# Best Medical Quality Management Systems (QMS) ## How Many Medical Quality Management Systems (QMS) Products Does G2 Track? **Total Products under this Category:** 121 ### Category Stats (Aug 2026) - **Average Rating:** 4.39/5 (↑0.01 vs Jul 2026) The average rating of products in this category, based on all submitted ratings - **Top Trending Product:** ValGenesis Validation Lifecycle Suite (+1.2%) - Among all products in this category, ValGenesis Validation Lifecycle Suite recorded the largest rating increase compared to last month _Last updated: August 01, 2026_ ## How Does G2 Rank Medical Quality Management Systems (QMS) Products? **Why You Can Trust G2's Software Rankings:** - 30 Analysts and Data Experts - 4,700+ Authentic Reviews - 121+ Products - Unbiased Rankings G2's software rankings are built on verified user reviews, rigorous moderation, and a consistent research methodology maintained by a team of analysts and data experts. Each product is measured using the same transparent criteria, with no paid placement or vendor influence. While reviews reflect real user experiences, which can be subjective, they offer valuable insight into how software performs in the hands of professionals. Together, these inputs power the G2 Score, a standardized way to compare tools within every category. ## G2 Grid® for Medical Quality Management Systems (QMS) ![G2 Grid® for Medical Quality Management Systems (QMS) plotting products by satisfaction and market presence](https://www.g2.com/categories/medical-qms/grids.png?focus%5B%5D=4169&focus%5B%5D=142801&focus%5B%5D=17363&focus%5B%5D=1470&focus%5B%5D=1255729&focus%5B%5D=50982&focus%5B%5D=39899&focus%5B%5D=1500618) Highlighted products: Qualio, Kneat Gx, TrackWise, Arena PLM & QMS, SimplerQMS, QT9 QMS, Octave Reliance (ETQ Reliance), and sterloCare. Underlying data: [Grid® JSON](https://www.g2.com/categories/medical-qms/grids.json?focus%5B%5D=qualio&focus%5B%5D=kneat-gx&focus%5B%5D=honeywell-trackwise&focus%5B%5D=arena-plm-qms&focus%5B%5D=simplerqms&focus%5B%5D=qt9-qms&focus%5B%5D=octave-reliance-etq-reliance&focus%5B%5D=sterlo-sterlocare) **Sponsored** ### Grand Avenue Software Grand Avenue Software (GAS) is a specialized quality management system (QMS) solution designed to assist life science companies in streamlining their operations and fostering innovation. This software addresses the complexities associated with documentation, compliance, and audit processes, enabling teams to shift their focus from managing administrative tasks to developing superior products. In a highly regulated industry where quality control is paramount, GAS serves as a critical tool for enhancing operational efficiency. The primary target audience for GAS includes life science organizations, such as pharmaceutical and biotechnology firms, that require robust quality management solutions to navigate the intricacies of regulatory compliance. These companies often grapple with challenges like documentation chaos and compliance friction, which can impede their ability to innovate and respond to market demands. GAS offers a modular approach, allowing organizations to implement specific features tailored to their immediate needs while maintaining the flexibility to scale as their requirements evolve. This adaptability is essential for companies operating in a dynamic and fast-paced environment. One of the key features of GAS is its configurable templates, which facilitate rapid onboarding and help organizations achieve regulatory readiness more efficiently. This feature not only accelerates the time to value for users but also ensures predictable pricing, making it easier for companies to budget for their quality management needs. Additionally, GAS provides hands-on implementation and ongoing guidance tailored to each customer’s unique processes. This personalized support ensures that organizations can maximize the benefits of the system, ultimately leading to improved operational outcomes. Moreover, GAS distinguishes itself through its two decades of experience in supporting life science quality teams. This extensive background positions the company as a stable and reliable partner for organizations looking to enhance their quality management practices. By reducing audit risk and simplifying compliance processes, GAS empowers life science companies to prioritize innovation and product development. This focus on quality not only helps organizations meet regulatory standards but also contributes to their long-term success in a competitive marketplace, allowing them to thrive while maintaining the highest levels of quality assurance. [Visit website](https://www.g2.com/external_clickthroughs/record?secure%5Bad_program%5D=ppc&secure%5Bad_slot%5D=category_product_list_llm&secure%5Bcategory_id%5D=1884&secure%5Bchosen_at%5D=2026-08-01T07%3A27%3A56Z&secure%5Bdisplayable_resource_id%5D=1884&secure%5Bdisplayable_resource_type%5D=Category&secure%5Bmedium%5D=sponsored&secure%5Bplacement_reason%5D=page_category&secure%5Bplacement_resource_ids%5D%5B%5D=1884&secure%5Bprioritized%5D=false&secure%5Bproduct_id%5D=80861&secure%5Bresource_id%5D=1884&secure%5Bresource_type%5D=Category&secure%5Bsource_type%5D=category_page&secure%5Bsource_url%5D=https%3A%2F%2Fwww.g2.com%2Fcategories%2Fmedical-qms%3Fopen_modal_url%3D%252Fproducts%252Fmatrix-req%252Fwishlists%253Fhost_path%253D%25252Fcategories%25252Fmedical-qms%2526source%253Dcategory&secure%5Btoken%5D=a5a9abab89e314ad75c96888494ffc7addb47c41e1e63467dd9fdaa7c9be28a2&secure%5Burl%5D=https%3A%2F%2Fgrandavenue.com%2Fget-a-demo%2F%3Futm_source%3Dg2&secure%5Burl_type%5D=book_demo) ### [Qualio](https://www.g2.com/products/qualio/reviews) Qualio is a quality management and compliance platform built exclusively for life sciences companies. It helps medical device, pharmaceutical, biotech, and digital health organizations accelerate regulatory approvals, stay audit-ready, and scale compliance operations without adding headcount. Our platform manages the full range of quality processes, including document control, training, CAPA, change control, supplier management, risk management, and design controls, all in one validated system, supporting FDA 21 CFR Part 11, ISO 13485, EU MDR, MDSAP, GxP, ICH Q10, and other life sciences requirements. Move faster without compliance as the bottleneck. Qualio connects regulatory affairs, quality, and R&D in one platform, with deep integrations into Jira, Azure DevOps, GitHub, Salesforce, and other tools teams already use, removing the handoffs and manual documentation that typically slow product development down. Get to market faster. Automated gap analysis and multi-framework compliance mapping cut audit preparation time by 80%. Reusing evidence across FDA, ISO, and EU submissions has helped customers shrink market entry timelines from 9 months to 3-4 months, while cross-mapped documentation accelerates 510(k) submissions, CE marking, and international expansion. Scale without growing your compliance overhead. Customers report a 99% reduction in quality administrative time and have eliminated $150K-$300K in annual consulting costs by replacing manual processes, driving 5X ROI within 2 months. See risk before it becomes a finding. End-to-end traceability connects requirements, risk assessments, CAPAs, and product changes, with risk-based alerting that flags gaps before they turn into FDA 483 observations, warning letters, or audit findings. Customers have passed ISO 13485 certifications and sponsor audits with zero major nonconformances using this always-on monitoring. Qualio serves life sciences companies from pre-market startups to established enterprises, with the SOC 2, HIPAA, and pharmacovigilance capabilities growth-stage companies need, deploying faster than legacy eQMS vendors while maintaining the validation rigor required for FDA inspections and notified body audits. **Average Rating:** 4.4/5.0 **Total Reviews:** 771 #### How Do G2 Users Rate Qualio? - **Has the product been a good partner in doing business?:** 9.1/10 (Category avg: 9.1/10) - **Design Controls:** 8.1/10 (Category avg: 8.5/10) - **Quality Processes:** 8.9/10 (Category avg: 9.0/10) - **Audit Management:** 8.5/10 (Category avg: 8.6/10) #### Who Is the Company Behind Qualio? - **Seller:** [Qualio](https://www.g2.com/sellers/qualio) - **Company Website:** www.qualio.com - **Year Founded:** 2012 - **HQ Location:** San Francisco, California - **Twitter:** @qualiohq 711 Twitter followers - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=3fd10a9fa4c3102febd247de60e18c839b14ee7fced992dc9ccce7c05e946ceb&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2F2498463%2F&secure%5Burl_type%5D=linkedin_company_website) 116 employees on LinkedIn® #### Who Uses This Product? - **Who Uses This:** Quality Manager, Clinical Data Associate - **Top Industries:** Medical Devices, Pharmaceuticals - **Company Size:** 52% Medium, 40% Small #### What Do G2 Reviewers Say About Qualio? _AI-generated summary from verified user reviews_ ##### Pros - Users commend Qualio for its **ease of use** , simplifying training and increasing efficiency with a clean interface. - Users love Qualio’s **user-friendly training modules** , which enhance efficiency and simplify tracking for all employees. - Users appreciate the **extremely searchable document management** in Qualio, streamlining control, storage, and approval processes. - Users value the **audit trail feature** in Qualio, ensuring clear tracking of document reviews and approvals. - Users praise Qualio for its **intuitive interface** , making quality management easy and efficient for everyone. ##### Cons - Users find **document management cumbersome** in Qualio, facing long setup times and frustrating editing issues. - Users find **feature limitations** in Qualio, particularly with slow performance, lack of theme options, and integration challenges. - Users find **difficult usability** in Qualio, facing challenges with document editing and formatting inconsistencies. - Users find the **user interface of Qualio frustrating** due to cumbersome text editing and lack of version control. - Users face **editing difficulties** with table formatting and lack timely notifications for overdue document reviews in Qualio. #### What Are Recent G2 Reviews of Qualio? **["Helpful QMS Platform for Daily Operations"](https://www.g2.com/survey_responses/qualio-review-9942483)** **Rating:** 4.5/5.0 stars _— Divyanshu R._ [Read full review](https://www.g2.com/survey_responses/qualio-review-9942483) **["It makes my onboarding life easier"](https://www.g2.com/survey_responses/qualio-review-12926290)** **Rating:** 4.5/5.0 stars _— Marta G._ [Read full review](https://www.g2.com/survey_responses/qualio-review-12926290) #### What Are G2 Users Discussing About Qualio? - [What is Qualio used for?](https://www.g2.com/discussions/what-is-qualio-used-for) - 1 comment, 1 upvote - [What does Qualio do?](https://www.g2.com/discussions/what-does-qualio-do) - 6 comments, 5 upvotes - [What is Eqms quality management system?](https://www.g2.com/discussions/what-is-eqms-quality-management-system) - 2 comments, 1 upvote - [What is QMS software?](https://www.g2.com/discussions/what-is-qms-software) - 2 comments, 1 upvote - [What is Qualio?](https://www.g2.com/discussions/what-is-qualio) - 3 comments, 2 upvotes ### [Kneat Gx](https://www.g2.com/products/kneat-gx/reviews) Kneat Gx is the only digital validation platform proven to deliver any validation process in one platform, your way, with unparalleled data integrity and usability. Now enhanced with Kneat AI, it is an end-to-end digital validation management platform enabling regulated companies to make validation easier, faster, and smarter than ever before. Why Leading Life Sciences Choose Kneat Our purpose-built software streamlines the validation lifecycle for BioPharma and Medical Device companies. By integrating advanced AI capabilities, Kneat Gx empowers users to automate repetitive tasks, gain deeper insights from their data, and accelerate speed-to-market. • Compliant & Secure: Fully 21 CFR Part 11 and EudraLex Annex 11 compliant. • Intelligence-Driven: Leverages AI to optimize document creation, manage complex workflows, and proactively identify compliance gaps. • Data Sovereignty: Eliminates paper-based silos, providing an unprecedented capability to create, manage, and mine validation data in real-time. • Industry Trusted: Trusted by the leaders in Life Sciences—including eight of the top 10 global companies—where equipment, computer systems, and processes must meet the highest standards for product quality and patient safety. The Kneat Advantage: By combining the flexibility of our enterprise platform with the power of AI, we transform validation from a regulatory burden into a strategic advantage. **Average Rating:** 4.5/5.0 **Total Reviews:** 95 #### How Do G2 Users Rate Kneat Gx? - **Has the product been a good partner in doing business?:** 9.6/10 (Category avg: 9.1/10) - **Design Controls:** 8.9/10 (Category avg: 8.5/10) - **Quality Processes:** 10.0/10 (Category avg: 9.0/10) - **Audit Management:** 9.2/10 (Category avg: 8.6/10) #### Who Is the Company Behind Kneat Gx? - **Seller:** [Kneat Solutions](https://www.g2.com/sellers/kneat-solutions) - **Company Website:** kneat.com - **Year Founded:** 2006 - **HQ Location:** Limerick, IE - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=c151dd4466743c96b88614eaf9278e908f1579991140cc8eff64bf763c6c6214&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fkneat-solutions-ltd&secure%5Burl_type%5D=linkedin_company_website) 342 employees on LinkedIn® - **Ownership:** FRA: FOBK #### Who Uses This Product? - **Top Industries:** Pharmaceuticals, Biotechnology - **Company Size:** 43% Large, 41% Medium #### What Do G2 Reviewers Say About Kneat Gx? _AI-generated summary from verified user reviews_ ##### Pros - Users appreciate the **ease of use** of Kneat Gx, simplifying reviews, approvals, and ensuring compliance and transparency. - Users appreciate the **user-friendly design** of Kneat Gx, which centralizes features and promotes a paperless validation process. - Users value the **efficiency improvement** provided by Kneat Gx, streamlining validation processes into a digital format. - Users value the **tracking efficiency** of Kneat Gx, facilitating compliance and enhancing the validation document management process. - Users value the **flexibility and centralized access** of Kneat Gx, enabling efficient document management and traceability. ##### Cons - Users experience **feature limitations** with Kneat Gx, disrupting workflows and restricting options without vendor support. - Users experience a **steep learning curve** , making it challenging to adapt to Kneat Gx effectively. - Users face a **noticeable learning curve** , making it time-consuming to fully grasp and adapt to Kneat Gx. - Users report **slow performance** with Kneat Gx, experiencing lag and glitches during important document workflows. - Users report **software bugs** in Kneat Gx, leading to slow loading and disruptions during document workflows. #### What Are Recent G2 Reviews of Kneat Gx? **["Will transform your traditional validation program and processes"](https://www.g2.com/survey_responses/kneat-gx-review-10955323)** **Rating:** 5.0/5.0 stars _— Kathianne R._ [Read full review](https://www.g2.com/survey_responses/kneat-gx-review-10955323) **["Highly Configurable Platform with a Smooth, Streamlined Implementation"](https://www.g2.com/survey_responses/kneat-gx-review-12528209)** **Rating:** 5.0/5.0 stars _— Nico V._ [Read full review](https://www.g2.com/survey_responses/kneat-gx-review-12528209) ### [TrackWise](https://www.g2.com/products/honeywell-trackwise/reviews) TrackWise® is the world’s leading on-premises QMS software. It brings all your quality processes together in a single place to give you the big picture of your compliance and operational effectiveness. TrackWise offers several industry best-practice workflows and can also adapt to fit your existing process and workflow. Companies across several industries use TrackWise to increase efficiency, improve quality, achieve compliance and reduce risk. **Average Rating:** 4.3/5.0 **Total Reviews:** 48 #### How Do G2 Users Rate TrackWise? - **Has the product been a good partner in doing business?:** 7.9/10 (Category avg: 9.1/10) - **Design Controls:** 9.2/10 (Category avg: 8.5/10) - **Quality Processes:** 8.3/10 (Category avg: 9.0/10) - **Audit Management:** 8.3/10 (Category avg: 8.6/10) #### Who Is the Company Behind TrackWise? - **Seller:** [Honeywell Technologies](https://www.g2.com/sellers/honeywell-technologies) - **Year Founded:** 1906 - **HQ Location:** Charlotte, North Carolina - **Twitter:** @HoneywellNow 2,526 Twitter followers - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=2439934c193c64f590ac3e59168d5255fa5931a7d9141987b03ad28a37fa5cfe&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fhoneywell%2F&secure%5Burl_type%5D=linkedin_company_website) 132,085 employees on LinkedIn® - **Ownership:** HON #### Who Uses This Product? - **Top Industries:** Pharmaceuticals, Biotechnology - **Company Size:** 56% Large, 35% Medium #### What Do G2 Reviewers Say About TrackWise? _AI-generated summary from verified user reviews_ ##### Pros - Users find TrackWise to be **very easy to use** , appreciating its flexibility and customization options for workflows. - Users enjoy the **ease of use and customization** of TrackWise, enhancing flexibility for various workflows and needs. - Users value the **great flexibility and ease of use** in customizing workflows and metadata fields on TrackWise. - Users value the **robust automation** capabilities of TrackWise, enhancing their workflow efficiency significantly. - Users appreciate the **great flexibility** of TrackWise, enabling extensive customization of metadata fields and workflows. ##### Cons - Users express frustration over **inefficient notifications** causing loss of unsaved work when timeouts occur. - Users express dissatisfaction with **poor collaboration** due to inadequate customer support and lack of community networking opportunities. - Users are frustrated by the **poor customer support** and absence of a networking community for sharing experiences. - Users are frustrated by the **time consumption** of TrackWise, often losing work due to timeouts before saving. - Users often face **time-consumption issues** with TrackWise, as losing unsaved work due to timeouts can be frustrating. #### What Are Recent G2 Reviews of TrackWise? **["Trackwise good for tracking all QMS record and user friendly.All QMS records available in excelsheet"](https://www.g2.com/survey_responses/trackwise-review-7442437)** **Rating:** 5.0/5.0 stars _— Ravindra J._ [Read full review](https://www.g2.com/survey_responses/trackwise-review-7442437) **["Very Easy to Use, Feature-Rich, and Highly Flexible Customization"](https://www.g2.com/survey_responses/trackwise-review-12250052)** **Rating:** 4.0/5.0 stars _— Marco B._ [Read full review](https://www.g2.com/survey_responses/trackwise-review-12250052) #### What Are G2 Users Discussing About TrackWise? - [How do you use Track wise?](https://www.g2.com/discussions/how-do-you-use-track-wise) - [Is TrackWise built on Salesforce?](https://www.g2.com/discussions/is-trackwise-built-on-salesforce) - [What is a TrackWise module?](https://www.g2.com/discussions/what-is-a-trackwise-module) - [What is TrackWise software used for?](https://www.g2.com/discussions/what-is-trackwise-software-used-for) ### [Arena PLM & QMS](https://www.g2.com/products/arena-plm-qms/reviews) Arena by PTC is a cloud-native product lifecycle management (PLM) and quality management system (QMS) that unifies product and quality information in a secure, single source of truth. By hosting all electrical, mechanical, and software information in a centralized product record, Arena enables every participant throughout the entire product lifecycle to work together anytime and anywhere, increasing visibility and traceability. This accelerates new product development (NPD) and new product introduction (NPI) by streamlining processes, automating review cycles, and reducing errors. Arena PLM keeps internal teams and supply chain partners on the same page. Our scalable and collaborative platform streamlines engineering change reviews, simplifies bill of materials (BOM) management and document control, mitigates supply chain risk, and helps speed product launches. Arena QMS connects quality and product record information into a single, secure system. Easily traceable closed-loop quality and product processes help you introduce high-quality products to market while ensuring compliance with quality standards and regulations, such as FDA 21 CFR Part 820, FDA 21 CFR Part 11, ISO 13485, and AS 9100. Arena Supply Chain Intelligence (SCI) provides real-time electronic component risk and compliance information to reduce supply chain risk throughout NPI and NPD. With Arena SCI embedded within Arena PLM, you can proactively monitor the health of your BOM and mitigate component issues throughout the product lifecycle, as well as ensure electronic component compliance as regulatory requirements evolve. Arena’s AI capabilities create smarter, more personalized experiences that empower every customer while adhering to its responsible AI policies. Arena AI Assistant uses a conversational interface to help users navigate Arena with ease and reduce onboarding time, while Arena AI Engine drives faster document reviews and comparisons to further speed workflows. Arena supports more than 1,500 complex high-tech electronics, medical device, and aerospace/defense companies around the world. Using Arena’s proven cloud-native solutions, your internal teams and external partners can leverage the most comprehensive product development platform to accelerate product launches while reducing expenses, increasing profitability, and speeding time to market. **Average Rating:** 4.2/5.0 **Total Reviews:** 452 #### How Do G2 Users Rate Arena PLM & QMS? - **Has the product been a good partner in doing business?:** 8.9/10 (Category avg: 9.1/10) - **Design Controls:** 8.3/10 (Category avg: 8.5/10) - **Quality Processes:** 8.6/10 (Category avg: 9.0/10) - **Audit Management:** 8.3/10 (Category avg: 8.6/10) #### Who Is the Company Behind Arena PLM & QMS? - **Seller:** [PTC](https://www.g2.com/sellers/ptc) - **Company Website:** www.ptc.com - **Year Founded:** 1985 - **HQ Location:** Boston, Massachusetts - **Twitter:** @PTC 37,560 Twitter followers - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=2562b24957155b8473247eb4a4b81fe707ca04fac9fc006da5825ec0a8c5e255&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2F1935%2F&secure%5Burl_type%5D=linkedin_company_website) 8,145 employees on LinkedIn® #### Who Uses This Product? - **Who Uses This:** Mechanical Engineer, Engineer - **Top Industries:** Medical Devices, Electrical/Electronic Manufacturing - **Company Size:** 57% Medium, 26% Small #### What Do G2 Reviewers Say About Arena PLM & QMS? _AI-generated summary from verified user reviews_ ##### Pros - Users find Arena PLM & QMS to be **extremely easy to use** , with quick learning curves and responsive support. - Users value the **convenient document management** features of Arena PLM & QMS, enhancing organization and efficiency. - Users value the **secure document control** in Arena PLM & QMS that enhances team collaboration and compliance. - Users highlight the **intuitive interface** of Arena PLM & QMS, making it easy to navigate for everyone. - Users value the **responsive customer support** of Arena PLM & QMS, consistently receiving timely assistance with concerns. ##### Cons - Users feel frustrated by **feature limitations** , needing better ERP integration and enhancements for improved usability and tracking. - Users find Arena PLM & QMS lacking in **essential features** , such as multi-item search and improved template creation. - Users struggle with **ineffective search functionality** and difficulties in maintaining data consistency across the organization. - Users find the **inefficient searching** in Arena PLM & QMS frustrating, as it limits their ability to locate items easily. - Users find the **search functionality lacking** , struggling to locate multiple items or documents effectively within Arena PLM & QMS. #### What Are Recent G2 Reviews of Arena PLM & QMS? **["Robust, Scalable Cloud PLM with Great Support and Onshape Integration"](https://www.g2.com/survey_responses/arena-plm-qms-review-13145402)** **Rating:** 5.0/5.0 stars _— Rob T._ [Read full review](https://www.g2.com/survey_responses/arena-plm-qms-review-13145402) **["Arena PLM: A Scalable, Well-Organized Platform for Growing Teams"](https://www.g2.com/survey_responses/arena-plm-qms-review-13169022)** **Rating:** 4.0/5.0 stars _— Verified User in Electrical/Electronic Manufacturing_ [Read full review](https://www.g2.com/survey_responses/arena-plm-qms-review-13169022) #### What Are G2 Users Discussing About Arena PLM & QMS? - [What is Arena PLM & QMS used for?](https://www.g2.com/discussions/what-is-arena-plm-qms-used-for) - 1 comment - [What is the difference between ALM and PLM?](https://www.g2.com/discussions/what-is-the-difference-between-alm-and-plm) - 1 comment - [What is PLM in supply chain?](https://www.g2.com/discussions/what-is-plm-in-supply-chain) - 1 comment - [What does a PLM do?](https://www.g2.com/discussions/what-does-a-plm-do) - 2 comments - [How Much Does Arena PLM cost?](https://www.g2.com/discussions/how-much-does-arena-plm-cost) - 1 comment ### [QT9 QMS](https://www.g2.com/products/qt9-qms/reviews) QT9™ QMS is your all-in-one quality management software. Centralize more quality data metrics than any other platform standard. Easy-to-use & ready-to-go. Fully-validated. Start a trial. All-In-One QMS QT9 provides an integrated solution with 25+ quality modules that include Document Management, Maintenance, Product, Customer, Supplier, Employee Training, ISO, FDA and regulatory compliance automation. Be more efficient with electronic signature approvals, dashboards, automated reminders, multi-site ready, approval management, web portals, user to-do lists and more. Simplify Compliance Make audits easy with one central place to see real-time data for FDA 21 CFR Part 11, FDA 21 CFR Part 210/211, FDA 21 CFR Part 820, ISO 9001, ISO 13485, ISO 14001, ISO 17025, AS9100, HACCP and SQF. Ideal for Life Sciences, Biotechnology, Medical Device Manufacturers, Pharmaceutical Companies, Laboratories, Aerospace and Defense Companies and Foods. Easy-To-Use QT9 QMS is easy to setup and use. See a demo and get started with a free trial today. We offer lots of resources including: QT9 Help, Training Academy, Support Requests, Training Webinars, Content Customization, Free Maintenance, Unlimited Training and Unlimited Support. For more information, visit QT9software.com. **Average Rating:** 4.8/5.0 **Total Reviews:** 125 #### How Do G2 Users Rate QT9 QMS? - **Has the product been a good partner in doing business?:** 9.6/10 (Category avg: 9.1/10) - **Design Controls:** 8.2/10 (Category avg: 8.5/10) - **Quality Processes:** 9.3/10 (Category avg: 9.0/10) - **Audit Management:** 8.8/10 (Category avg: 8.6/10) #### Who Is the Company Behind QT9 QMS? - **Seller:** [QT9 Software](https://www.g2.com/sellers/qt9-software) - **Company Website:** qt9software.com - **Year Founded:** 2005 - **HQ Location:** Aurora, Illinois - **Twitter:** @Qt9Software 26 Twitter followers - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=07270194debe81b701af8df72ac40cc5d4de72c71cff3959733b2cb77ab22b65&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fqt9-software%2F&secure%5Burl_type%5D=linkedin_company_website) 67 employees on LinkedIn® #### Who Uses This Product? - **Who Uses This:** Quality Manager, Quality Assurance Manager - **Top Industries:** Medical Devices, Manufacturing - **Company Size:** 54% Medium, 45% Small #### What Do G2 Reviewers Say About QT9 QMS? _AI-generated summary from verified user reviews_ ##### Pros - Users praise QT9 QMS for its **intuitive ease of use** , facilitating quick adoption and minimizing training needs. - Users commend the **responsive and knowledgeable customer support** of QT9 QMS, enhancing their overall experience with the platform. - Users value the **ease of setup and intuitive design** of QT9 QMS, facilitating swift implementation for MDSW launches. - Users value the **modular document control** in QT9 QMS, enhancing visibility, accountability, and compliance effortlessly. - Users value the **modular integration** of QT9 QMS, enhancing efficiency and supporting smoother quality management processes. ##### Cons - Users express frustration with **module setup issues** due to prerequisites that complicate implementation, especially for startups. - Users find the **complex setup** of QT9 QMS time-consuming and challenging, impacting initial usability. - Users note **feature limitations** in QT9 QMS, particularly in calibration options and record linking capabilities. - Users find the **learning difficulty** of QT9 QMS challenging due to its busy interface and prerequisite setups. - Users feel that QT9 QMS lacks **limited flexibility** , wishing for more customization options for their specific processes. #### What Are Recent G2 Reviews of QT9 QMS? **["QT9 QMS Makes Audits, CAPA, and Training Records Easy to Manage"](https://www.g2.com/survey_responses/qt9-qms-review-12667729)** **Rating:** 4.5/5.0 stars _— Stefanie C._ [Read full review](https://www.g2.com/survey_responses/qt9-qms-review-12667729) **["Excellent Training, Document Control, and CAPA Modules"](https://www.g2.com/survey_responses/qt9-qms-review-12955172)** **Rating:** 5.0/5.0 stars _— Renea K._ [Read full review](https://www.g2.com/survey_responses/qt9-qms-review-12955172) #### What Are G2 Users Discussing About QT9 QMS? - [What is QT9 QMS used for?](https://www.g2.com/discussions/what-is-qt9-qms-used-for) - 2 comments, 1 upvote ### [SimplerQMS](https://www.g2.com/products/simplerqms/reviews) SimplerQMS is an expert-driven electronic Quality Management System (eQMS) purpose-built for Life Science organizations. Our eQMS is designed by professionals with deep industry experience and supports compliance with FDA, ISO, and GxP requirements through automated, audit-ready quality processes. The platform centralizes and automates core quality workflows within a cloud-based, fully validated system. Customers benefit from reduced manual work, fewer errors, and consistently organized, inspection-ready records. Unlike generic QMS tools, SimplerQMS comes pre-configured for Life Science needs, with built-in templates, workflows, and controls aligned with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other applicable standards. Beyond software, customers gain a trusted partner backed by deep regulatory and quality expertise. This includes: • Audit-proven insights • Guidance from compliance specialists • Continuous system validation • Unlimited user training • 24/7 customer support • Smooth implementation and data migration • Dedicated Customer Success Experts With a mission to help Life Science companies manage quality and regulatory documentation efficiently, SimplerQMS supports organizations from early-stage growth to global scale to strengthen compliance, operational control, and quality culture. **Average Rating:** 4.9/5.0 **Total Reviews:** 13 #### How Do G2 Users Rate SimplerQMS? - **Has the product been a good partner in doing business?:** 9.6/10 (Category avg: 9.1/10) - **Design Controls:** 8.3/10 (Category avg: 8.5/10) - **Quality Processes:** 9.8/10 (Category avg: 9.0/10) - **Audit Management:** 8.7/10 (Category avg: 8.6/10) #### Who Is the Company Behind SimplerQMS? - **Seller:** [SimplerQMS](https://www.g2.com/sellers/simplerqms) - **Company Website:** www.simplerqms.com - **Year Founded:** 2017 - **HQ Location:** København, DK - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=9d988c0065043fde3fd4dedf0cc314ff3b7a35771d8941eddf91b47cd64bd084&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsimplerqms%2F&secure%5Burl_type%5D=linkedin_company_website) 80 employees on LinkedIn® #### Who Uses This Product? - **Top Industries:** Medical Devices - **Company Size:** 86% Small, 7% Medium #### What Do G2 Reviewers Say About SimplerQMS? _AI-generated summary from verified user reviews_ ##### Pros - Users commend the **excellent customer support** of SimplerQMS, highlighting responsiveness and helpfulness in addressing their needs. - Users value the **user-friendly interface** of SimplerQMS, which enhances efficiency in daily quality tasks. - Users love the **intuitive interface** of SimplerQMS, enhancing efficiency in daily quality management tasks. - Users appreciate the **straightforward implementation** of SimplerQMS, allowing for quick deployment and effective utilization in their processes. - Users commend SimplerQMS for its **effective document control** , enhancing compliance and streamlining document management processes. ##### Cons - Users find **feature limitations** in SimplerQMS, like one-way product-supplier relations and cumbersome document entries. - Users experience a **difficult installation** process that requires significant time and planning for effective setup. - Users find the **difficult usability** of SimplerQMS impacts their ability to efficiently access and utilize features. - Users find the **inefficient workflow** in SimplerQMS burdensome due to extra steps and non-intuitive terminology. - Users experience a **slight learning difficulty** initially, needing time to adapt to the system's features and workflows. #### What Are Recent G2 Reviews of SimplerQMS? **["Intuitive Interface and Outstanding Support Make SimplerQMS a Standout"](https://www.g2.com/survey_responses/simplerqms-review-12128025)** **Rating:** 5.0/5.0 stars _— Verified User in Medical Devices_ [Read full review](https://www.g2.com/survey_responses/simplerqms-review-12128025) **["Streamlined Compliance with Outstanding Training and Support"](https://www.g2.com/survey_responses/simplerqms-review-12402144)** **Rating:** 5.0/5.0 stars _— Cindi M._ [Read full review](https://www.g2.com/survey_responses/simplerqms-review-12402144) ### [Octave Reliance (ETQ Reliance)](https://www.g2.com/products/octave-reliance-etq-reliance/reviews) Octave Reliance® (formerly ETQ Reliance) is the leading provider of quality, EHS and compliance management software, trusted by the world’s strongest brands. More than 600 customers globally, spanning industries such as manufacturing, medical devices, electronics, heavy industry, food and beverage, pharmaceuticals and automotive, use Reliance to secure positive brand reputations, enable higher levels of customer loyalty and enhance profitability. Octave Reliance offers built-in best practices and powerful flexibility to drive business excellence through quality. Reliance QMS provides customers with a suite of fundamental capabilities and a set of core applications that optimize quality management programs: • Document Control • Change Management • Audit Management • Corrective Action (CAPA) • Insights Advanced Analytics • Training Management • Suppliers, Materials and Chemicals • And more Reliance customers have long relied on its comprehensive, cross-industry portfolio of QMS applications to advance their quality programs and meet critical business goals. With Reliance NXG, customers can now accelerate their quality journey into the resilient and adaptable world of cloud-native quality and safety management, advanced analytics, controlled ubiquitous access and enterprise digital transformation. Reliance NXG allows customers to effectively future-proof their quality management systems and provide a powerful catalyst to digital transformation in their organizations. The technological foundation of Reliance NXG is based on four value pillars: usability, flexibility, visibility and scalability, enabled by advanced cloud-native technologies and a transformational vision. • Usability: The solution’s new search capability enables users to quickly find anything within the system, with enhanced navigation to streamline the user experience from any device. • Flexibility: New integration features, built upon a multi-tenant architecture, allow customers to break down the barriers that limit collaboration and keep up with changes in their business. • Visibility: Digital transformation efforts will drive QMS solutions deeper into an organization’s enterprise technology stack. Powered by Insights analytics, workflows can be configured to automatically classify events, improving the speed and accuracy of decisions. Users are provided not just with better information, but also guidance that can be used to streamline investigations and root cause analyses. • Scalability: The cloud-native QMS enables enterprise-wide quality processes, providing support for any number of users, any volume of data and any configuration with a high availability architecture with no single point of failure. Customers in regulated markets can leverage expedited validation and risk-based verification in Reliance to reduce testing effort required. Octave Reliance was originally founded in 1992 as ETQ and has main offices located in the U.S. and Europe. To learn more about Octave Reliance and its various product offerings, visit https://www.octave.com/products/asset-performance-management/reliance. **Average Rating:** 4.3/5.0 **Total Reviews:** 603 #### How Do G2 Users Rate Octave Reliance (ETQ Reliance)? - **Has the product been a good partner in doing business?:** 8.1/10 (Category avg: 9.1/10) - **Design Controls:** 8.1/10 (Category avg: 8.5/10) - **Quality Processes:** 8.3/10 (Category avg: 9.0/10) - **Audit Management:** 7.9/10 (Category avg: 8.6/10) #### Who Is the Company Behind Octave Reliance (ETQ Reliance)? - **Seller:** [Octave](https://www.g2.com/sellers/octave-9e5a428c-f303-4735-9417-dff1ef5736d4) - **Company Website:** www.octave.com - **HQ Location:** Madison, US - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=430404c61b1403ac110b9bef1eccdb226c2d152f09d020a4c9da5926e5df6ee5&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Foctaveintelligence%2F&secure%5Burl_type%5D=linkedin_company_website) 3,001 employees on LinkedIn® #### Who Uses This Product? - **Who Uses This:** Quality Manager, Quality Engineer - **Top Industries:** Medical Devices, Pharmaceuticals - **Company Size:** 50% Large, 42% Medium #### What Do G2 Reviewers Say About Octave Reliance (ETQ Reliance)? _AI-generated summary from verified user reviews_ ##### Pros - Users enjoy the **ease of use** of Octave Reliance, highlighting its simple workflows and convenient administration. - Users value the **user-friendly interface and customizable features** of ETQ Reliance, enhancing performance and interaction. - Users value the **customizability** of Octave Reliance, enabling tailored solutions that enhance organizational efficiency and functionality. - Users value the **customization options** of Octave Reliance, enhancing usability and tailoring it to their specific needs. - Users value the **user-friendly document management** in Octave Reliance, enhancing interaction and performance throughout the organization. ##### Cons - Users find the **missing features** in Octave Reliance hinder their productivity and limit functionality significantly. - Users highlight **feature limitations** in ETQ Reliance, citing poor mobile capabilities and overwhelming customization options. - Users find the **limited customization** options frustrating, hindering efficiency and complicating the onboarding process. - Users express frustration over **missing functionality** in Octave Reliance, particularly regarding reports and mobile capabilities. - Users find the **lack of user-friendliness** in ETQ Reliance frustrating, especially during onboarding and workflow customization. #### What Are Recent G2 Reviews of Octave Reliance (ETQ Reliance)? **["Streamlined Quality Management in One Configurable Platform"](https://www.g2.com/survey_responses/octave-reliance-etq-reliance-review-13177775)** **Rating:** 4.0/5.0 stars _— Palkirat Kaur C._ [Read full review](https://www.g2.com/survey_responses/octave-reliance-etq-reliance-review-13177775) **["ETQ perfect system to improve and promote quality in the company"](https://www.g2.com/survey_responses/octave-reliance-etq-reliance-review-11059581)** **Rating:** 5.0/5.0 stars _— Madison S._ [Read full review](https://www.g2.com/survey_responses/octave-reliance-etq-reliance-review-11059581) #### What Are G2 Users Discussing About Octave Reliance (ETQ Reliance)? - [What is ETQ Reliance QMS used for?](https://www.g2.com/discussions/what-is-etq-reliance-qms-used-for) - [What is an electronic quality management system?](https://www.g2.com/discussions/what-is-an-electronic-quality-management-system) - [What is Qualio?](https://www.g2.com/discussions/etq-reliance-qms-what-is-qualio) - 2 comments - [What is EtQ software?](https://www.g2.com/discussions/what-is-etq-software) - 1 comment - [What is EtQ reliance?](https://www.g2.com/discussions/what-is-etq-reliance) ### [sterloCare](https://www.g2.com/products/sterlo-sterlocare/reviews) sterloCare is a comprehensive healthcare digitization platform designed to enhance patient satisfaction and ensure compliance with regulatory standards such as NABH and JCI. Developed on a no-code platform, it enables hospitals to streamline operations across all departments, improving service quality and operational efficiency. The system seamlessly integrates with existing Hospital Information Systems (HIS) and offers flexible deployment options, including cloud and on-premise solutions. Accessible via desktops, tablets, and mobile devices, sterloCare provides real-time updates and supports role-based workflows with automated escalations to ensure timely task completion. Key Features and Functionality: - Service Request Management: Utilizes QR code-based triggers to efficiently manage service requests, track complaints, and gather patient feedback, facilitating prompt responses and improved patient care. - Digital Token System: Monitors outpatient journeys, reducing wait times and enhancing the overall patient experience. - Porter Management Software: Optimizes porter services, ensuring efficient patient transport within the hospital. - Automated Workflows and Escalations: Implements role-based workflows with built-in escalations, ensuring tasks are completed promptly and efficiently. - Real-Time Notifications: Delivers instant updates via mobile and email, keeping staff informed about task statuses and approvals. - Multilingual Support: Offers a user-friendly interface with support for multiple languages, catering to diverse regional needs. - Seamless Integration: Facilitates integration with existing HIS and other software systems, promoting efficient information flow and harmonious workflows. - Customizable Dashboards and Reports: Provides interactive dashboards and detailed reports, enabling data-driven decision-making and performance monitoring across departments. Primary Value and Solutions Provided: sterloCare addresses critical challenges in healthcare management by digitizing and automating various hospital processes. It enhances operational efficiency, reduces manual workloads, and ensures compliance with accreditation standards like NABH and JCI. By improving patient engagement through efficient service request handling and feedback mechanisms, sterloCare contributes to higher patient satisfaction. Its comprehensive reporting tools and real-time monitoring capabilities empower healthcare administrators to make informed decisions, ultimately leading to better patient outcomes and streamlined hospital operations. **Average Rating:** 4.7/5.0 **Total Reviews:** 21 #### How Do G2 Users Rate sterloCare? - **Design Controls:** 8.9/10 (Category avg: 8.5/10) - **Quality Processes:** 9.4/10 (Category avg: 9.0/10) - **Audit Management:** 9.6/10 (Category avg: 8.6/10) #### Who Is the Company Behind sterloCare? - **Seller:** [sterlo](https://www.g2.com/sellers/sterlo-a4c301d4-2da5-4501-aeb2-f54421a73486) - **Year Founded:** 2019 - **HQ Location:** Erode, IN - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=9901b7808ed4703e16335f857a87576d4be7fd42976f9764754f9631ee6ff621&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsterlocare&secure%5Burl_type%5D=linkedin_company_website) 16 employees on LinkedIn® #### Who Uses This Product? - **Top Industries:** Hospital & Health Care - **Company Size:** 86% Large, 14% Medium #### What Do G2 Reviewers Say About sterloCare? _AI-generated summary from verified user reviews_ ##### Pros - Users praise the **ease of use** of sterloCare, allowing seamless integration and quick adaptation for all staff. - Users appreciate the **improved patient care** offered by sterloCare, enhancing service and satisfaction through real-time feedback. - Users value the **excellent customer support** of sterloCare, enhancing smooth operations and quick issue resolution. - Users appreciate the **efficient communication** features of sterloCare, enhancing transparency and coordination within porter operations. - Users value the **efficiency** of sterloCare, facilitating seamless operations and enhancing patient satisfaction across the medical center. ##### Cons - Users report **notification issues** with delays and missed alerts, suggesting improvements for better communication flow. - Users report **excessive notifications** can be overwhelming, and delays occur during busy times affecting user experience. - Users experience **messaging issues** with delays in notifications and queue updates, affecting overall efficiency. - Users experience **notification problems** , including missed alerts and delays in low network coverage areas. - Users face **connectivity issues** in low network areas, leading to missed notifications and a need for offline functionality. #### What Are Recent G2 Reviews of sterloCare? **["A very effective porter management system that improved our hospital operations"](https://www.g2.com/survey_responses/sterlocare-review-11988847)** **Rating:** 5.0/5.0 stars _— Hari H._ [Read full review](https://www.g2.com/survey_responses/sterlocare-review-11988847) **["Simple and Seamless Housekeeping Workflow"](https://www.g2.com/survey_responses/sterlocare-review-12027480)** **Rating:** 4.5/5.0 stars _— Vera B._ [Read full review](https://www.g2.com/survey_responses/sterlocare-review-12027480) ### [MasterControl Quality Management System](https://www.g2.com/products/mastercontrol-quality-management-system/reviews) MasterControl Quality Excellence is the #1 Quality Management System (QMS) in life sciences. Built on an AI-driven platform, it enables life-sciences companies to enable flexible quality event management, simplified document management, and automated training management—that all work seamlessly together to close the loop on quality. Targeted primarily at quality professionals within the life sciences industry, MasterControl Qx serves a diverse range of organizations, from pharmaceuticals to biotechnology and medical devices. These industries often face stringent regulatory requirements and complex quality assurance processes. MasterControl Qx offers a centralized platform that integrates various quality management functions, allowing users to manage quality events, documentation, training, and audits seamlessly. This integration not only enhances operational efficiency but also ensures that organizations remain compliant with industry standards. One of the standout features of MasterControl Qx is its intelligent automation capabilities. By automating routine quality management tasks, organizations can reduce manual errors and free up valuable time for quality professionals to focus on more strategic initiatives. Additionally, the platform provides robust data insights that empower users to make informed decisions based on real-time information. This data-driven approach enhances the ability to identify trends, monitor compliance, and drive continuous improvement within quality processes. Furthermore, MasterControl Qx is designed to foster collaboration across departments and teams. The platform's connected nature allows for easy sharing of information and documentation, ensuring that all stakeholders are aligned and informed. This collaborative environment not only enhances communication but also supports a culture of quality throughout the organization. By utilizing MasterControl Qx, companies can create a more agile and responsive quality management system that adapts to changing regulatory landscapes and market demands. Overall, MasterControl Quality Excellence (Qx) stands out in the QMS category by providing a holistic solution tailored to the specific needs of the life sciences industry. Its combination of intelligent automation, robust data insights, and collaborative features positions it as a valuable tool for organizations striving to maintain high-quality standards while navigating the complexities of regulatory compliance. **Average Rating:** 4.3/5.0 **Total Reviews:** 522 #### How Do G2 Users Rate MasterControl Quality Management System? - **Has the product been a good partner in doing business?:** 8.8/10 (Category avg: 9.1/10) - **Design Controls:** 7.1/10 (Category avg: 8.5/10) - **Quality Processes:** 7.9/10 (Category avg: 9.0/10) - **Audit Management:** 6.7/10 (Category avg: 8.6/10) #### Who Is the Company Behind MasterControl Quality Management System? - **Seller:** [MasterControl](https://www.g2.com/sellers/mastercontrol) - **Company Website:** www.mastercontrol.com - **Year Founded:** 1993 - **HQ Location:** Salt Lake City, UT - **Twitter:** @MCMasterControl 6,258 Twitter followers - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=00588802c89147f00f07e6bed17054a50d4b885bbdcab7c82c6ef17d1397df09&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2F23070%2F&secure%5Burl_type%5D=linkedin_company_website) 742 employees on LinkedIn® #### Who Uses This Product? - **Who Uses This:** Quality Assurance Specialist, Quality Engineer - **Top Industries:** Pharmaceuticals, Medical Devices - **Company Size:** 64% Medium, 25% Large #### What Do G2 Reviewers Say About MasterControl Quality Management System? _AI-generated summary from verified user reviews_ ##### Pros - Users appreciate the **ease of use** of MasterControl, benefiting from its intuitive interface and customizable features. - Users value the **centralized document management** features of MasterControl, enhancing integration and user experience effectively. - Users value the **user-friendly training integration** and centralized system for managing compliance and quality events effectively. - Users value the **efficient document control** in MasterControl, appreciating easy access to documents and timely upgrades. - Users appreciate the **customizable and user-friendly features** of MasterControl, facilitating efficient quality management processes. ##### Cons - Users find the **interface not intuitive** , struggling with complex setups and unclear iconography affecting user experience. - Users face a **steep learning curve** with MasterControl, particularly during initial setup and navigation between modules. - Users find the **difficult usability** of MasterControl's system a challenge, particularly with report creation and workflow setup. - Users struggle with the **not user-friendly interface** of MasterControl, finding navigation and search features cumbersome and challenging. - Users find the **complex setup** challenging, requiring extensive training to effectively use MasterControl's capabilities. #### What Are Recent G2 Reviews of MasterControl Quality Management System? **["Easy-to-Use, Well-Organized Interface with Strong SysAdmin Resources"](https://www.g2.com/survey_responses/mastercontrol-quality-management-system-review-13179229)** **Rating:** 4.5/5.0 stars _— Kaitlyn P._ [Read full review](https://www.g2.com/survey_responses/mastercontrol-quality-management-system-review-13179229) **["Perfect for life sciences companies!"](https://www.g2.com/survey_responses/mastercontrol-quality-management-system-review-12477103)** **Rating:** 4.0/5.0 stars _— Sean M._ [Read full review](https://www.g2.com/survey_responses/mastercontrol-quality-management-system-review-12477103) #### What Are G2 Users Discussing About MasterControl Quality Management System? - [What is MasterControl Quality Management System used for?](https://www.g2.com/discussions/what-is-mastercontrol-quality-management-system-used-for) - 1 comment - [What is MasterControl Customer Complaints used for?](https://www.g2.com/discussions/what-is-mastercontrol-customer-complaints-used-for) ### [Greenlight Guru Quality Management System](https://www.g2.com/products/greenlight-guru-quality-management-system/reviews) Greenlight Guru is the #1 quality management system built exclusively for medical device companies. Not life sciences. Not pharma with a medtech configuration layer. Because we built exclusively for medical devices, ISO 13485, ISO 14971, and FDA QMSR aren't frameworks you configure after the fact. They're the foundation. Most quality teams manage compliance across systems that were never designed to talk to each other. A document control tool here, a spreadsheet for CAPAs there, a separate process for change control. In a regulated environment, that gap doesn't stay invisible, it shows up during audits. Greenlight Guru gives Quality and Product teams a single connected system where document control, training, CAPA, nonconformance, change control, supplier management, risk management, and design controls work together. When a change happens, it flows through the workflow. Meaning limited manual handoffs, and nothing falling through the cracks between teams. For Quality and Regulatory Affairs professionals, that means audit-ready workflows with automated routing, electronic signatures, and complete audit trails built in, including end-to-end traceability across design controls. No more chasing approvals or manually tracking compliance status. Teams that run on Greenlight Guru are 3.5x less likely to receive a major audit finding. For R&D and product teams, it means staying in the tools they already use, with changes automatically syncing to design controls so documentation builds itself as you work, not after the fact as a separate project. Greenlight Guru AI handles the repetitive work that slows teams down, and it was built with 15 years of medtech context behind it, not bolted on from a general-purpose model. AI-powered search finds answers across your QMS instantly. Chat analyzes system data to surface insights. Auto-generated summaries give immediate context on documents, suppliers, and quality events. For product teams, verifiability checks catch vague requirements before they become audit findings, suggested links close traceability gaps automatically, and AI brainstorming gets engineers moving faster. For quality teams, AI generates training quizzes and drafts change order summaries, so your team spends less time writing and more time on the work that actually requires their expertise. The platform is validated out of the box and aligned to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR Part 11. Implementation is measured in weeks, not the quarters-long projects that come with legacy enterprise platforms. Backed by 80+ audit-tested, customizable templates and a team of experts who know medtech inside and out. You're not managing a separate validation project before you can go live. For 15 years and across more than 1,000 device companies worldwide, Greenlight Guru has been the QMS medical device teams trust to pass audits, bring products to market, and stay on the market longer. **Average Rating:** 4.5/5.0 **Total Reviews:** 401 #### How Do G2 Users Rate Greenlight Guru Quality Management System? - **Has the product been a good partner in doing business?:** 9.3/10 (Category avg: 9.1/10) - **Design Controls:** 8.4/10 (Category avg: 8.5/10) - **Quality Processes:** 8.9/10 (Category avg: 9.0/10) - **Audit Management:** 8.3/10 (Category avg: 8.6/10) #### Who Is the Company Behind Greenlight Guru Quality Management System? - **Seller:** [Greenlight Guru](https://www.g2.com/sellers/greenlight-guru) - **Company Website:** www.greenlight.guru - **Year Founded:** 2013 - **HQ Location:** Indianapolis, IN - **Twitter:** @greenlightguru 10,590 Twitter followers - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=7df50f335a6d5a650bbc46a24d2ab5da06b02fc852b348529906f73428faacd5&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2F3837459%2F&secure%5Burl_type%5D=linkedin_company_website) 139 employees on LinkedIn® #### Who Uses This Product? - **Who Uses This:** Quality Manager, Quality Engineer - **Top Industries:** Medical Devices, Biotechnology - **Company Size:** 79% Small, 20% Medium #### What Do G2 Reviewers Say About Greenlight Guru Quality Management System? _AI-generated summary from verified user reviews_ ##### Pros - Users find Greenlight Guru's eQMS to be **intuitive and easy to use** , enhancing compliance and streamlining processes. - Users value the **user-friendly design and robust compliance features** of Greenlight Guru, enhancing their quality management processes. - Users praise the **effective training tools** of Greenlight Guru, facilitating quick onboarding and compliance with industry standards. - Users value the **streamlined audit management** features of Greenlight Guru, enhancing compliance and organization effectively. - Users value the **configurability** of Greenlight Guru, facilitating easy organization and efficient management of quality processes. ##### Cons - Users find the **pricing to be expensive** , which may not be competitive for many teams and adds frustration. - Users note the **feature limitations** of Greenlight Guru, particularly regarding flexibility and costly extra projects. - Users find the **current search function inefficient** , suggesting improvements like AI for better information retrieval. - Users find the **inflexibility of quality events** in Greenlight Guru challenges their workflow despite its adherence to CAPA requirements. - Users find the **analytics limited** , lacking depth despite offering some useful data insights in Greenlight Guru. #### What Are Recent G2 Reviews of Greenlight Guru Quality Management System? **["Greenlight Guru eQMS - year 5"](https://www.g2.com/survey_responses/greenlight-guru-quality-management-system-review-7404775)** **Rating:** 5.0/5.0 stars _— Verified User in Medical Devices_ [Read full review](https://www.g2.com/survey_responses/greenlight-guru-quality-management-system-review-7404775) **["Simple, Clean, and Efficient eQMS for ISO 13485 Compliance"](https://www.g2.com/survey_responses/greenlight-guru-quality-management-system-review-12670075)** **Rating:** 4.0/5.0 stars _— Holly Lawrence O._ [Read full review](https://www.g2.com/survey_responses/greenlight-guru-quality-management-system-review-12670075) #### What Are G2 Users Discussing About Greenlight Guru Quality Management System? - [What is the best quality management system?](https://www.g2.com/discussions/what-is-the-best-quality-management-system) - 1 comment - [What is quality management system software?](https://www.g2.com/discussions/what-is-quality-management-system-software) - 1 comment - [How much does greenlight guru cost?](https://www.g2.com/discussions/how-much-does-greenlight-guru-cost) - [What is Greenlight guru?](https://www.g2.com/discussions/what-is-greenlight-guru) - 2 comments ### [1factory](https://www.g2.com/products/1factory/reviews) 1factory's Quality Control and Quality Management software solutions digitize, simplify and automate all Quality Control and Quality Management activities, including, Document Control, Training Management, Quality Planning, Inspection, SPC, PPAP, Gage Calibration, NCR, CAPA and more. With 1factory, manufacturers speed-up QC tasks, improve factory yield, maintain compliance, and ace their audits. **Average Rating:** 5.0/5.0 **Total Reviews:** 20 #### How Do G2 Users Rate 1factory? - **Has the product been a good partner in doing business?:** 10.0/10 (Category avg: 9.1/10) - **Design Controls:** 1.7/10 (Category avg: 8.5/10) - **Quality Processes:** 10.0/10 (Category avg: 9.0/10) - **Audit Management:** 6.7/10 (Category avg: 8.6/10) #### Who Is the Company Behind 1factory? - **Seller:** [1factory](https://www.g2.com/sellers/1factory) - **Year Founded:** 2011 - **HQ Location:** Milpitas, CA - **Twitter:** @1FactoryInc 130 Twitter followers - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=2686c6e2a4a1d1b88eaa516cdf944a05d52d21f8503923e5f29bebb091cfdebf&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2F2287768%2F&secure%5Burl_type%5D=linkedin_company_website) 19 employees on LinkedIn® #### Who Uses This Product? - **Top Industries:** Machinery - **Company Size:** 65% Small, 30% Medium #### What Do G2 Reviewers Say About 1factory? _AI-generated summary from verified user reviews_ ##### Pros - Users find 1factory to be **easy to learn and navigate** , making quality control efficient and user-friendly. - Users appreciate the **efficiency and user-friendly features** of 1factory, enhancing quality control and inspection processes. - Users love the **intuitive UI** of 1factory, making implementation and navigation quick and easy. - Users commend the **top-notch customer support** of 1factory, ensuring quick assistance and seamless software usage. - Users appreciate the **easy learning curve** of 1factory, making it accessible and intuitive for everyone. ##### Cons - Users find the **confusing interface** of 1Factory challenging, especially when accessing advanced features and navigating menus. - Users find the **difficult usability** in deleting or modifying old prints cumbersome and inefficient in 1factory. - Users find that **modifying old prints** can be cumbersome, especially with attached inspection report histories. - Users find that **editing difficulties** arise when deleting or modifying old prints with inspection reports history. - Users find the **steep learning curve** of 1Factory challenging, especially for navigating advanced features and menus. #### What Are Recent G2 Reviews of 1factory? **["1Factory Streamlines Data Collection and Communication the setup and customer service were excellent"](https://www.g2.com/survey_responses/1factory-review-12756617)** **Rating:** 5.0/5.0 stars _— Connor M._ [Read full review](https://www.g2.com/survey_responses/1factory-review-12756617) **["1Factory is 1Fantastic!! - Easy to Implement, Fast-Responding UI with Outstanding Visuals"](https://www.g2.com/survey_responses/1factory-review-12846846)** **Rating:** 5.0/5.0 stars _— John M._ [Read full review](https://www.g2.com/survey_responses/1factory-review-12846846) #### What Are G2 Users Discussing About 1factory? - [What is 1factory used for?](https://www.g2.com/discussions/what-is-1factory-used-for) - 1 comment ### [Orcanos](https://www.g2.com/products/orcanos/reviews) Orcanos is a modern MedTech eQMS platform designed to help regulated teams accelerate compliance, stay audit-ready, and streamline quality processes — from design to post-market. Unlike traditional QMS solutions, Orcanos also includes integrated development lifecycle tools (ALM), enabling full traceability across requirements, risks, testing, and quality in one system — without coding. Key Capabilities Document Control & Training CAPA, NCR, Complaints & Audits Risk Management (ISO 14971) Design Control / DHF / DMR Requirements & Test Management End-to-End Traceability Electronic Signatures & Validation Support (FDA, ISO, EU MDR) Why Orcanos Built for regulated hardware, MedTech & pharma Codeless workflows & fast implementation Unified quality + product development data **Average Rating:** 4.3/5.0 **Total Reviews:** 124 #### How Do G2 Users Rate Orcanos? - **Has the product been a good partner in doing business?:** 9.1/10 (Category avg: 9.1/10) - **Design Controls:** 8.4/10 (Category avg: 8.5/10) - **Quality Processes:** 8.6/10 (Category avg: 9.0/10) - **Audit Management:** 8.0/10 (Category avg: 8.6/10) #### Who Is the Company Behind Orcanos? - **Seller:** [Orcanos](https://www.g2.com/sellers/orcanos) - **Year Founded:** 2015 - **HQ Location:** Givatyim - **Twitter:** @orcanos 63 Twitter followers - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=5f14d7c380d2bb8ec8c4a892b335a50b3c5fe8cfda125060970ec849404c2468&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Forcanos%2F&secure%5Burl_type%5D=linkedin_company_website) 38 employees on LinkedIn® #### Who Uses This Product? - **Top Industries:** Medical Devices, Hospital & Health Care - **Company Size:** 58% Small, 40% Medium #### What Do G2 Reviewers Say About Orcanos? _AI-generated summary from verified user reviews_ ##### Pros - Users commend Orcanos for their **exceptional customer support** , showcasing readiness to assist and resolve issues effectively. - Users commend the **ease of use** of Orcanos, highlighting its intuitive interface and excellent support for all skill levels. - Users value Orcanos for its **comprehensive tools** that enhance traceability and streamline product development processes effectively. - Users value the **high customization** options of Orcanos, allowing seamless adaptation to their unique processes and needs. - Users appreciate the **user-friendly document management** of Orcanos, benefiting from its intuitive and flexible interface. ##### Cons - Users find **feature limitations** in Orcanos, noting gaps in integrations, slow performance, and a lackluster export process. - Users note that **slow performance** with loading times and server responses hampers their overall Orcanos experience. - Users find the **learning curve steep** , complicating the use of Orcanos, especially during implementation and revision management. - Users find the **difficult usability** of Orcanos challenging, particularly with complex administration and limited user support. - Users find Orcanos to be **not intuitive** , struggling with its complex UI that obscures essential content and files. #### What Are Recent G2 Reviews of Orcanos? **["Highly Adjustable and User-Friendly Platform"](https://www.g2.com/survey_responses/orcanos-review-7052884)** **Rating:** 5.0/5.0 stars _— Shay N._ [Read full review](https://www.g2.com/survey_responses/orcanos-review-7052884) **["Highly Customizable Solution That Adapts to Your Workflow"](https://www.g2.com/survey_responses/orcanos-review-11906568)** **Rating:** 4.0/5.0 stars _— Verified User in Medical Devices_ [Read full review](https://www.g2.com/survey_responses/orcanos-review-11906568) #### What Are G2 Users Discussing About Orcanos? - [How has Orcanos supported your quality management and compliance needs, and what features do you rely on?](https://www.g2.com/discussions/how-has-orcanos-supported-your-quality-management-and-compliance-needs-and-what-features-do-you-rely-on) - [What is Orcanos used for?](https://www.g2.com/discussions/what-is-orcanos-used-for) ### [AmpleLogic Electronic Quality Management System (eQMS)](https://www.g2.com/products/amplelogic-electronic-quality-management-system-eqms/reviews) AmpleLogic’s eQMS software is specially crafted for highly regulated sectors such as Lifesciences, Medical Devices, Food & Beverages, Beauty and Cosmetics, Gene Therapy and so on. AL’s eQMS software renders 11 specific modules: CAPA, Change Control, Market Complaints, Deviations, Audits, Vendor Qualification, Out of Specification, Out of Trend, Lab Incident Reporting. All these modules are seamlessly integrated with one another. AmpleLogic also has other COTS products like Data Management System (DMS), Learning Management System (LMS), Regulatory Information Management System (RIMS), Electronic Batch Management System (eBMR), Environmental Monitoring Software (EMS), etc that are integrated with eQMS to offer best quality management! Benefits:  Perks of a Low-Code-No-Code QMS  Customized to your needs  Manual work reduced  Keeps track of quality concerns across departments  Centralized repository for quality records  Be assessment ready  Provides Quality Metric Analysis guided by KPIs  Pending Task Feature at each level  Customized dashboards  Realtime Insights  History report  483 issue compliance (USFD)  Alcoa+ Principles compliance  Cost Effective modifications and approvals **Average Rating:** 4.9/5.0 **Total Reviews:** 85 #### How Do G2 Users Rate AmpleLogic Electronic Quality Management System (eQMS)? - **Has the product been a good partner in doing business?:** 9.8/10 (Category avg: 9.1/10) - **Design Controls:** 9.4/10 (Category avg: 8.5/10) - **Quality Processes:** 9.6/10 (Category avg: 9.0/10) - **Audit Management:** 9.5/10 (Category avg: 8.6/10) #### Who Is the Company Behind AmpleLogic Electronic Quality Management System (eQMS)? - **Seller:** [AmpleLogic](https://www.g2.com/sellers/amplelogic) - **Year Founded:** 2010 - **HQ Location:** Hyderabad, Telangana - **Twitter:** @Ample\_Logic 636 Twitter followers - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=3246b9b1f3c515fa97614cffcb695872158b221aee65a7dac379dd9bd4e2b4be&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fample-logic%2F&secure%5Burl_type%5D=linkedin_company_website) 322 employees on LinkedIn® #### Who Uses This Product? - **Top Industries:** Pharmaceuticals, Manufacturing - **Company Size:** 92% Medium, 4% Large #### What Do G2 Reviewers Say About AmpleLogic Electronic Quality Management System (eQMS)? _AI-generated summary from verified user reviews_ ##### Pros - Users appreciate the **excellent customer support** from AmpleLogic eQMS, making setup and usage seamless and efficient. - Users value the **ease of use** of AmpleLogic eQMS, appreciating its user-friendly interface and efficient functionalities. - Users appreciate the **intuitive design and effective dashboards** of AmpleLogic eQMS, enhancing usability and efficiency. - Users appreciate the **implementation ease** of AmpleLogic eQMS, highlighting its user-friendly interface and helpful technical support. - Users commend the **efficient search functionality** of AmpleLogic eQMS, making access to records quick and effective. #### What Are Recent G2 Reviews of AmpleLogic Electronic Quality Management System (eQMS)? **["Highly Configurable eQMS That Aligns Perfectly With Our Quality Processes"](https://www.g2.com/survey_responses/amplelogic-electronic-quality-management-system-eqms-review-13028164)** **Rating:** 4.5/5.0 stars _— Lalit N._ [Read full review](https://www.g2.com/survey_responses/amplelogic-electronic-quality-management-system-eqms-review-13028164) **["QMS SYSTEM"](https://www.g2.com/survey_responses/amplelogic-electronic-quality-management-system-eqms-review-8994271)** **Rating:** 5.0/5.0 stars _— Avinash M._ [Read full review](https://www.g2.com/survey_responses/amplelogic-electronic-quality-management-system-eqms-review-8994271) ### [Kivo](https://www.g2.com/products/kivo/reviews) Kivo is building the infrastructure for GxP compliance in the era of AI-powered drug development. Its unified cloud platform supports Regulatory, Clinical, and Quality operations — including RIM, eTMF, QMS, controlled document management, submission assembly, eCTD lifecycle management, inspection readiness, SOP management, and training management — within a single, audit-ready environment. With Part 11-compliant e-signatures, role-based permissions, continuous validation assurance, and a lossless data model that preserves context from legacy systems, Kivo gives life sciences teams the compliant foundation to reduce operational friction and accelerate time to market. ▶ For Regulatory • Customizable, automatic authoring, review, QC, and approval workflows • Real-time collaboration online or locally in Office 365 • Smart document placeholders, with pre-formatted ICH templates available • Assemble submissions from pre-built submission structures aligned to country guidelines • Create automated tracking spreadsheets for external publishing groups ▶ For Quality • Controlled document and SOP management that meets GxP standards • Training management linked directly to documents in the DMS • Build curricula for teams or individual users with documents, videos, and quizzes • Auto-fill quality forms with metadata • Manage change controls, CAPAs, Deviations, Audits, and Vendors ▶ For Clinical • Workflows mapped to the TMF reference model • Accelerate active trial management, from study start up and beyond • Migrate TMFs into the system in weeks, including recompiled audit trails • Real-time reporting into TMF completeness • Long-term TMF storage at a fraction of the typical cost, with automatic checksums to ensure data integrity • Separate inspector access to help streamline your trial narrative **Average Rating:** 4.9/5.0 **Total Reviews:** 20 #### How Do G2 Users Rate Kivo? - **Has the product been a good partner in doing business?:** 10.0/10 (Category avg: 9.1/10) - **Quality Processes:** 10.0/10 (Category avg: 9.0/10) - **Audit Management:** 10.0/10 (Category avg: 8.6/10) #### Who Is the Company Behind Kivo? - **Seller:** [Kivo](https://www.g2.com/sellers/kivo) - **Company Website:** kivo.io - **Year Founded:** 2021 - **HQ Location:** Portland, US - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=77800174ab31242ee73d16023e24a33fc267a57870a2980ed57490a50393d799&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fkivoio&secure%5Burl_type%5D=linkedin_company_website) 43 employees on LinkedIn® #### Who Uses This Product? - **Top Industries:** Biotechnology, Pharmaceuticals - **Company Size:** 65% Small, 35% Medium #### What Do G2 Reviewers Say About Kivo? _AI-generated summary from verified user reviews_ ##### Pros - Users value the **ease of use** of Kivo, appreciating its intuitive design and minimal learning curve. - Users value the **implementation ease** of Kivo, appreciating fast setup and excellent customer support throughout the process. - Users praise Kivo's **intuitive interface and organization** , making navigation effortless even for first-time users. - Users commend Kivo for its **excellent customer support** , enhancing the overall experience and ensuring smooth implementation. - Users value the **customization options** in Kivo, enabling tailored functionality that meets diverse organizational needs effectively. ##### Cons - Users find the **feature limitations** of Kivo frustrating, needing workarounds for incomplete functionalities like electronic signatures. - Users find the **missing features** in Kivo frustrating, needing workarounds for tasks like electronic signatures. - Users find the **left-side navigation confusing** , which hinders their overall experience with Kivo. #### What Are Recent G2 Reviews of Kivo? **["Intuitive, Fast, and Highly Customizable DMS with Exceptional Support"](https://www.g2.com/survey_responses/kivo-review-12757149)** **Rating:** 4.5/5.0 stars _— Mike M._ [Read full review](https://www.g2.com/survey_responses/kivo-review-12757149) **["Intuitive Interface That Saves Time, Money, and Effort"](https://www.g2.com/survey_responses/kivo-review-12756771)** **Rating:** 4.5/5.0 stars _— Andy W._ [Read full review](https://www.g2.com/survey_responses/kivo-review-12756771) ### [qmsWrapper](https://www.g2.com/products/qmswrapper/reviews) VALIDATED Medical QMS System purpose built to facilitate compliance with standards ISO 13485, ISO 14971, 21 CFR part 11, ISO 9001 and regulations enacted by the FDA. Very complete including: Document-, Project-, Quality-, Risk-, Training-, CAPA-, Change-,Complaint-, Supplier-, Audit-, Nonconformity Module; Traceability Matrix for DHFs, inbuilt Team Messaging, Processes, Procedure Templates, Quality Manual, Forms, many more, Jira integration. Reliable+Secure+Flexible+Affordable even for startups. Our pricing is for annual subscription. Starter 10 Package starting from $500/month/10 users +1GB, providing access to ALL MODULES and services for ALL USERS from Day 1, as well as lifetime in-house support. We offer eight additional packages based on the number of users. qmsWraper cloud-based QMS using the latest technology and powerful feature set has transformed the quality management systems of 800+ Companies into a collaborative and paperless environment for continual improvement. Book Your Live Demo: contact@qmswrapper.com **Average Rating:** 4.5/5.0 **Total Reviews:** 59 #### How Do G2 Users Rate qmsWrapper? - **Has the product been a good partner in doing business?:** 9.2/10 (Category avg: 9.1/10) - **Design Controls:** 9.2/10 (Category avg: 8.5/10) - **Quality Processes:** 9.7/10 (Category avg: 9.0/10) - **Audit Management:** 8.4/10 (Category avg: 8.6/10) #### Who Is the Company Behind qmsWrapper? - **Seller:** [qmsWrapper](https://www.g2.com/sellers/qmswrapper) - **HQ Location:** Toronto, Ontario - **Twitter:** @qmsWrapper 687 Twitter followers - **LinkedIn® Page:** [www.linkedin.com](https://www.g2.com/external_clickthroughs/record?secure%5Bsource_type%5D=product_profile&secure%5Btoken%5D=5b463b9d1a9e66c41962599e6b9bb9ca8b3b00fa9216ae09760e6830bd08854c&secure%5Burl%5D=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fqmswrapper%2F&secure%5Burl_type%5D=linkedin_company_website) 14 employees on LinkedIn® #### Who Uses This Product? - **Top Industries:** Medical Devices, E-Learning - **Company Size:** 92% Small, 7% Medium #### What Do G2 Reviewers Say About qmsWrapper? _AI-generated summary from verified user reviews_ ##### Pros - Users find qmsWrapper to have **ease of use** , facilitated by helpful training and responsive support for quick implementation. - Users value the **event capture and reporting features** of qmsWrapper for their impressive flexibility and comprehensive functionality. - Users value the **responsive customer support** , highlighting quick answers and helpful assistance from the QMS Wrapper team. - Users value the **customization capabilities** of QMS Wrapper, allowing easy adaptation to evolving business needs and standards. - Users value the **flexibility** of qmsWrapper, allowing tailored workflows and seamless integration across various standards and environments. ##### Cons - Users note **feature limitations** like insufficient access control and time-consuming process creation hinder productivity. - Users struggle with **document retrieval** as tags are ineffective, making it difficult to locate needed files. - Users struggle with **inefficient searching** , making it difficult to locate documents despite the use of tags. - Users find **limited customization** options in qmsWrapper, which restricts their ability to tailor the system to specific needs. - Users express frustration with the **limited flexibility** in feature adjustments and access controls within qmsWrapper. #### What Are Recent G2 Reviews of qmsWrapper? **["A Modern QMS That Isn’t Afraid of AI"](https://www.g2.com/survey_responses/qmswrapper-review-12441494)** **Rating:** 4.0/5.0 stars _— Dusan P._ [Read full review](https://www.g2.com/survey_responses/qmswrapper-review-12441494) **["Better than the others we used so far"](https://www.g2.com/survey_responses/qmswrapper-review-8284790)** **Rating:** 5.0/5.0 stars _— Lise V._ [Read full review](https://www.g2.com/survey_responses/qmswrapper-review-8284790) #### What Are G2 Users Discussing About qmsWrapper? - [What is qmsWrapper used for?](https://www.g2.com/discussions/what-is-qmswrapper-used-for) - 1 comment - ‹ Prev‹ Prev - 1 - [2](/categories/medical-qms?open_modal_url=%2Fproducts%2Fmatrix-req%2Fwishlists%3Fhost_path%3D%252Fcategories%252Fmedical-qms%26source%3Dcategory&order=g2_score&page=2#product-list) - [3](/categories/medical-qms?open_modal_url=%2Fproducts%2Fmatrix-req%2Fwishlists%3Fhost_path%3D%252Fcategories%252Fmedical-qms%26source%3Dcategory&order=g2_score&page=3#product-list) - [4](/categories/medical-qms?open_modal_url=%2Fproducts%2Fmatrix-req%2Fwishlists%3Fhost_path%3D%252Fcategories%252Fmedical-qms%26source%3Dcategory&order=g2_score&page=4#product-list) - [5](/categories/medical-qms?open_modal_url=%2Fproducts%2Fmatrix-req%2Fwishlists%3Fhost_path%3D%252Fcategories%252Fmedical-qms%26source%3Dcategory&order=g2_score&page=5#product-list) - … - [8](/categories/medical-qms?open_modal_url=%2Fproducts%2Fmatrix-req%2Fwishlists%3Fhost_path%3D%252Fcategories%252Fmedical-qms%26source%3Dcategory&order=g2_score&page=8#product-list) - [9](/categories/medical-qms?open_modal_url=%2Fproducts%2Fmatrix-req%2Fwishlists%3Fhost_path%3D%252Fcategories%252Fmedical-qms%26source%3Dcategory&order=g2_score&page=9#product-list) - [Next ›Next ›](/categories/medical-qms?open_modal_url=%2Fproducts%2Fmatrix-req%2Fwishlists%3Fhost_path%3D%252Fcategories%252Fmedical-qms%26source%3Dcategory&order=g2_score&page=2#product-list) Spotlight Categories [User Research Tools](https://www.g2.com/categories/user-research) [Compensation Management Software](https://www.g2.com/categories/compensation-management) [Anti Money Laundering Software](https://www.g2.com/categories/anti-money-laundering) [CMMS Software](https://www.g2.com/categories/cmms) [Influencer Marketing Platforms](https://www.g2.com/categories/influencer-marketing-platforms) Similar Categories - [Clinical Research](/categories/clinical-research) - [Drug Discovery](/categories/drug-discovery) - [Other Life Sciences](/categories/other-life-sciences) - [Pharma and Biotech](/categories/pharma-and-biotech) - [Regulatory Information Management (RIM) Systems](/categories/regulatory-information-management-rim-systems) [Browse Medical QMS Themes](/categories/medical-qms/themes) ![Emma Stein](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Emma Stein") ES Researched and written by [Emma Stein](https://research.g2.com/insights/author/emma-stein) Updated October 3, 2024 For highly regulated industries like life sciences and pharma, industry-specific quality management systems (QMS) address the complex product development lifecycle of pharmaceutical, biotech, and medical devices products. Medical Quality Management Systems (QMS) are designed to facilitate compliance with regulations enacted by the FDA and standards like ISO 13485 (the International Organization for Standardization specific to medical devices). Additionally, with a medical QMS, life science businesses can eliminate paper-based quality processes, improve product quality and safety, reduce overall costs, increase operational efficiency, and unify and standardize processes, documentation, and communication. If you are looking for a quality system that facilitates the standardization and maintenance of standard operating procedures (SOP) or internal business processes, take a look at the [healthcare compliance software](https://www.g2.com/categories/healthcare-compliance). Additionally, some horizontal [quality management software](https://www.g2.com/categories/quality-management-qms) solutions can be, and are, used for less complicated quality processes for pharmaceutical, biotech, and medical device products. To qualify for inclusion in the Medical Quality Management Systems (QMS) category, a product must: - Provide product traceability functionality - Track and document every event and process that occurs during the product lifecycle - Monitor industry regulation and set up reminders or triggers for potential violations - Capture customer complains to assess and manage risk - Facilitate product testing and inspections - Provide support and workflows for corrective actions to tested products Top Tools at a Glance | | Regulated QMS document control with audit-ready traceability | User Review "Helpful QMS Platform for Daily Operations" | | | Paperless CQV execution with end-to-end traceability | User Review "Will transform your traditional validation program and processes" | | | GxP deviation, CAPA, and change-control tracking | User Review "Trackwise good for tracking all QMS record and user friendly.All QMS records available in excelsheet" | | | Regulated device change control with BOM traceability | User Review "Robust, Scalable Cloud PLM with Great Support and Onshape Integration" | | | ISO 13485 compliance with concurrent-user licensing | User Review "Excellent Training, Document Control, and CAPA Modules" | | | Pre-validated eQMS for life sciences compliance | User Review "Intuitive Interface and Outstanding Support Make SimplerQMS a Standout" | | | Configurable eQMS with cross-module CAPA traceability | User Review "Streamlined Quality Management in One Configurable Platform" | | | QR-based hospital complaint and CAPA workflows | User Review "A very effective porter management system that improved our hospital operations" | | | Regulated QMS document control and CAPA traceability | User Review "Perfect for life sciences companies!" | | | Medical device DHF traceability with built-in compliance | User Review "Greenlight Guru eQMS - year 5" | * * * Show More