Best ISO Compliance Software for Windows (2024)

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

Hyperproof makes building out and managing your information security frameworks easy by automating repetitive compliance operation tasks so your team can focus on the bigger things. The Hyperproof solution also offers powerful collaboration features that make it easy for your team to coordinate efforts, collect evidence, and work directly with auditors in a single interface. Gone are the days of uncertainty around audit preparation and compliance management process. With Hyperproof you get a holistic view of your compliance programs with progress tracking, program health monitoring, and risk management.

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

Netwrix Auditor is a visibility platform that enables control over changes, configurations and access in hybrid IT environments and eliminates the stress of your next compliance audit. Monitor all changes across your on-prem and cloud systems, including AD, Windows Server, file storage, databases, Exchange, VMware and more. Simplify your reporting and inventory routines. Regularly review your identity and access configurations, and easily verify that they match a known good state.

Build a simple and efficient Quality Management System (QMS). Install on your local server or leverage our Cloud QMS solution. Implement risk based thinking required by ISO 9001:2015. Risk Assessment: Failure Modes and Effects Analysis (FMEA). Implement risk based strategies for ISO 9001:2015, ISO 14971. Identify failure modes for each process or item. Identify effects and severity. Identify causes and frequency. Identify current controls and detection levels. Develop multiple actions associated with this failure mode. Assign owners and due dates. Establish verification and validation criteria. Electronic signature for management approval. User login: define user passwords and privileges. Rich set of reports. Track open actions and delinquent due dates. Free runtime version of Access is available from Microsoft. Export data to Excel for further analysis. Common, convenient software platform.

Starting Price:$135.00/one-time

6clicks is an easy way to implement your risk and compliance program or achieve compliance with ISO 27001, SOC 2, PCI-DSS, HIPAA, NIST, FedRamp and many other standards.Hundreds of businesses trust 6clicks to set up and automate their risk and compliance programs and streamline audit, vendor risk assessment, incident and risk management and policy implementation. Easily import standards, laws, regulations or templates from our massive content library, use AI-powered features to automate manual tasks, and integrate 6clicks with over 3,000 apps you know and love.6clicks has been built for businesses of all shapes and sizes and is also used by advisors with a world-class partner program and white label capability available.6clicks was founded in 2019 and has offices in the United States, United Kingdom, India and Australia.

Mobile app and complete solution for auditing & inspections. Increase your standards and quality scores the most efficient way!Conduct mobile audits and inspections on your favorite device, even offline, with digital checklists, photos, signatures, annotations. With each inspection, automatically generate detailed, engaging and informative PDF reports that reflect your brand. Close the loop with corrective actions. With our advanced analytics dashboard, gain unprecedented insights into your operations and maximize your ROI.

Starting Price:$10 per user per month

RiskWatch risk assessment and compliance management solutions use a survey-based process for physical & information security in which a series of questions are asked about an asset and a score is calculated based on responses. Additional metrics can be combined with the survey score to value the asset, rate likelihood, and impact. Assign tasks and manage remediation based on survey results. Identify the risk factors of each asset you assess. Receive notifications for non-compliance to your custom requirements and any relevant standards/regulations.

Starting Price:$99/month/user

Envelop is a risk management, audit workflow, and document management system. You can easily create and manage risks, and audits, attach work papers and create reports. Web application. Risk Management, Audits (process, objective, risk, control, test, finding and action) framework. Built-in report generator. Simple user interface and web-based! Flexible for internal control, SOX compliance, ISO 27001, PCI DSS, Internal Financial Controls, and many more. Workpapers can be attached at all levels, to an audit, process, objective, risk, control or test. Worried about reliability or budget? Use the free and open-source community version. MIT license is provided. We can host the community version for you! Envelop is a risk and audit management tool.

IsoComplete is a market leading, cloud based solution that helps to manage Quality, Safety and Risk effectively and simply. A web-based solution that can be accessed anytime, anywhere, IsoComplete is a comprehensive digital solution that supports all aspects of an organizations quality management. IsoComplete helps you to meet the major ISO standards as well as PSA and SIA standards, SOX and CMMi.

Starting Price:£1500 per year

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

QT9's comprehensive cloud-based quality management software platform enables you to access real-time analytics in one unified suite. QT9 QMS makes it easy to automate ISO & FDA Compliance with 21 CFR Part 11 Electronic Approvals. Optimize processes for Document Control, CAPA's, Audits & More in one unified platform.Centralize records across multiple sites with ease. Never miss a deadline with automated email alerts/reminders. QT9 QMS makes quality management easy.Digitally transform Life Sciences, Biotechnology, Medical Device Manufacturers, Pharma, Aerospace and Food companies with user-friendly web portals for unlimited scalability.Get a free product tour! Start a Free 30-Day Trial. Visit QT9qms.com

Starting Price:$1600/year

IsoMetrix is an award-winning risk management software developer, providing state-of-the-art solutions for EHS, ESG and GRC management. For over 25 years, global companies have trusted IsoMetrix to manage their environmental, health, safety, and sustainability risks. IsoMetrix believes that proper management of governance, risk and compliance provides powerful and wide-reaching benefits. It is good for our planet, and the people and communities we work and live with. It also leads to more profitable and resilient businesses. In helping our customers to do good, we also help them do well. With offices in the USA, Canada, UK, Australia, and South Africa, we are well-positioned to provide international companies with support across the globe. Trusted by the world’s best known companies for over 25 years. Recognized as a leader in environment, health and safety (EHS) software by an independent analyst firm.

Starting Price:$34000.00/one-time

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

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.

ISO Standards such as 9001, 18001, 27001 and others are available within a system for Audit purpose. Standards can be saved as templates and can be reused for future audits. Internal and third-party audits are required by ISO 9000 and by additional ISO standards. The auditor can perform an offline audit from their smartphone. The auditor can customize the questions and tooltips to suit their needs. An auditor can upload evidence in form of images, comments, documents and video. NiftyISO comes with native apps for iPhone and Android. This allows auditors to perform an offline audit in remote areas. Once the internet is available Audits can be uploaded to a central database. Audit reports are available to be printed in PDF format and can be easily customized. The system allows management to generate KPI reports for a number of audits performed and non-conformances.

Starting Price:$9 per month

The 27k1 ISMS is a total, ISO 27001 compliance solution, wrapped into an intuitive, easy to use, low cost system. The software moves away from spreadsheet-based processes, making compliance and certification easy for both implementers and end customers. The software leverages the end customers Document Management System, pointing to policies, supporting documents, evidence etc through the use of URL's/Hyperlinks, thereby saving massive duplication and cost.Version 7 of the software, launched in April, 2022 includes the new, ISO 27002:2022 controls, allowing users to choose the control set on which they want to base their ISMS. They system delivers a single, "go-to" solution for ISO 27001 compliance, certification and continuous improvement.

Starting Price:$2,500/annum - 5 user system

COMPLYment provides a unified dashboard for managing & tracking the various relevant IT compliance standards to help organisations achieve the desired compliance level.This solution combines pre-audit consulting services and expertise of GRC experts within Skillmine to streamline your compliance needs. It includes 12+ prepacked standards like PCI, ISO, HIPAA, SEBI, SAMA, GDPR, NIST and 650+ controls designed to simplify the IT & Cyber Compliance management workflow with real-time visibility.COMPLYment provides features like:1. IT GRC Environment Design2. Pre-packed Content (PCI, RBI, SEBI, SAMA, ISO 20007, HIPAA, and more,covering more than 650+ controls in total).3. Federated Data Library for Effective IT Compliance4. IT Risk & Cyber Policy Management5. IT and Cyber Compliance and Control Assessments6. Continuous Control Monitoring and Real-Time Visibility

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

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

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.

Soaring cyber-attacks emphasize the need for organizations to look forward and see what is coming ahead. A formal Risk Assessment helps entities to disclose vulnerabilities and build a robust security architecture. While assessing risks is highly recommended for organizations to gain insights into the evolving cyber threats, automated risk assessment tools simplify the job for businesses. With the right Risk Assessment tool, organizations can save 70 – 80% of efforts to conduct risk-related activities and concentrate on critical tasks. SISA being a PCI Risk and Compliance expert for more than a decade, identified the challenges faced by organizations in anticipating risks and built SISA Risk Assessor, an intuitive Risk Assessment solution. SISA’s Risk Assessor is the first PCI Risk Assessment tool in the market, built based on world-renowned security methodologies, including NIST, OCTAVE, ISO 27001, and PCI DSS risk assessment guidelines.

SaaS and On-Premise solutions to empower risk identification, improve risk communication and create a risk aware culture. IRIS Intelligence Risk Management software helps you to deliver company strategy more effectively. Our tool improves risk communication, increases visibility of both risks and mitigations and improves decision making through automated reports and return on investment calculations. Best Practice Risk Management Processes Swiftly embed from ISO 31000, the PMBoK, ISO 27001 or government risk guidance. Checklists and Brainstorming prompts as recommended by the International Risk Governance Council available at your fingertips. Criteria are flexible enough to adapt to any environment but ensure consistency of assessment within each register. Quantify your risk exposure using robust statistical techniques rather than simple estimation procedures (for those that need it).

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.

BarnOwl is a fully integrated governance, risk management, compliance and audit software solution used by over 200 organizations in Africa, Europe and the UK. BarnOwl supports best practice risk management, compliance and audit frameworks (e.g. COSO, ISO31000, Generally Accepted Compliance Practice Framework (GACP), International Professional Practice Framework (IPPF)), whilst offering a highly flexible and configurable parameter-driven system allowing you to configure BarnOwl to meet your specific requirements. BarnOwl Risk Management software helps you achieve your strategic objectives and enables a culture of risk planning and control with accountability and ownership throughout your organization. Continual monitoring of your risk universe gives you comfort and confidence in managing your business. BarnOwl Compliance software allows you to import the various acts, legislation, policies and procedures that you are required to comply with, link these to associated risks.