Alternatives to SimplerQMS
Compare SimplerQMS alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to SimplerQMS in 2026. Compare features, ratings, user reviews, pricing, and more from SimplerQMS competitors and alternatives in order to make an informed decision for your business.
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Interfacing Integrated Management System (IMS)
Interfacing Technologies Corporation
Interfacing’s Integrated Management System (IMS) is an AI-powered platform that unifies BPM, QMS, Document Control, and GRC into one platform. Organizations use IMS to model and automate processes, control documents, manage risks, and maintain regulatory compliance with full traceability and audit readiness. Built for highly regulated sectors such as aerospace, life sciences, finance, and government, IMS provides real-time visibility, automated workflows, and AI-driven insights that improve quality and reduce operational risk. The platform is ISO 27001 certified and fully validated for 21 CFR Part 11, making it suitable for mission-critical environments requiring strong governance, security, and control. IMS also includes low-code automation, process mining, audit management, training tracking, CAPA workflows, and dashboards to help teams streamline operations and continuously improve. AI strengthens governance, improves accuracy, and reinforces regulatory control. -
2
Intelex
Intelex Technologies
Intelex is an integrated software solution for managing Environmental, Health, Safety and Quality (EHSQ) programs. Intelex’s scalable platform is designed to store, manage and analyze EHS and Quality data in one place. The solution works on any device to meet the realities of your workplace. With Intelex, your organization can: - Drive better results in your EHSQ program by monitoring workflows to achieve top performance and gain control. - Identify trends and tendencies by setting goals to gain greater insight into your EHSQ program to enhance judgement. - Reduce incidents and administrative work by easily monitoring, managing, optimizing and drawing insights from your safety data with our user-friendly safety software solution. - Streamline air, water and waste emissions management and reporting, and track and manage environmental outputs to achieve sustainability goals. - Drive continuous quality improvement activities across multiple departments, sites or locations. -
3
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 -
4
AlisQI
AlisQI
AlisQI is a modular, cloud-based Quality Management platform for process and batch manufacturers who want to reduce firefighting, improve predictability, and stay compliant by default. Unlike traditional EQMS platforms that were built around documents and later adapted for analytics, AlisQI was designed from the start as a data-first system. Quality, lab, and production data are structured and connected in one operational backbone. That foundation now enables practical AI capabilities inside daily workflows. Manufacturers can automatically extract data from diverse supplier COAs without predefined templates, generate structured digital forms from existing files or plain language, query their QMS conversationally, and detect recurring incident patterns across sites. Core modules include Document Control, Training, Deviations, CAPA, Audits, Risk Management, Supplier Quality, SPC, and EHS, supported by targeted out-of-the-box Solvers that address specific operational problems. -
5
isoTracker Quality Management
isoTracker Solutions Ltd
isoTracker Quality Management is a popular cloud-based quality management software (QMS) that is used by small to medium sized businesses on a worldwide basis. It helps to manage ISO 9001, ISO 13485, ISO 22000, ISO/IEC 17025, ISO 14001, ISO 45001, ISO/TS 16949, ISO 14971 systems...plus many other systems. It also conforms to the requirements of 21 CFR Part 11 and has been validated to it. It is a flexible and modular product with modules in document control, audit management, non-conformance management, customer complaints management, risk management, training management and CAPA management. It can be configured to meet an organization's specific needs and provides free training and free support. It has been independently judged to provide the best customer support in its category. -
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SBS Quality Management Software
Sunday Business Systems
The SBS Quality Management Software Suite (QMS Suite) is a group of 5 software modules that work together for efficient Quality compliance. The QMS Suite can be deployed on your local server or accessed from our cloud server. Each module is designed for ease-of-use to reduce training overhead and improve overall compliance. Password controlled access and privileges ensure you may control access to critical features for each user. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, etc.) - Audit management - EHS module SBS Ground Control - Employee training management (LMS) - Document control SBS Asset Tracking Database - Calibrated equipment - Preventive maintenance SBS Inspection Database - Data collection / SPC - Control Plans SBS Vendor Management - Approved vendor list / AVL - Supplier qualification plans Great product for efficient and affordable QMS Compliance -
7
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 -
8
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 -
9
TenForce
TenForce
Track, analyze and report on your EHSQ processes from a single platform. Automate workflows, centralize data and simplifiy collaboration across departments. TenForce offers various integrated modules to help streamline processes such as Audits, Incident Management, CAPA, Permit to Work, Management of Change, and Shift Management. It offers mobile capabilities, which allow field workers and inspectors to access the software on mobile devices. Its built-in data analytics and reporting functionality enables managers to gain insights into the processes and risks of their industrial plants or public infrastructure assets. This visibility helps them address environmental, health, safety, quality, and compliance issues. TenForce helps manufacturers optimize their established processes while minimizing incidents.Starting Price: $9000 per year -
10
Sunday Business Systems
Sunday Business Systems
Sunday Business Systems (SBS) offers comprehensive quality management software (QMS) and consulting services to improve compliance with quality management standards, including ISO 9001, AS9100, ISO 14001, ISO 45001, and ISO 13485. Our solutions, such as Corrective Action and Preventive Action (CAPA) management, document control, and employee training management, help businesses streamline operations while ensuring compliance with industry regulations. SBS provides software tools for a full rangce of systems including audit management, calibration control, Preventive maintenance, EHS tracking, vendor management and inspection data collection and statistical process control (SPC). SBS provides on-premise and cloud-based solutions and customized software tailored to the unique needs of small businesses, improving productivity and operational efficiency. SBS offers the best value in QMS software.Starting Price: $295 -
11
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 -
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Adaptive Compliance Engine (ACE)
PSC Software
ACE is a quality management software solution for companies of any size, in any stage, in any highly regulated industry. ACE is fully configurable allowing your company to adapt ACE to fit into your exact quality needs. Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform. Our one-stop software includes: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And so much more! ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions. -
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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 -
14
BPAQuality365
BPA Solutions
BPAQuality365 is a prebuilt QMS software to use in your secured Microsoft 365 cloud, leveraging tools used by collaborators daily, with no need to change user habits. It’s modern, compliant with any device, flexible to match your unique needs, and powered by innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, risk, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app is closely integrated to discussion flows in Teams and enable instant quality improvement. Go a step further and reach your Quality 4.0 objectives by combining powerful AI features, best-in-class workflow automation, business intelligence and mobile Power Apps to run on any device. Benefit from BPA’s Microsoft Preferred status to configure your QMS to your needs, transfer knowledge to your power users and get trained on M365 technologies. -
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ComplianceQuest
ComplianceQuest
Fastest growing Enterprise Quality, Health and Safety Management System (QHSE) natively built and run on the Salesforce platform. Unified QHSE solutions, which combine EQMS and EHS, help our customers of all sizes deliver quality products and services in the safest, most sustainable way by mitigating risk, problems, and inefficiencies while protecting customers, employees, suppliers and brand. Every organization – irrespective of its industry, geography or size – involves an interaction of activities and processes with the environment. These activities may have an adverse or favorable impact on the environment depending on the type of activity being carried out. Our Environment Management solution has been designed to minimize and mitigate these adverse impacts on environment, to such an extent that our already depleting biodiversity is protected, and nurture an ecosystem where all living organisms coexist sustainably.Starting Price: $30 per user per month -
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Artintech ERP
Artintech
Artintech ERP is a comprehensive enterprise resource planning solution designed to optimize and streamline your business operations across various departments. Tailored for small to medium-sized enterprises (SMEs), Artintech ERP offers robust functionality with a user-friendly interface, allowing businesses to seamlessly manage their resources, inventory, human capital, finances, and customer relations all in one integrated platform. Artintech ERP includes a wide range of modules designed to optimize business operations. Key modules include Procurement, Warehousing, CRM, Distribution, Quality Management (QMS), Workplace Safety, Document Control, Non-Conformance and Corrective and Preventive Actions (CAPA), Inspection, and Computerized Maintenance Management System (CMMS).Starting Price: $24.95/Module/Month -
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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. -
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Qualtrax
Qualtrax
Qualtrax is a complete quality and compliance software system used to manage and control documentation, automate key business processes with customizable workflows, streamline training management, manage internal and external audits and ensure critical industry regulations are addressed in real-time. Qualtrax is an invaluable resource in heavily-regulated industries, where complying with standards including ISO 17025, 17020, 13485, and 9001, TNI, GFSI, FDA, and FQS is required. -
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MasterControl
MasterControl
Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.Starting Price: $25,000 / 1st year -
20
QEdge
Sarjen Systems Pvt Ltd
Sarjen’s Quality Management Software brings meaningful digital transformation to how quality is managed across regulated manufacturing environments. More than just a system to store compliance records, it uses AI to turn quality data into actionable insights. AI analyzes trends, spots early signals of deviation, and predicts potential quality risks before they impact products or processes. Automated alerts and intelligent recommendations help teams act faster, reduce manual errors, and strengthen decision-making with context-aware guidance. With machine learning, the system continuously learns from data patterns and improves accuracy over time. By combining robust quality workflows with AI-driven intelligence, the solution enhances product consistency, accelerates investigation cycles, and ensures stronger compliance. It makes quality management smarter, more proactive, and easier for your teams to adopt and trust. -
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Stendard Solution
Stendard
We are a regulatory consultancy and technology company that helps businesses implement international standards, streamline business processes across the organization, and accelerate global growth. Our team of in-house ISO consultants can provide trusted guidance towards your management systems requirements. Given our international expertise, besides experience with companies handling hardware and software products in nature, our advisory services have proven successful for a wide variety of clients. From setting up your QMS with a complete set of documents to maintaining your QMS through proper document version control and automated workflow processes, you will find valuable features tailored to your organization, regardless of whether you are a start-up or an established organization.Starting Price: $250 per month -
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QualityPro by TecWork
TecWork Global Business Solutions Pvt. Ltd.
QualityPro by TecWork is a modern, 𝐞𝐧𝐭𝐞𝐫𝐩𝐫𝐢𝐬𝐞-𝐠𝐫𝐚𝐝𝐞 𝐰𝐞𝐛/𝐜𝐥𝐨𝐮𝐝-𝐛𝐚𝐬𝐞𝐝 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦 (𝐐𝐌𝐒) designed to help manufacturing , automotive, and regulated organizations strengthen compliance, reduce operational risk, and build a proactive quality culture. Unlike traditional systems that only store documentation, 𝐐𝐮𝐚𝐥𝐢𝐭𝐲𝐏𝐫𝐨 𝐐𝐌𝐒 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 connects quality processes into one intelligent platform—ensuring clarity, accountability, and audit readiness across the entire organization. QualityPro centralizes critical QMS workflows including: ▶ Non-Conformance & Deviation Management ▶ Corrective and Preventive Actions (CAPA) ▶ Complaint Handling & Customer Quality Events ▶ Audit Planning & Execution ▶ Calibration & Equipment Management ▶ Inspection & Quality Control ▶ Document Control ▶ Training Management & Competency Tracking ▶ Risk Management & Continuous Improvement ▶ Change ManagementStarting Price: Contact us for pricing -
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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. -
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qmsWrapper
qmsWrapper
qmsWrapper is an interconnected Quality Management Software for startups and small businesses. It helps all companies that want to increase productivity with ISO 9001:2015 and MedDev creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820. At qmsWrapper, we cater to each industry’s unique quality management needs with tailored features: Compliance Made Easy: Adhere to standards like ISO 13485 and ISO 9001 effortlessly, maintaining a robust QMS. Risk Management: Simplify risk assessment with ISO 14971-compliant tools, effectively mitigating risks. Document Control: Intuitively manage documents for enhanced traceability and version control. Cloud-Based Accessibility: Access your QMS anytime, anywhere. Electronic QMS: Embrace efficiency with digitized QMS for faster approvals and real-time updates. Audit Management: Prepare for audits confidently with scheduling, tracking, and reporting tools.Starting Price: $500/month/10 users -
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Sierra QMS
Sierra Labs
Workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820 once you're ready to start selling your device. Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports. As you scale and improve your workflows, policies and procedures, keep your team trained automatically. Automate validation testing on devices, apps, web, and custom off the shelf software for your enterprise. Reduce time and resources needed for lengthy testing, reporting, and approvals. Generate all your policies, procedures, and artifacts into traditional documents for audit review. -
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Grand Avenue Software
Grand Avenue Software
A web-based quality system software suite that helps medical device companies automate their processes and simplify regulatory compliance. Modules include: Audit Management, CAPA, Complaint Handling, Design Control, Document Control, Equipment Management, Nonconforming Materials Reporting, Supplier Management and Training Management. Designed from the beginning for ISO 13485 and 21 CFR Part 11 compliance. Audit results are recorded for each requirement in the audit. Requirements are marked as conforming, nonconforming, or not applicable. Each result may be detailed with one or more findings. Findings that may be recorded include observations, major nonconformances, and/or minor nonconformances. Findings may result in Corrective and Preventive Actions (CAPA) and/or may be documents with audit actions already completed. -
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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. -
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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. -
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CAQ.Net
CAQ AG Factory Systems
CAQ AG Factory Systems has established itself as one of the worldwide leading providers of quality management software. We have over 30 years of experience in the development and distribution of modular, multilingual, and industry-specific management solutions for small and medium-sized enterprises as well as multinational corporations. Our CAQ.Net software suite covers every aspect of computer aided quality assurance and was designed with the highest degrees of adaptability and customizability in mind. Just like a construction kit, our system allows you to pick the most suitable building blocks and thereby create the perfect solution to your individual quality management demands. Why CAQ.Net? Updates, Upgrades & Release Changes Support from QM & IT Professionals User Workshops Screencasts Conformity to Standards Information Security SaaS or On-Premises Floating Licenses Multitenancy Multilingual No-Code-Designer Validation Capability AI Assistants ... -
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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 -
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ZEBSOFT
Zebra Software
ZEBSOFT GRC & ISO management software platform is a holistic approach to managing Governance, Risk & Compliance. With an intuitive and easy to use web interface, ZEBSOFT makes to easy to manage ISO (9001, 14001, 22301, 27001, 45001) and many other standards. ZEBSOFT has powerful integrated modules for Risk, Quality, Environmental, InfoSec, Compliances, policies (templates included) & documents, equipment & asset management with maintenance/calibration/testing planning. Improve internal communication, assign ownership, plan and carry out audits. Book a demo today to see what ZEBSOFT can do! -
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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. -
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MyBlueLabel
MyBlueLabel
Now you have the option of your own Quality Management Expert in the shape of an online platform. Templates ready to be integrated in your company to enable smooth processes. We offer complete Quality Management Systems and online solutions for ISO 13485 Medical Devices and ISO 9001 General Quality Management.Starting Price: $235 per month -
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BlueKanGo
BlueKanGo
Digitize your processes. Security. Environment. Quality. Hygiene. Of Business. Centralize. Simplify. Automate. One tool to manage everything. For a sustainable performance of your organization. The performance and safety of an organization is based on automated processes. BlueKanGo is the digital EHSQ solution to manage them. Whether you are looking to address societal and environmental issues, minimize your risks, improve your operational excellence, rely on the solution approved by more than 3500 customers for more than 18 years. Digitize your Quality, EHS and more processes. Quality & audits management. Health and Safety of employees. Environment. CMMS & inspection. Certification, Standards. Corporate Social Responsibility (CSR). Regulatory Watch. Strategic Planning. 6 differences that are our key strength. With more than 18 years of existence, BlueKanGo is the SaaS platform that has no limits but your imagination. An innovative, scalable and all-inclusive solution -
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IMSXpress is a sophisticated document control, regulatory compliance, and quality system management platform used for operating ISO 13485 and FDA 21 CFR part 820 quality system that include document distribution, document control, CAPA, complaints, audits, training, MDR, supplier control, NC product, and more. Available as a local install or cloud data hosting, this cutting-edge software comes pre-loaded with template manuals and procedures, employee training booklets, and audit checklists.Starting Price: $1460.00/one-time
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Veeva Vault QMS
Veeva Industries
Ensure quality and GxP compliance with Vault QMS. With built-in best practices and automated workflows, Vault QMS brings all parties – pharma and biotech companies, contract manufacturers, and suppliers – into quality processes for better control and visibility. Easily bring departments, sites, suppliers, contract manufacturers, contract test labs, and other partners into continuous quality improvement processes. Increase operational efficiency with automated workflows and built-in best practices. Improve risk visibility across products and processes with a unified approach to risk management. Improve speed, efficiency, and GxP compliance with a unified suite of quality applications. Readily enable quality management processes with built-in best practices for deviation, internal and external audits, complaints, lab investigations, change control, CAPA, and quality risk management. -
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IQE is MediaLab’s non-conforming event management system that allows clinical laboratory teams to track, assess, and prevent non-conforming events (NCE). With the capability to import or create event forms and data logs, IQE enables laboratory teams to eliminate deficiencies, correct common NCEs, and, most importantly, focus on improving healthcare. With a MediaLab institutional subscription, administrators can easily document each phase of the event management lifecycle, from initial event description to risk analysis, investigation, and root cause analysis, corrective and preventive actions plans, and overall CAPA effectiveness evaluations. IQE supports: • Customizable, pre-built event forms and workflow • Monitoring and evaluating change control events, failed PT events, customer complaints / feedback, safety / injury events, supplier / vendor issues, and more • Tracking periodic data entries • Robust reporting and dashboards to identify common NCEs and CAPA effectiveness
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Cority
Cority
Proven solutions to operationalize your pandemic response plans, systematically monitor, and report on the health status of your employees and visitors, and assist your business’ return to productivity. Improve your safety culture by engaging employees, enhancing workflows, and increasing data visibility across all levels of your organization. Cority helps you break down departmental silos, improve reporting, and achieve operational excellence. Cority's unified compliance management solution is designed to help you take the guesswork out of compliance. myCority connects your frontline employees no matter where they are with the tools they need to mitigate risk and drive compliance. EHSQ experts design, implement and support the Cority solution. That’s why we are the leader in Occupational Health, Industrial Hygiene, and Employee Health solutions. Take your safety programs to the next level by proactively mitigating risks, managing compliance, and reducing incidents. -
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FORM OpX
FORM.com
Compliance software that drives operations. Improve safety and increase accuracy with the top mobile audit and inspection platform for teams trusted by Walmart, Wendy’s, and Fannie Mae. Upgrade your paper, Excel, and digital processes to the #1 field management platform for teams. FORM OpX combines advanced data collection and configurable workflows with powerful operational insights to boost compliance in real-time. Configure audits, inspections, and workflows to ensure teams consistently follow procedures and meet regulatory obligations. Capture data instantly with digital forms that guide teams to the right action. Configure automated alerts and escalations to trigger corrective action as soon as issues arise. Save time and money with customizable workflows that improve processes and increase compliance — everywhere. -
40
MetricStream
MetricStream
Reduce losses and risk events with forward-looking risk visibility. Enable a modern and integrated risk management approach with real-time aggregated risk intelligence and their impact on business objectives and investments. Protect brand reputation, lower the cost of compliance, and build regulators and board’s trust. Stay on top of evolving regulatory requirements, proactively manage compliance risks, policies, cases, and controls assessments. Drive risk-aware decisions and accelerate business performance by aligning audits to strategic imperatives, business objectives and risks. Provide timely insights on risks and strengthen collaboration across various functions. Reduce exposure to third-party risks, make superior sourcing decisions. Prevent third-party risk incidents with continuous third-party risk, compliance and performance monitoring. Simplify and streamline entire third-party risk management lifecycle. -
41
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 -
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Lyons QMS Audit Pro
Lyons Information Systems
QMS Audit Pro is an audit, issue capture and corrective action platform that's used over 15,000 times a month. QMS Audit Pro lets your team collect consistent data, standardize operations, send reports, identify failed areas and get problems resolved with this easy-to-use checklist audit platform. Best of all it's free. No contracts or commitment required. Cancel anytime. Create Audit Plans, conduct Audits, and monitor non-conformances within one tool and achieve End-to-End Traceability. Define company-wide audit and checklist templates which can be re-used when creating and performing audits. Create an audit report with pertinent audit information such as; audit summary, non-conformances, and audit participants. This report can be customized based on company's requirements. Take action quickly and confidently by linking data sources from different modules into powerful dashboards. -
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Audit Manager
Focus Informatica
Audit Manager is the software supporting quality management that allows digital management of audits, quality controls and tests in all their phases: planning and compilation through checklists, collection of evidence and field surveys, verification and management of the entire nonconformity flow, definition of corrective actions and data monitoring. Access the calendar and schedule the audits by associating the relevant information with each one (subject, checklist, lead auditor, co-auditor, participants, etc.). The staff involved, both internal and external, can receive an invitation via email and consult the prepared audit schedule directly from the app. Once the inspection is completed, generate the audit report in PDF or Excel and share it directly from mobile with the company management or managers. The archive of all minutes is always available and organized and you can add it to the document repositories used by the company. -
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IMSXpress ISO 9001
IMSXpress
IMSXpress ISO 9001 is a document control and quality system management software. The IMSXpress client application can be installed directly on user computers, or on a Windows server and then be distributed to users by remote desktop services as a remote application. The database is an MS SQL database. It can be installed on any MS SQL Server 2014 or higher and be accessed by the IMSXpress application over any type of network. You can set up your own remote access, use our cloud-based data hosting service, or get the online subscription package. Fully automated training system with self-training, integrated document training, job descriptions, and more. Use for document, engineering, and process changes. Make fillable PDF form templates, fill the forms with data, and create records. Use for scheduling and administrating maintenance, and for managing spare parts inventory. Manage complaints, non-conformities, risk management, audit findings, and more.Starting Price: $160 per month -
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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. -
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SolvoNext NCR CAPA
ORCA LEAN
SolvoNext – NCR CAPA is a manufacturing software designed to digitize non-conformance reporting (NCR) and corrective & preventive actions (CAPA), reducing the cost of poor quality. It streamlines documentation and collaboration for production, quality, and other teams with an easy-to-follow, four-step process that includes initiation, root cause analysis, financial tracking, and approval. The platform replaces manual, paper-driven processes with visual dashboards, automated charts, and real-time reports, eliminating human errors from spreadsheets. It also supports COPQ tracking, enabling factories to calculate and monitor the financial impact of quality issues and inefficiencies. Users benefit from built-in tools like 5 Whys and Fishbone analysis, role-based access, and automated notifications. With optional AI integration, SolvoNext provides advanced analytics, pattern recognition, and decision-making insights for smarter manufacturing operations. -
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Agatha
Agatha
Agatha offers a suite of cloud-based applications tailored to the life sciences industry, enabling centralized management of documents and processes across clinical operations, quality, regulatory, and training functions. It supports biotech, pharmaceutical, medical-device, and contract-research-organization workflows by offering modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, SOP creation and approval, Quality document management for CAPAs, deviations, and change controls, and regulatory document management. Agatha enables streamlined document creation, review, approval, storage, and sharing in one unified system, supports paperless transformation to reduce administrative burden and strengthen data security, and is built on a global-compliance architecture addressing standards like 21 CFR Part 11, GDPR, and EU Annex 11. -
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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. -
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QCBD
CAMA Software
Quality Collaboration By Design (QCBD) is a fully integrated quality management software solution designed specifically for manufacturing businesses. This affordable, Windows-based application reduces the cost of achieving and/or maintaining compliance with quality management standards such as ISO 13485, ISO 9001, TS 16949, AS9100, and SQF 2000 / ISO 22000. QCBD by CAMA Software offers a host of modules for training management, supplier management, process deviations, document control, equipment management, and more. -
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uniPoint Quality Management Software
uniPoint Software
uniPoint's Quality Management Software is a modular on-premise quality management software. Quality Management Software can integrate with other ERP systems with ease. Quality Management Software is suitable for manufacturers of any kind of product in any manufacturing mode. With Quality Management Software, users can manage processes such as document control, equipment management, non-conformances, corrective/prevantative actions, and more.Starting Price: $6000.00/one-time
