aligned elements vs. qmsWrapper Comparison


aligned elements Aligned AG	qmsWrapper	+	+
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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. 66 Ratings Visit Website Propel Propel is a cloud-native platform that unifies PLM, QMS, and PIM in one connected system, giving manufacturers complete visibility and control across the entire product lifecycle. It provides a single source of truth for product data, streamlines change management, strengthens quality and compliance, and accelerates time-to-market by eliminating silos. With real-world AI use cases and enterprise-grade security, Propel helps organizations reduce errors and improve cross-functional alignment. 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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. 19 Ratings Visit Website Epsilon3 Epsilon3 is an AI-powered procedure and resource management tool designed for teams building, testing, and operating advanced products and systems. ✔ Standardize & Optimize Processes Our interoperable procedure execution system replaces inefficient checklists managed with paper, spreadsheets, docs, and outdated planning tools. Automatically track every step to ensure quality, consistency, and traceability. ✔ Fuel Rapid Iteration & Innovation Built-in version control, conditional workflows, and real-time data synchronization keep teams on the same page. Enable continuous improvement and quick, data-driven decisions to stay far ahead of the competition. ✔ Streamline & Scale Operations Securely integrate siloed systems and automate error-prone tasks to boost productivity and prevent delays. Simplify training, reduce costs, and maintain efficiency as your operations expand to meet demand. Trusted by industry leaders like NASA, Firefly Aerospace, and Commonwealth Fusion. 265 Ratings Visit Website Captain Compliance Captain Compliance is an all-in-one privacy management platform designed to simplify compliance with global data protection laws and new AI regulatory requirements. Our leading Consent Management Platform (CMP) allows businesses to effortlessly manage user consent and create customizable cookie banners. Our advanced Cookie Scanner automatically identifies and categorizes cookies on your website, ensuring ongoing compliance with a dynamic cookie policy. Our DSAR Portal streamlines data subject requests, while our AI Compliance tool monitors and adapts your practices based on evolving regulations and we even offer a virtual DPO and CPO if you need data privacy guidance. Additionally, our Hosted Privacy Policy generator automatically updates your privacy notices in real-time, keeping your policies aligned with the latest legal requirements. Captain Compliance provides the tools you need to protect user data and maintain regulatory compliance with ease at an affordable fee. 337 Ratings Visit Website Epicor Connected Process Control Epicor Connected Process Control (CPC) is a flexible no-code/low-code MES and manufacturing operations platform that helps manufacturers improve quality, consistency, and visibility across production and assembly operations. Create digital work instructions with multimedia content, guide operators through critical tasks, connect equipment and devices across the shop floor, and capture production and quality data without extensive programming. CPC provides product traceability with a complete historical record of each product's build and inspection history. Real-time insights into quality, performance, defects, rework, and production trends help teams identify issues faster, reduce waste, and support continuous improvement. Manufacturers use CPC to standardize production and assembly processes, improve operator consistency, and support assembly verification, error proofing, quality inspections, and production monitoring across the shop floor. Whether deployed in a single work cell, across multiple production lines, or enterprise-wide, CPC scales to support manufacturers of all sizes. 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Delivered as a SaaS solution with an evergreen upgrade model, it ensures predictable costs, minimal maintenance, and long-term scalability. 3 Ratings Visit Website
About Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity. The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle. Aligned products, designed for collaboration between quality, regulatory, R&D, and management teams, combines a complete electronic Quality Management System with deep Design Control functionality in one fully integrated environment. Design inputs, outputs, verification, validation, risk management, and change control are natively connected to the QMS, ensuring end to end traceability that stands up to audits and inspections.	About qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance. Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.
Platforms Supported Windows Supported Mac Not Supported Linux Not Supported Cloud Supported On-Premises Supported iPhone Not Supported iPad Not Supported Android Not Supported Chromebook Not Supported	Platforms Supported Windows Supported Mac Supported Linux Supported Cloud Supported On-Premises Not Supported iPhone Not Supported iPad Not Supported Android Not Supported Chromebook Not Supported
Audience Medical Device Manufacturers looking for a design control management solution	Audience Medical Device Companies, MedTech Startups, SaMD, eQMS, ISO 13485, ISO 14971, FDA QMSR, EU MDR, Quality Management, Regulatory Affairs, Quality Assurance, CAPA, Risk Management, Technical File, Traceability
Support Phone Support Supported 24/7 Live Support Not Supported Online Supported	Support Phone Support Not Supported 24/7 Live Support Not Supported Online Supported
API Offers API Supported	API Offers API Not Supported
Screenshots and Videos View more images or videos	Screenshots and Videos View more images or videos
Pricing €1300 per year See: 'How to buy' on our homepage for the full offer Free Version Not Supported Free Trial Supported	Pricing €3,499 Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform. Free Version Not Supported Free Trial Supported
Reviews/Ratings Overall 0.0 / 5 ease 0.0 / 5 features 0.0 / 5 design 0.0 / 5 support 0.0 / 5 This software hasn't been reviewed yet. Be the first to provide a review: Review this Software	Reviews/Ratings Overall 4.7 / 5 ease 4.5 / 5 features 4.6 / 5 design 4.1 / 5 support 4.8 / 5 Read all reviews
	Pros & Cons from Real Users Pros I like having documents, training, CAPAs, risks and other QMS activities in one place. It saves a lot of time compared with working across different files and tools, and it is much easier to see how things are connected. I also like that the system is flexible and we can adjust processes when needed. I love the interface and the helpful dashboard that reminds you daily of tasks related to you. The Quality Manual is editable and free to use, making it very user-friendly. Custom templates, notifications, automation, and risk management features are ideal for small and medium-sized companies. The technical support is excellent, answering all our questions quickly and accurately. If we need additional explanation, they are happy to schedule video training for us. Additionally, it's great for managing all kinds of projects, not just those related to quality. Documentation management, including approvals, revision history, and organization in folders, is straightforward. The Traceability Matrix is the best I've seen and very easy to use. The new Risk Module is very helpful with its added questions. Robust process engine automates workflows, minimizing errors and improving efficiency. Responsive development team actively listens to user feedback and implements requested features. Managing with qmsWrapper is easy, I am using it to organize my department. The team works easily and everything is recorded in detail in the system. qmsWrapper is an exceptional QMS software that has transformed our quality management processes. The software is intuitive and the modules are meticulously designed. The traceability matrix capability provides valuable insights into the relationships between requirements, tests, and other project elements, enhancing overall quality and compliance. Cons There is a bit of a learning curve at the beginning because there are a lot of features. Some areas could also be a little more intuitive, but once you get used to the system, everyday work becomes quite straightforward. Sometimes you need to refresh the page for updates to show Primarily designed for small and medium-sized companies, limiting functionality for larger enterprises. Sometimes slow, but regardless, I can work without interruption. While qmsWrapper offers impressive features, some users may experience slight slowness in the software's performance. However, this minor issue does not significantly impact its overall functionality or hinder the effectiveness of the quality management processes.
Training Documentation Supported Webinars Not Supported Live Online Supported In Person Supported	Training Documentation Supported Webinars Not Supported Live Online Supported In Person Not Supported
Company Information Aligned AG Founded: 2007 Switzerland www.aligned.ch/	Company Information qmsWrapper Canada www.qmswrapper.com
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Categories Application Lifecycle Management Supported Requirements Management Supported	Categories CAPA Supported Medical Quality Management Systems Supported Quality Management Supported
Show More Features Application Lifecycle Management Features Administrator Level Control Supported Defect Tracking Supported Iteration Planning Not Supported Project Management Not Supported Release Management Supported Requirements Review Supported Task Management Supported Test Case Tracking Supported User Level Management Supported Version Control Supported Requirements Management Features Automated Functional Sizing Not Supported Automated Requirements QA Supported Automated Test Generation Supported Automated Use Case Modeling Not Supported Change Management Supported Collaboration Supported History Tracking Supported Prioritization Supported Reporting Supported Status Reporting Supported Status Tracking Supported Summary Reports Supported Task Management Supported To-Do List Supported Traceability Supported User Defined Attributes Supported	Show More Features CAPA Features Audit Management Supported CAPA Planning Supported Change Management Supported Complaint Management Supported Incident Management Not Supported Nonconformance Tracking Supported Quality Control Supported Risk Management Supported Root Cause Analysis Supported Training Management Supported Quality Management Features Audit Management Supported Complaint Management Supported Compliance Management Supported Corrective and Preventive Actions (CAPA) Supported Defect Tracking Supported Document Control Supported Equipment Management Not Supported ISO Standards Management Supported Maintenance Management Not Supported Risk Management Supported Supplier Quality Control Supported Training Management Supported
Integrations Apache Subversion Supported Azure DevOps Server Supported GitHub Supported GitLab Supported Jira Not Supported Jira Align Supported Redmine Supported View All 6 Integrations	Integrations Apache Subversion Not Supported Azure DevOps Server Not Supported GitHub Not Supported GitLab Not Supported Jira Supported Jira Align Not Supported Redmine Not Supported View All 1 Integration
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