Alternatives to iPassport

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

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    Interfacing Integrated Management System (IMS)

    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.
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    Process Street

    Process Street

    Process Street

    Process Street is an AI-powered compliance operations platform that automates complex workflows, enforces standards, and tracks audit data in real time. Teams use it to create structured SOPs, assign tasks, collect data, and monitor execution with intelligent oversight. From onboarding and audits to vendor management and document control, Process Street ensures every step is followed and every action is logged. Built for regulated industries like financial services, healthcare, and manufacturing, it supports frameworks such as ISO, SOC 2, SOX, and HIPAA. With role-based permissions, audit logs, and powerful integrations, Process Street replaces static documents, spreadsheets, and manual processes with a single automated system of record. Use AI to streamline approvals, catch risks early, and generate audit-ready evidence. Trusted by teams at Cargill, DoorDash, Farmers Insurance, and Hartford Healthcare.
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    AlisQI

    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.
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  • 4
    isoTracker Quality Management

    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

    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
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    QBench

    QBench

    QBench

    The modern, flexible, easy-to-use LIMS. QBench enables our customers to get a LIMS up and running faster. Automate your entire lab with our developer-friendly API, Inventory Management, Customer Portal, Billing, and Quality Management System modules. QBench is a cloud-based Laboratory Information Management System (LIMS) that enables labs to streamline their entire testing workflow, from sample receiving to automated results reporting. QBench allows you to keep track of all your samples and where they are located in the workflow using a single system. QBench eliminates the need for spreadsheets, shared folders in the network, and paper-based tracking systems. View hundreds of PDF reports/COAs before publishing or emailing. Generate barcodes and create labels that you can customize for your samples. See counts and latencies for different data types in QBench. This includes metrics like turnaround time, sample counts per test, sample delay, and more!
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    Total Lean Management (TLM) Software

    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 Orders
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    Starting Price: $45/user/month
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    Dot Compliance QMS

    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-Shop
    Starting Price: $10,000 / Annually
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    SimplerQMS

    SimplerQMS

    SimplerQMS

    SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.
    Starting Price: $13,750/year
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    TenForce

    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
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    Sunday Business Systems

    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.
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    MediaLab Document Control
    MediaLab’s Document Control is a powerful way to manage your laboratory’s policies, procedures, and documentation. Our twenty years of expertise in clinical laboratories have created a document control solution that guides you to full compliance with all laboratory standards, regulations, and best practices. Document Control provides an automated, centralized platform for all of your document approvals, workflows, edits, sign-offs, audits, and more—with flexibility and customization features to match your laboratory’s unique needs. MediaLab's Document Control supports: • Digital records and version control of all documents, • Standardization across all documents from all sites, • Electronic signatures that meet 21 CFR Part 11 standards, • Customized approval workflows and processes, • Robust searching to easily locate specific documents, and more!
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    Qualityze EQMS Suite
    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.
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    Starting Price: $30/User/Month
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    QT9 QMS

    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
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    BPAQuality365

    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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    Xybion LIMS
    Xybion LIMS (formerly Labwise XD) is an all-inclusive LIMS, ELN, QMS, and DMS. Xybion LIMS drives lab workflows, instills consistency, improves data quality, and supports regulatory compliance with a complete laboratory management solution that connects with your operating systems with powerful laboratory information management and analytics. Xybion LIMS creates optimized workflows for the unique business needs of all regulated laboratories including research, diagnostics, quality control, stability studies, and more.
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    Qualcy QMS

    Qualcy QMS

    Qualcy Systems

    Qualcy Bio-Med QMS Software has been designed for Bio-Medical companies (including Biotech, Pharma and Medical Device) to manage QMS records for ISO13485 and FDA requirements. * Designed for meeting the requirements for 21 CFR Part 820 * Has built in features for E-sign, audit trails and complies with 21 CFR part 11 requirements. This software helps manage the records for Doc. change control, complaints, audits, CAPA, NC Records, Training Records and more.
    Starting Price: $799 per month
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    Qualtrax

    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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    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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    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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    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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    IMSXpress Quality Management
    IMSXpress is a cutting-edge document control and quality management system (QMS) software solution. Easy to install and intuitive, IMSXpress Quality Management improve the overall business efficiency while maintaining compliance. The solution offers a plethora of modules, such as document distribution, document control, internal audit, training, management review, Corrective/Preventive Action (CAPA), customer companies, risk management, preventative maintenance, measuring equipment, supplier control, and more.
    Starting Price: $790.00/one-time
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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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    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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    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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    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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    LabRelations

    LabRelations

    LabRelations

    LabRelations is a modern, configurable laboratory platform built to centralize and streamline scientific and test workflows by combining core modules, including LIMS (Laboratory Information Management System), ELN (Electronic Lab Notebook), CTMS (Clinical Trial Management System) and EDC (Electronic Data Capture), into a single system that supports everything from sample tracking and experiment documentation to study management and regulatory-grade reporting while reducing manual work, errors and data silos; it lets labs store all data in one place, define rule-based workflows and automations, connect instruments and external systems, enforce full audit trails and compliance (such as GxP, 21 CFR and versioned controls), and configure objects, forms, views and permissions to fit specific lab needs, while enabling cross-functional collaboration and real-time visibility from discovery and quality control to clinical research and complex regulated environments.
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    Quality Forward

    Quality Forward

    Quality Forward

    Quality Forward is a cloud-based electronic Quality Management System (eQMS) designed to help organizations in highly regulated industries digitize, manage, and automate their quality processes within a unified platform. Built on the ServiceNow architecture, it enables teams to centralize and control critical workflows such as deviations, corrective and preventive actions (CAPAs), audits, complaints, change control, document management, training, supplier quality, and risk management, all with full traceability and audit-ready documentation. It provides real-time monitoring, automated workflows, and AI-driven insights that streamline compliance, reduce manual effort, and improve operational efficiency across the product lifecycle. It offers a highly configurable, no-code environment that allows quality assurance teams to adapt processes to evolving regulatory requirements without relying on IT, while maintaining adherence to global standards such as FDA, ISO, and GxP.
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    Computer Frameworks Lab Management System
    The Laboratory Management System (LMS) is a Medical/Business Management system designed to support Laboratory and Clinic processes as well as administrative processes. It manages both patient and staff records as well as forms, work lists, and reports. It has built-in modules for Andrology and Embryology that can be modified to suit the practice's internal processes. We identified a gap between the current capabilities of clinic software and what is really essential to clinics and laboratories. LMS was created for Australian laboratories and clinics and is designed to maintain quality assurance following NATA requirements for laboratories. Extra modules can be incorporated into the application to suit your unique requirements. Drug dispensing software which keeps track of medications dispensed to patients and can also be used to manage an inventory of medications, order medications from pharmaceutical suppliers and to create PBS claims for IVF medications.
    Starting Price: $1,200 per month
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    Electronic Lab Logs

    Electronic Lab Logs

    Electronic Lab Logs

    Electronic Lab Logs tracks maintenance tasks and QC for all your lab instruments so that you can always be ready for audits and inspections. Electronic Lab Logs offers a comprehensive software platform designed to streamline laboratory maintenance and quality control tasks. By replacing traditional paper logs and binders, the platform enables labs to efficiently track maintenance schedules and QC activities across all instruments, ensuring readiness for audits and inspections. The user-friendly dashboard centralizes task management, allowing users to prioritize and complete tasks from a single interface. Administrators can define new instruments and tasks, providing flexibility to accommodate various laboratory needs. The system supports the attachment of service records, such as preventive maintenance and service reports, facilitating comprehensive documentation. As a cloud-based solution, Electronic Lab Logs requires no server installations.
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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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    FactoryQA

    FactoryQA

    FactoryQA

    FactoryQA is an all-in-one Quality Management software for Manufacturers. Software Features: 1. Non-Conformance/CAPA Management 2. Document Control 3. Work Instructions 4. Inspection Sheets 5. Audits 6. Analytics Services: 1. ISO Certification Consultants 2. ISO Certification Workshops 3. Fractional Quality Management Services
    Starting Price: $1200 per year
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    Metaware QMS Platform
    Metaware.nl is a modern, scalable quality management software platform that helps organizations implement, manage and continuously improve their Quality Management System (QMS or GRC). The platform fully supports ISO 9001, ISO 14001, ISO 27001 and other international standards, enabling organizations to demonstrably comply with laws, regulations and certification requirements. Metaware centralizes document control, process management, risk management, incident and complaint management, CAPA, internal audits and management reviews in one secure, cloud-based sovereign solution. With real-time dashboards, workflow automation, role-based access and version control, organizations gain full control over quality, compliance and operational performance. Metaware reduces administrative burden, increases transparency and supports continuous improvement, making it suitable for both SMEs and enterprise-level organizations focused on professional quality assurance and compliance management.
    Starting Price: €142/month (Bronze)
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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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    CompliantPro
    CompliantPro Quality Management System Software is a tool that ensures a company’s quality assurance requirements are documented in a single, integrated system which demolishes silos of information managed as point solutions. CompliantPro allows an organization to manage its compliance and regulatory requirements beyond just document control. Key areas include Environmental Health & Safety, Enterprise Risk Management, Training & Qualifications, Audits, and customer / supplier management.
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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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    OurRecords Compliance Network
    OurRecords offers a secure, cloud-based credential and document management solution for businesses in the food, mortgage, and healthcare industries. With OurRecords, companies can take advantage of a centralized platform for storing, managing, and enabling access to verified credentials and records. Top features include supplier/vendor management, workforce prerequisite program, proactive alerts/notifications, document distribution, centralized documentation, and automated reports. Automate the distribution of required organizational and product compliance documents to your customers, auditors, and state regulators. Centralized Location for all your Standard Operating Procedures, Policies, Quality Programs, Certifications, Production Specifications, and other compliance documents. Automated alerts proactively notify suppliers, vendors, contractors, and staff of current and pending non-compliance issues that require attention.
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    CLIN1 LAB

    CLIN1 LAB

    Clinical Software Solutions

    The CLIN1 team understands how important the laboratory is to the healthcare world. We have laboratory software designed for your specific work in mind. We can help keep your laboratory successful with the functionality needed to be organized and efficient doing your daily tasks. And, our solution incorporates the best quality control and quality assurance tools! We offer software and services to make your laboratory and daily work more efficient & effective. No matter what type of laboratory: independent, specialized, clinical, hospital, research, veterinary, etc -- we have the software and configuration you need to create a productive environment. Our solutions will help you deliver the best information to your clients. Looking for a laboratory system that can handle clinical as well as histology and pathology sample processing? Our system has features and options specifically designed to address these aspects for your lab.
    Starting Price: $15000 one-time payment
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    inblue QMS
    Modify the fields based on the reality of your company. Grant permissions and define your deadlines. Take control of Documents. Evaluate your suppliers. Generate a SWOT Matrix. Create Corrective Action Status reports. And everything that the ISO Standard requires. Get reminders of due deadlines and notifications every time you're assigned a task; by email and on the panel. Record comments and versions for better follow-up. Includes change history. It maintains a history of creation, edition, derivation of the collaboration processes. Planning, registration and monitoring of processes, audits and procedures. Attach evidence and documentation. Optimization of time, cost reduction, visualization and interaction of processes, methodologies for follow-up, timely resolution of problems. These are just some of the benefits of digitizing your management system with inblue QMS.
    Starting Price: $10 per user per month
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    SBS Quality Database

    SBS Quality Database

    Sunday Business Systems

    The SBS Quality Database is a simple, inexpensive, ISO 9001 compliant software program that allows small businesses to efficiency manage the Quality Management System or QMS. The database tracks corrective actions, preventive actions (CAPA), internal audits, safety improvement, supplier corrective actions, continual improvement projects. Compile and analyze Customer Survey results. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Document interested parties as part of the Context of the organization. Use the dashboard for a quick view of the overall performance. Cloud based or locally installed options are available. The program is ideal for small businesses striving for ISO 9001:2015, API Q1, AS9100, or TS16949 compliance. Free demo downloads are available from our website so you may try before your buy.
    Starting Price: $499/one-time
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    ISO 13485 Quality Management
    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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    TrackWise

    TrackWise

    Honeywell International

    Honeywell's TrackWise Digital® is a cloud-based Quality Management System (QMS) designed to help organizations efficiently manage quality and compliance processes. Leveraging nearly three decades of industry experience, it offers integrated modules that support various quality management aspects, including document control, training management, and corrective and preventive actions (CAPA). The platform incorporates advanced digital technologies such as artificial intelligence and machine learning to provide actionable, real-time insights, enabling proactive quality management. Its flexible, modular architecture allows for seamless integration with existing enterprise systems, facilitating rapid deployment and scalability. By streamlining quality processes and ensuring compliance with industry standards, TrackWise Digital® empowers organizations to bring products to market faster while minimizing risk.
    Starting Price: $200 per month
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    HCLAB

    HCLAB

    Sysmex

    HCLAB is a comprehensive, flexible and practical laboratory information system (LIS) that can be easily configured to the needs of your laboratory. Designed to streamline routine tasks, HCLAB is suitable for medical and diagnostic laboratory disciplines including hematology, coagulation, biochemistry, immunology, urinalysis, microbiology, and molecular and anatomical pathology. HCLAB is highly scalable, making it ideal for any size laboratory, from small dedicated project sites to complex multi-site healthcare organizations and university hospitals. HCLAB ensures end-to-end information management, from initial test requests through to results reporting and delivery. HCL's smart client workstation provides web access for clinical staff on the ward or branch to request an order, as well as enabling order entry in the laboratory. Manages and tracks samples sent to external laboratories for testing that is not performed in-house.
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    eQMS::LIMS
    The application of this LIMS system establishes full control over the procedures of safety and quality control of products, raw materials, procurement procedures, production processes and environmental indicators. eQMS :: LIMS enables the establishment and implementation of demonstrable traceability, thus ensuring the maintenance of compliance with legal regulations and adopted standards, and thus significantly facilitates the implementation and day-to-day implementation of regulatory requirements. This modern LIMS system extends its functionality beyond the laboratory, especially in the field of quality management, enabling systematic monitoring and supervision of all resources and audit of all business units.
    Starting Price: $5000.00/one-time
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    LabCup

    LabCup

    LabCup

    The complete chemical inventory software and laboratory management enterprise system for industry and research universities. LabCup provides complete laboratory and research institution software management systems. From full chemical inventory software, risk assessment/COSHH, equipment booking, and asset inventory, to live emergency information, LabCup covers a huge range of functionality. LabCup is fully modular, users can choose which modules they require, and is cloud based so available on any device. Designed for the users, to minimise administration and automate procedures – LabCup automatically pulls in chemical data (SDS, GHS, all synonyms, structure, emergency information, and much more) – and this is all used throughout the system, with every chemical and item on the system tracked uniquely by barcode/ID. Multiple processes (including COSHH risk assessment, equipment and room bookings, training records, digital fire registry, purchasing, radioactives, and much more).
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    LIS 365

    LIS 365

    LIS 365

    LIS 365 is a laboratory information system (LIS) software system that records, manages, and stores data for clinical & medical laboratories. A best LIS has traditionally been most adept at sending laboratory test orders to lab instruments, tracking those orders, and then recording the results. LIS Software should be used for the automation of workflows for the same purpose for which it is used to automate record keeping. This may not save you effort but it will definitely save you precious time. LIS365 also empowers laboratories to increase their revenues and enhance customer retention. We help them in boosting efficiency, streamline workflows, ensure patient satisfaction and safety. Commonly found functions in a LIS (laboratory information system) are the following, for instance Sample Management, Workflow management, reporting, EHR and ERP
    Starting Price: $5000.00/one-time/user
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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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    Silabmed

    Silabmed

    TainoSystems

    Silabmed is comprehensive medical laboratory management software designed to increase the speed, productivity and profitability of your laboratory. The results of a medical laboratory are the compass that guides doctors’ decisions. It is therefore essential for any medical laboratory to optimize its services by integrating a computerized management system. Silabmed complies with the latest regulations in the management of medical analysis laboratories. Its modularity, as well as its ability to integrate with other software, allows proven efficiency and superior communication speed with other users. As a lab manager, it can be a challenge to make sure that the software you invest in provides you with optimal outputs. Integrated on-premise software can provide your staff with the necessary tools they need, but over time can become sluggish and expensive to keep up with developing needs.
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    Prolis

    Prolis

    American Soft Solutions

    Developed by American Soft Solutions, Prolis is a professional laboratory information management system for hospitals and reference labs of all sizes. Purpose-built for multi-specialty laboratories and used in microbiology, chemistry, pathology, coagulation, molecular testing, and toxicology, Prolis helps users to efficiently manage and automate laboratory functions. Core components of Prolis include physician panels, a laboratory-barcode system, patient scheduling, audit trails, logistics monitoring, remote accessioning, integrated billing and reporting, a search tool for physicians, and so much more.
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    Oasis LIMS

    Oasis LIMS

    Oasis Infotech

    Oasis infotech is ISO 9001:2015 certified, a leading application development company, with many industry specific products in QC/QA area as core competence, offering LIMS (Laboratory Information Management System), QMS (Quality Management Systems) and Automation Solutions in making laboratories more productive and efficient with integrated informatics, services and solutions. Oasis products line provide state-of-the art technology and consulting services for automating modern laboratories and has been instrumental in developing a wide range of associated applications to computerize manufacturing units / analytical and research labs and other related activities. Oasis is committed to provide prompt, consistent, reliable and cost-effective quality service to its clients in various sectors worldwide, maintaining confidentiality and integrity to help organizations meet regulatory compliance.