Alternatives to Matrix Quality
Compare Matrix Quality alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Matrix Quality in 2026. Compare features, ratings, user reviews, pricing, and more from Matrix Quality competitors and alternatives in order to make an informed decision for your business.
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1
Qualio
Qualio
Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health. With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems. What Qualio delivers: ✔️ Audit ready in weeks ✔️ Inspection ready anytime — no fire drills ✔️ Faster market entry ✔️ Lower total cost of compliance ✔️ Confident, risk-managed scaling -
2
Propel
Propel Software
Propel is a cloud-native platform that unifies PLM, QMS, and PIM in one connected system, giving manufacturers complete visibility and control across the entire product lifecycle. It provides a single source of truth for product data, streamlines change management, strengthens quality and compliance, and accelerates time-to-market by eliminating silos. With real-world AI use cases and enterprise-grade security, Propel helps organizations reduce errors and improve cross-functional alignment. Agentic AI accelerates change reviews, surfaces BOM and quality risks, enriches product information, and guides decisions—while role-based permissions and audit trails protect IP. From design through manufacturing and commercialization, Propel empowers companies to deliver innovative, high-quality products faster with greater confidence. Each module deploys independently with no required dependencies. -
3
Lockbox LIMS
Third Wave Analytics
A sample tracking, test result capture, and inventory management cloud LIMS for life science research, biotech/NGS, and industrial QC labs. Includes regulatory support for CLIA, HIPAA, Part 11, and ISO 17025. Nothing is more critical to a lab’s success than the quality, security, and traceability of samples. The Lockbox LIMS system provides robust sample management functionality to laboratory professionals, giving them full visibility on every aspect of a sample’s journey, from accessioning to long-term storage. LIMS analysis is about more than just tracking results- Lockbox’s multi-layered sample storage and location management functionality allows you to define your lab’s storage framework using a variety of location options: rooms, storage units, shelves, racks, boxes, and positions. -
4
Total Lean Management (TLM) Software
Lean & Mean Business Systems
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work OrdersStarting Price: $45/user/month -
5
Dot Compliance QMS
QMS for Life Sciences
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-ShopStarting Price: $10,000 / Annually -
6
SimplerQMS
SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.Starting Price: $13,750/year -
7
Matrix Req
Matrix Requirements
Matrix Req (formerly Matrix Requirements) is a collaborative, AI-powered software explicitly built to meet the rigorous needs of medical device development. It helps cross-functional teams design, build, and launch high-quality medical devices while maintaining complete, end-to-end traceability of requirements, risks, and tests. The platform automates the cumbersome audit preparation process by generating structured documentation and trace matrices directly from live data, reducing regulatory submission timelines from weeks to days. Trusted by over 500+ life sciences companies, Matrix Req ensures that compliance is built-by-design rather than treated as an afterthought.Starting Price: $500 per month -
8
Qualityze EQMS Suite
Qualityze
Qualityze is a leading provider of cloud-based Quality Management System (QMS) and Enterprise Quality Management Software (EQMS) solutions built natively on the Salesforce platform. Designed to streamline quality processes, ensure regulatory compliance, and drive operational excellence, Qualityze empowers organizations to manage CAPA, audits, document control, training, change management, risk management, and supplier quality within a unified, scalable ecosystem. Focused exclusively on quality and compliance, Qualityze delivers purpose-built QMS and EQMS solutions without distractions from unrelated custom development. Our platform enables organizations across life sciences, manufacturing, and other regulated industries to simplify compliance with global standards while improving visibility, traceability, and accountability. Qualityze fosters a true culture of quality by making enterprise quality management intuitive, user-friendly, and collaborative.Starting Price: $30/User/Month -
9
QT9 QMS
QT9 Software
Struggling with complex compliance requirements or disconnected quality systems? QT9 QMS eliminates these challenges with one integrated, fully validated platform that scales with your business. Designed for life sciences, aerospace, and manufacturing, QT9 offers cloud or secure on-premise deployment to meet your needs. Stay audit-ready automatically with built-in FDA, ISO, and EU MDR compliance while reducing manual work by up to 70%. With 28+ modules included—like document control, CAPA, training, and supplier management—QT9 deploys fast without costly customization. Backed by ISO 27001 certification, unlimited support, and 20+ years of proven success, QT9 helps 1,100+ organizations accelerate compliance, improve visibility, and simplify quality management. Start your free trial or book a personalized demo today.Starting Price: $10,000/year -
10
ARMATURE Fabric
ARMATURE
With ARMATURE Fabric™ you can manage your accreditation, certification, credentialing, audit, quality, and compliance activities within a single platform. Our software enables you to save time, operate more effectively and securely, and better serve your stakeholder communities. Whether you are managing institutional, programmatic, or specialized accreditation programs; certifying individuals, products, or organizations; conducting audits or assessments; or resolving non-conformances or other issues, ARMATURE Fabric can make it easier and more efficient for you and your stakeholders. Our secure, cloud-based software allows you to collect data in multiple ways (through online applications, audits, assessments, self-evaluations, inspections, forms, and surveys); manage your accreditation, certification, audit, and compliance workflows; capture and manage documents and artifacts, identify and remediate issues; generate reports; and spot new trends. -
11
Intellect
Intellect
Intellect QMS is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps. Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device. Intellect’s Environmental, health, safety and quality (EHSQ) software acts as a data management system for capturing, storing, and analyzing information related to occupational health and safety, waste management, and sustainability. It aims at reducing operational risk and improving health while attaining sustainability goals. -
12
Orcanos
Orcanos
Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation. -
13
ZenQMS
ZenQMS
ZenQMS is an AI-enabled electronic Quality Management System (eQMS) built for life sciences and GxP-regulated organizations, including biotech, pharma, CROs, and CMO/CDMO companies. The cloud-based, fully validated platform supports document control, training management, audits, supplier management, CAPA management, quality data intelligence, and compliance with FDA 21 CFR Part 11 and ISO standards. Unlike legacy systems, ZenQMS is designed for companies of all sizes to be easier to use, quicker to validate, and more effective at managing GxP activities. ZenQMS supports key quality processes, including: Document management/document control Training management and learning management CAPAs (Corrective and Preventive Actions) Deviations, nonconformances, complaints, issues, and other quality events Change controls Audit management Supplier and vendor management Electronic signatures with 21 CFR Part 11-compliance Risk management Quality metrics tracking and reporting -
14
ACE Essentials
PSC Software
Reduce risk with ACE Essentials, the pre-validated Electronic Quality Management System (EQMS) software created for all highly regulated industries. ACE Essentials comes equipped with 10 workflows built in and all the necessary Standard Operating Procedures and Policies, resulting in a fully compliant quality management system from the beginning. Understand the risks associated with your assets with ACE Essentials features including a full audit trail tracking every single action in the system. Pre-Configured Workflows. Pre-Configured Event Management (Due Dates, Scheduling and Reminders). Pre-Configured Permission-Based Security. Full Documentation Pre-Configured. 50+ Documents. Multiple Site Capability. Free Upgrades Throughout the Life of the Product. Pre-Configured Tasks List. No Validation Time. Pre-Configured In-System Notifications. Pre-Configured Email NotificationsStarting Price: $500 one-time payment -
15
Greenlight Guru
Greenlight Guru
Greenlight Guru’s Medical Device Success Platform is the only all-in-one solution that helps you get your products to market faster, with less risk, and advance your success in-market. The platform helps companies manufacture safer products and get to market faster, simplifies regulatory compliance, and provides a single source of truth by connecting the management of all product development, regulatory, and quality processes from documentation and design controls to submission and ongoing compliance. Device makers across the globe are replacing reactive quality management tools and shifting their focus and efforts to ensure successful product launches and in-market success of innovative, life-changing devices. -
16
QUMAS EQMS
Dassault Systemes
To bring new products to market as quickly as possible in compliance with global regulations, organizations need to standardize and automate their business processes that manage the collection, tracking and analysis of information and the resolution of related issues. QUMAS EQMS (formerly ProcessCompliance) is a cloud-based solution for Enterprise Quality and Process Management that delivers comprehensive integrated regulatory, quality and compliance management capabilities in a validated QMS environment. QUMAS’s data-centric approach allows you to flexibly manage quality content and to access and re-use all quality data, providing comprehensive visibility into Quality. QUMAS’s interactive quality dashboards provide QMS overview across business areas and quality initiatives. Reports are available for export, email and scheduling. QUMAS allows QMS departments to exchange information securely, efficiently and compliantly in the cloud. -
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AmpleLogic Quality Management
AmpleLogic
AmpleLogic's Quality Management Software (eQMS) is intricately crafted to meet the rigorous requirements of heavily regulated industries. The ISO 9001 certified cloud-based Quality Management System (QMS) is ideal for Lifesciences, Food & Beverages (F&B), Cosmetics, Medical Devices, Gene Therapy, and analogous sectors. As businesses acknowledge the challenges associated with manual quality checks—prone to both laborious efforts and errors—they are increasingly adopting QMS software solutions. These systems play a pivotal role in enhancing audit quality through process automation, efficient data management, and seamless API integration. -
18
Nova-QMS
Novatek International
Maintaining consistent product quality and quality processes can be challenging in today’s pharmaceutical manufacturing environments. Regulated industries such as the Pharmaceutical, Biotech and Life Sciences are required to maintain Good Manufacturing Practices (GMP) to meet regulatory requirements. Not only do you need to meet GMP requirements you must also be able to prove this. Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, integrated quality management processes, which follow industry best practices. -
19
ZipQuality
Consensia
ZipQuality is a software-enabled service that assists medical device companies in bringing new products to market. Our collaboration platform manages rapid design changes for agile teams while ensuring regulatory compliance. Pre-configured system(processes and tools); no need to alter your quality system. The integrated system easily handles rapid design iterations for product documentation. Experienced consultants guide your team at every step. Fully-featured, scalable software tools built on the proven, powerful ENOVIA platform. Our integrated system enables rapid design changes while keeping product documentation and data in sync and maintaining all the records in an audit-ready state. Product requirements, hardware requirements, software requirements. We understand complex, software-intensive medical devices. The ZipQuality system is based on a structured documentation framework that supports good systems engineering, efficient risk management, and clear traceability. -
20
ValGenesis
ValGenesis
ValGenesis's VLMS is chock-full of features and functions that are designed to significantly improve traditional validation processes. Our system provides a holistic view of the entire validation process, comprehensive validation lifecycle management functionality, and the ability to integrate with existing systems. With paperless validation software, workflows are automated, compliance requirements are instantiated in automated processes, and electronic signatures are performed via instantaneous routing along with automatic notifications. Metrics, dashboards, and reporting are immediately available. Requests during audits and inspections are fulfilled with minimal effort. Standards are implemented and consistency is therefore attained as it pertains to requirements management, testing methodology, and risk management. -
21
Arena PLM
Arena by PTC
Arena PLM is a cloud-native and helps high-tech, medical device, life science, and aerospace and defense companies design, produce, and deliver innovative products quickly. By unifying all product information in a single, secure source of truth, product teams can collaborate anytime, anywhere. Arena streamlines new product development (NPD) and new product introduction (NPI) processes while ensuring regulatory compliance for FDA, ISO, ITAR, EAR, and environmental compliance. -
22
Veeva Vault QualityDocs
Veeva Systems
Providing automated workflows and comprehensive audit trails, Vault QualityDocs reduces compliance risk and improves quality processes. It accelerates review and approval processes and facilitates the sharing of SOPs and other GxP documents among employees and partners. Automated workflows and visibility into the content status and processes enable effective SOP management, reducing compliance risk. Intuitive, easy-to-use user interface drives adoption and efficiency. Detailed audit trails, content organization, and powerful search facilitate better audits and inspections. Securely access and use documents from any major web browser, or if enabled, print, distribute, and track controlled PDF copies. Predefined document taxonomy, metadata, and pick lists for quality, manufacturing, and validation documents facilitate operational harmonization and allow organizations to quickly adopt best practices. -
23
Quality Connect
Montrium
Enterprise Quality Management Software in the cloud for the life sciences. In today’s complex operational environment, technology plays a vital role in ensuring that QA is made aware of the issues as they happen. Gaining insight into the performance of your quality management system and the current state of your operation helps you to be more proactive, which minimizes risk and eliminates costly delays. Montrium has designed its Enterprise Quality Management system (EQMS) to enable life science companies to tackle the quality challenges that they face in content management head-on. All of our SharePoint QMS modules can be used independently or together as a fully integrated quality management system. These modules are available as part of our Montrium Connect Platform and can be deployed on-premise or in the cloud. Perfect for pharmaceutical companies, contract manufacturing organizations, medical device companies. Built to achieve compliance with GMP and GCP requirements. -
24
BIOVIA
Dassault Systèmes
BIOVIA solutions create an unmatched scientific management environment that can help science-based organizations create and connect biological, chemical and material innovations to improve the way we live. The industry-leading BIOVIA portfolio is focused on integrating the diversity of science, experimental processes and information requirements end-to-end across research, development, QA/QC and manufacturing. Capabilities over the areas of Scientific Informatics, Molecular Modeling/Simulation, Data Science, Laboratory Informatics, Formulation Design, BioPharma Quality & Compliance and Manufacturing Analytics. BIOVIA is committed to enhancing and speeding innovation, increasing productivity, improving quality and compliance, reducing costs and accelerating product development for customers in multiple industries. Manage and connect scientific innovation processes and information across the product lifecycle. -
25
Scilife
Scilife
Revolutionize your Life Sciences processes. Drastically improve the control, efficiency, and quality of your processes and products. Ensure inspection readiness at all times through our fully compliant platform, pre-validated according to GAMP5. Maintain total control over processes and documents, customize workflows to perfection, and automate where possible. Enjoy uninterrupted workflows and full traceability through seamlessly connected and integrated modules. Our dedicated team is ready to answer your questions at any time. Only a first-class Scilife experience will do! Our Scilife platform streamlines automates and organizes every process in your industry space, whether you’re in Medical Devices, Pharma & Biotech, or ATMP. Click below to discover which Scilife modules support your unique industry lifecycle stages. Our software is equipped with all the advanced quality tools you would expect, and a bunch more that go above and beyond!Starting Price: $1000 -
26
SmartSolve eQMS
IQVIA
Eliminate manual, repetitive tasks so you can focus on delivering safer, more effective products – faster. IQVIA’s SmartSolve Postmarket Surveillance is your complete, SaaS approach for postmarket surveillance (PMS) and provides best practices for centrally managing all post market surveillance activities. Fusion is a SmartSolve and RIM Smart user event that provides an in-depth education into timely and relevant quality and regulatory topics with actionable insights and practical tools that can be applied within any Life Sciences organization. Fusion started as a live SmartSolve user conference and has evolved over the past couple of years to include virtual and live events for both SmartSolve and RIM Smart users. Simplify, automate and integrate your compliance response times, accuracy, predictive planning and efficiency with IQVIA SmartSolve™ Regulatory Connector. Connected Intelligence is our innovative, interconnected approach that helps to drive operational efficiencies.Starting Price: $542 one-time payment -
27
TraxQM
TraxQM
TraxQM is a risk-based Quality Management System (QMS) designed to help organizations manage regulatory compliance, streamline quality processes, and improve operational efficiency through a centralized, AI-enhanced platform. It enables companies to take a proactive approach to compliance by digitizing workflows and applying structured methodologies aligned with international standards such as ISO and GxP. It includes core modules for document management, risk analysis, CAPA (Corrective and Preventive Actions), change control, audits, and training, allowing teams to manage the full lifecycle of quality operations in one system. It supports data integrity through automated version control, audit trails, and compliant electronic signatures, ensuring traceability and adherence to regulatory requirements. TraxQM leverages AI to enhance decision-making by analyzing risks, suggesting targeted control measures, and recommending relevant KPIs based on organizational objectives.Starting Price: $403.97 per month -
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Kivo
Kivo
Kivo is a better way to work for sponsors and CROs, offering an affordable document and process management system that helps life sciences teams get work done in one intuitive, compliant workspace. It brings DMS, RIM, QMS, eTMF, and eCTD capabilities together so pharmaceutical, biotech, medical device, and biologics teams can manage regulated documents, quality activities, clinical trial files, regulatory submissions, and process workflows without disconnected tools. Kivo’s Document Management System provides one place for controlled documents, process automation, project management, corporate documents, and diligence readiness, with centralized storage, version control, collaboration, audit trails, search, workflow automation, and Part 11-compliant e-signatures. Its RIM system supports correspondence, project management, submission building, publishing handoff, eCTD viewing, dossier management, agency interactions, health authority commitments, etc.Starting Price: $1,800 per month -
29
DHC VISION
DHC Business Solutions
We offer solutions for companies with a high demand for quality. Our software solutions inspire with a modern UX, useful functionality, high modularity, and consistent compliance. Integrated solutions for quality management and quality assurance. Focused on the digitization of controlled documents and QA processes. Solutions specifically designed to meet the needs of the financial industry for the written rules of procedure, management of policies, and the control of information security. The cloud-based, pre-validated solution to automate your validation processes and to digitally control and manage validation documents. Early set-up of a digital QMS with a dedicated solution for startups and young companies. Based on DHC VISION. It can be used out of the box with immediate compliance and no license costs. Together, we digitize quality management and quality assurance processes and ensure regulatory compliance. -
30
Ennov Quality Suite
Ennov
Ennov Quality Suite. A comprehensive QMS to improve efficiency and ensure compliance. Ennov Quality Suite Ennov’s Quality suite combines the power and flexibility of Ennov Doc, Ennov QMS, Ennov Report and Ennov Training to create a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions is very easy to configure and requires no IT skills. An intuitive and unified content and information management platform to support and enrich the entire Life Sciences product life cycle. Our comprehensive QMS improves operational efficiency -
31
QAD EQMS
QAD
QAD EQMS, formerly CEBOS, is a fully integrated enterprise quality solution that provides timely visibility into manufacturing and quality related issues. It facilitates a preventative approach resulting in reduced cost of quality, improved manufacturing throughput, improved customer satisfaction and higher manufacturing margins. QAD EQMS addresses the breadth of the value chain of suppliers and internal manufacturing to optimize quality performance. -
32
Almond
Almond
Almond is a professional, cloud-based, quality management software for healthcare companies. The software enables computerized management of the quality processes in compliance with regulatory requirements. The system maintains a document audit trail, and full document indexing and ultimately achieves documented evidence of all QMS processes. Manage your suppliers seamlessly through the electronic organization of certificates and agreements; all information is concentrated in one place. Assign permission to your suppliers to perform training, required by your system at their premises, using your quality system. Receive automatic email notifications before supplier certification expires. An electronic control dashboard allows you to be updated at any time on the status of the project. Create as many logbooks as you need, with no budget considerations or storage restrictions. Automatic conversion to effective after training completion. -
33
QAPI360
QAPI360
QAPI360 is a cloud-based, HIPAA-compliant Quality Assurance Performance Improvement (QAPI) software that centralizes, organizes and tracks all elements of a healthcare provider’s quality program so agencies can move beyond spreadsheets and disconnected processes to a systematic, data-driven approach; it includes structured QAPI plans, quality indicators, patient and staff incident tracking, infection control surveillance, medication error and adverse drug reaction logs, hand hygiene programs, performance improvement project templates, patient satisfaction surveys, and contracted provider performance tracking, with interactive dashboards, trending and analysis that help users visualize patterns, implement corrective actions, and monitor outcomes; it supports easy data entry, EMR integration or automated imports, built-in reporting and charts for compliance documentation and audits, and tools to streamline data collection, charting, and root-cause analysis.Starting Price: $249.99 per month -
34
QualityKick
SoftDoit
QualityKick is a QMS compliance solution in the cloud for quality management of the biological sciences. It consists of different modules; each of them solves a specific part of the quality management processes: document control, training, change control, events, CAPA, risk assessment, qualification, and audits of suppliers and equipment. As it is a web-based application, it can be accessed from anywhere and from any device mobile. Works everywhere: computer, smartphone, and tablet. Guided tour which loads automatically when new users log in for the first time. Allows you to edit documents with MS Word and send them through a configurable review and approval process. Different types of events can be configured such as deviations, nonconformities, or complaints. It is possible to define CAPA plans, record the actions, and verify their effectiveness. Solutions for quality management in the pharmacy, biotechnology, and medicine sectors. -
35
Clinevo OneQMS
Clinevo
Clinevo OneQMS is a cloud-based quality management system that enables organizations to manage quality and compliance processes digitally. Clinevo OneQMS is an interactive platform to manage all quality and compliance processes of an organization. OneQMS enables organizations to manage documents, training, change, CAPA, and audits in one place. It can be accessed with basic internet/intranet using IE, Chrome, and Firefox browsers. Provides powerful and actionable dashboards and reports for real-time monitoring and tracking of quality and compliance. Business, quality, IT teams, and others can be trained on the Clinevo within a few hours. Clinevo OneQMS complies with all current and emerging regulations. It ships with an inbuilt training management system to efficiently manage the organization’s training processes. It is the best QMS software and comes with transparent optimized pricing. -
36
QM
SOLABS
Document control made simple, document lifecycles, create, review/approve, revise, and retire documents. All transactions are recorded with e-signatures and timestamps and stored in the Audit Trail. Audits from start to finish. From audit planning to audit preparation and all the way to audit closure, track and document your internal and external audits with the SOLABS QM10 Audit APP. Intuitive reporting because trending and tracking are so critical to any quality management system, the SOLABS QM Essentials package includes advanced reporting capabilities. The reports and dashboards are available in formats that are easy to use, customizable and share the most common formats, whether it be Excel, PowerPoint, PDF, etc. with anyone within your organization. Create, assign, schedule and monitor training in a few clicks. Leverage online assessments to validate your team’s learnings. The SOLABS QM Training section allows you to handle all aspects of training. -
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SoftExpert EQM
SoftExpert
SoftExpert EQM is the most comprehensive enterprise quality management software (EQMS). It helps companies to achieve and maintain ISO 9001 certification through automated, highly interactive quality processes tailored to an organization’s specific products, operations and business practices. As a modular and scalable solution platform, SoftExpert Quality Management Software seamlessly integrates all key quality initiatives, including process mapping, documented information (SOP – standard operating procedures, work instructions and records), non-conformance reports (NCR/NCMR), corrective/preventive actions (CAPA), quality indicators (KPIs). The solution also manages supplier relations, customer complaints, quality audits, competence and training, quality risks and controls, quality inspection and statistical process control, increasing QMS agility and robustness. -
38
AmpleLogic APQR
AmpleLogic
Introducing AmpleLogic AI-based APQR software, a revolutionary solution that helps you generate accurate Product Quality Review (PQR) reports and CPV reports for audits and regulatory submissions as per the current Good Manufacturing Practices (CGMP) regulations for drug products (21 CFR 211.180(e), 21 CFR 211.180(e)). With OCR data extraction and AI chatbot integration, AmpleLogic APQR solution streamlines document data extraction and quickens access to information, boosting audit readiness and operational efficiency. -
39
InstantGMP QMS
InstantGMP
Overall, a well-implemented QMS is essential for biotech companies to achieve regulatory compliance, maintain product quality and safety, manage risks effectively, drive operational efficiency, foster innovation, and build trust with customers. InstantGMP QMS is a complete, simple, and affordable quality management system software designed by quality and regulatory experts for biotech companies. It can also apply to small-to-midsize manufacturers in a variety of industries. This quality management software has guided workflows that reinforce adherence to government standards throughout the entire production process with a diverse array of innovative features and specialized modules. Helps maintain and improve the quality and safety of biotech products. Provides frameworks for identifying, assessing, and mitigating risks throughout the product lifecycle, reducing the likelihood of quality incidents and product recalls. -
40
Validfor
Validfor
Validfor is a secure, modular digital validation platform that centralizes the entire validation lifecycle on a single, paperless system. Designed specifically for regulated industries, Validfor enables efficient validation while ensuring full compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11. The platform supports electronic records and advanced electronic signatures with full audit trails, role-based workflows (Author, Reviewer, Approver), and complete CSV compliance. All documents and records are securely managed in a centralized repository, capturing every change with full traceability to protect data integrity and Quality Assurance. Validfor offers integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, enabling seamless impact assessments, CAPA tracking, Computer Software Assurance (CSA), and audit-ready lifecycle management. -
41
Quality Link
Quality Mapping Solutions
Inspired by people and technology, Quality Link 7 builds on our experience and proven platform for helping organizations automate processes, save money, and achieve regulatory compliance with an easy-to-use business operating solution. Quality Link delivers improved efficiency while eliminating manual paperwork with our document management. Every document you create will be stored and managed from within this module. You can print “uncontrolled” copies of your documentation from within this module, as well as perform many other document-related activities. With the enhanced organization, you’ll see clerical tasks by quality personnel reduced by up to 90 percent. Our software effortlessly converts existing documentation from your previous management system, and there’s no learning curve. But you won’t miss your favorite applications, as they can be easily integrated. With Quality Link, you can say good-bye to manual document maintenance, which requires constant monitoring. -
42
ins2outs
ins2outs
ins2outs is a cloud-based SaaS integrated compliance management platform that empowers organizations to define, operate, and maintain multiple management systems, such as quality, information security, privacy, environment, and AI, within a single unified environment by combining powerful software, pre-built “know-how” sets mapped to standards like ISO 13485/21 CFR 820, ISO 27001, ISO 27701, IEC 62304, and ISO 42001, and expert consulting services. It helps organizations build structured documentation, including policies, processes, procedures, instructions, and document templates, and manage workflows with automated role-based training, push notifications, compliance KPIs, configurable documentation logic, version control, and audit trails, all hosted securely in the cloud. Users can operate integrated systems that address multiple regulatory and standard requirements, manage electronic documentation collaboratively with traceability and export options.Starting Price: $25 per month -
43
Loftware Cloud Clinical Trials
Loftware
Loftware Cloud Clinical Trials is a comprehensive labeling and booklet management solution designed for the clinical trials industry. This platform helps streamline the creation, approval, and distribution of clinical trial labels, ensuring strict compliance with regulatory requirements such as FDA, EMA, and ICH. Loftware offers a centralized solution that manages labeling operations across global clinical trials, reducing errors, ensuring consistency, and improving overall efficiency. The software supports customizable templates, barcode generation, and integration with other systems to provide a seamless workflow throughout the clinical trial process. -
44
Close-Up CRM
Close-Up International
Close-Up International is a leading provider of market data and technology solutions tailored for the pharmaceutical and life sciences industry. With over 55 years of experience, Close-Up supports more than 650 clients across 50 countries by delivering high-quality, certified data and innovative analytic tools. Their solutions help companies assess market potential, target healthcare professionals, and optimize product launches. The platform integrates market, prescription, and sales data with CRM capabilities for a comprehensive view of market dynamics. Close-Up’s offerings are designed to improve decision-making and strengthen relationships between pharmaceutical companies and healthcare providers. They emphasize data security, holding ISO 9001 and 27001 certifications. -
45
RQM+
RQM+
RQM+ is a global medical technology service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for medical technology companies, from concept to commercialization to post-market. Our portfolio of services enables the delivery of end-to-end solutions across the complete medical device product lifecycle. RQM+’s quality assurance engineers review material lists, set up suppliers, and support the design change process. RQM+’s design quality engineers help support packaging, sterility, biocompatibility, and device testing that may be needed. RQM+’s regulatory affairs consultants provide guidance and help with submissions to the FDA, notified bodies, or other government agencies. We use our extensive experience with the latest reimbursement requirements and value-based compensation models. -
46
DELMIAworks
Dassault Systemes
Combine manufacturing, MES, supply chain, and ERP software to optimize your shop floor. Learn how DELMIAworks (formerly IQMS) can help increase visibility into every aspect of your manufacturing operation and solve your most trying production challenges. Prevent unnecessary downtime, while increasing manufacturing efficiency, quality, and profit margins. Improve decision making with real-time access to data across the entire supply chain. A single system for all ERP, manufacturing, MES, and supply chain requirements. Lower your overall cost of investment and maintenance by automating your business. Our easy-to-use solution can help you double plant output, eliminate human errors, and increase the efficiency of your production planning process. Manage, track and monitor the complete production process to eliminate unplanned downtime and increase throughput. OEE charts and graphs are dynamically updated with performance and quality data in real-time. -
47
LabWay-LIMS
Ambidata
With LabWay-LIMS dedicate yourself to what you know how to do best and manage your laboratory. Integrated digital solutions for the organization and management of laboratory information. With the main objective of promoting productivity increases and process quality improvement, and oriented to any reality, LabWay-LIMS allows to computation of all areas of the laboratory. LabWay-LIMS is a highly competitive LIMS and QMS solution for different areas of activity. Proactive communication system and control of records of pending activities and processes. Integrated document management, quick and easy to use, providing verification and evaluation of orders and purchases. Management of internal and external audits for continuous improvement. Efficient team management, offering both profitability and speed. We align quality with management strategy. Management of immediate actions and effective resource management. Speed in sending results and improvement in service quality. -
48
1factory Manufacturing Quality
1factory
1factory's Manufacturing Quality is a cloud-based and on-premises quality control software solution specifically created for manufacturing companies of all types and sizes. Powerful, reliable, and secure Manufacturing Quality by 1factory provides first article inspections, factory monitoring, quality control plans, in-process and final inspections, incoming inspections, inspection management, CAPAs, non-conformances, and more. Additional key features include running metrics calculations for Process Performance (Pp, Ppk), Process Capability (Cp, Cpk), variation / SPC control management, defect-risk monitoring, and more. -
49
DataMetrics
DATAMYTE
No matter what product you manufacture, DataMetrics can provide your operators, engineers, quality team, and managers with the detailed, real-time SPC data, analytics and reporting, they need to assess current processes and take a proactive approach to maintain or improve product quality, meet production goals, reduce costs arounds scrap and rework, comply with OEM or industry standards. A genius interface to your entire manufacturing floor to support universal data collection across manual, semi-automated, automated and portable data acquisition; giving you the ability to capture ALL of your quality data into one centralized repository or database and report on this data. Eliminate data silos while consolidating data from hundreds of gages, sensors, CMM, PLC; essentially any type of open interface. Compliant with OPC-UA, DataMetrics is a solution backed by stringent access control and advanced security. -
50
Ennov Doc
Ennov
Unified Access to All Documents - Consolidates documents & processes in a unified document repository that can be used for Quality, Regulatory, R&D and more. - Metadata-based document model to adapt to your company’s organizational needs. - Configurable without any IT skills. - Scalable & secure: manage large volumes of documents. Improved Productivity and Efficiency - Intuitive user interface - Efficient search capabilities - User-centric design and connectivity to Microsoft Office 365 and Google Drive - PDF viewer to allow instant access to documents without MS Office or Acrobat - Versioning - Complete document cycle management Supports wide EDM needs - Quality, regulatory, cR&D, legal, commercial - CFR21 part 11 compliant - Document archival included - Seamless integration with Ennov Process (BPMS) & Dossier (eCTD publishing) - Advanced live reporting and dashboarding - Configurable without IT skills (including dashboards) - Suitable for regulated industries
