Simplify Structured Content with ComplianceAuthor AI®

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

ComplianceAuthor AI takes an inside out approach, designed to easily scale and generate any required document type or output.

Word-based, structured content authoring is part of our Life Science platform, making end-user adoption easy.

  • Life sciences extensions (CFR Part 11, EU Annex 11, e-Signatures, etc.)
  • Modular, componentized authoring and assembly
  • Automatic XML Generation, No XML Expertise Needed
  • Direct Metadata Tagging
  • Granular Integrations of Authoring Processes and Data Sources
  • Placement of Components in Central Server for Reuse
  • Collaborative, parallel review processes from inside MS Word with automatic merging of feedback
  • Centralized Component Content Management System (CCMS) cloud repository, SaaS model
  • Structured Component Management (SCM) processes for tracking, managing and reusing components

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.

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