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Ratings and Reviews 0 Ratings
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QualioQualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk. With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive. Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box. Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand. The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.
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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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Interfacing Integrated Management System (IMS)Interfacing’s IMS is an AI-enabled platform that combines business process modeling, quality management, controlled documentation, and governance/risk capabilities in a single hub. Organizations rely on IMS to document and automate workflows, maintain versioned records, manage risk programs, and keep compliance activities aligned with regulatory requirements through full lifecycle traceability. Developed for industries where accountability and oversight are essential, including aerospace, pharma/biotech, finance, and government, IMS delivers operational insight, workflow automation, and intelligent recommendations that help reduce risk and improve quality outcomes. The platform holds ISO 27001 certification and includes 21 CFR Part 11 validation, supporting secure use in high-compliance environments. Additional capabilities include low-code app creation, AI-based process mining, audit management, CAPA and training modules, and performance dashboards. AI improves governance accuracy, strengthens compliance posture, and supports ongoing improvement.
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HSI DonesafeHSI Donesafe revolutionizes environmental, health, and safety (EHS) management through a no-code, cloud-based solution that simplifies intricate processes into efficient and intuitive workflows. Widely embraced by various sectors, Donesafe integrates tracking, management, and reporting in a single, user-friendly platform, enhancing compliance efforts and improving safety outcomes. The platform's flexible structure enables teams to tailor workflows, forms, and dashboards according to their changing compliance requirements. By providing essential tools for incident reporting, audits, training, and risk assessments, it ensures organizations can swiftly adapt to regulatory shifts. Highlighted Features: - Tailor-made workflows that comply with regulations - Instant insights for real-time safety monitoring - Scalable framework that evolves alongside your organization - Efficient compliance tools for hassle-free audits and reporting Empower your EHS team to reach new heights of safety excellence with HSI Donesafe, and experience a transformation in how safety management is approached. With Donesafe, achieving compliance and safety goals becomes not only feasible but also straightforward.
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Certainty SoftwareCertainty is a comprehensive software solution for auditing and inspection that offers reliable support in managing and reporting on business risks, compliance, and performance indicators swiftly and effectively. Utilized by countless professionals, Certainty Software facilitates millions of inspections and audits annually, equipping users with essential tools to gather, organize, and present precise, consistent, and actionable metrics throughout the organization. In addition to its data management capabilities, Certainty empowers users to design, oversee, and report on inspection and audit findings while also assisting in the identification and mitigation of risks, incidents, and challenges that may arise during the auditing process. This software not only enhances operational efficiency but also ensures that businesses maintain high standards of accountability and performance.
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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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D&B Risk AnalyticsAround the world, teams focused on risk management, procurement, and compliance face increasing demands to navigate the challenges posed by geopolitical and business risks. The intricacies of both domestic and international operations, alongside a myriad of regulations, significantly influence third-party risks. Therefore, it is essential for organizations to take a proactive approach in managing their relationships with third parties. This innovative platform, leveraging the D&B Data Cloud's extensive database of over 520 million global business records and more than 2 billion updates each year, serves as an AI-driven tool that continually assesses and mitigates counterparty risk. D&B Risk Analytics incorporates top-tier risk data, providing alerts on high-risk transactions and identifying connections across a billion data points, all of which empower businesses to make well-informed choices. Additionally, the platform's intelligent workflows facilitate rapid and comprehensive screening processes, ensuring timely alerts on critical business metrics. As a result, companies can enhance their risk management strategies and improve their overall operational resilience.
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HaastHaast is the AI engine for marketing compliance, built for enterprise marketing, legal, and compliance teams. It deploys AI agents that automate manual compliance work across the entire content lifecycle - from pre-publication review and approvals to continuous monitoring of live websites, social media, and partner channels. Unlike traditional compliance tools, Haast learns your organization’s unique risk tolerance and applies it consistently across all content, channels, and teams. This enables marketers to self-serve compliance and resolve issues before publishing, while giving legal teams faster, more reliable oversight without becoming a bottleneck. Haast analyzes text, images, PDFs, video, and web content to identify real regulatory and brand risks, providing clear, actionable fixes. It supports both pre-launch checks and always-on monitoring, helping enterprises detect issues early and reduce exposure to regulatory fines or reputational damage. Built for complex, regulated environments like financial services, retail, telecommunications and gaming, Haast adapts to internal policies, approval workflows, and evolving regulatory requirements across regions and business units. By embedding directly into end-to-end workflows, it replaces slow, manual review processes with scalable, automated compliance infrastructure. The result is faster go-to-market, reduced compliance risk, and a more efficient way for marketing and legal teams to work together.
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PoloniousPolonious serves as an investigation management workflow solution that adheres to ISO27001 standards, built upon three foundational principles: 1 - Security 2 - Process orientation 3 - Adaptability and customization This framework empowers users to design workflows that not only safeguard data and evidence in a secure, ISO27001 certified manner but also streamline compliance with regulatory obligations with minimal hassle, thanks to workflows that are inherently compliant. Furthermore, the platform eliminates the need for costly and time-intensive coding alterations, allowing users to make modifications independently through an intuitive graphical user interface (GUI). Additionally, Polonious offers the capability to generate comprehensive reports on case outcomes, timelines, and financial metrics, which can be analyzed by case types, investigators, and investigation statuses. This functionality not only demonstrates value to higher management but also aids in pinpointing inefficiencies, paving the way for enhanced operational productivity. By leveraging these insights, organizations can continually refine their investigation processes to achieve better results.
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SiteDocsMaking Safety and Compliance Effortless! Companies engaged in construction, oil and gas, mining, manufacturing, electrical work, plumbing, heating, and excavation clearly recognize the significance of adhering to essential documentation requirements. Additionally, it's crucial for these businesses to efficiently manage their organizational structures. SiteDocs offers an innovative safety management platform that shifts enterprises from traditional paper-based systems to a comprehensive cloud-driven digital environment. This versatile system is compatible with any device that operates on iOS or Android, empowering users to work from anywhere, whether remotely, on-the-go, or even offline. Employees can seamlessly sign documents, upload images, provide feedback, and confirm the receipt of vital paperwork. Furthermore, administrators benefit from the web-based panel, which ensures that all staff records, reports, and certifications are kept up-to-date automatically by utilizing the system's configurable parameters. This modernization not only streamlines processes but also enhances overall workplace safety and compliance.
What is C2P?
Compliance & Risks collaborates with leading global brands such as Dyson, Bose, EPSON and Samsung to streamline the ESG and Product Compliance process, facilitating smoother market entry.
Our offerings include three essential components:
1. An enterprise technology solution designed to enhance productivity and efficiency through our C2P platform, featuring the most extensive regulatory content available, encompassing over 40 topics across more than 20 industries and covering 195 nations globally.
2. Access to a dedicated team of experts ready to provide answers to any regulatory inquiries you might encounter.
3. Assistance in monitoring and evaluating the relevant regulations and standards pertinent to your products and business, ensuring you can demonstrate compliance to sustain and grow your market presence.
With over two decades of experience, we have established a stellar reputation for effectively aiding iconic brands in managing compliance risks, allowing them to thrive in competitive markets. Our commitment to supporting our clients positions us as a trusted partner in navigating the complexities of regulatory environments.
What is Assent?
The Assent platform stands out in its ability to develop detailed maps of intricate manufacturing supply chains across multiple industries, including aerospace and defense, automotive, electronics, industrial equipment, and medical devices. By managing suppliers, products, and components effectively, we guarantee that your offerings are not only safe and compliant but also environmentally responsible, tackling both product compliance and ESG issues. Assent's distinctive approach to mapping the entire manufacturing genome sets a foundation for authentic supply chain sustainability. With our exceptional access to suppliers and components, even at the minutest level, your business is equipped to thrive, grow, and succeed. Furthermore, we deliver a holistic perspective on sustainability throughout the organization, facilitating the recognition and prioritization of key challenges while keeping you updated on changing regulations through automatic notifications. Assent reveals previously hidden insights, validates beneficial characteristics, and helps mitigate unexpected challenges. By providing solutions that span from product compliance to ESG initiatives, Assent enables the world's leading sustainable manufacturers to flourish. Ultimately, our platform significantly boosts operational transparency and cultivates a culture of innovation and resilience within the manufacturing sector, ensuring that companies can adapt to future demands with confidence. This strategic advantage not only enhances productivity but also positions businesses for long-term success in an ever-evolving marketplace.
Integrations Supported
Aleph
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
Compliance and Risks
Date Founded
2000
Company Location
Ireland
Company Website
www.complianceandrisks.com
Company Facts
Organization Name
Assent
Date Founded
2010
Company Location
Canada
Company Website
assent.com
Categories and Features
Compliance
Archiving & Retention
Artificial Intelligence (AI)
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
Risk Management
Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment
Categories and Features
Compliance
Archiving & Retention
Artificial Intelligence (AI)
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
ESG
Activity Dashboard
Analytics/Reporting
Audit Management
Benchmarking
Compliance Management
Data Visualization
Document Management
Performance Metrics
Risk Assessment
Supply Chain Management
Demand Planning
Electronic Data Interchange
Import / Export Management
Inventory Management
Order Fulfillment
Order Management
Sales & Operations Planning
Shipping Management
Supplier Management
Transportation Management
Warehouse Management
Sustainability
Audit Management
Benchmarking
Compliance Management
Corrective Actions (CAPA)
Emissions Management
Employee Training
Energy Management
Incident Management
KPIs
Performance Metrics
Stakeholder Engagement
Supplier Management
Waste Management
Vendor Management
Audit Management
Contact Management
Customer Database
Self Service Portal
Supplier Master Data
Transaction History
Vendor Maintained Profiles
Vendor Managed Inventory
Vendor Performance Rating
Vendor Qualification Tracking