Audience
Life science companies seeking a solution to manage global product labeling
About ComplianceAuthor
Glemser provides IT solutions for regulated industries with a focus on global life sciences and the ecosystem that improves patient outcomes. ComplianceAuthor makes it seamless for life science companies to manage global product labeling, provide affordable IDMP and reduce compliance risk. ComplianceAuthor for Global Labeling helps life science regulatory professionals manage, scale, and streamline global product labeling and compliance through artificial intelligence, structured content, and natural language generation. Artificial intelligence and machine learning to find, index and derive knowledge needed to recommend your next best course of action. Our workflow overlays provide innovation for process standardization, resulting in components that are compliant and controlled. Natural language generation enables you to adopt operational efficiencies and smarter automation.
Qualio
Qualio is an all-in-one quality and compliance management platform built for small and growing businesses in life sciences and healthcare. Reliable, affordable, and easy to use, Qualio helps companies building life saving products get to market faster by reaching 100% ISO, GxP, and FDA compliance. With Qualio, companies can conveniently manage document control, training, CAPAs, NCRs, audits, suppliers, complaints, and more in one platform.
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Kalypso Accel for RIM
Kalypso provides life sciences companies with a cost-effective accelerator for a RIM system implementation - Accel for RIM. The solution enables an integrated platform to effectively manage and track product registrations, accelerate and improve the submissions accuracy, manage global UDI information, and enable efficient product distribution. It consolidates compliance and quality data from various enterprise solutions into a global source of truth for product registrations and tracking to accelerate regulatory submissions. Deployed using modern APIs to aggregate product data, regulatory documentation and submission packages. Pre-configured for rapid implementation with a validated software system. Based on industry-leading RIM practices and implementations.
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Infor PLM Optiva
Infor PLM for Process (Optiva®) is specifically designed for food, beverage, chemicals, and life science manufacturers and provides a unified product view of data and processes across organizations. It helps manufacturers easily achieve regulatory and labeling compliance, whether it’s meeting reporting requirements, complying with labeling laws, or supplying ingredient details. Project management capabilities give the right people the right visibility into project data, from concept, to development, to final sign-off. Reckitt Benckiser (RB), a British multinational consumer goods company, adopts modern PLM capabilities using Infor® PLM for Process to boost global safety and compliance and get one version of the truth about its products, from development to manufacturing. Integration capabilities with ERP systems helps provide better insight into costs.
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RIMTrack
With ever-changing national regulations, data standards, and complexities around preparing for regulatory submissions, regulatory affairs organizations in the healthcare and life sciences industry are convinced and driven towards smarter processes and intelligent systems to optimize costs, maximize accuracy and minimize timelines for the submission. Addressing the concern, regulatory information management, RIMTrack, is a cloud-ready artificial intelligence (AI) based new age regulatory information management system. It’s developed from scratch with the mission to help organizations to prepare submissions accurately and efficiently and by streamlining the regulatory processes related to tracking, licensing, approvals, regulatory and competitive intelligence, clinical trials, and reporting across global sites and stakeholders. Integrate with existing RIM system and achieve complete end-to-end management of regulatory life cycle process.
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Integrations
No integrations listed.
Company Information
Glemser Technologies
Founded: 1987
United States
glemser.com
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Product Details
Platforms Supported
SaaS
Training
Documentation
Support
Online
ComplianceAuthor Frequently Asked Questions
ComplianceAuthor Product Features
Compliance
Artificial Intelligence (AI)
Archiving & Retention
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation