Alternatives to 8Dflow

Compare 8Dflow alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to 8Dflow in 2026. Compare features, ratings, user reviews, pricing, and more from 8Dflow competitors and alternatives in order to make an informed decision for your business.

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    Epicor Connected Process Control
    Epicor Connected Process Control (CPC) is a flexible no-code/low-code MES and manufacturing operations platform that helps manufacturers improve quality, consistency, and visibility across production and assembly operations. Create digital work instructions with multimedia content, guide operators through critical tasks, connect equipment and devices across the shop floor, and capture production and quality data without extensive programming. CPC provides product traceability with a complete historical record of each product's build and inspection history. Real-time insights into quality, performance, defects, rework, and production trends help teams identify issues faster, reduce waste, and support continuous improvement. Manufacturers use CPC to standardize production and assembly processes, improve operator consistency, and support assembly verification, error proofing, quality inspections, and production monitoring across the shop floor. Whether deployed in a single work cell, across multiple production lines, or enterprise-wide, CPC scales to support manufacturers of all sizes. Available on-premises or in the cloud, it adapts to your operational requirements and manufacturing processes.
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    SBS Quality Management Software

    SBS Quality Management Software

    Sunday Business Systems

    Affordable QMS Software for Small and Midsize Organizations The SBS QMS Suite is an integrated Quality Management System (QMS) software solution designed to help small and midsize manufacturers and other quality-driven organizations efficiently manage ISO 9001 and related quality requirements. Five specialized modules provide document control, employee training, CAPA and nonconformance management, audits, risk management, calibration, preventive maintenance, supplier management, inspection and SPC. SBS QMS Software is available as a cloud-based or locally installed solution and uses flexible concurrent-user licensing. Organizations may implement the complete QMS Suite or purchase individual modules to fit their quality system requirements and budget. Professional QMS capabilities without the enterprise price tag. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, etc.) - Audit management - Environmental Health and Safety (EHS) module SBS Ground Control - Employee training management (LMS) - Document control - Change 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 For a small or midsize manufacturer seeking ISO 9001 QMS functionality without enterprise-level cost and complexity, SBS QMS Suite is an option worth considering.
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    ARMATURE Fabric
    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.
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    Artintech ERP

    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).
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    Starting Price: $24.95/Module/Month
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    GainSeeker Suite

    GainSeeker Suite

    Hertzler Systems

    GainSeeker Suite is the enterprise real-time SPC software and manufacturing intelligence platform that compiles disparate manufacturing operations and quality data, and turns it into useful, actionable intelligence. Our clients are able to triage, prioritize, and address issues faster and more reliably. With automated drill down analytics, they are able to diagnose the root cause of problems faster, uncover hidden opportunities to increase revenue, grow margins, and improve asset performance. GainSeeker collects and connects data from a wide range of systems. It will connect to gages, PLC's and vision systems. Additionally, you can connect other enterprise systems like ERP and MES to connect all your manufacturing data.
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    Starting Price: $2195.00/one-time/user
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    MasterControl

    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
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    CAPA Manager

    CAPA Manager

    Adaptive Business Management Systems

    Automate the identification, containment, investigation, and resolution of problems within your organization and supply chain. Trusted by thousands of users globally, this is one of the best CAPA software applications available. CAPA Manager corrective action software automates the assignment, notification, investigation, reporting, and approval of corrective actions. It error-proofs the control of the entire CAPA process, from initiation to investigation and all the way through to closure. CAPA Manager meets the requirements of all important quality management standards: 21 CFR part 11, ISO 9001, AS9100, TS 16949, and more. It keeps records of root-cause and corrective action while providing pre-defined workflows and approval gates.
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    Starting Price: $12.49 per user/month
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    QFacts

    QFacts

    QFacts

    QFacts is a cloud-based Quality Management System for pharmacies, compounding facilities, and regulated industries. It covers the full quality lifecycle: controlled document management with version control and approval workflows, training and competency tracking with curriculum-based assignments, event and complaint handling, root cause investigations, CAPA management, and change control. All with complete audit trails. Built for GAMP 5 and European GMP/GDP compliance, QFacts enforces role-based access control across organisations, sites, and departments. Quality managers configure review workflows, track due dates, and monitor compliance through real-time dashboards. Every action is logged and traceable, giving inspectors and auditors a clear chain of accountability from document approval through training completion to corrective action closure.
    Starting Price: $17/month/user
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    80/20 Quality

    80/20 Quality

    CFA Solutions

    Monitoring Performance. Recording Results. Contact us to get access to a demo account, or to set up your organization. Download 80/20 Quality from the Apple App Store, Google Play, or use our web app. Customize the dropdown menus to meet your needs. Inspectors on the floor can document a non-conformance directly in the 80/20 Quality App with enough detail and pictures to illustrate the issue for the decision-makers in your business. Management receives an alert that an issue has been identified and can make a decision on what steps manufacturing should take to fix, scrap or return a non-conformance. The inspector is alerted through the app with explicit instructions on how to move forward. The inspector takes the approved action and documents its completion. All activities are logged for data capture and analytics to look for trends and find improvement opportunities.
    Starting Price: $900/year
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    uniPoint Quality Management 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
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    TRACKMEDIUM

    TRACKMEDIUM

    Trackmedium

    Cloud-based Quality Management System (QMS) software that is ideal for small to medium businesses (SMEs). TRACKMEDIUM is a monthly-based subscription service with modules including Audit Management, CAPA, Document Control, Management of Change, Nonconformance Management (NCM), and Training Management. TRACKMEDIUM enables companies to create better and safer products, improve efficiency, and achieve compliance with industry standards including ISO 9001, 14001 & OSHA while lowering costs and risks. TRACKMEDIUM's Audit Management software streamlines audit-related tasks which include creating standardized audit and checklist templates, generating an audit plan, conducting audits, identifying nonconformances and recommendations, tracking CAPAs through closure and reporting results.
    Starting Price: $299 per month
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    Grand Avenue Software

    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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    ZenQMS

    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
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    QualityPro by TecWork

    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 Management
    Starting Price: Contact us for pricing
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    Ideagen Qadex
    Food Safety Software enabling cost-effective transformation of food safety, NPD, customer complaints and supply chain transparency. Save time and complete consistent, auditable risk assessments of products & suppliers; our food safety software includes horizon scanning and VACCP/TACCP. Be audit-ready 24/7 and never receive an audit non-conformance, guaranteed. Transform specification management for raw materials, and finished products and answer product queries instantly. Automate supplier quality monitoring or internal non-conformance management with automated workflows to ensure prompt closure of non-conformances. Let our team manage the entire complaints process using market-leading software to save time, money and improve customer service. Deliver new product launches faster, better, together while ensuring that all safety, quality, legality and profitability requirements are met.
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    SoftExpert EQM

    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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    isoTracker Complaints Management

    isoTracker Complaints Management

    isoTracker Solutions Ltd

    The isoTracker Complaints Module is designed to help organizations capture, manage, and resolve customer complaints in a controlled, traceable, and compliant manner. It provides a centralized system for logging complaints from multiple sources, assigning responsibility, and tracking investigation and corrective actions through to closure. The module supports configurable workflows, automated notifications, and escalation rules to ensure timely handling and accountability. Users can categorize complaints, analyze root causes, link them to corrective and preventive actions, and generate trend reports for management review. Full audit trails, role-based access control, and document attachments help maintain regulatory compliance and transparency, making the module a powerful tool for continuous improvement and customer satisfaction management.
    Starting Price: $17 USD/month/user
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    E-Data Now!

    E-Data Now!

    E-Data Now!

    Drive exceptional quality and process performance with a platform that puts you in cruise control. Crush poor quality, safety concerns and redundant processes with the all-in-one E-Data Now!® Audit and Quality Inspection platform, that includes the tools you need to connect your team performance, simplify checklists, root cause non-conformance, improve processes and grow customer satisfaction. E-Data Now! is a leading manufacturing, construction and site safety/compliance no-code, cloud-based platform, that digitizes quality inspection and process audits, automates workflows and provides mobile data-driven insights. The obvious benefit – clearing out your paperwork, cleans up the clutter in your audit processes and identifies unknown audit redundancies. The simple answer – a custom form creation and mobile data collection platform with digital tools made for the trades: to train, record, capture, react, correct, schedule, comply and build better processes.
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    Fast Quality Software

    Fast Quality Software

    Fast Quality Software

    Fast Quality Software is a comprehensive quality management solution designed to streamline quality assurance processes across various industries. Fast Quality Software facilitates the management of quality-based processes such as non-conformance and corrective actions, improves data integrity and consistency, enforces controlled and repeatable processes, and provides audit information and reporting. It aids in measuring the cost of quality/non-conformance, communicating quality across the enterprise, capturing necessary quality data for compliance, identifying improvement opportunities, and managing changes. By implementing Fast TQM Software, organizations can improve product quality, lower production costs, enhance decision-making, maintain traceability and compliance, monitor supply chains, decrease human error, minimize waste, reduce inventory costs, and optimize manufacturing process efficiency.
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    QualSmart

    QualSmart

    QualSmart.ai

    QualSmart is a cloud-based Quality Management Software (QMS) that helps organizations digitize, standardize, and manage quality and compliance processes through configurable solutions tailored to their business needs. The platform offers dedicated products for document management, audit management, corrective and preventive actions (CAPA), supplier quality management, training management, laboratory information management (LIMS), environmental monitoring, regulatory management, specification management, digital records, recall management, and visitor management. Designed for organizations in Food & Beverage, FMCG, Manufacturing, Packaging, Chemicals, Cosmetics, Hospitality, and Retail, Qualsmart enables teams to replace manual quality activities with structured digital workflows, automated approvals, configurable forms, notifications, dashboards, and reporting. Organizations can improve process consistency, maintain accurate quality records.
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    Audit Manager

    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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    SHEQsys

    SHEQsys

    SHEQsys

    SHEQsys is an online web application, which allows users and managers to log, investigate, report, and determine trends of Safety, Health, Environment, Risk, and Quality related activities within their organisation. It does this through the use of smaller modules that all work individually, or together, in an easy-to-navigate web interface with in-built wizards to assist users in operating the system. SHEQsys is a framework that allows your organisation to work the way you want. The flexible utilities available enable you to switch features and modules on or off, and flavor nomenclature to your industry, which means this system can be scaled to always meet your needs. Capture only the information that is required, Relevant users and managers are automatically emailed notifications of new entries and actions for their attention, as well as scheduled overdue reports.
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    QM

    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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    1factory Manufacturing Quality
    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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    QSE SMART

    QSE SMART

    CY Innovations

    QSE SMART is a quality, safety, environmental and risk management software application developed especially for small to medium-size business organizations and projects of 5 to 500 users. QSE SMART provides a solid framework that complies with key requirements of ISO9001, 45001 and 14001, and simplifies the day-to-day running of your integrated QSE management system. QSE SMART makes ISO make sense in your business. Designed around a risk-based approach according to ISO 31000, QSE SMART helps you to capture and exploit the key information and metrics that support your business objectives in respect to quality, safety, environmental and business risk management including your objectives and targets, management reviews, risks and opportunities, non-conformances and improvements, audits and inspections, accidents, incidents and hazards, corrective actions, equipment calibration and control of documented information.
    Starting Price: $3742.28 one-time payment
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    EASE

    EASE

    Ease Inc.

    EASE is the innovative audit and insights platform used by leading manufacturers to conduct layered process audits, safety audits, 5S and more. EASE brings visibility and accountability to the plant floor through real-time actionable data and streamlines how manufacturers administer, conduct and respond to plant floor audits. Forget paper and pencils. The EASE mobile app guides your audits including responses to non-conformances and annotated photos that provide visual evidence. With Issue tracking, assign issues to appropriate parties and ensure they’re closed out. Interactive dashboards and customizable reports provide real-time audit results and insights by line, plant, region or business unit.
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    QEdge

    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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    Plex Quality Management System (QMS)
    Plex Quality Management System (QMS) helps process and discrete manufacturers meet strict industry and customer compliance with a closed-loop digital system of record. Ensure predictable, repeatable quality delivery through in-line quality, clear reporting, and simple audit tracking. Meet industry compliance and customer regulations with quality documentation available in real-time, digitally, across the enterprise. Drive new and repeat business growth with on-time delivery performance, improved supplier management, and increased customer satisfaction. Making quality management inherent to your workflows and processes reduces quality loss and risk of warranty issues or recalls, improving your brand reputation and customer relationships. With Plex quality requirements and documentation are available and shared in real-time across the enterprise. Plex helps you generate process control plans with detailed inspection instructions and digital checksheets.
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    Pyraman

    Pyraman

    Pyraman Management Solutions

    Pyraman is a business management system software platform designed to help organizations streamline quality, compliance, and EHS operations. The platform includes core modules for document management, record management, non-conformance management, audit management, complaint management, training management, objective management, and minutes of meeting management. Pyraman also offers add-on modules such as legal register, incident management, HIRA, aspect impact, and calibration management. The software helps businesses move away from paper-based processes by centralizing documents, records, workflows, and compliance activities in one digital system. Its real-time collaboration and document security features support better process control, accountability, and operational consistency. By combining QMS and EHS capabilities, Pyraman helps organizations save time, reduce costs, and improve compliance management.
    Starting Price: ₹60000
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    PaKalite

    PaKalite

    PaKalite

    PaKalite is a quality management system for small and mid-sized automotive and industrial manufacturers, built on IATF 16949, ISO 9001/14001/45001, AIAG (PPAP, APQP, MSA, SPC) and VDA 6.3. 17 integrated modules: PPAP (18 elements, PSW, MSA/GRR), APQP (5 phases), audits (14 types, question bank, scoring, findings to CAPA), KPI scorecards (targets, deviation alerts, supplier rating), inspection & control plans (12 types, SPC Cp/Cpk, quarantine, EN 10204 certs), calibration, drawing revision control, nonconformity (NCR/8D), continuous improvement (Kaizen, 5S), supplier quality, management review, meetings, HR competence and training, TPM maintenance, OHS, and document management. Modules feed each other: an audit finding opens a corrective action; a chronic KPI deviation triggers one automatically. Cloud data with a Windows desktop client and an Android shop-floor app. PDF reporting, Excel import, role-based permissions, per-company data isolation. Free plan. Turkish interface.
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    IMS Compliance Manager

    IMS Compliance Manager

    Innovative Management Systems

    Compliance Manager is a Software As A Service application that allows you to manage: Documents - Add, update, archive and manage your Policies, Procedures, Forms and Templates. Projects - Manage your projects and documentation allowing team members to share project information. Tasks - Manage tasks, audits, nonconformances, corrective & preventive actions, complaints and incidents. Alerts - Manage e-mail alerts to improve timely close out of corrective & preventive actions. Incidents - Manage incidents, investigations, resolutions and root cause analysis. Training - Manage employee records, training logs and appraisals. Suppliers - Manage supplier records and performance evaluations. Reports - Produce reports on Audit Results, Root Cause Analysis, Training, and Supplier Performance. Manage e-mail alerts to improve the timely close-out of corrective actions. Manage supplier records and performance evaluations.
    Starting Price: $50 per month
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    SolvoNext NCR CAPA
    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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    Nova-QMS

    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.
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    RealityCharting

    RealityCharting

    RealityCharting

    Apollo Root Cause Analysis™ is a principle-based problem solving method designed to help you master problem-solving strategies. Combined with RC Pro® software, you can easily construct an evidence-based understanding of any problem. An evidence-based understanding of causes and effects leads to effective solutions that are accepted by your entire organization. The Apollo Root Cause AnalysisTM methodology facilitates the creation of a common reality using input from all stakeholders to produce an evidence-based understanding of the problem. This ensures your solutions address proven causes to prevent a recurrence. It makes problem-solving easy and gives those who have been trained, the skills to solve real-world problems more efficiently and effectively. RC Pro is a complete and adaptable root cause analysis software solution that can be fit to companies of any size and across any industry. RC Pro allows your organization to integrate its problem-solving capabilities.
    Starting Price: $295.00/one-time/user
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    Veeva Vault QMS

    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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    Qualiex

    Qualiex

    ForLogic

    Quality Management Software. Overcome the challenges of Quality in your company with the software rated as the easiest to use. More than 45,000 professionals are already simplifying their management systems. Ask questions about Qualiex via Online Chat. In addition to email and phone, you can chat in real time with ISO 9001 Lead Auditors during our office hours, taking questions quickly and conveniently. Non-Compliance Management. No more feeling lost in the non-conformity process. Forlogic Tracker will eliminate spreadsheets, automate the charges made by email, centralize your information and evolve your NC management. Be more efficient in dealing with non-conformities by managing the main causes. Looking back, we can see that Quality has undergone several transformations. We have already lived through the era of Inspection, the era of Statistical Control and then Total Quality Management.
    Starting Price: $1500 per month
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    BuildSafe

    BuildSafe

    BuildSafe

    More efficient construction projects by increased risk reporting, automated administration and reduced lead times for resolving issues. GDPR-compliant and digital inductions involve all workers and reduce the administrative burden for site management. Provides all workers with the possibility to report observations, near-misses and accidents and thereby also the opportunity to contribute to safety and efficiency on site. Build your own checklists and forms and use them for safety inspections, quality controls, LEED/BREEAM inspections, daily logbooks, toolbox talks and more. Full control over all ongoing actions with bespoke task lists updated in real-time. Automatic reminders and documented actions lays the foundation for individual responsibility. Investigation of incidents and accidents to identify and identify root causes and hazards. Possibility to adapt to different investigation formats such as 5 WHY and MTO.
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    WinSPC

    WinSPC

    Advantive

    WinSPC is a real-time statistical process control application that helps manufacturers create the highest quality product for the lowest possible cost -- collecting and analyzing real-time shop-floor data from virtually any source. Dashboards combine real-time statistics, charts, and events into grids to summarize current plant or line performance. WinSPC empowers monitoring. Detect process change and deliver actionable intelligence. WinSPC real-time control charts on the shop floor, enable anyone to immediately detect and process issues. Close the quality loop from "detection-to-correction" with built-in triggers that alert, or take action for you, when violations occur. Experiment, visualize and reveal more about any variable or relationship using the one-click variable analyzer. Quickly create, publish, and share quality reports throughout your organization using a graphical report builder with dozens of standard report templates.
    Starting Price: $1600.00/one-time
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    Quality Inspector

    Quality Inspector

    Insight Works

    Quality Inspector by Insight Works is a comprehensive quality control app. It empowers companies to enhance product quality, reduce costs, and maintain compliance. It integrates seamlessly with Microsoft Dynamics 365 Business Central with customizable entry forms and various inspection types. Quality Inspector simplifies data collection and automates processes. It offers real-time visibility into quality issues. Benefits * Streamlined Inspection Processes * Enhanced Quality Control * Improved Data Management * Increased Compliance and Process Control * Better Decision Making and Reporting Features * Inspection Execution: Benefit from a mobile-friendly user interface, automated test creation, and support for various test result types. * Data Management & Integration: Centralize inspection data, store detailed test information, and add supporting documents. * Process Control & Compliance: Utilize retest features, and enforce inspections before specific activities.
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    EPIQ QMS by Caliber

    EPIQ QMS by Caliber

    Caliber Technologies

    Caliber’s Integrated Quality Management platform – EPIQ stands out from the crowd of generic quality offerings in the market. Caliber offers unmatched, in-depth integrations and functionalities across departments making it far more capable of providing a seamless quality management experience like no other. In addition, this platform offers capabilities that go beyond regular quality management requirements and provides a foundation for quality metrics, performance analytics, CPV, and PQR. Many companies are heavily investing into automation currently. Yet, there still are inadequacies in terms of information sharing across departments. Quality Assurance departments are mandated to see the effect of a deviation across the other departments. Many planned and unplanned changes have to go through more than one department for analysis and closure. As part of risk mitigation, interdepartmental transactions gather high importance.
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    Sierra QMS

    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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    SMP 365

    SMP 365

    SMP 365 SAAS

    SMP 365 AI-Assisted ICAM is a Microsoft 365 and SharePoint-native incident management and investigation solution designed to help organisations capture incidents, conduct structured investigations, identify contributing factors and root causes, implement corrective actions, and generate professional investigation reports. Key Features: • Incident notification and management • AI-assisted ICAM investigations • 5 Whys analysis • PEEPO analysis • Evidence and image management • Witness statements and interviews • Corrective action management • Executive investigation reports • Approval workflows • Automated email notifications and alerts • Real-time dashboards and analytics • Microsoft 365 and SharePoint integration • Mobile-friendly access • Light mode & dark mode user interface options Benefits: • Reduce investigation administration time • Standardise investigation processes • Improve incident reporting quality • Support compliance and governance requirements
    Starting Price: $999 per user per year
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    MediaLab Intelligent Quality Engine (IQE)
    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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    Paradigm 3

    Paradigm 3

    Interax Group

    Paradigm 3 is a web and desktop-based platform designed to aid businesses in compliance management in regards to Document Control, CAPA Compliance, and Competency Tracking and Training. The software offers tools such as an event manager for incident investigations and customer complaints, tasks delivered by e-mail, audit preparations, among others. Some of the industries that benefit from Paradigm 3 are Healthcare, Manufacturing, Test Labs, and Service Industries. With Paradigm 3 it is no longer necessary to buy endless add on modules to manage all your compliance needs. Our system is made up of 4 modules with over 50 standard forms to meet all of your requirements for Quality, Safety and Environmental and by utilizing our form designer you can create new forms or redesign the ones supplied to ensure they exactly meet your needs.
    Starting Price: $1000.00/one-time
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    BabtecQ

    BabtecQ

    Babtec Informationssysteme

    Quality management software. We manufacture and offer QM solutions for all quality tasks – as we have done for 25 years. As quality specialists, we have developed an all-round solution for quality management with our modular software BabtecQ. In addition, we offer Babtec Qube, a cloud-based platform with which you can interconnect with your suppliers and customers to edit your quality tasks. Our products allow you to depict the whole range of quality processes, both internal and across companies – for quality you will love to share. Would you like to refresh your knowledge about quality management? Then you have come to the right place! On our knowledge pages you can find out, for example, what complaint management or 8D report are all about. The System FMEA (also termed a system analysis) is a subsection of the FMEA (Failure Mode and Effects Analysis). It is intended to investigate an entire system and check whether all of the individual components within it work together correctly.
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    FlightAtom AURORA Ai

    FlightAtom AURORA Ai

    FlightAtom LLC

    AURORA Ai is FlightAtom's standalone aviation safety management system (SMS) and quality management system (QMS) software. Safety and quality teams use it for occurrence reporting, hazard and risk assessment with barriers, audits with clause-linked findings, corrective actions with effectiveness checks, regulatory change and management of change, controlled documents, training and currency records, and emergency response plans. Cited AI assistance supports classification, search, summaries, and drafting under tenant AI policies, while approvals and closure stay with accountable people. Regulator dossiers come with a verification manifest tied to the governed records. AURORA Ai does not certify compliance; the operator remains responsible for its approved procedures.
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    QIS

    QIS

    QiSOFT

    QIS is now used by hundreds of customers worldwide to improve product consistency, reduce quality losses, optimize process efficiency, and provide critical information to deliver improved performance across manufacturing operations. QIS facilitates the collection, analysis and presentation of shop-floor data, giving complete visibility of real-time, actionable intelligence throughout the manufacturing process. It provides users with the insight to support immediate in-line decisions, and the analytical tools required to drive longer-term strategic goals. Providing enhanced visibility, access to and traceability of real-time quality data, QiS enables operators and quality teams to take pre-emptive and proactive action, mitigating the risk of product failure and reducing the overall cost of quality. Supporting both manual and automatic data collection, QIS makes it easy for operators to record and review both in-line quality checks and Laboratory test results.
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    Rave Collaborate

    Rave Collaborate

    Rave Mobile Safety

    Rave Collaborate provides tactical incident collaboration for both planned and unplanned events. Designed for the early minutes of response, this user-friendly tool reinforces policies and procedures while providing critical information in real time. View and interact with critical tasks within an intuitive online dashboard to assign clear ownership of roles, provide real-time updates, and react instantly during an active event. Make sure you are always prepared with prebuilt templates for all types of scenarios alongside reference documents added before, collected during, or shared after an event. Speed response and ensure compliance with a detailed timeline recording all necessary actions taken during routine situations or unexpected emergencies. Initiate communication during major events, from severe weather to facility closures, power outages and road closures to operational issues that impact your supply chain, infrastructure and IT.
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    QAD EQMS
    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.
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    Harrington Quality Management Software (HQMS)
    HQMS' applications include Document Control, Audits, Corrective Action, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management and the HQMS Supplier Portal. In business since 1991 – trustworthy source with SME Experts in Sales and Support will help with Business Case, Flexibility (on-premise or hosted, CapEx and Opex pricing models) with Support and Training & deployment planning that provides rapid learning curve with implementation guides. Secure deployment – including Single Sign On (SSO). Configuration and personalization features with customization if needed. HQMS is used cross several markets, including manufacturing (Aerospace and Defense, Automotive, Consumer Products, Medical Device, Food, Energy, and more), healthcare, retail, non-profits, and government.
    Starting Price: $500/month