Best ISO Compliance Software for Microsoft 365

Qualio is a purpose-built quality and compliance platform for life sciences companies operating in complex, high-stakes regulatory environments. Medical device, SaMD, biotech, and pharma teams use Qualio to replace fragmented eQMS tools, spreadsheets, and consultant-driven audits with a single, validated system that delivers continuous audit and inspection readiness. Qualio combines a modern eQMS with Compliance Intelligence—an AI-driven layer that continuously evaluates how well real operating data aligns with regulatory requirements. Instead of treating audits as one-off events, teams gain always-on visibility into compliance coverage, risk exposure, and readiness across FDA, ISO, EU MDR, GxP, and software-intensive standards. Core quality workflows—document control, training, CAPA, change management, supplier quality, and design controls—are directly connected to regulatory obligations and objective evidence. Deep integrations with Jira, Azure DevOps, GitHub, TestRail, and Salesforce automatically capture proof from development and operational systems, eliminating manual evidence gathering and reducing compliance drag on engineering teams. Compliance Intelligence runs multi-standard gap analysis in under an hour, flags emerging risks before they become findings or 483s, and maps reusable evidence across frameworks to accelerate submissions and market expansion. All insights are explainable and traceable back to specific clauses and internal policies, supporting validation and audit expectations. The result: audit readiness in weeks instead of months, fewer fire drills, faster launches, and lower long-term compliance cost. Qualio turns compliance from a reactive burden into a predictable, scalable system.

Create a simple, efficient Quality Management System (QMS). You can install on your local server, or use our Cloud QMS solution. ISO 9001:2015 requires risk-based thinking. Risk Assessment: Failure Modes Analysis (FMEA) Implement risk-based strategies for ISO 9001, ISO 14971. Identify failure modes for each item or process. Identify the effects and severity. Identify the causes and frequency. Identify current controls and detection levels. Multiple actions should be taken in response to this failure mode. Assign owners and due dates. Establish verification and validation criteria. Management approval can be obtained by electronic signature. User login: Define passwords and privileges. Rich set of reports. Track open actions and delinquent due date. Microsoft Access is free to download. To further analyze the data, export it to Excel. Common, easy-to-use software platform

Ostendio is the only integrated security and risk management platform that leverages the strength of your greatest asset. Your people. Ostendio is the only security platform perfected for more than a decade by security industry leaders and visionaries. We know the daily challenges businesses face, from increasing external threats to complex organizational issues. Ostendio is designed to give you the power of smart security and compliance that grows with you and around you, allowing you to demonstrate trust with customers and excellence with auditors. Ostendio is a HITRUST Readiness Licensee.

OpenText CloudAlly Backup is a comprehensive cloud-to-cloud backup and recovery platform designed to safeguard business-critical SaaS data across dozens of applications. It automates multiple daily backups with immutable storage, enabling organizations to restore data instantly at the file, folder, mailbox, or full-environment level. Customers can choose between CloudAlly’s global AWS S3 storage or bring their own cloud storage, offering flexibility for governance and compliance requirements. The platform supports full metadata capture, unlimited exports, advanced search, and easy point-in-time restores, making recovery fast and intuitive. CloudAlly’s enterprise-grade security includes encrypted storage, multi-factor authentication, strict compliance certifications, and globally distributed data centers. Its Partner Portal provides MSPs and resellers with centralized subscription management, white-label options, and consolidated reporting. As a pioneer in SaaS backup since 2011, CloudAlly has earned a reputation for reliability and continuous innovation. By preventing data loss and ensuring audit-ready protection, it empowers organizations to operate confidently in the cloud.

AuditBoard, the cloud-based platform that transforms how enterprises manage risk, is the leader. Its integrated suite provides easy-to-use compliance, audit, and risk solutions that streamline internal audit, SOX compliance management, controls management and risk management. AuditBoard's clients include Fortune 50 companies and pre-IPO companies that are looking to simplify, improve, and elevate their functions. AuditBoard is the highest-rated GRC and audit management system on G2 and was recently ranked by Deloitte as the third fastest-growing North American technology company.

SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry. SimplerQMS 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, and ICH Q10, among others. The system is fully validated according to GAMP5. The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more. SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel. Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.

Netwrix Auditor is a comprehensive IT audit software platform that helps organizations monitor and analyze activity across their IT infrastructure. It provides detailed visibility into who is accessing systems, what changes are being made, and how data is being used. The platform supports a wide range of systems, including Active Directory, Microsoft 365, file servers, databases, and network devices. It delivers near real-time alerts to help security teams detect suspicious behavior and respond quickly to potential threats. Netwrix Auditor also identifies risks such as excessive permissions and unusual access patterns that could lead to security incidents. The solution includes prebuilt compliance reports for standards like HIPAA, PCI DSS, and SOX, making it easier to meet regulatory requirements. It automates routine auditing tasks, reducing the time and effort required for reporting and analysis. The platform offers powerful search capabilities that allow teams to investigate incidents efficiently. It centralizes audit data from multiple sources into a single interface for better visibility. Netwrix Auditor integrates with existing IT systems and security tools to enhance overall monitoring capabilities. By combining auditing, reporting, and threat detection, it helps organizations strengthen their security posture and maintain compliance.

BPAQuality365, a QMS software, can be used in your secure Microsoft 365 cloud. It leverages tools used daily by collaborators and does not require you to change your user habits. It is modern, compatible with all devices, adaptable to your specific needs, and powered through innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, process and process maps, incident, change, risk, FMEA, SWOT, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app integrates with Teams discussions and users can ask the QMS while chatting in Teams and share QMS card with their colleagues. You can go further to achieve your Quality 4.0 goals by combining powerful AI features with best-in-class workflow automation and business intelligence. BPA's Microsoft Preferred status allows you to customize your QMS to meet your needs, share knowledge with your power users, and learn about M365 technologies.

Utilize your Microsoft 365 account to seamlessly incorporate SharePoint, Outlook, Teams, Dynamics, Azure, and Power BI for a comprehensive compliance experience. By taking advantage of Microsoft Power Automate and Power Flow, you can integrate compliance controls directly into your workflows. Your data remains securely within the Microsoft ecosystem, providing peace of mind. Explore how a software solution can facilitate the adoption of a streamlined management system recognized within your organization. ISOPlanner allows you to embed all necessary compliance requirements into the Microsoft tools you already utilize. You can easily enhance Microsoft 365 with additional lightweight features. The highly effective functionalities will undoubtedly bring a sense of satisfaction and clarity, enabling you to focus on your tasks. With ISOPlanner integrated within Microsoft 365, there's no need to switch to a separate tool, fostering collaboration with colleagues in a single, centralized platform. This efficient approach makes implementing ISO standards more straightforward and faster than ever before, ensuring that your compliance journey is as smooth as possible.

Are you a risk or quality manager in search of a powerful solution to your problems? ISO2HANDLE gives you superpowers to control your quality, safety and HR processes. ISO2HANDLE can be used by businesses in any industry. Our software provides capabilities such as risk and resource management, complaint management (including task management), risk assessment, registrations and notifications, document management (including audits), onboarding, evaluations of employees, expense claims, leave requests, and environmental measures. You can generate reports with just one click. This makes audits easy. We are proud to support hundreds of companies around the world from our base in the Netherlands.

Qualtrax is a quality and compliance software program that can manage and control documentation, automate key business processes, streamline training management, manage external and internal audits, and ensure that critical industry regulations are met in real time. Qualtrax is a valuable resource in highly-regulated industries where compliance with standards such as ISO 17025 and 17020, 13485 and 9001, TNI and GFSI, FDA and FQS are required.

You can now gather a vast amount of evidence within minutes by leveraging a multitude of plugins designed to adhere to various compliance frameworks such as SOC 2, PCI, ISO, and SOX ITGC, as well as customized internal audits, making it simple to fulfill your compliance needs. The platform consistently aggregates and organizes pertinent data into standardized, credible evidence while providing enhanced visibility to facilitate optimal collaboration across teams. Our solution is not only swift and user-friendly, but you can also initiate your free trial right away. Say goodbye to tedious compliance tasks and embrace a SaaS platform that automates evidence gathering and grows alongside your organization. For the first time, gain continuous insight into your compliance standing and monitor audit activities in real time. With Anecdotes' cutting-edge audit platform, you can deliver an unparalleled audit experience to your clients and set a new standard in the industry. This innovative approach ensures that you stay ahead in compliance management, making it easier than ever to meet regulatory demands.

Secureframe simplifies the path to SOC 2 and ISO 27001 compliance for organizations, ensuring a smart approach to security as they grow. Achieve SOC 2 readiness in just weeks instead of months, eliminating the confusion and unexpected hurdles often associated with the process. We are committed to making best-in-class security transparent throughout, with straightforward pricing and a well-defined process so you always know what to expect. Time is precious, and that's why we eliminate the hassle of gathering vendor data and manually onboarding employees by automating countless tasks for you. Our user-friendly workflows allow your staff to onboard themselves effortlessly, significantly saving you valuable time. Maintaining your SOC 2 compliance is simple with our timely alerts and reports that inform you of any critical vulnerabilities, allowing for swift resolution. We provide comprehensive guidance for addressing each issue, ensuring you can rectify problems correctly. Furthermore, our dedicated team of security and compliance experts is readily available, with a commitment to responding to inquiries within one business day or less. Partnering with us not only enhances your security posture but also allows you to focus on your core business operations without the compliance burden.

Drata is the most advanced security and compliance platform in the world. Its mission is to help companies win and maintain the trust of their customers, partners and prospects. Drata assists hundreds of companies in ensuring their SOC 2 compliance. It does this by continuously monitoring and collecting evidence. This results in lower costs and less time spent on annual audit preparations. Cowboy Ventures, Leaders Fund and SV Angel are among the backers of Drata, as well as many industry leaders. Drata is located in San Diego, CA.

Intellicta, an innovative solution developed by TechDemocracy, is a groundbreaking tool that offers a comprehensive evaluation of an organization's cybersecurity, compliance, risk, and governance. This unique product can foresee possible financial repercussions stemming from risks associated with cyber vulnerabilities. Intellicta equips senior business leaders, even those without technical backgrounds, with the knowledge to assess and quantify the effectiveness of their current cybersecurity and compliance strategies. Furthermore, the platform can be tailored to satisfy the distinct needs of each organization. It utilizes measurable metrics derived from well-established frameworks such as ISM3, NIST, and ISO to deliver effective solutions. With its open-source design, Intellicta compiles and scrutinizes every aspect of an enterprise's individual ecosystem, allowing for seamless integration and ongoing monitoring. Additionally, it is capable of retrieving essential data from various environments, including cloud-based, on-premises, and external systems, thereby enhancing its utility for diverse organizational structures. This versatility makes Intellicta a vital asset for companies striving to bolster their security posture in an ever-evolving digital landscape.

Your cybersecurity requirements are distinct, necessitating tailored solutions. We guide you through every phase of your assessment, compliance, and insurance experience, ensuring you never feel lost. While your goal might be to secure compliance with industry standards like SOC2 or ISO27001, the journey is broader and more dynamic. At Trava, we equip you with advanced tools to help close the gap between your current position and your goals, empowering you to evaluate risks, address the most critical vulnerabilities, and mitigate risks through insurance options. Our user-friendly platform enhances your understanding of security and risk factors related to potential clients, enabling insurance carriers to make more educated policy decisions, often resulting in more competitive quotes. Achieving compliance is a vital element of an all-encompassing cybersecurity strategy. At Trava, we are dedicated to supporting you throughout your compliance journey, helping you expand your service portfolio, boost your revenue, and establish yourself as a reliable strategic ally for your clients. In addition, our commitment to innovation ensures that you stay ahead in an ever-evolving threat landscape.

Strac is a comprehensive solution for managing Personally Identifiable Information (PII) and safeguarding businesses from compliance and security risks. It automatically detects and redacts sensitive data across platforms such as email, Slack, Zendesk, Google Drive, OneDrive, and Intercom. Additionally, it secures sensitive information by preventing it from ever touching servers, ensuring robust front-end and back-end protection. With quick integration into your SaaS tools, Strac helps eliminate data leaks while ensuring compliance with PCI, SOC 2, HIPAA, GDPR, and CCPA. Its advanced machine learning models, real-time alerts, and seamless redaction features save time and enhance productivity for your team.

Scrut is a comprehensive AI-powered GRC platform designed to help organizations manage risk, security, and compliance in a more intelligent and automated way. It provides real-time insights into an organization’s security posture by monitoring risks across infrastructure, applications, employees, and third-party vendors. The platform automates key processes such as control monitoring, evidence collection, and audit preparation, reducing the burden of manual work. Scrut offers a library of pre-built compliance frameworks, policies, and templates, enabling faster implementation and continuous compliance. Its AI-powered teammates provide guidance for remediation, risk assessments, and compliance tasks, helping teams resolve issues quickly. The platform also supports customizable workflows, allowing businesses to tailor their security programs to their unique needs. With seamless integrations, Scrut connects with existing tools to streamline operations and improve collaboration. It enables organizations to manage multiple compliance frameworks simultaneously without redundancy. The system ensures audit readiness by continuously tracking compliance status and validating evidence. Overall, Scrut empowers organizations to move beyond basic compliance and build a proactive, scalable security program.

Kertos revolutionizes the way data protection translates into compliance. Meeting legal obligations and automating compliance workflows has never been simpler. We empower organizations to achieve comprehensive compliance, allowing you to concentrate on your core business activities. Our no-code platform and unique REST API facilitate the seamless integration of both internal and external data sources, including your proprietary databases, SaaS applications, and third-party services. With our discovery feature, you receive immediate compliance insights and automated categorization of data processes that easily fit into essential documents such as RoPA, TIA, DPIA, and TOMs. By using Kertos, you can enhance your compliance initiatives, ensure ongoing audit readiness, and access daily insights into data protection while utilizing our dashboard for predictive analytics and effective risk management. Uncover your data framework, fulfill regulatory requirements, automate your privacy tasks, and simplify reporting for maximum efficiency. Ultimately, Kertos empowers you to manage compliance effortlessly and stay ahead in a rapidly evolving regulatory landscape.

Secfix has emerged as a frontrunner in the security compliance arena, assisting numerous small and medium-sized enterprises, as well as startups, in attaining vital certifications such as ISO 27001, TISAX, GDPR, and SOC 2, all while maintaining a flawless audit success rate. Our goal is to make security compliance more accessible for SMBs and startups throughout Europe. The inception of Secfix stemmed from the recognition that small and medium businesses were often hindered by outdated, expensive, and ineffective approaches to security compliance. By merging innovative automation with expert guidance, Secfix enables these businesses to achieve compliance with ISO 27001, TISAX, NIS 2, SOC 2, and GDPR in a more efficient and straightforward manner. Our dedicated and diverse team of professionals plays a crucial role in ensuring that SMBs navigate the complexities of compliance with ease, fostering a supportive environment for their growth and security. Together, we are transforming the landscape of security compliance for smaller enterprises.

OneClickComply serves as a comprehensive platform for cybersecurity compliance, streamlining the entire compliance process from the deployment of technical controls to ongoing monitoring, audit preparation, and the generation of necessary policies and documents. It accommodates prominent compliance frameworks, including SOC 2 Type II, ISO/IEC 27001:2022, Cyber Essentials (and Plus), as well as CIS Controls v8. With its innovative one-click feature, it identifies and resolves configuration problems across a vast array of technical controls, ensuring compliance with minimal manual intervention. Once set up, OneClickComply provides round-the-clock surveillance of your systems, promptly identifying or correcting deviations to reduce audit risks and maintain continuous compliance. Additionally, it includes a variety of functionalities such as automated IT and security policy creation through its “AutoComplete Policies” module, vendor risk management capabilities, vulnerability assessments, penetration testing, asset management, and systematic evidence gathering to further enhance your security posture. This multifaceted approach not only simplifies compliance but also strengthens overall cybersecurity resilience.

An audit without acrimony? Compliance without crisis? Yes, we are talking about that. All of your favorite information-security frameworks, including SOC 2, ISO 27001 and PCI DSS are now worry-free. We can help you with all your challenges, whether it's a last-minute compliance for a deal or multiple frameworks for expanding into new markets. We can help you get started quickly, whether you're new to compliance, or you want to reboot old processes. Let your team focus on strategy and innovation instead of time-consuming evidence gathering. Thororpass allows you to complete your audit from beginning to end, without any gaps or surprises. Our in-house auditors will provide you with the support you need at any time and can use our platform to develop future-proof strategies.