Streamline the way you draft and manage regulatory documents with structured content authoring software for pharma.
Any Output or
Get Improved Time to Market with End-to-End Ecosystem Support
Perpetually Sustain Compliance with Audit Trail & e-Signature Capabilities
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.
Automate the rote, time-intensive steps in your authoring workflow – from cutting and pasting component content, to rewriting approved language, to XML conversion.
As you generate, review, and approve your content, ComplianceAuthor AI maintains everything in its appropriate health authority output format. No coding necessary.
Using ComplianceAuthor AI, authoring teams can significantly reduce the amount of time spent on the creation and management of regulatory documents.
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.
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.
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.
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.
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.
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.
Talk to one of our experts today about ComplianceAuthor® AI or learn more about our on-demand SPL services.