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Ratings and Reviews 4 Ratings
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isoTracker Quality ManagementisoTracker Quality Management is a widely recognized cloud-based quality management software (QMS) that serves organizations globally in overseeing their compliance with various ISO standards such as ISO 9001, ISO 13485, ISO 22000, ISO 17025, and ISO 14001, among others. This versatile solution is designed as a modular platform, allowing businesses to tailor it according to their unique needs while maintaining a competitive pricing structure and providing exceptional customer support. Organizations can choose from a variety of modules, including Document Control, Complaints, CAPA, Audits, Training, Non-Conformance, and Risk, to create a customized quality management system that addresses all aspects of their operations effectively. By utilizing isoTracker, companies can enhance their quality management processes and ensure ongoing compliance with industry standards.
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IntelexIntelex provides an integrated software solution designed to manage Environmental, Health, Safety, and Quality (EHSQ) initiatives effectively. Its versatile platform is engineered to gather, control, and analyze EHS and Quality data in a comprehensive manner. This solution is accessible on any device, aligning perfectly with the demands of your workplace. Utilizing Intelex allows your organization to: Enhance the results of your EHSQ program by overseeing workflows for improved performance and control. Identify trends and behaviors through effective goal-setting to enrich insights and enhance decision-making within your EHSQ framework. Reduce incidents and minimize administrative burdens by adeptly supervising, managing, refining, and deriving insights from your safety data with our user-friendly safety software. Streamline the management and reporting of air, water, and waste emissions while overseeing environmental outputs to achieve sustainability goals. Encourage continuous quality improvements by effortlessly recording and tracking all instances of nonconformity within a centralized, web-based system, allowing for trend analysis across multiple departments or locations. Intelex also aids in navigating compliance with global standards and regulations like OSHA, WCB, ISO 45001, EPA, and ISO, fostering a culture of safety and accountability within your organization. By leveraging these tools, companies can not only comply with regulations but also drive long-term growth and sustainability.
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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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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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SBS Quality Management SoftwareThe SBS QMS Suite is composed of five interrelated software modules designed to enhance Quality compliance efficiency. 1) The SBS Quality Database includes tools for managing CAPA and 8D corrective actions, overseeing nonconformance issues, conducting risk analyses such as FMEA and SWOT, handling various audit management needs, and ensuring Environmental Health and Safety (EHS/HSE) compliance. 2) SBS Ground Control focuses on managing employee training through a Learning Management System (LMS), offering self-paced training options, and providing document control features. 3) SBS Asset Tracking Database oversees calibrated equipment, preventive maintenance schedules, and comprehensive asset inventory management. 4) The SBS Inspection Database captures and records inspection data for incoming materials, in-process checks, and final product assessments, allowing for the generation of real-time SPC charts, development of inspection and control plans, and archiving data for future statistical evaluations. 5) The SBS Vendor Management maintains an approved vendor list (AVL), formulates vendor qualification plans, and tracks the qualification history of suppliers. Each of these modules may be purchased individually or in any combination to meet your needs. On-premise and cloud-based options are available. Free demos are available for download or contact us for a cloud-based demo.
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AlisQIAlisQI is a Quality Management platform built for process and batch manufacturers who want operational control without adding administrative overhead. Where many QMS platforms were designed around document storage and event tracking, AlisQI was architected as a data-first system. Quality, laboratory, and production data are structured and connected in a single operational backbone. This enables teams to see deviations earlier, understand performance trends in context, and act before issues escalate into waste, rework, or customer complaints. The platform includes modular capabilities across document control, training, deviations, CAPA, audits, risk management, supplier quality, SPC, and EHS. These capabilities are deployed through focused, ready-to-use Solvers that combine workflows, logic, dashboards, and analytics to address specific operational challenges without unnecessary scope. Because the system is built on structured, connected data, manufacturers can apply practical AI directly inside their workflows. This includes automated extraction of supplier COA data without predefined templates, conversational access to quality records, intelligent rule generation, and pattern recognition across incidents to strengthen corrective action effectiveness. Solvers are production-ready from the outset and evolve as products, processes, or sites change. Improvements do not require custom development or large IT programs, allowing organizations to modernize quality step by step. Manufacturers across chemicals, plastics, packaging, food and beverage, automotive, and industrial sectors use AlisQI to reduce firefighting, increase predictability, strengthen compliance, and turn quality data into operational intelligence.
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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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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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Process StreetProcess Street is the Compliance Operations Platform that helps fast-moving teams in regulated industries enforce standards, automate execution, and prove compliance with confidence. It brings document control, workflow automation, and real-time oversight into one unified platform so policies are not just written, they are followed and verified. With Process Street, teams can create version-controlled SOPs and policies using Pages, link them directly to automated workflows, and ensure every task, approval, and data point is tracked with audit-ready logs. Cora, the AI compliance agent, monitors execution in real time, flags issues, and recommends improvements, turning manual oversight into continuous control. Whether you need to onboard employees, prepare for audits, manage policy changes, or enforce vendor compliance, Process Street gives you the tools to do it faster and without the risk of missed steps or tribal execution. Automate form collection, task assignments, escalations, and approvals with no code. Keep teams aligned, even as you scale. Used across financial services, real estate, healthcare, and manufacturing, Process Street supports compliance with standards like ISO 9001, SOC 2, SOX, HIPAA, and FDA CFR Part 11. Thousands of teams at companies like Salesforce, Colliers, Hartford Healthcare, and Drift use Process Street to reduce audit prep time, streamline training, and build systems that run without micromanagement. Every workflow is structured. Every policy is enforced. Every action is proven. With native integrations, role-based access, automated evidence capture, and AI-powered insights, Process Street replaces checklists, spreadsheets, and siloed tools with a closed-loop system of control. If you run high-stakes processes and need to stay compliant without slowing down, Process Street is built for you.
What is Orcanos?
Orcanos is a unified eQMS and ALM platform designed specifically for medical device companies that need to manage regulated product development and quality operations together. The platform helps R&D, Quality, Regulatory, and Operations teams work from a single source of truth instead of relying on disconnected documents, spreadsheets, and siloed systems. Orcanos connects design control, quality management, document control, risk management, requirements, testing, validation, training, and audit evidence across the full medical device lifecycle. Its eQMS capabilities support quality processes such as document approvals, revision control, electronic signatures, training automation, CAPA, complaints, audits, nonconformances, and compliance records. Its ALM and design control tools help teams manage user needs, design inputs, risks, mitigations, verification, validation, DHF documentation, and automated impact analysis. Orcanos supports key medical device compliance needs, including ISO 13485, EU MDR, ISO 14971, FDA expectations, and 21 CFR Part 11 requirements. The platform is built for adaptive compliance, allowing teams to configure workflows, forms, fields, status flows, permission structures, and approval processes without heavy coding. Document control features help automate lifecycle routing, publishing, archiving, read-and-understand training tasks, and audit trails for every revision. Risk management becomes a live process by linking hazards, requirements, mitigations, design changes, and verification evidence in real time instead of maintaining static Excel files. Orcanos also includes Ask Paul, an AI-powered assistant designed to help users work more efficiently across regulated quality and development activities. With rapid implementation, traceability, configurable workflows, and centralized compliance data, Orcanos helps medical device teams reduce regulatory friction, stay audit-ready, and bring safer products to market faster.
What is Modern Requirements4DevOps?
Modern Requirements4DevOps stands out as Microsoft's recommended partner for managing requirements, elevating Azure DevOps into a comprehensive Requirements Management Tool. This integration allows teams to collaborate seamlessly on a unified platform, establishing a centralized source of truth. Requirements are conveniently housed alongside your Test Cases and Code Repositories, ensuring easy access and management. Our tool is designed to accommodate agile, waterfall, and hybrid methodologies by offering functionalities such as reviews, end-to-end traceability, reporting, elaboration, and modeling, all integrated within Azure DevOps. Additionally, our powerful requirements solution boasts a premier feature set, including project audit capabilities to enhance oversight and compliance. With these robust offerings, teams can streamline their workflows and improve project outcomes significantly.
Integrations Supported
Jira
Azure DevOps Server
Digital.ai Agility
GitHub
Jama Connect
Microsoft 365
OpsHub
Planview Hub
Planview Viz
QVscribe
Integrations Supported
Jira
Azure DevOps Server
Digital.ai Agility
GitHub
Jama Connect
Microsoft 365
OpsHub
Planview Hub
Planview Viz
QVscribe
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
Orcanos
Date Founded
2004
Company Location
Israel
Company Website
www.orcanos.com
Company Facts
Organization Name
Modern Requirements
Date Founded
1999
Company Location
Canada
Company Website
www.modernrequirements.com
Categories and Features
Application Lifecycle Management
Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
Audit
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
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
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Requirements Management
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
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
Agile Project Management Tools
Backlog Management
Feedback Management
Gantt/Timeline View
Kanban Board
Prioritization
Request Management
Resource Management
Retrospectives Management
Status Tracking
Supports Scrum
Team Management
Template Management
Workflow Management
Application Lifecycle Management
Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
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
DevOps
Approval Workflow
Dashboard
KPIs
Policy Management
Portfolio Management
Prioritization
Release Management
Timeline Management
Troubleshooting Reports
Requirements Management
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
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
Test Management
Automation Integration
Collaboration Tools
Pass/Fail Results Tabulation
Reporting / Analytics
Requirements Management
Test Scheduling
Test Tracking
Time/Budget Tracking