approach allows our solution to scale for any document or output required in the future (HL7 FHIR, IDMP), meeting your needs for the near and long-term.

Investment varies by client and commercial terms. We leverage a return-on-investment model to support your business case development. The ROI metrics include time savings, reduced cost, sustained compliance (cost avoidance), and quality improvements.

Need Help with Your
Structured Content Workflow?

Need to streamline your authoring processes?

Talk to one of our experts today about ComplianceAuthor® AI or learn more about our on-demand SPL services.