Best Medical Quality Management Systems (QMS) - Page 6

First Ascent Biomedical

First Ascent Biomedical is a pioneering biotech company dedicated to transforming oncology through its innovative Drug Prediction Platform (DxPP). This first-of-its-kind system integrates functional drug testing, DNA/RNA sequencing, and AI-driven tumor analysis to develop personalized treatment plans for cancer patients. By rapidly growing therapy-resistant cells from patient samples and testing them against hundreds of FDA-approved drugs, DxPP identifies the most effective therapies tailored to each individual's tumor vulnerabilities. This approach delivers actionable treatment recommendations to physicians within an average of 10 days, offering new hope to patients who have exhausted standard therapies.

Fission, Inc

Fission DLM is an eQMS alternative that unites design controls, quality, and regulatory processes for medical device teams. It replaces static documents with connected, traceable data - so you can build faster, stay compliant, and move confidently from idea to market.

GoVal

GoVal – AI-Powered Paperless Validation Software for Pharma & Life Sciences GoVal is an advanced digital validation platform designed for pharmaceutical, biotech, and life sciences companies to streamline and automate their validation processes. By replacing traditional paper-based workflows, GoVal reduces manual effort by up to 50%, significantly improving productivity, accuracy, and compliance. Built to meet stringent regulatory requirements, GoVal ensures full compliance with FDA 21 CFR Part 11, EMA, EU Annex 11, and other global regulatory guidelines, providing a robust audit trail, e-signatures, and complete data integrity. Its AI-powered features simplify risk assessments, Requirement Traceability Matrices (RTM), Validation Summary Reports (VSR), and other compliance documents—all generated automatically from project data, reducing time and human errors. GoVal delivers high ROI by minimizing validation cycle times, reducing costly rework, and enabling teams to focus on innovation rather than paperwork. Whether for computer system validation (CSV), equipment qualification, or process validation, GoVal is the go-to solution for organizations seeking faster, smarter, and fully compliant validation processes. Key Highlights: * Up to 50% reduction in manual work and validation effort. * Automated reporting (RTM, VSR, and compliance docs). * AI-enabled risk assessment and document intelligence. * Seamless regulatory compliance (FDA, EMA, WHO). * Quick ROI with faster deployment and digitized workflows.

GxP-Desk

HQMS

Harringtons QMS Software & Enterprise Quality Management System Software (HQMS) is software for enterprise process improvement, compliance and EQMS Enterprise Quality Management Software System.

Average Rating: 5.0/5.0

Total Reviews: 1

iLAB Laboratory Execution System (LES)

The iLAB Laboratory Execution System (LES) provides QA/QC laboratories with a structured platform that eliminates paper while automating and controlling testing procedures.

IMSXpress ISO 9001

IMSXpress ISO 9001 is a document control and quality system management software.

Average Rating: 4.5/5.0

Total Reviews: 1

Indelio

InSilicoTrials

InSilicoTrials works with Pharma & Medical Devices companies to create a secure cloud-based computational hub in an easy & cheap way

InstantGMP MD

Cloud-based Electronic Device History Record software with integrated modules that manage documents, inventory, and quality assurance together with the device history records. The software will guide you through the workflows required for manufacturing medical device Class II and Class III products.

ISO 13485 Quality Management

juleb connect

Juleb Connect App for Pharmaceutical Warehouses Revolutionize Pharmaceutical Warehouse Management with Juleb Connect Juleb Connect is a powerful mobile application designed to transform warehouse operations in the pharmaceutical industry. Built with advanced machine learning and real-time capabilities, it empowers warehouse teams and sales reps with full control, accuracy, and speed — all from their mobile devices. 🔹 Package Aggregation with Lightning-Fast Scanning Leverage cutting-edge machine learning to perform fast, accurate package aggregation for seamless drug traceability and compliance. Flexible labeling options support regulatory needs while keeping workflows smooth and uninterrupted. 🔹 Efficient Inventory Operations Easily manage stock movements including receiving, transfers, and adjustments directly from the app. Stay compliant with drug tracking regulations while optimizing operational efficiency. 🔹 Streamlined Sales Order Creation Enable your sales team to create, review, and manage orders on the go. Gain full visibility on approvals, pricing, and stock availability. Juleb Connect automates pricing and simplifies the sales order workflow. 🔹 Seamless Payment Collection Collect customer payments directly through the app and automatically sync them with your accounting ledgers. Improve accuracy and streamline financial operations. Boost traceability, productivity, and compliance with Juleb Connect — the smart mobile app for pharmaceutical warehouses.

Karminn EzyPro

Karminn EzyPro is a QHSE-QMS Management System Software Solution

Kintavo

Kintavo is a cloud-based, AI-native electronic quality management system (eQMS) purpose-built for regulated healthcare and life sciences. It brings document control, CAPA, deviation management, training, audits, risk, equipment and calibration, supplier quality, and change control into one connected platform — engineered for 21 CFR Part 11, ISO 13485, AABB, GxP, and related frameworks from day one, not configured in after the fact. Seventeen modules share a single data model, AI engine, and immutable audit trail, so CAPAs, deviations, training, and documents stay linked instead of scattered across disconnected tools. Quality teams configure their own approval routing, escalation rules, and branching workflows through a visual builder — no IT tickets, no vendor change requests — while AI Smart Assist, the 360° Compliance Map, and Audit Intelligence surface compliance gaps before an inspector does. Kintavo serves blood banks, clinical and reference laboratories, medical device manufacturers, pharma and biotech, CDMOs, CROs, health systems, and cell and gene therapy programs — and is the only mid-market eQMS with a dedicated Cell Therapy Suite for CAR-T, TIL, and HSC programs. Implementation runs in weeks rather than months, with phased deployment, quality-team training, and IQ/OQ/PQ validation documentation included in every plan and pricing published up front. Quality teams of all types, from regional blood centers to NCI-designated cancer programs, run their compliance infrastructure on Kintavo.

KOSA AI