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RegDeskRegDesk stands out as the leading RIMS platform enhanced by AI, tailored specifically for Medical Device, Pharmaceutical, and IVD companies. • Our unique Regulatory Intelligence encompasses data from over 120 countries, all presented in a uniform format, and includes timely alerts regarding regulatory updates. • With our AI-driven Application Builder, regulatory affairs teams can efficiently create and submit global applications in a fraction of the usual time. • The Change Assessment feature enables RA teams to evaluate the implications of changes on current products and determine the necessary actions. • Our Distributor Collaboration tool facilitates smooth workflows for communication and document sharing with external partners. • The Standards Management function simplifies the process for RA teams to locate and oversee both international and country-specific standards. • Additionally, our Tracking & Reporting capability empowers teams to monitor regulatory initiatives worldwide, receive notifications for renewals, and quickly compile reports on key performance indicators. To learn more about our offerings, please explore our website.
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Adaptive Compliance Engine (ACE)The Adaptive Compliance Engine® (ACE®) is a versatile, workflow-driven eQMS/eDMS solution that can seamlessly adjust to various business processes, providing real-time oversight, management, and reporting for compliance, quality, and operational tasks. By utilizing ACE®, organizations can alleviate administrative burdens and enhance ROI through immediate productivity improvements, while maintaining adherence to 21 CFR Part 11 regulations. Our comprehensive software suite features: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And numerous additional capabilities! Enable every tier of your organization with user-friendly interfaces, effortlessly locate all documents and records, and convert your data into insightful intelligence through advanced analytics, all within one unified platform. Every essential application is bundled together at a single price with ACE, eliminating the need for separate purchases. Enjoy the convenience of one software solution with countless functionalities, making it a truly invaluable asset for your business.
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FusionAuthFusionAuth is a comprehensive authentication and authorization platform purpose-built for modern development teams and IT departments. Designed for seamless integration, it supports virtually any application stack or programming language. Every capability is fully exposed via APIs, giving your team the flexibility to address complex identity and access management (IAM) requirements without compromise. From core features like user registration and login, to advanced protocols such as passwordless authentication, MFA, SAML, and OIDC — FusionAuth delivers enterprise-level functionality out of the box. Built-in compliance tools make it easy to align with regulatory standards including GDPR, HIPAA, and COPPA, reducing risk and accelerating deployment. FusionAuth offers total deployment freedom: run it on any OS, in containers, in your private cloud, or choose FusionAuth Cloud — our fully managed, scalable SaaS hosting option. Whether you’re a startup or an enterprise, FusionAuth empowers your organization to customize and scale your identity infrastructure with confidence and control.
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Monitask🚀 Elevate Your Team's Efficiency to New Heights! 🚀 Presenting the ultimate solution to enhance productivity in today’s work environment. Whether your team excels in the office, operates remotely, or thrives in a hybrid setup, we have the perfect tools for you. 📊 What's included? Intelligent Time Tracking: Automatic clock-in/out functionality to eliminate those "I forgot" moments! Random Screenshots: Catch those sneaky social media scrolling sessions. Web Monitoring: Determine if team members are diligently working or... "working" 😉 Live Performance Dashboard: Monitor who is excelling at their tasks. Stealth Mode: Discreet observation for maximum effectiveness. Ideal for: Startups, agencies, freelancers, and major corporations alike. 💡 What makes it remarkable: Transform productivity metrics into team strengths. Identify inefficiencies in workflows and eliminate them. Maintain ethics: Employee privacy respected while you gain valuable insights. 🕵️ Stealth Mode: Our discreet feature allows you to witness genuine work patterns, akin to having a productivity oracle! 🔒 Top-tier security measures in place. We prioritize safety so you can focus on results. Are you ready to turn your team into champions of productivity? Let's get started! 🦸♂️🦸♀️ Plus, watch as morale soars when everyone feels empowered to perform their best.
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Predict360Predict360, developed by 360factors, serves as a comprehensive risk and compliance management platform designed to streamline workflows and improve reporting for various financial institutions, including banks, credit unions, and insurance companies. This cloud-based SaaS solution consolidates essential components such as regulations, compliance management, risk assessments, controls, key risk indicators (KRIs), audits, policies, and training into one cohesive platform while offering powerful analytics and insights that help clients foresee risks and enhance compliance efforts. If your current Governance, Risk, and Compliance (GRC) system isn't equipped with an effective analytics and business intelligence tool for creating insightful reports for executives and board members, consider Lumify360 from 360factors. This predictive analytics platform can seamlessly integrate with any existing GRC, allowing you to maintain your workflow processes while equipping stakeholders with the timely reports and dashboards they require for informed decision-making. With these advanced tools at your disposal, you'll be better positioned to navigate the complexities of regulatory compliance and risk management.
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Nasdaq MetrioNasdaq Metrio serves as a sustainability reporting platform designed to assist businesses regardless of their progress in the ESG landscape. By integrating thorough data gathering, monitoring, and management with precise emissions assessments and verification, it creates a robust solution for sustainability reporting. Furthermore, it boasts an extensive repository of metrics sourced from multiple rating and ranking frameworks, along with regulatory organizations, ensuring that all information is cross-referenced, de-duplicated, and made clear, accompanied by helpful guidance notes for users. This makes it an invaluable tool for organizations aiming to enhance their sustainability practices and compliance efforts.
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DNSimpleThe automatic process begins immediately once you transfer or add a domain to your account. You gain access to trusted and established libraries that streamline your tasks. This configuration significantly reduces the likelihood of your application facing interruptions from DDoS attacks. Additionally, you can improve the redundancy of your zones by allowing them to be duplicated across different DNS providers. Moreover, any emails sent to your domain can be conveniently forwarded straight to your existing inbox. There are no limits on the number of records you can hold within your zones, offering flexibility in management. Each transfer of a domain provides an extra year added to its registration period. To register, transfer, or renew domain names, a DNSimple subscription is required. It's important to understand that the costs related to domain registration, transfer, and renewal are distinct from your subscription fees. This thorough approach guarantees that your management of domains is both efficient and effective, allowing you to focus on other aspects of your business. To maintain optimal performance, regular monitoring of your DNS settings is also recommended.
What is RIMExpert?
RIMExpert™ significantly optimizes regulatory planning, tracking, and data management by managing global rollout strategies and automating the preparation of regulatory submissions, activities, and medicinal products. By reducing the need for extensive data entry, RIMExpert™ improves data integrity and increases global oversight and control. The platform standardizes processes involved in regulatory planning, tracking, and registration management, which enhances collaboration between headquarters and their affiliates. It creates a centralized hub for all activities related to registrations, allowing for a single access point that gathers inquiries, commitments, correspondence, and authorizations for each application, thus aligning efforts to maximize efficiency in regulatory resources across the enterprise. Moreover, RIMExpert™ provides meticulous oversight of registration activities throughout the entire product lifecycle, ensuring that timelines, commitments, and agency inquiries are consistently monitored. It includes interactive dashboards that deliver a holistic view of regulatory actions and registrations, equipping teams with the insights needed for informed decision-making and prompt responses. By doing so, RIMExpert™ not only fortifies regulatory compliance but also enhances the overall effectiveness of the organization, paving the way for improved operational success. This comprehensive approach ultimately strengthens the framework within which regulatory processes are managed and executed.
What is Calyx?
At Calyx, we recognize that the success of any clinical development project hinges on the integrity of your data, highlighting the crucial role of an effective electronic data collection (EDC) system. Utilized in more than 2,600 clinical trials around the world, Calyx EDC streamlines the collection and reporting of clinical trial data through a platform that is both intuitive and efficient. It is vital to protect your essential data with a dependable partner—contact us to learn how Calyx can bolster the success of your initiative. With Calyx EDC, you acquire the flexibility to seamlessly plan, design, and manage studies, regardless of their complexity. Its comprehensive features are designed to reduce costs, improve site visibility, and enhance overall efficiency, ensuring your trial stays on track. Count on Calyx to be the support you need to navigate the intricate landscape of clinical trials, enabling you to focus on what truly matters. Your journey toward successful clinical outcomes begins with the right partnership.
Integrations Supported
ConformX
LodeStar
Mage Dynamic Data Masking
Mage Static Data Masking
SOLEX
Integrations Supported
ConformX
LodeStar
Mage Dynamic Data Masking
Mage Static Data Masking
SOLEX
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
AMPLEXOR
Date Founded
1987
Company Location
Luxembourg
Company Website
www.amplexor.com/en/life-sciences-suite/rim/regulatory-planning-tracking.html
Company Facts
Organization Name
Calyx
Date Founded
2021
Company Location
United Kingdom
Company Website
www.calyx.ai
Categories and Features
Categories and Features
Clinical Trial Management
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
Electronic Data Capture
Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management