Total Products under this Category: 123
Last updated: September 26, 2026
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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.
Highlighted products: Qualio, Kneat Gx, TrackWise, Grand Avenue Software, sterloCare, Greenlight Guru Quality Management System, QT9 QMS, and Arena PLM & QMS.
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=grand-avenue-software&focus%5B%5D=sterlo-sterlocare&focus%5B%5D=greenlight-guru-quality-management-system&focus%5B%5D=qt9-qms&focus%5B%5D=arena-plm-qms)
QM is an integrated, scalable enterprise quality management software (EQMS) that helps Life Sciences companies improve their operational efficiency and maintain compliance with GxPs by automating quality operations with respect to FDA 21 CFR Part 11 and Annex 11.
QP-Liver® is an advanced AI-powered software developed by Quibim, designed to enhance the diagnosis and management of diffuse liver diseases through precise MRI analysis. By automating liver segmentation and quantifying tissue fat and iron levels, QP-Liver® facilitates early disease detection, personalized treatment planning, and accurate monitoring, ultimately improving patient care outcomes.
Quality Connect is cloud-based quality management system (QMS) software designed for life sciences organizations to manage document control, training, quality events, CAPA, and change control. The system automates quality workflows while providing real-time visibility into compliance status. Core capabilities: - Document Control: Real-time collaborative authoring in Microsoft Word, configurable review and approval workflows, electronic signatures compliant with 21 CFR Part 11 and Annex 11, automatic versioning with PDF conversion, and document template center - Training Management: Role-based training matrix with automatic assignment, system-generated gap identification and remediation reports, online quizzes, centralized e-learning content, and training tracking for external employees - Quality Events & CAPA: Intelligent event capture with adaptive forms, automated investigation workflows, action tracking through closure, root cause analysis support, and real-time KPI dashboards - Change Control: Centralized change planning with structured workflows, automated routing and notifications, change rationale tracking with audit trails, and configurable reporting - Inspector Area: Dedicated space to copy quality records for regulator and auditor review Compliance: 21 CFR Part 11 and EudraLex Annex 11 compliant, ISO 9001:2015 aligned, hosted on Microsoft Azure with SOC 2 Type I certification, GDPR compliant. Problems solved: Small-to-mid-sized life sciences organizations transitioning from manual, paper-based, Excel, or SharePoint quality systems face audit readiness anxiety from lack of real-time compliance visibility, administrative overhead from chasing signatures and training acknowledgments, version control chaos with uncertainty about current SOP versions, training compliance gaps with inability to quickly identify overdue requirements, and manual CAPA tracking that creates compliance risk. Value delivered: - Audit readiness: System-generated reports provide instant compliance status without manual compilation - Operational efficiency: Automated workflows reduce administrative tasks, freeing QA teams for strategic work - Automated compliance: Role-based training matrices automatically assign requirements and identify gaps in real-time - Rapid implementation: 4-8 week implementation with included validation package - Scalability: Automated processes support growth without proportional QA team expansion - Cost-effective: Right-sized for growing companies without enterprise complexity Target users: QA/RA Directors, Quality Managers, Regulatory Affairs professionals, Clinical Operations Managers, and Compliance teams at biotech, pharma, and medical device companies preparing for FDA/EMA inspections or client audits.
Quality Control Tracking (QCT) software, by Zaavia, is designed for clinical laboratories to monitor and track quality control systems. It features seamless QC result transmission from multiple analysers, integrating Levey Jennings charts and Westgard rules to detect data trends and shifts. Why Choose this Quality Control Tracking System? -Multi-analyser integration, - Customizable setups, - Real-time dashboards, and - Instant notifications for rule violations, ensuring accuracy and informed decision-making in lab environments. How this QCT stand out from competitors? Customizable QC Setups: Tailor the system to meet specific lab requirements. Levey Jennings Charts & Westgard Rules: Ensures high accuracy in detecting trends and shifts. Automated Alerts: Immediate notifications for rule violations, helping to prevent errors. User-Friendly Dashboard: Offers quick insights for easy management and decision-making. So what are you waiting for, Book a free DEMO TODAY!
Quality Link provides organizations with a reliable, flexible, and cost-effective total quality management, compliance, and productivity solution.
SCIEX food testing solutions will help you meet maximum residue limits (MRLs) with high-quality data you know is right every time. Plus, your lab can experience greater market diversity. Whether you are a commercial lab or a food manufacturer, the quality of the food testing data you acquire is vital to your business
SOFTDMS is an enterprise DMS that helps to control & distribute the SOP's , STP's, BMRs, Protocols and other regulated documents for pharmacies.
A quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management. Of all QMS regimes, Pharma Soft Sol Quality Management System Software deals with quality and sustainability and their integration.
Spine BMS facilitates to manage all business disciplines including HR, Purchase, Inventory, Production Planning & Control, QA, Machine Management, Sales, Export- Import, Supply Chain, Sales Force Automation, Financials & Accounts.
traqx is AI-native GxP compliance software for regulated teams in pharma, biotech and medtech. It helps experts turn controlled source material into review-ready GxP work: research, new and updated documents, requirements, traceability and audit preparation. The AI works from a defined source space and prepares drafts or tracked changes. Each statement stays linked to its source context; open points and changes remain visible. Qualified experts review the evidence and decide what is adopted. The audit trail records what changed, who decided and on which basis. The traqx System provides the shared foundation for source-bound document work. Separately bookable GxP modules add process-specific methods, templates and review paths for computer system validation, SOP management, audit readiness, equipment qualification, process validation and cleanroom qualification. traqx is built in Germany by GxP and validation practitioners, hosted in the EU and does not use customer data to train the underlying language models.
"Tricentis Vera is a digital validation management platform designed for life sciences organizations that must demonstrate software compliance with regulatory standards including FDA 21 CFR Part 11. It is a type of Computer Systems Validation (CSV) solution that helps regulated organizations streamline approval workflows, manage electronic records, and embed compliance controls directly into modern software delivery practices. Vera modernizes traditional document-centric Computer Systems Validation by replacing paper-based processes and manual audit trails with automated, auditable digital workflows. It integrates with testing and quality management tools including Tricentis Tosca, Tricentis qTest, and Jira, enabling teams to generate compliant validation evidence as a byproduct of their existing testing activities rather than as a separate documentation effort. Key capabilities include: - 21 CFR Part 11 compliant electronic signatures and record management - Centralized review and approval portal across integrated testing and ALM tools - Pre and post-execution approval workflows for both manual and automated Tosca tests managed in qTest - Record locking during active approval workflows to prevent unauthorized changes - Full audit history and auditable electronic records for regulatory inspection readiness - Technical controls that reduce the risk of human error and compliance deviation - Integration with Agile and DevOps environments to support continuous compliance Vera is designed for quality and regulatory affairs teams at pharmaceutical, medical device, and biotechnology companies that are adopting Agile or DevOps delivery models and need to maintain compliance with FDA and other regulatory bodies. It enables these organizations to accelerate software delivery without compromising the rigor required for regulatory validation documentation."
Process Excellence. From Design to Verification. ValGenesis Process Lifecycle Suite combines iCMC and iCPV to unify the process lifecycle - powering smarter decisions, seamless tech transfer, and sustained product quality. iCMC: Design robustness, not rework, with ValGenesis iCMC™. Centralized QbD tools link QTPP targets to CQA/CPP analysis, FMEA and HAZOP risk scoring, and ML-powered trend analytics in one traceable hub. Harmonize processes across products, satisfy regulators with confidence, accelerate development, and get to market first. iCPV: Join the world of real-time monitoring with ValGenesis iCPV™. Multivariate analytics, SPC control charts, and guided workflows transform siloed data into early-warning insights, automating CPV reports across sites and batches. Detect drifts before they hurt quality, maintain continuous readiness, and future-proof production.
Average Rating: 4.5/5.0
Total Reviews: 1
"Highly Flexible Configuration that Opens Up Workflow Migration"
Rating: 4.5/5.0 stars
— Verified User in Pharmaceuticals
Vastian Rounding streamlines the identification and resolution of safety issues, ensuring your hospital operates at the highest safety and care standards. It’s time to empower staff to proactively address potential hazards and maintain an optimal care environment with real-time data, automated workflows, and comprehensive reporting. Vastian Rounding helps you meet these and related requirements: Joint Commission: EC.04.01.01, EC.02.01.01, LD.04.01.05, RC.01.01.01 DNV NIAHO: PE.1, EC.2 SR.1, QPS.8, CMS §482.41 Robust Features & Functionality: -Customizable options Customize checklists to address specific departmental needs or unique requirements, ensuring that all relevant factors are considered during the rounding. -Timely notifications Automate reminders and notifications to ensure that staff are aware of upcoming rounds and any outstanding tasks. -Comprehensive reporting Generate detailed rounding reports that provide insights into trends, patterns, and areas needing improvement. -Progress tracking Track the status of each rounding task, providing visibility into progress and highlighting any overdue actions. -Centralized information sharing Store all information related to rounds and share it to other Vastian apps for further remediation in one centralized, easily accessible platform. -Safety enhancement Emphasize the importance of patient safety and continuous improvement in a platform that enables a culture of ongoing vigilance.
QuickVault by Veeva is the leading device-to-market solution for small MedTech companies. Built for full device lifecycle support, the platform unifies design, regulatory, quality, and post-commercial operations in one scalable environment — helping teams stay agile, compliant, and ready to grow. From concept through commercialization and beyond, QuickVault by Veeva gives MedTech companies the visibility and control they need to deliver safe, effective products to patients and succeed at every stage.
Verifarma QMS is Verifarma’s Quality Management System, specifically designed for the pharmaceutical, veterinary, and life sciences industries. The solution centralizes, digitizes, and controls all key quality processes, ensuring compliance with local and international regulations while promoting continuous improvement. The platform enables integrated management of deviations, CAPAs, change controls, audits, documentation, training, and risk management, providing full traceability, version control, and audit-ready records. Verifarma QMS replaces manual and fragmented processes with a unified, validated environment aligned with regulatory best practices. Designed to scale alongside organizational growth, Verifarma QMS adapts to companies of different sizes and regulatory frameworks, helping quality teams reduce errors, improve operational efficiency, and ensure patient safety.
