Best ISO Compliance Software in Asia

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.

Carbide is a tech-enabled solution that helps organizations elevate their information security and privacy management programs. Designed for teams pursuing a mature security posture, Carbide is especially valuable for companies with strict compliance obligations and a need for hands-on expert support. With features like continuous cloud monitoring and access to Carbide Academy’s educational resources, our platform empowers teams to stay secure and informed. Carbide also supports 100+ technical integrations to streamline evidence collection and satisfy security framework controls, making audit readiness faster and more efficient.

The HYPERSECURE Platform by DriveLock is designed to fortify IT systems against cyber threats. Just as securing your home is a given, protecting business-critical data and endpoints should be seamless. DriveLock’s advanced security solutions ensure full lifecycle data protection, combining state-of-the-art technology with deep industry expertise. Unlike traditional security models that rely on patching vulnerabilities, the DriveLock Zero Trust Platform proactively prevents unauthorized access. With centralized policy enforcement, only authorized users and endpoints gain access to essential data and applications—strictly adhering to the never trust, always verify principle.

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 and 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.

6clicks offers a straightforward solution for establishing your risk and compliance program, ensuring adherence to various standards such as ISO 27001, SOC 2, PCI-DSS, HIPAA, NIST, and FedRamp, among others. Numerous organizations rely on 6clicks to effectively automate their risk and compliance initiatives, facilitating processes like audits, vendor risk assessments, incident management, and policy enforcement. Users can effortlessly import standards, regulations, and templates from a vast content library, leverage AI-driven tools to minimize manual effort, and connect 6clicks with over 3,000 familiar applications. Designed to cater to businesses of all sizes, 6clicks is also utilized by consultants through a premier partner program that includes the option for white labeling. Founded in 2019, the company has expanded its presence with offices located in the United States, the United Kingdom, India, and Australia, continually evolving to meet the needs of its diverse clientele.

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

Runecast is an enterprise IT platform that saves your Security and Operations teams time and resources by enabling a proactive approach to ITOM, CSPM, and compliance. Your team can do more with less via a single platform that checks all your cloud infrastructure, for increased visibility, security, and time-saving. Security teams benefit from simplified vulnerability management and regulatory compliance, across multiple standards and technologies. Operations teams are able to reduce operational overheads and increase clarity, enabling you to be proactive and return to the valuable work you want to be doing.

Intellect's QMS software has been proven to improve quality operations and reduce overall quality cost by up to 40%. Our apps were designed by certified quality professionals and can be easily customized with our no-code platform or drag-and-drop technology. Remote access for your team, mobile apps, dynamic workflows, analytics, reporting, and remote access are all possible with this modern and simple solution. Apps include Document Control and Employee Training, Audit Management CAPA, Nonconformance, as well as other useful features.

GRC solution for technology-focused SMBs and Enterprise Information Security Teams. StandardFusion eliminates the need for spreadsheets by using one system of record. You can identify, assess, treat and track risks with confidence. Audit-based activities can be made a standard process. Audits can be conducted with confidence and easy access to evidence. Manage compliance to multiple standards: ISO, SOC and NIST, HIPAA. GDPR, PCI–DSS, FedRAMP, HIPAA. All vendor and third party risk and security questionnaires can be managed in one place. StandardFusion, a Cloud-Based SaaS platform or on-premise GRC platform, is designed to make InfoSec compliance easy, accessible and scalable. Connect what you do with what your company needs.

FaceUp is a web and mobile platform that serves as an online anonymous reporting software. Through FaceUp, anyone can open up anonymously about any issues or suggest ideas for improvement when something feels off. It's trusted by 3,700 organizations of all sizes around the world - over 10,000 reports have already been made through our platform. The software has a rich set of features including a customizable reporting form and advanced report management, both available in 113 languages. It is GDPR compliant and ISO 27001 certified. FaceUp is compliant with the EU Whistleblowing Direction and Whistleblower Protection Act. Try out FaceUp with a 14 day free trial. It can be set up within 5 minutes.

IsoComplete, a cloud-based solution, is the market leader in managing Quality, Safety and Risk. It helps you manage these three areas effectively and efficiently. IsoComplete, a web-based digital solution, can be accessed anywhere and anytime. It supports all aspects of a company's quality management. IsoComplete allows you to meet all major ISO standards, as well as PSA/SIA standards, SOX/CMMI and CMMi.

Delve is an innovative compliance platform powered by AI, aimed at simplifying and automating the acquisition and upkeep of crucial certifications like SOC 2, HIPAA, ISO 27001, GDPR, and PCI-DSS. It seamlessly integrates with a company's existing technology stack, including popular tools such as AWS, GitHub, and other internal systems, deploying AI agents that consistently monitor for compliance gaps while automatically collecting requisite evidence, thus alleviating the burdensome manual efforts usually tied to compliance activities. Among its features are AI-enhanced code scanning that identifies business logic flaws, daily infrastructure oversight, autofill capabilities for security questionnaires, and notifications for any unauthorized access attempts. Delve excels in providing a premium onboarding experience and offers dedicated support through Slack, ensuring that teams receive comprehensive assistance throughout their compliance journey. By catering to both startups and larger enterprises, Delve aims to significantly conserve time and resources by automating traditionally manual compliance processes, ultimately enhancing operational efficiency. This transformative approach not only streamlines compliance but also fosters a culture of continuous improvement in regulatory adherence within organizations.

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.

Take control of SOC2, ISO-27001, NIST, CSA STAR, or other Infosec certifications with a simple, easy-to-use, fully automated platform. ControlMap's smart mapping saves you hundreds of hours responding and assessing data requests. It automatically and continuously associates RISKS CONTROLS, POLICIES, AND PROCEDURES so that you don't have the task of responding to each request. ControlMap's integration with other ticketing systems like Jira makes it easier to use. Our Jira Marketplace App, Jira integration collects evidence, raises alerts, or simply creates tasks in other systems. You can eliminate any last-minute surprises. We have created a product that modern teams can use. Start with a free trial, or contact us to learn more.

RiskWatch compliance management solutions and risk assessment use a survey-based process. A series of questions about an asset are asked and a score calculated based on the responses. You can combine the survey score with additional metrics to value the asset, rate its likelihood, and assess its impact. Based on survey results, assign tasks and manage remediation. Identify the risk factors for each asset you evaluate. Receive notifications for non-compliance to your custom requirements and any relevant standards/regulations.

You can achieve ISO 27001, NIST, GDPR, NFC, PCI-DSS, HIPAA, FERPA and more in three steps. Cetbix® ISMS empowers your certification. An integrated, comprehensive, document-driven and paperless information security management system. Other features include IT/OT/Employees asset management, document management, risk assessment and management, scada inventory, financial risk, software distribution automation, Cyber Threat Intelligence Maturity Assessment and others. More than 190 organizations worldwide rely on Cetbix® ISMS to efficiently manage information security and ensure ongoing compliance with the Data Protection Regulation and other regulations.

Envelop is a document management, risk management, and audit workflow system. Envelop allows you to easily create and manage audits, risks, attach work papers, and create reports. Web application. Framework for Risk Management and Audits (process objective, risk, control. test, finding, and action). Built-in report generator. Web-based interface with a simple user interface Flexible for internal control, SOX compliance and PCI DSS. Internal Financial Controls. You can attach workpapers to any level, including an audit, process or objective, risk, control, or test. Are you concerned about budget or reliability? Use the free, open-source community version. The license is available under the MIT License. We can host the community version! Envelop is a risk- and audit management tool.

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.

Ignyte Assurance Platform, an AI-enabled integrated management platform, helps organizations in different industries implement simple, repeatable, and measurable GRC processes. This platform's main objective is to make it easy for users to keep up with and comply with cybersecurity regulations, standards, guidelines, and standards. The Ignyte Assurance Platform allows users to automatically monitor and assess how their organization is meeting the requirements of GDPR, HIPAA and PCI–DSS, FedRAMP and FFIEC. Security frameworks and regulations can be automatically mapped to the policies and internal controls they are implementing. The compliance management platform also provides audit management capabilities, which make it easy to gather and organize all the information required by external auditors.

ZenGRC is an innovative GRC platform that enables businesses to effectively manage their risk and compliance needs with ease. Designed with simplicity in mind, ZenGRC offers a unified system for storing and accessing all risk and compliance data, providing users with a secure and centralized platform. The solution’s AI automation helps businesses streamline their workflows and gain valuable insights, accelerating decision-making. ZenGRC integrates seamlessly with over 30 systems, ensuring maximum efficiency and minimizing manual effort. With customizable frameworks, flexible pricing, and a user-friendly interface, ZenGRC helps organizations achieve compliance and manage risks effortlessly. Trusted by global enterprises, ZenGRC’s commitment to security is certified by GDPR and SOC, ensuring data protection at the highest standards.

The GRC software you've been looking for: Onspring. A flexible, no-code, cloud-based platform, ranked #1 in GRC delivery for 5 years running. Easily manage and share information for risk-based decision-making, monitor risk evaluations and remediation results in real-time, and create reports with with KPIs and single-clicks into details. Whether leaving an existing platform or implementing GRC software for the first time, Onspring has the technology, transparency, and service-minded approach you need to achieve your goals rapidly. Our ready-made product products are designed to get you going as fast as 30 days. SOC, SOX, NIST, ISO, CMMC, NERC, HIPAA, PCI, GDPR, CCPA - name any regulation, framework, or standard, and you can capture, test, and report on controls and then activate remediation of risk findings. Onspring customers love the no-code platform because they can make changes on the fly and build new workflows or reports in minutes, all on their own without the need for IT or developers. When you need nimble, flexible, and fast, Onspring is the best software option on the market.

Enactia provides essential functionality that allows your organization to manage Data Privacy and Governance Risk and Compliance, efficiently and effectively, and to monitor compliance with ISO27001, ISO27701, GDPR, CCPA, PDPL, CITC SAMA, and other regulations.

Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance solution includes an extensive set of off-the-shelf ready eQMS and compliance pre-configured processes, enabling customers to deploy quickly and cost effectively. Dot Compliance ready to use solutions include full project validation services and product validation packages. Dot Compliance offers the industry’s most cost-effective quality and compliance management solution available, allowing users to quickly deploy flexible and scalable solutions. Automate core quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, Supplier Quality, and more. Our solution is fully configurable and offers seamless integration abilities, with easy adaptation and implementation of customer’s specific requirements.

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.

Databunker is a lightning-fast, open-source vault developed in Go for secure storage of sensitive personal records. Protect user records from SQL and GraphQL injections with a simple API. Streamline GDPR, HIPAA, ISO 27001, and SOC2 compliance. Databunker is a special secure storage system designed to protect: - Personally Identifiable Information (PII) - Protected Health Information (PHI) - Payment Card Industry (PCI) data - Know Your Customer (KYC) records Databunker introduces a new approach to customer data protection: - Secure Indexing: Utilizes hash-based indexing for all search indexes - No Clear Text Storage: Ensures all information is encrypted, enhancing overall security - Restricted Bulk Retrieval: Bulk retrieval is disabled by default, adding an extra layer of defense - API-Based Communication: Backend interacts with Databunker through API calls, similar to NoSQL solutions - Record Token: Databunker creates a secured version of your data object - an object UUID token that is safe to use in your database