Alternatives to SmartISO
Compare SmartISO alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to SmartISO in 2026. Compare features, ratings, user reviews, pricing, and more from SmartISO competitors and alternatives in order to make an informed decision for your business.
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Hyperproof
Hyperproof
Hyperproof is a governance, risk, and compliance platform built for organizations that juggle multiple regulatory frameworks. Rather than treating each standard as a separate project, Hyperproof maps a single set of controls across 160+ frameworks, including SOC 2, ISO 27001, HIPAA, and NIST, so evidence gathered once can satisfy multiple audits without duplicate work. Purpose-built AI agents surface relevant evidence, validate controls, and flag compliance gaps automatically, cutting down the manual review that typically eats up a compliance team's week. The platform connects directly to the tools IT and security teams already use — including GitHub, Jira, ServiceNow, Snyk, CrowdStrike, MongoDB Atlas, Google Workspace, and Microsoft SharePoint — and pulls evidence into Hyperproof, eliminating the need for teams to chase it down manually. High-frequency controls can be tested on a recurring schedule, with failures automatically generating tasks and escalations so nothing slips through the cracks between audit cycles. A built-in risk register lets risk owners across departments document risk treatment plans and tie them directly to the controls that address them. Hyperproof also supports organizations with complex structures, letting larger companies scope controls to specific business units, subsidiaries, or entities rather than forcing everything into one flat compliance program. Customers report meaningful results from this approach: a 70% increase in compliance productivity, roughly $150,000 in annual savings on control orchestration, a 66% cut in duplicative controls, and about 350 fewer hours spent on audit preparation each year. Founded in 2018 and based in the Seattle area, Hyperproof works with organizations like Reddit, Fortinet, Appian, Outreach, and Thales as they move from reactive, spreadsheet-driven compliance to a continuous, audit-ready operating model. Best fit: IT, security, and compliance teams at growing technology companies that manage multiple frameworks simultaneously and want to reduce the manual overhead of audit prep. -
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Qualio
Qualio
Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health. With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems. What Qualio delivers: ✔️ Audit ready in weeks ✔️ Inspection ready anytime — no fire drills ✔️ Faster market entry ✔️ Lower total cost of compliance ✔️ Confident, risk-managed scaling -
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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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Total Lean Management (TLM) Software
Lean & Mean Business Systems
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work OrdersStarting Price: $45/user/month -
5
Dot Compliance QMS
QMS for Life Sciences
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-ShopStarting Price: $10,000 / Annually -
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Teramind
Teramind
Teramind provides a user-centric security approach to monitoring your employees’ digital behavior. Our software streamlines employee data collection in order to identify suspicious activity, improve employee productivity, detect possible threats, monitor employee efficiency, and ensure industry compliance. We help reduce security incidents using highly customizable Smart Rules that can alert, block or lockout users when rule violations are detected, to keep your business running securely and efficiently. Our live & recorded screen monitoring lets you see user actions as they’re happening or after they’ve occurred with video-quality session recordings that can be used to review a security or compliance event, or to analyze productivity behaviors. Teramind can be installed in minutes and can be deployed either without employees knowing or with full transparency and employee control to maintain trust.Starting Price: $12/month/user -
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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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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
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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Intellect
Intellect
Intellect QMS is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps. Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device. Intellect’s Environmental, health, safety and quality (EHSQ) software acts as a data management system for capturing, storing, and analyzing information related to occupational health and safety, waste management, and sustainability. It aims at reducing operational risk and improving health while attaining sustainability goals. -
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Qualtrax
Qualtrax
Qualtrax is a complete quality and compliance software system used to manage and control documentation, automate key business processes with customizable workflows, streamline training management, manage internal and external audits and ensure critical industry regulations are addressed in real-time. Qualtrax is an invaluable resource in heavily-regulated industries, where complying with standards including ISO 17025, 17020, 13485, and 9001, TNI, GFSI, FDA, and FQS is required. -
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Drata
Drata
Drata is an agentic trust management platform that helps organizations automate compliance, manage internal and third-party risk, and continuously demonstrate their security posture. The platform combines Enterprise GRC, compliance automation, Trust Center capabilities, security questionnaire automation, third-party risk management, AI agent governance, and integrations within a centralized environment. Drata automates activities such as control mapping, evidence collection, continuous control monitoring, risk identification, and guided remediation to help organizations maintain audit readiness across multiple frameworks. Its AI capabilities can draft questionnaire responses from an organization's knowledge base, assess third-party vendors, collect vendor documentation, and automate follow-up activities. Organizations can also use Drata's Trust Center to securely share security information and documents with customers, prospects, and other stakeholders.Starting Price: $10,000/year -
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IMSXpress is a sophisticated document control, regulatory compliance, and quality system management platform used for operating ISO 13485 and FDA 21 CFR part 820 quality system that include document distribution, document control, CAPA, complaints, audits, training, MDR, supplier control, NC product, and more. Available as a local install or cloud data hosting, this cutting-edge software comes pre-loaded with template manuals and procedures, employee training booklets, and audit checklists.Starting Price: $1460.00/one-time
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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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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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ProActive Compliance Tool
ProActive Compliance Tool
The ProActive Compliance Tool helps you comply with the correct internal and external laws and regulations. Whether it’s about information security or going through the right process for your (internal) audit or certification, with the PCT you can easily and without knowledge get started. This user-friendly and well-organized digital tool ensures that your company gains and maintains insight into your management information and certifications. The ProActive Compliance Tool is an online tool for the design, implementation, and maintenance of your management system. With the PCT you get a grip on information security, business continuity, quality, and risk management. Document, analyze, and optimize your business information. The PCT allows you to store the documentation of your organization in one central place. The PCT is suitable for all common standards, certification schemes, and assessment guidelines.Starting Price: €220.50 per month -
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ZEBSOFT
Zebra Software
ZEBSOFT GRC & ISO management software platform is a holistic approach to managing Governance, Risk & Compliance. With an intuitive and easy to use web interface, ZEBSOFT makes to easy to manage ISO (9001, 14001, 22301, 27001, 45001) and many other standards. ZEBSOFT has powerful integrated modules for Risk, Quality, Environmental, InfoSec, Compliances, policies (templates included) & documents, equipment & asset management with maintenance/calibration/testing planning. Improve internal communication, assign ownership, plan and carry out audits. Book a demo today to see what ZEBSOFT can do! -
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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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ProActive QMS
ProActive QMS
ISO and BRC compliance software meet the requirements of multiple management standards including ISO 9001, 14001, ISO 45001, ISO 27001, and the BRC standards. Intuitive powerful CAPA software, capturing continual improvement activities, non-conformities, root cause analysis, corrective and preventive actions, and top loss performance data. Effective version and change controls for system documents and controlled forms. Location issue controls for user access to role-related documents only. Compliance evaluation software listing compliance requirements, departmental/area accountability, guidance on legal and other requirements conformity for single or multiple standards including ISO 9001, ISO 14001, ISO 45001, ISO 27001, etc. Supplier, service provider, and contractor qualification, ongoing assessment, and performance enhancement made easy through customized risk work streams, assessments, software scheduled re-assessments, and targeted action logs.Starting Price: $150.95 per month -
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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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QUALITYWEB 360
QUALITYWEB 360
15 modules such as Control of Documents, Internal Audits, Corrective Actions, KPI’s, etc. that assure you compliance with ISO 9001 and similar standards. Control all the processes of your company, with QUALITYWEB 360 you will have everything in one place with instant analysis, which will allow you to increase the productivity of your company at any time and in any place. Allow our ISO 9001 Software to do the heavy job for you, with its unique features: accessibility wherever you go, security of your data, certificates and acknowledgments. Undoubtedly if you are looking for an easy-to-use Quality Management System Software QUALITYWEB 360 is your solution, Is so friendly that everyone will know how to use it.Starting Price: $50 per month -
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QwizPRO
Telonic IQ
QwizPRO simplifies quality management for ISO 9001 and AS9100 compliance, ensuring stress-free audits. Its user-friendly automation minimizes errors, saves time, and streamlines the compliance process. QwizPRO is essential for today’s competitive business environment, enabling quality excellence that’s hassle-free. Monitor and evaluate each supplier consistently, ensuring they align with your stringent quality benchmarks. With real-time analytics and customizable reporting features, the software offers a clear view of supplier performance, highlighting areas of excellence and identifying potential risks. Empower your team with QMS training that is designed to elevate their knowledge from quickly understanding industry standards to mastering complex procedures. QwizPRO allows you to automatically deploy training, monitor learning progress, and identify areas for further development. Leverage QwizPRO for instant access to the right documents for daily tasks.Starting Price: $199 per month -
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CompLions
CompLions
Save time and get a grip on your Risk & Compliance processes with 1 handy tool for every organization, regardless of industry or size. With our governance functionality you demonstrate that you handle your internal information security management with care and that you guarantee confidentiality, integrity and availability as laid down in ISO27001, NEN, NIST and BIO. With our tool you can monitor your GRC related problems. This way a lot of problems can be prevented and your company experiences control over the most important processes, the possible risks and consequences thereof. We make the handling of assessments from the management system and the selection of measures to control the risks clear and efficient. This gives you control and saves you time. You save time through smart deduplication of compliance, stricter quality requirements, standards, laws and regulations. Process assurance with the burden of proof towards your stakeholders. -
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Optial EHS SmartStart
Optial
Implemented by Fortune 500 organizations in over 50 countries, Optial SmartStart provides advanced IT solutions for Environmental, Health & Safety, Audit, Governance, Risk and Compliance. Equipped with features that include Audit Trail, Environmental, FDA, HIPAA, ISO, OSHA, and Sarbanes-Oxley compliance, the platform also provides a number key solutions. The seamless data import from existing third-party systems allows onboarding business to integrate current configurations easily with the Optial SmartStart solution.Starting Price: $15000.00/year -
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Effivity
Effivity Technologies
Effivity is a cloud-based / on-premise QHSE/FSMS/ISMS software to implement a robust Quality - Occupational Health & Safety - Environment Management System & offers 100% conformity to ISO 9001, ISO 14001, ISO 45001, ISO 22000, HACCP standards. Effivity makes ISO compliance simple, easy, quick, value adding, cost-effective, collaborative and time-saving which results in enabling an organization to enhance efficiency and augment productivity as validated by users in more than 120 countries. Effivity offers a unique approach to optimize your management system with world-renowned QMS software, HSE software & FSMS-HACCP software. Simplicity, standardization and customer satisfaction delivered with no-code quality management system software, safe workplace enabled with 100% customizable occupational health & safety management system, sustainable environment possible with a user-friendly environment management system and safe food delivered with HACCP software that is ready to use.Starting Price: $30 per month -
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Probo
Probo
Probo is an open source compliance management platform that helps organizations achieve and maintain compliance across frameworks including SOC 2, ISO 27001, ISO 27701, ISO 42001, GDPR, HIPAA, CCPA, FERPA, CASA, NIS2, and DORA. It combines expert support with automation so compliance programs can run end-to-end without the overhead of traditional do-it-yourself platforms. Probo’s compliance officers review the organization’s environment, complete risk and vendor assessments, identify gaps, and create a program tailored to how the team operates. It automates evidence collection, updates, and approvals, while experts prepare documents, manage policies, controls, reviews, and assessments, coordinate with auditors, and guide teams through essential calls. After certification, Probo continues monitoring controls, refreshing evidence, maintaining assessments, and keeping the program continuously audit-ready.Starting Price: Free -
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ISO2HANDLE
ISO2HANDLE
Are you a quality or risk manager looking for a powerful solution? With ISO2HANDLE, you gain superpowers that give you control over your quality, safety, HR, and environmental processes in no time. ISO2HANDLE is the perfect solution for businesses in virtually any industry. Our software supports capabilities such as risk management, resource management, complaint management, task management, risk assessment, registrations, notifications, document management, audits, onboarding, evaluations, expense claims, leave requests, environmental measures, and more. With just one click, you can generate reports, making audits a breeze. Based in the Netherlands, we proudly support hundreds of companies worldwide.Starting Price: $0 -
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Mango QHSE
Mango
By integrating your Quality, Health, Safety & Environmental Management systems in the Cloud and on a Mobile App. Organizations who rely on Mango for their QHSE compliance come in all different shapes and sizes. Our clients are located across United Kingdom, Australia, New Zealand and South Africa. Our certifications to both ISO 9001 and ISO 27001 gives you the assurance that we manage our quality and your information security. Supercharge your consulting company's growth by building a new recurring revenue stream and delivering more value to your clients. Mango sets you apart from your competitors. And because it's in the cloud, there’s no question that Mango is also the future of the industry. With Mango in your tool bag, you're able to give your clients an easier, more cost-effective way of tackling their compliance obligations. Mango is a popular Compliance Management solution developed by Mango Limited.Starting Price: $250 per month -
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Qalea
Qalea
Qalea is a cybersecurity and compliance platform with a specialist team behind it, built for midsize companies that need ISO 27001, ENS or SOC 2 and want their security to stay in good shape between audits. Instead of combining a compliance tool, an EDR vendor and a consultant, Qalea brings three areas together under continuous monitoring (EDR, SIEM and SOC). Processes: ISO 27001, ENS and SOC 2, with policies, risk management and audit evidence kept current. People: awareness training, phishing simulations, endpoint protection, MDM, SaaS management and a password manager. Infrastructure: external and internal attack surface, cloud and code security, with findings ranked by real risk and a remediation plan. Qalea works with your existing IT or security team, so you have someone in charge of your security who answers to you. Automation handles repetitive tasks and our specialists review and complete the work. Based in Barcelona, Qalea serves more than 80 clients. -
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QuickTrust
QuickTrust
QuickTrust combines a compliance platform with implementation engineering for B2B SaaS teams pursuing SOC 2 and ISO 27001. The platform supports requirements mapping, control-gap tracking, evidence organization, and audit-readiness workflows. Security, DevOps, and compliance engineers help implement controls, remediate gaps, prepare evidence, and coordinate with auditors. QuickTrust is intended for founders, CTOs, security leaders, and engineering teams that need practical implementation support alongside compliance software. Engagements are scoped to the organization and priced by quote. -
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Q5SMS
Q5 Systems
Q5SMS is a safety and quality management systems deployed at large and small organization all over the world. Q5SMS can be deployed on your servers or in the Q5 data centers. Q5SMS is a safety and quality management systems deployed at large and small organization all over the world. Q5SMS can be deployed on your servers or in the Q5 data centers. Modules included in Q5SMS are: audit, inspection, corrective/preventative actions, incident reporting, risk management, skills management and business intelligence and associated work flow processes. Industry sectors include: CAA, Airports, Air Nav Services, Airlines, GSP, Rotor and MRO Compliance processes managed by Q5SMS include: IOSA, ISAGO, EASA, ISO, 29 CFR Part 1926, FAA, 14 CFR, Part 61, Part 91, Part 121, Part 135 - as well as your company specific requirements. Q5SMS is very flexible and can easily be configured for your operational needs. Contact Q5 to review your requirements and a no-hassle, free demo.Starting Price: $1100.00/one-time/user -
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Sword Quality Manager
Sword GRC
For over 10 years Sword Quality Manager has been instrumental in helping international organizations from manufacturing, pharmaceutical, FMCG and other quality conscious industry sectors to comply with standards such as ISO9001, safety and hygiene regulations, promote safety in the workplace and streamline quality processes efficiently, adding to bottom line profitability. -
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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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Dossier
Dossier Solutions
Taking competence management as a starting point we improve quality and performance, reduce the risk of errors and ensure compliance. Monitor and manage enterprise-wide compliance in real time and produce reports to demonstrate compliance to satisfy any internal and external audit (e.g. ISO/FDA/GMP) when necessary. Dossier’s customers are always audit ready. Learning does not equal competence at the point of work. By managing competence requirements, Dossier connects learning to organisational objectives. Managers and subject matter experts cannot easily create elearning courses. They can, however, easily create and manage competence plans. This means more relevant, timely and cost effective competence development. Competence requirements make up the DNA of Learning and Development. It’s the fundamental building block of strategic HR and quality management. -
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JLB Track
JLB
JLB Track deals specifically with consolidating and simplifying Quality (ISO 9001:2015), Safety (ISO 45001:2018), and Environmental (ISO 14001:2015) reporting requirements. With the end user in mind, the software is very easy to navigate and is considered a one-stop-shop for all your compliance requirements. -
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Metaware QMS Platform
Metaware
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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NiftyISO
Niftysol
NiftyISO 9001 Audit software streamlines quality management, ensuring compliance, efficiency, and consistency across your organization. Accessible on the web, mobile, and tablets, it empowers you to improve quality from anywhere, enhancing operations whether in-office or remote.Starting Price: $9 per month -
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iPassport
Genial Genetic Solutions
iPassport is a managed software service designed specifically for healthcare laboratories to help digitize, streamline and improve the day to day management of quality and compliance. iPassport provides a complete suite of quality management modules, allowing you to easily keep on top of everything from document control to staff training. All your controlled documents stored in one place with appropriate access and edit permissions and full revision history. Everything you need to keep on top of internal and external audits. Record and manage NCs, CAPAs and incidents. Manage staff training and competencies, tasks, meetings and leave. A complete supplier database and audit tool including performance reviews. Manage and track assets and stock including equipment maintenance records. -
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MSX
Strategix Application Solutions
Our integrated management system (msx) merges all organizational systems and processes in to one common cohesive framework that drives business excellence and ensures continual improvement. Msx enables business leadership to view management performance across the business activities and assists leaders to make informed actionable decisions. This means that a company can have a combination of any number of management disciplines such as quality, health and safety, environment, business continuity management, food safety and many more that will enable compliance with iso international standards and guidelines. Harmonize and optimise practices creating consistency. Reduce duplication, paperwork and therefore costs.Starting Price: $41 per user per month -
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Stendard Solution
Stendard
We are a regulatory consultancy and technology company that helps businesses implement international standards, streamline business processes across the organization, and accelerate global growth. Our team of in-house ISO consultants can provide trusted guidance towards your management systems requirements. Given our international expertise, besides experience with companies handling hardware and software products in nature, our advisory services have proven successful for a wide variety of clients. From setting up your QMS with a complete set of documents to maintaining your QMS through proper document version control and automated workflow processes, you will find valuable features tailored to your organization, regardless of whether you are a start-up or an established organization.Starting Price: $250 per month -
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COMPLYment
Skillmine Technology Consulting
COMPLYment is an intelligent, automation-driven GRC platform that helps organizations simplify compliance, streamline audits, manage risks, and ensure end-to-end governance. It provides AI-assisted control mapping, evidence collection, auto-suggestions for compliance, integrated risk management, and real-time dashboards — all within a centralized system. -
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Truzta
Truzta
Truzta is an AI-powered security and compliance automation platform that helps organizations achieve, maintain, and scale compliance with major frameworks such as ISO 27001, SOC 2, HIPAA, and GDPR by automating gap assessments, controls implementation, policy generation, evidence collection, continuous monitoring, and audit readiness in one unified dashboard. It accelerates compliance readiness with automated evidence collection that integrates with hundreds of tools, real-time alerts on failing controls, and continuous penetration testing and risk assessment to detect vulnerabilities proactively. Truzta includes secure code review, cloud security posture management, API security, automated access reviews, incident management, third-party risk management, and customizable policy templates, reducing manual work and errors while keeping documentation audit-ready. It simplifies workflows with seamless integrations, structured change management, and centralized reporting. -
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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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qmsWrapper
qmsWrapper
qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance. Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.Starting Price: €3,499 -
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QualityKick
SoftDoit
QualityKick is a QMS compliance solution in the cloud for quality management of the biological sciences. It consists of different modules; each of them solves a specific part of the quality management processes: document control, training, change control, events, CAPA, risk assessment, qualification, and audits of suppliers and equipment. As it is a web-based application, it can be accessed from anywhere and from any device mobile. Works everywhere: computer, smartphone, and tablet. Guided tour which loads automatically when new users log in for the first time. Allows you to edit documents with MS Word and send them through a configurable review and approval process. Different types of events can be configured such as deviations, nonconformities, or complaints. It is possible to define CAPA plans, record the actions, and verify their effectiveness. Solutions for quality management in the pharmacy, biotechnology, and medicine sectors. -
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TraxQM
TraxQM
TraxQM is a risk-based Quality Management System (QMS) designed to help organizations manage regulatory compliance, streamline quality processes, and improve operational efficiency through a centralized, AI-enhanced platform. It enables companies to take a proactive approach to compliance by digitizing workflows and applying structured methodologies aligned with international standards such as ISO and GxP. It includes core modules for document management, risk analysis, CAPA (Corrective and Preventive Actions), change control, audits, and training, allowing teams to manage the full lifecycle of quality operations in one system. It supports data integrity through automated version control, audit trails, and compliant electronic signatures, ensuring traceability and adherence to regulatory requirements. TraxQM leverages AI to enhance decision-making by analyzing risks, suggesting targeted control measures, and recommending relevant KPIs based on organizational objectives.Starting Price: $403.97 per month -
47
AuditCore
Notion Tech Pty Ltd
AuditCore is a cloud-based compliance platform for Australian NDIS providers. It brings participant and worker records together with policies, incident reporting, feedback and complaints, risk registers, continuous-improvement actions, meeting records, behaviour-support tracking and internal audit preparation. Teams can upload participant and policy documents, monitor screening checks and compliance deadlines, assign follow-up actions, and prepare reports and evidence aligned with the NDIS Practice Standards. AI-assisted features can analyse uploaded material and help draft records for staff review; providers may connect supported cloud storage and configure an organisation-provided Claude API key for those features. The platform is designed for registered NDIS providers and their compliance and quality managers, team leaders, coordinators, practitioners and business leaders who maintain safeguarding records, workforce checks, operational policies and audit readiness.Starting Price: A$350/mo -
48
Jurisphere
Jurisphere
Jurisphere is a cloud-based legal AI workspace for law firms and in-house legal teams. It brings legal research, document review, due diligence, and drafting into a shared platform. Teams can review large document sets, identify clauses and potential issues, research legal materials with cited sources, and compare contract language across documents. AI-assisted drafting supports the preparation and refinement of legal work. Jurisphere describes workflows for mergers and acquisitions, transactions, litigation, in-house legal work, and real estate. The platform is available through a web application and an Android app, and the vendor identifies a Microsoft Word add-in and Outlook support. Its features are intended to help legal professionals organize research and document workflows while retaining access to underlying source materials. -
49
Restorepoint
ScienceLogic
Restorepoint enables organizations to increase availability, security and compliance by automating critical tasks across their multi-vendor infrastructures Restorepoint automates network configuration backup, recovery, compliance analysis, and change management for more than 100 network and security vendors. Save hours of network administration, auditing time, and reduce risk by using a single solution for multi-vendor management. Meet internal, best practice or external network security standards such as PCI, GDPR, ITIL, ISO27001, NIST, SOX and HIPAA. Automate network change processes, make complex network configuration changes in seconds, and see the results. Automatically discover manage and track your network assets. Forget about maintaining network asset management spreadsheets. Save hours of administration per week, backup network configurations without complex scripts or manual process. -
50
Conformance Works
Conformance Works
Every organizational structure is unique, requiring a custom tailored approach when dealing with concerns related to international standards. More often than not, this is a time intensive process. To address these needs, ISMS Solutions offers Conformance Works, a proprietary platform that walks customers through an automated system assisting customers with becoming compliant with whatever ISO standard they need. Simply put, Conformance Works simplifies and customizes the standard certification approach for each organization. With a built in document management system, global change editor, compliance management system, and risk assessment module, company documentation becomes straight-forward and efficient. The software will be accessible via multiple digital methods. Allows faster implementation of ISO standards for certification. Provides a streamlined user experience to meeting or exceeding ISO standards.
