List of the Top 25 ISO Compliance Software for Windows in 2025

Hyperproof streamlines tedious compliance tasks, allowing your team to focus on more significant challenges. Additionally, it boasts robust collaboration tools that facilitate seamless communication among team members, evidence collection, and direct interaction with auditors, all within a single platform. This eliminates the ambiguity often associated with audit readiness and compliance oversight. With Hyperproof, you gain an all-encompassing perspective of your compliance initiatives, featuring capabilities for tracking progress, monitoring programs, and managing risks effectively. Furthermore, this comprehensive approach enhances overall organizational efficiency and accountability in compliance processes.

Netwrix Auditor is a visibility solution that empowers you to manage modifications, settings, and access across hybrid IT landscapes. Additionally, it alleviates the pressure of upcoming compliance audits. You can track all alterations in both your cloud and on-premises systems, encompassing Active Directory, Windows Servers, file storage, Exchange, VMware, and various databases. Simplifying your inventory and reporting processes is achievable, and you can effortlessly confirm that your access and identity configurations align with the established good state by conducting regular reviews. This proactive approach not only enhances security but also boosts overall operational efficiency.

6clicks simplifies the implementation of your risk management strategies and facilitates compliance with standards such as ISO 27001, SOC2, PCI-DSS, HIPAA, NIST, and FedRamp. Numerous organizations trust 6clicks to establish and automate their risk and compliance frameworks while enhancing their auditing processes, vendor risk assessments, and overall incident management. You can easily import various standards, regulations, templates, and laws from an extensive content library, leverage AI capabilities to reduce manual tasks, and seamlessly connect 6clicks with over 3,000 familiar applications. Designed to cater to diverse business needs, 6clicks is also advantageous for consultants, offering a white label option and a premium partner program. Since its inception in 2019, 6clicks has expanded its presence with offices located in the USA, UK, India, and Australia, showcasing its global reach and commitment to enhancing risk management solutions.

Develop a straightforward and effective Quality Management System (QMS) which can be hosted on your local server or accessed via our Cloud QMS option. Adhering to ISO 9001:2015 mandates the incorporation of risk-based thinking. Conducting a Risk Assessment through Failure Modes and Effects Analysis (FMEA) is essential for implementing risk-based strategies aligned with ISO 9001 and ISO 14971. It is crucial to identify potential failure modes for every item or process, assess their effects and severity, determine the underlying causes and their frequency, and recognize existing controls along with their detection capabilities. A series of actions must be initiated in response to each identified failure mode, with clear assignment of ownership and due dates. Additionally, it is important to set up criteria for verification and validation, which can be approved by management through electronic signatures. User login protocols should include defined passwords and privilege levels, while a comprehensive suite of reports will facilitate tracking of unresolved actions and overdue tasks. Microsoft Access can be downloaded free of charge, and for deeper data analysis, the information can be exported to Excel. This system operates on a commonly used software platform that is both accessible and user-friendly, ensuring that organizations can maintain high standards of quality management effortlessly.

IsoComplete stands out as a premier cloud solution for overseeing Quality, Safety, and Risk management, enabling organizations to handle these critical areas with both effectiveness and efficiency. This web-based platform is accessible from any location at any time, ensuring that quality management can be conducted seamlessly. Furthermore, IsoComplete comprehensively addresses all facets of a company's quality management needs. With its capabilities, IsoComplete empowers users to comply with significant ISO standards alongside PSA/SIA standards, SOX/CMMI, and CMMi, thus enhancing overall organizational integrity and performance. Its versatility makes it an invaluable tool for businesses striving for excellence in their operations.

The mobile application serves as a comprehensive tool for conducting audits and inspections, representing the most effective method to elevate your standards and enhance your quality ratings. Inspections and audits can seamlessly occur on any device, even in offline settings. Users can effortlessly create visually appealing and informative PDF reports for each inspection, ensuring clarity and engagement. By implementing corrective actions, the process becomes a complete circle of improvement. Furthermore, our sophisticated analytics dashboard offers unparalleled visibility into your operations, helping to maximize your return on investment while driving continuous improvement.

RiskWatch provides compliance management and risk assessment tools that rely on a survey-driven methodology. A set of questions regarding a particular asset is posed, and a score is derived from the answers provided. This survey score can be integrated with other metrics to appraise the asset's worth, evaluate its risk probability, and determine its potential consequences. Following the survey analysis, you can delegate tasks and oversee corrective actions. It is crucial to pinpoint the risk factors associated with every asset under review. Additionally, you will be alerted about any instances of non-compliance with your tailored requirements as well as pertinent standards and regulations, ensuring a comprehensive approach to risk management. This proactive notification system helps organizations maintain adherence and mitigate potential risks effectively.

Envelop serves as a comprehensive system for document management, risk oversight, and audit workflows. It simplifies the process of creating and overseeing audits and risks, allowing users to attach relevant work papers and generate insightful reports. This web application operates on a framework that addresses risk management and audits, focusing on essential elements such as process objectives, risks, controls, tests, findings, and actions. Additionally, it features a built-in report generator and offers a user-friendly web-based interface that is adaptable for internal controls, SOX compliance, and PCI DSS requirements. Users can attach work papers at various levels, whether it pertains to an audit, process or objective, risk, control, or test. If you have concerns regarding budget constraints or reliability, you can opt for the free, open-source community version, which is available under the MIT License. We also provide hosting services for this community version! Envelop truly stands out as a versatile tool for managing risks and audits effectively.

Streamline your quality processes with QT9's comprehensive cloud-based Quality Management System (QMS) Software Suite. Designed for ease of use, QT9 QMS features over 25 modules that offer unlimited scalability to meet your needs. Enhance your ISO and FDA compliance efforts with automated email alerts, task lists, and FDA 21 CFR Part 11 compliant electronic approvals. QT9 QMS empowers organizations in the Life Sciences, Biotechnology, Medical Device Manufacturing, and Pharmaceutical sectors to achieve digital transformation in their operations. Stay informed with real-time status updates and instantly visualize your quality metrics. The software includes essential features such as document control, revision management, corrective actions (CAPAs), and nonconformance tracking, among others. Additionally, it facilitates streamlined product releases with modules for Deviation Management, Engineering Change Orders, Failure Mode and Effects Analysis (FMEA), and Inspection Management. Transition to a paperless environment and automate your labor-intensive tasks effortlessly. QT9 QMS is ready for immediate use, allowing you to get started quickly. Experience it firsthand by signing up for a free product tour or beginning your free trial today at QT9qms.com. Embrace the future of quality management and elevate your organization's efficiency.

Teramind adopts a user-focused approach to overseeing the digital activities of employees. Our software simplifies the process of gathering employee data to uncover any suspicious behaviors, enhance productivity, identify potential threats, track efficiency, and ensure compliance with industry standards. By implementing highly adaptable Smart Rules, we help mitigate security breaches by enabling alerts, blocks, or user lockouts when violations occur, thereby maintaining both security and operational efficiency for your organization. With live and recorded screen monitoring capabilities, you can observe user actions in real-time or review them later through high-quality video recordings, which are invaluable for examining security or compliance incidents, as well as for assessing productivity trends. Additionally, Teramind can be swiftly installed and configured; it can either operate discreetly without employee awareness or be implemented transparently with employee involvement to foster trust within the workplace. This flexibility allows organizations to choose the monitoring approach that best fits their culture and security needs.

Dot Compliance has introduced the first ready-to-use Quality Management Solution integrated with the Salesforce.com platform. This innovative solution encompasses a comprehensive array of pre-configured eQMS and compliance processes, allowing clients to implement it swiftly and affordably. Included in the Dot Compliance offerings are complete project validation services alongside product validation packages. Their solution stands out as the most economical option for quality and compliance management in the industry, empowering users to deploy adaptable and scalable solutions without delay. Key quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, and Supplier Quality can be automated effortlessly. Furthermore, the solution is designed to be fully configurable and supports seamless integration, which makes it easy for customers to tailor the system to meet their unique specifications. By prioritizing user needs, Dot Compliance ensures a smooth transition and effective management of quality across various operations.

SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector. This innovative platform ensures adherence to an array of regulatory standards, 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, and ICH Q10, among others, and is fully validated under GAMP5 guidelines. The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities. Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel. In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.

NiftyISO 9001 Audit software streamlines quality management by ensuring compliance, enhancing efficiency, and promoting uniformity across your organization. Accessible on multiple platforms such as the web, mobile devices, and tablets, it empowers users to improve quality from any setting, thus optimizing operations whether in the office or working from home. This adaptability helps teams to remain coordinated and dedicated to quality goals, ultimately resulting in improved performance and outcomes for the entire organization. With its user-friendly interface and comprehensive features, NiftyISO stands out as a vital tool for modern quality management.

The 27k1 ISMS offers a comprehensive solution for achieving ISO 27001 compliance. It is user-friendly and cost-effective, providing a more adaptable alternative to traditional spreadsheet methods while facilitating certification and compliance for both users and clients. Leveraging the customer's Document Management System, the software links to relevant policies and evidence through URLs and hyperlinks, significantly reducing duplication and associated costs. The latest release, Version 7, introduced in April 2022, incorporates the updated ISO 27002/2022 controls, allowing users the flexibility to select their desired control set for the ISMS. This system delivers a streamlined, efficient approach to ISO 27001 compliance, certification, and ongoing improvement, enhancing the overall experience for its users. By simplifying complex processes, it empowers organizations to maintain robust information security management systems effortlessly.

IsoMetrix, an acclaimed developer of risk management software, offers cutting-edge solutions tailored for EHS and ESG management. For over 25 years, organizations worldwide have depended on IsoMetrix to enhance their sustainability practices, along with health and safety management. The company champions the idea that robust governance, risk management, and compliance yield significant and far-reaching advantages. Such practices not only benefit the environment but also positively impact the individuals and communities where we operate. Moreover, they contribute to creating more resilient and profitable businesses. Our mission is to empower our clients to make a positive difference. With offices located in the USA and South Africa, we have earned the trust of some of the globe’s most prominent companies over the past quarter-century. An independent analyst firm has also distinguished us as a leader in the EHS software sector, reinforcing our commitment to excellence. This recognition motivates us to innovate continuously and support our customers in achieving their sustainability goals.

Effivity is a versatile program available as both a cloud-based and on-premise solution for managing QHSE, FSMS, and ISMS, designed to facilitate the establishment of a comprehensive Quality, Occupational Health & Safety, and Environmental Management System. It adheres to essential standards including ISO 9001, ISO 14001, and ISO 45001. By streamlining the process, Effivity simplifies ISO compliance, making it not only efficient but also economical. Additionally, it enhances collaboration among users, leading to significant time savings. The effectiveness of Effivity is recognized globally, with validation from over 120 countries, showcasing its widespread acceptance and reliability.

Qualtrax is an advanced software solution designed for quality and compliance that facilitates the management and control of documentation, automates essential business processes, optimizes training management, oversees both internal and external audits, and guarantees adherence to vital industry regulations in real-time. This software proves to be an essential tool for organizations operating within tightly regulated sectors that must comply with standards like ISO 17025, 17020, 13485, 9001, TNI, GFSI, FDA, and FQS. By integrating these functionalities, Qualtrax not only enhances operational efficiency but also helps organizations mitigate risks associated with non-compliance.

You can streamline the often slow, tedious, and error-ridden journey to achieve SOC 2, ISO 27001, and GDPR compliance by opting for a fast, straightforward, and technology-driven solution. Unlike traditional compliance programs, Sprinto is tailored specifically for businesses that operate in the cloud. Each type of organization has distinct requirements concerning SOC 2, ISO 27001, and HIPAA, and using generic compliance solutions can result in increased compliance liabilities and decreased security. Sprinto has been meticulously crafted to cater to the unique needs of cloud-based companies. It transcends the typical SaaS platform by offering not only compliance but also invaluable security insights. Engaging in live sessions with compliance specialists will provide essential guidance. The program is specifically tailored for your needs, eliminating unnecessary complexity. With a well-structured implementation program comprising 14 sessions, engineering leaders will feel empowered and in command of their compliance journey. You'll benefit from guaranteed 100% compliance coverage, while Sprinto ensures that no evidence is shared. Furthermore, all other compliance requirements, such as policies and system integrations, can be automated, paving the way for a seamless compliance experience. This enables companies to focus on their core operations without being bogged down by compliance concerns.

With Skillmine's COMPLYment, organizations can effectively oversee IT governance and compliance through the standardization and automation of processes, evidence gathering, and task management to guarantee compliance. Key features of COMPLYment include: 1. Design for IT Governance, Risk, and Compliance (GRC) environments. 2. Comprehensive pre-packaged content (such as PCI, RBI, SEBI, SAMA, ISO 20007, HIPAA), encompassing over 650 controls. 3. A Federated Data Library aimed at enhancing IT compliance efforts. 4. Management of IT risks and cyber policy frameworks. 5. Assessments for IT and cyber compliance and control. 6. Continuous monitoring of controls with real-time visibility into compliance status. The results of utilizing COMPLYment are significant, boasting a 50% increase in operational efficiency through streamlined processes, a 47% decrease in cybersecurity risks, and an 85% improvement in the management of IT compliance and audit workflows. Additionally, organizations can expect a 55% reduction in risks associated with regulatory non-compliance and a 55% enhancement in remediation strategies for addressing control weaknesses. In summary, COMPLYment effectively simplifies, streamlines, and automates workflows related to IT and cyber GRC, leading to a more secure and compliant organizational environment.

IMSXpress is a sophisticated platform tailored for the administration of document control, the assurance of regulatory compliance, and the management of quality systems in accordance with ISO 13485 and FDA 21 CFR part 820 regulations. It includes a range of features such as document distribution, control, CAPA management, complaint resolution, auditing, training oversight, MDR processes, supplier management, and tracking of non-conforming products. This cutting-edge software is available for either local installation or cloud deployment, and it comes with a variety of pre-built template manuals, procedures, employee training resources, and audit checklists to facilitate a smooth implementation process. Furthermore, its user-friendly interface significantly improves the overall experience, making the management of compliance more streamlined and effective than ever before. Consequently, organizations can ensure they remain up-to-date with regulatory demands while enhancing their operational efficiency.

Optial SmartStart, employed by leading Fortune 500 firms in over 50 countries, provides advanced IT solutions specifically designed for Environmental, Health & Safety, Audit, Governance, Risk, and Compliance requirements. The platform boasts a wide range of features, including Audit Trail capabilities and adherence to critical standards such as FDA, HIPAA, ISO, OSHA, and Sarbanes-Oxley. Furthermore, it offers a variety of vital solutions aimed at improving operational efficiency. A significant benefit of this system is its ability to facilitate the effortless import of data from current third-party platforms, which allows businesses to smoothly transition by integrating their existing setups into the Optial SmartStart environment. This seamless integration not only supports organizations in adapting to the new system with minimal disruption but also enhances their overall productivity and compliance readiness. By leveraging such capabilities, companies can focus on their core operations while ensuring they meet regulatory demands effectively.

JLB Track aims to simplify and consolidate the reporting requirements for Quality (ISO 9001:2015), Safety (ISO 45001:2018), and Environmental (ISO 14001:2015) standards. With a strong emphasis on enhancing user experience, this software provides easy navigation and acts as an all-in-one solution for compliance, allowing users to effectively oversee their obligations from a single, accessible platform. Additionally, its design facilitates quick access to essential features, making compliance management more efficient than ever before.

The increasing frequency of cyber-attacks underscores the pressing need for organizations to proactively foresee and prepare for potential threats. A formal Risk Assessment process is vital for businesses to pinpoint vulnerabilities and establish a robust security infrastructure. While assessing risks is fundamental for grasping the evolving nature of cyber threats, automated risk assessment solutions can greatly simplify this task for enterprises. By implementing an effective Risk Assessment tool, organizations can significantly cut down the time allocated to risk management tasks, potentially by 70 to 80%, allowing them to redirect their efforts toward more pressing priorities. SISA, a pioneer in PCI Risk and Compliance for over ten years, has acknowledged the challenges that organizations encounter in forecasting risks and has created the SISA Risk Assessor, an accessible tool for conducting Risk Assessments. Remarkably, SISA’s Risk Assessor is the first PCI Risk Assessment solution on the market, formulated according to internationally accepted security frameworks such as NIST, OCTAVE, ISO 27001, and PCI DSS risk assessment standards. This groundbreaking tool not only streamlines the risk evaluation process but also enables organizations to significantly bolster their overall cybersecurity defenses. With such innovative resources at their disposal, organizations can better navigate the complexities of the cyber threat landscape.

SaaS and on-premises solutions are specifically crafted to improve risk identification, enhance risk communication, and nurture a culture that emphasizes risk awareness. The IRIS Intelligence Risk Management software plays a crucial role in executing your organization’s strategy more effectively. This tool not only improves communication regarding risks but also increases the visibility of potential threats and their corresponding mitigations, enabling enhanced decision-making through automated reporting and evaluations of investment returns. It quickly integrates best practice risk management processes with established standards like ISO 31000, PMBoK, ISO 27001, or governmental risk guidelines. Users benefit from access to checklists and brainstorming prompts endorsed by the International Risk Governance Council, providing essential resources at their fingertips. The criteria provided are flexible enough to adapt to various contexts, ensuring consistency in assessments across different registers. For those requiring in-depth analysis, this software offers the capability to quantify risk exposure utilizing advanced statistical methodologies, moving beyond mere estimation techniques. This all-encompassing approach not only streamlines the risk management process but also fosters a proactive mindset in recognizing potential risks, thereby empowering organizations to stay ahead of threats. Furthermore, by promoting a comprehensive understanding of risks, companies can better allocate their resources and improve their overall resilience.

SoftExpert EQM is a comprehensive enterprise quality management software (EQMS) that supports organizations in achieving and maintaining ISO 9001 certification by automating and improving quality processes tailored to their specific products, operations, and business methodologies. This flexible and modular platform consolidates all vital quality initiatives, which encompass process mapping and the management of documented information, such as standard operating procedures, work instructions, and records, in addition to handling non-conformance reports, corrective and preventive actions, and quality metrics. Moreover, the software adeptly manages supplier relationships, resolves customer complaints, conducts quality audits, oversees training and competencies, and assesses quality risks and controls, including quality inspections and statistical process control, thus fostering a more agile and robust quality management system. By optimizing these various functions, SoftExpert EQM enables organizations to significantly elevate their overall quality performance and regulatory compliance, ultimately leading to enhanced customer satisfaction and operational efficiency. This powerful tool not only streamlines processes but also provides valuable insights that help drive continuous improvement initiatives within the organization.