ISO 13485 Quality Management vs. QFacts Comparison Chart

isoTracker Quality Management is a popular cloud-based quality management software (QMS) that is used by small to medium sized businesses on a worldwide basis. It helps to manage ISO 9001, ISO 13485, ISO 22000, ISO/IEC 17025, ISO 14001, ISO 45001, ISO/TS 16949, ISO 14971 systems...plus many other systems. It also conforms to the requirements of 21 CFR Part 11 and has been validated to it. It is a flexible and modular product with modules in document control, audit management, non-conformance management, customer complaints management, risk management, training management and CAPA management. It can be configured to meet an organization's specific needs and provides free training and free support. It has been independently judged to provide the best customer support in its category.

Interfacing’s Integrated Management System (IMS) is an AI-powered platform that unifies BPM, QMS, Document Control, and GRC into one platform. Organizations use IMS to model and automate processes, control documents, manage risks, and maintain regulatory compliance with full traceability and audit readiness. Built for highly regulated sectors such as aerospace, life sciences, finance, and government, IMS provides real-time visibility, automated workflows, and AI-driven insights that improve quality and reduce operational risk. The platform is ISO 27001 certified and fully validated for 21 CFR Part 11, making it suitable for mission-critical environments requiring strong governance, security, and control. IMS also includes low-code automation, process mining, audit management, training tracking, CAPA workflows, and dashboards to help teams streamline operations and continuously improve. AI strengthens governance, improves accuracy, and reinforces regulatory control.

Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health. With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems. What Qualio delivers: ✔️ Audit ready in weeks ✔️ Inspection ready anytime — no fire drills ✔️ Faster market entry ✔️ Lower total cost of compliance ✔️ Confident, risk-managed scaling

Carbide is a tech-enabled service that strengthens your company’s information security and privacy management capabilities. Our platform and expert services are tailored for companies aiming for a sophisticated security posture, particularly valuable for organizations that must meet rigorous compliance requirements of security frameworks like SOC 2, ISO 27001, HIPAA, GDPR, and more. With Carbide, you can benefit from continuous cloud monitoring and the educational resources of Carbide Academy. Our platform supports over 100 technical integrations, enabling efficient evidence collection and meeting of security framework controls necessary for passing audits.

The SBS Quality Management Software Suite (QMS Suite) is a group of 5 software modules that work together for efficient Quality compliance. The QMS Suite can be deployed on your local server or accessed from our cloud server. Each module is designed for ease-of-use to reduce training overhead and improve overall compliance. Password controlled access and privileges ensure you may control access to critical features for each user. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, etc.) - Audit management - EHS module SBS Ground Control - Employee training management (LMS) - Document control SBS Asset Tracking Database - Calibrated equipment - Preventive maintenance SBS Inspection Database - Data collection / SPC - Control Plans SBS Vendor Management - Approved vendor list / AVL - Supplier qualification plans Great product for efficient and affordable QMS Compliance

AlisQI is a modular, cloud-based Quality Management platform for process and batch manufacturers who want to reduce firefighting, improve predictability, and stay compliant by default. Unlike traditional EQMS platforms that were built around documents and later adapted for analytics, AlisQI was designed from the start as a data-first system. Quality, lab, and production data are structured and connected in one operational backbone. That foundation now enables practical AI capabilities inside daily workflows. Manufacturers can automatically extract data from diverse supplier COAs without predefined templates, generate structured digital forms from existing files or plain language, query their QMS conversationally, and detect recurring incident patterns across sites. Core modules include Document Control, Training, Deviations, CAPA, Audits, Risk Management, Supplier Quality, SPC, and EHS, supported by targeted out-of-the-box Solvers that address specific operational problems.

Cyber threats are everywhere, but protecting your IT systems should be as natural as locking your front door. With DriveLock’s HYPERSECURE Platform, safeguarding your endpoints and business data is easier than ever. We integrate the latest security technologies and share our expertise, so you can focus on what matters—without worrying about data protection. Zero Trust Platform takes a proactive approach, eliminating security gaps before they become a risk. By enforcing centralized policies, DriveLock ensures employees and endpoints access only what they need—following the golden rule of cybersecurity: ''never trust, always verify''.

MaintainX is the world-leading mobile-first workflow management platform for industrial and frontline workers. We are a modern IoT-enabled cloud-based tool for maintenance, safety, and operations on equipment and facilities. MaintainX helps businesses track reactive and preventive maintenance, and control daily operations, such as safety inspections, quality inspections, and operating checklists—all with a digital audit trail. Here's what we digitize and take away from the clipboard: - Safety Procedures - Environmental Checklists - Tooling & Gauge Reporting - Maintenance Procedures - Auditing/Inspection Workflows - Training Checklists We allow plant managers to become more efficient operators by delivering real-time business insights from the field. MaintainX is designed to work with organizations of all sizes - whether you're running a small team of 2 or coordinating a massive team of thousands of folks around multiple locations.

Ansarada is a SaaS company that provides world-leading AI-powered Virtual Data Rooms and dealmaking tools. These tools include advanced AI insights and automation, next level Q&A and collaboration, plus purpose-built, digitized and customizable workflows and checklists for M&A, capital raising, business audits, tenders and other high stakes outcomes. Unlike some competitor Virtual Data Rooms, Ansarada offers free trials, 24/7 localized expert support, integrated Q&A via email, AI-assisted deal prediction, plus easy drag and drop upload and superior document security controls. Ansarada is designed to drive stronger business outcomes based on best practices from over 35,000 transactions. More than just a Virtual Data room, Ansarada provides end-to-end deal management to help you maximize your potential and stay in control. Keep your files in a centralized repository for always-on deal activity, and share your files securely with Secure File Share.

Improve Performance and Sustainability with Certainty! Certainty is an enterprise-level software solution to easily collect and report inspection data and manage issues identified. Used by hundreds of thousands of professionals to complete millions of audits and inspections annually, Certainty helps companies around the globe ensure compliance, reduce risk, and improve performance with easy-to-use forms, real-time reports, and complete action management. Collect, track, and report accurate and powerful data to provide detailed business insights that will empower your team to improve performance and business sustainability. Certainty is used worldwide for: Safety inspections Quality assurance and control audits Supplier and supply chain compliance audits ESG assessments And much more . . .