Ratings and Reviews 0 Ratings
Ratings and Reviews 0 Ratings
Alternatives to Consider
-
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.
-
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.
-
Lockbox LIMSA cloud-based Laboratory Information Management System (LIMS) is designed to oversee sample tracking, test outcomes, and inventory management specifically for life sciences research, industrial quality control laboratories, and biotechnology/next-generation sequencing applications. This comprehensive system provides essential regulatory compliance support for standards such as CLIA, HIPAA, Part 11, and ISO 17025, ensuring that laboratories operate within the necessary legal frameworks. The importance of quality, security, and traceability in managing samples cannot be overstated, as these factors play a pivotal role in a lab's effectiveness and reliability. Utilizing the Lockbox LIMS platform, laboratory professionals gain the ability to meticulously oversee their samples, offering complete transparency throughout the entire process, from initial accession to long-term preservation. Additionally, LIMS analysis encompasses far more than merely tracking outcomes; the Lockbox system features advanced multilayered sample storage capabilities and location management, allowing users to customize their laboratory's storage framework with diverse options that include rooms, storage units, shelves, racks, and boxes. This flexibility empowers labs to efficiently organize and access their samples, ultimately enhancing operational productivity and accuracy.
-
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.
-
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.
-
Captain ComplianceCaptain Compliance is a comprehensive privacy management solution designed to facilitate adherence to international data protection laws and emerging AI regulatory standards. Featuring a Consent Management Platform, it allows organizations to efficiently handle user consent and design personalized cookie consent banners tailored to their needs. Additionally, the platform includes an advanced Cookie Scanner that identifies and classifies all cookies present on your website, thereby guaranteeing compliance with a fluid regulatory framework. The DSAR Portal simplifies the process of handling requests from data subjects, while the AI Compliance Tool provides ongoing monitoring and adaptation to changing regulations. For those requiring expert guidance on data privacy matters, we also offer the option of a virtual Data Protection Officer or Chief Privacy Officer. Our Hosted Privacy Policy Generator ensures that your privacy policies are automatically updated in real-time, aligning them with the latest legal requirements. With Captain Compliance, you gain access to a suite of tools designed to help you maintain regulatory compliance, safeguard user data, and do so at a cost-effective rate. Ultimately, this platform empowers businesses to navigate the complexities of data privacy with confidence and ease.
-
SkillcastSkillcast delivers compliance training and RegTech through a unified Compliance Portal that brings e-learning, Policy Hub (versioning & attestations), staff declarations, compliance registers, CPD/Training 360 and Events Management in one place. Use Skillcast as your LMS or deliver content into your LMS via Remote SCORM/xAPI. Aida, the built-in AI assistant, answers policy-aware questions. Integrates with HR/LXP platforms and supports SCIM. Security: Azure hosting; ISO 27001, Cyber Essentials/Plus and SOC 2. Standards: SCORM 1.2/2004, xAPI. Library: 400+ courses spanning anti-money laundering, financial crime, GDPR/data protection, health & safety, cybersecurity, anti-bribery, sanctions and equality. Prebuilt registers cover Gifts & Hospitality, Whistleblowing, Data Breach and RIDDOR, with configurable workflows and approvals. Industries: financial services, manufacturing, hospitality and retail. Free trial available. Multilingual, accessible delivery.
-
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.
-
LendingPadLendingPad is an enterprise-grade, cloud-based loan origination solution (LOS) crafted to advance mortgage lending for banks, credit unions, brokers, and lenders. Developed by seasoned mortgage experts, the system prioritizes rapid processing, transparency, and intuitive usability—empowering teams to expedite closings and enhance the borrower journey. This platform brings together essential workflows, streamlines repetitive processes, and upholds compliance using a robust, API-centric design. By minimizing operational slowdowns and making daily tasks easier, LendingPad lets mortgage professionals dedicate more time to client service rather than administrative duties. Its adaptable framework supports institutions of any size in responding swiftly to shifts in the market, regulatory updates, and new business strategies.
-
Proton DriveProton Drive is a secure cloud storage and collaboration platform built for professionals who manage sensitive data. Whether you’re sharing internal documents, legal contracts, or client files, Proton Drive keeps your data private — by default. Files are encrypted on your device before upload, and only you and your collaborators can access them. Even Proton can’t read your files. You can set passwords, add expiration dates, or revoke access instantly — so you’re always in control. Each user gets 1 TB of storage, with the flexibility to add more as your team or projects grow. Designed and hosted in Switzerland, Proton Drive is developed by the team behind Proton Mail and Proton VPN — trusted by over 100 million users worldwide. We’re independent, open source, and committed to keeping your data safe from surveillance and vendor lock-in. Proton Drive helps you stay compliant, with support for: - GDPR, HIPAA, ISO 27001, NIS2, and DORA - Verified SOC 2 Type II audits - No complex setup. No third-party tools required. Built for security teams, law firms, healthcare providers, consultancies, and privacy-conscious organizations of all sizes.
What is Ennov Regulatory Suite?
The Ennov Regulatory Suite stands out as a premier solution for managing regulatory content and information. This comprehensive, centralized platform facilitates the entire regulatory information workflow, spanning from initial stages to market authorization. Companies aiming for excellence in regulatory operations commonly adopt this approach because it fosters harmonization and promotes standardization, enhances collaboration while ensuring compliance, reduces waste and costs, accelerates time-to-market, and enables them to effectively compete in the global arena. The suite includes Ennov Doc, Ennov Dossier, and Ennov Process, which collectively support the complete regulatory product lifecycle, from the early phases of setting registration goals to the eventual retirement of products. By utilizing the Ennov Regulatory Suite, organizations can strategically plan their regulatory activities and streamline their processes efficiently. This makes it an indispensable asset for companies navigating the complexities of regulatory compliance.
What is DFIN Arc Suite?
As a leading provider of risk and compliance solutions on a global level, DFIN offers a distinctive integrated platform that covers regulatory, reporting, legal, filing, and distribution solutions. Our established role as a market leader allows us to provide the financial sector with unmatched experience and expertise. The Arc Suite financial regulatory compliance software is crafted to assist users in managing the challenges and complexities of a constantly changing regulatory environment, boosting both confidence and control throughout the process. This versatile platform supports a broad spectrum of data, accommodates multilingual content, and meets various compliance requirements through a range of innovative, award-winning products. Designed by experts in mutual fund and product technology, Arc Suite adeptly addresses reporting obligations set by regulatory authorities worldwide, such as the SEC, OSC, and ESMA. In addition, Arc Suite's regulatory compliance management software integrates effortlessly with all aspects of front, middle, and back office operations, leveraging cloud-based proprietary tools to optimize efficiency and flexibility. With our all-encompassing strategy, DFIN guarantees that clients are thoroughly prepared to navigate the intricacies of regulatory compliance in the financial sector, ensuring they can adapt to future regulatory changes with confidence. This proactive approach positions our clients for ongoing success amid the evolving landscape of financial regulation.
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
Ennov
Date Founded
1999
Company Location
France
Company Website
en.ennov.com
Company Facts
Organization Name
Donnelley Financial Solutions
Date Founded
1983
Company Location
United States
Company Website
www.dfinsolutions.com/products/arcsuite
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
Categories and Features
Financial Reporting
"What If" Scenarios
Audit Trail
Balance Sheet
Cash Management
Consolidation / Roll-Up
Forecasting
General Ledger
Income Statements
Multi-Company
Multi-Department / Project
Profit / Loss Statement