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Quality Management Software with FDA Compliance (2026) - Page 2

Last updated: April 2026

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83 software options

Cetec ERP logo

Cetec ERP: Built to Run your Manufacturing Business

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Manage inspections, nonconformances, and corrective actions inside the ERP. Tie quality records to jobs, materials, and suppliers to improve traceability and keep documentation audit-ready.

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Document Locator logo

Windows-based document management solution.

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Document Locator is a document management solution with full Windows integration supporting task automation and paperless office deployment.

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Momentum QMS logo

Quality and Safety software with no User License Fees

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Momentum QMS is an solution designed to help manufacturing, mining, & aviation sectors maintain the quality standards of their products/services, & ensure regulatory compliance.

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FORM OpX logo

The Digital Assistant for the Frontline

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FORM OpX drives quality and operational compliance by digitizing audits and inspections on mobile to reduce risk and improve safety and quality.

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Qualcy QMS logo

QMS for complex engineering, bio-medical devices & pharma

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Qualcy QMS is a quality management system which enables complex engineering, bio-medical device and pharma companies to manage their records, assets and documents with ISO and FDA compliance, audit trails, role-based identification, automated reminders, e-signature functionality, and more.

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SimplerQMS logo

Cloud-based quality management software for life sciences.

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Expert-driven, fully validated eQMS for Life Science companies to streamline quality processes, ensure compliance, and stay audit-ready.

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Radar Healthcare logo

Risk & compliance management tool for the healthcare sector

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Radar Healthcare supports organisations across health and social care to improve quality and compliance. With an in-depth understanding of operational challenges and by working collaboratively across all areas of healthcare, the platform simplifies the regulatory complexities.

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ACE logo

Enterprise Quality Management System

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Adaptive Compliance Engine (ACE) is a cloud-based quality management system designed to help businesses in biotechnology, cosmetics, pharmaceuticals, healthcare, manufacturing, and other industries manage compliance, quality, and efficiency across all operations in real-time.

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Orcanos logo

Compliance for Design Control, Risk and Quality Management

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e-QMS that satisfies ISO 13485

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Digital Integrated Management System logo

Quality, compliance, governance, improvement & digitization

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Interfacing’s EPC ensures full visibility from audit management, CAPA, regulatory training and management of standard operating procedu

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OurRecords logo

Record, credential & compliance management

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OurRecords is a record and credentialing management solution that allows businesses to manage the compliance of their business partners, vendors or workforce

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CERDAAC logo

Operations Excellence platform

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CERDAAC is a Regulated Operations Excellence platform that includes Calibration, Maintenance, Asset, and Facility Management solutions, among many others.

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AssurX logo

Regulatory compliance and quality management system.

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AssurX’s powerfully flexible enterprise quality management software unites and coordinates information, activities and documentation in one reliable system, effectively managing any quality or compliance-related operations. No other system is easier to deploy, configure and modify.

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QUALITYWEB 360 logo

Streamline ISO 9001 compliance with an all-in-one QMS platfo

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QualityWeb 360 is a modular, cloud-based platform for managing ISO 9001-compliant quality systems. It includes 15 modules such as document control, audits, CAPAs, KPIs, training, and more—designed to streamline compliance and digitalize your QMS.

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QISS Quality Management System logo

Cloud-based Quality Management Software

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QISS QMS is software for quality management systems. It is designed to streamline your organization’s processes and support compliance.

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Sierra QMS logo

Automate Regulatory Compliance and Speed Your Innovations!

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Sierra QMS makes it easy for your team to design, plan, and track your quality roadmap's progress and regulatory goals! Strategically map out your quality journey by utilizing Sierra QMS, ensuring you reach each of your compliance milestones in your desired timeframes.

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ZenQMS logo

Quality and compliance management solution for businesses

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ZenQMS is a cloud-based solution that assists businesses with quality management, employee training, and regulatory compliance. Key features include document management, change control, issue tracking, auditing, data export, notifications, and reporting.

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Auditrunner logo

Internal audit risk compliance quality management GRC GDPR

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Establish quality accreditations and execute specialized activities. Create action plans for nonconformities, assign to departments, track their progress.
Quality Assurance Audits
Customer Complaints ISO9001
Corrective Actions ISO9001
Information Assets ISO27001
Business Continuity ISO22301

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AdaptiveGRC logo

Flexible. Interconnected. Comprehensive.

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Measure, monitor and manage key quality records including findings, countermeasures, actions, deviations and incidents.

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Paradigm 3 logo

Document and compliance management solution

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Paradigm 3 is a web-based document and compliance management solution which helps businesses in maintaining ISO certification & promoting compliance management

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BIC GRC logo

Governance, risk and compliance management software platform

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BIC GRC lets you digitalize your GRC processes professionally, sustainably, and cost-effectively. Depending on your business model, you can choose from a fast-to-implement, pre-built solution or a BIC Custom GRC solution tailored to your specific requirements.

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BPI System logo

Web-Based & On-Premise CAPA Automation Software

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Web-based and On-Premise Quality Management Software that will assist your organization in automating your business processes.

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BlackBelt Enterprise logo

Quality management solution for manufacturers of all sizes

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BlackBelt Enterprise is a cloud-based quality management solution designed to help manufacturing firms of all sizes manage workflows, analysis, measurement characterization, issue tracking & data normalization. The platform's consulting tools aid users in streamline processes.

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TrackWise logo

Quality management (EQMS) for highly regulated industries

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TrackWise quality management provides a centralized system for managing, tracking, and reporting issues and actions while reducing risk and managing compliance

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Iristrace logo

Helping great brands deliver on their promise

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Collect the data only once and put all your business information in context and more effective collaboration across your team.

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