Alternatives to ins2outs
Compare ins2outs alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to ins2outs in 2026. Compare features, ratings, user reviews, pricing, and more from ins2outs competitors and alternatives in order to make an informed decision for your business.
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Propel
Propel Software
Propel is a cloud-native platform that unifies PLM, QMS, and PIM in one connected system, giving manufacturers complete visibility and control across the entire product lifecycle. It provides a single source of truth for product data, streamlines change management, strengthens quality and compliance, and accelerates time-to-market by eliminating silos. With real-world AI use cases and enterprise-grade security, Propel helps organizations reduce errors and improve cross-functional alignment. Agentic AI accelerates change reviews, surfaces BOM and quality risks, enriches product information, and guides decisions—while role-based permissions and audit trails protect IP. From design through manufacturing and commercialization, Propel empowers companies to deliver innovative, high-quality products faster with greater confidence. Each module deploys independently with no required dependencies. -
2
Carbide
Carbide
Carbide is a tech-enabled service that strengthens your company’s information security and privacy management capabilities. Our platform and expert services are tailored for companies aiming for a sophisticated security posture, particularly valuable for organizations that must meet rigorous compliance requirements of security frameworks like SOC 2, ISO 27001, HIPAA, GDPR, and more. With Carbide, you can benefit from continuous cloud monitoring and the educational resources of Carbide Academy. Our platform supports over 100 technical integrations, enabling efficient evidence collection and meeting of security framework controls necessary for passing audits.Starting Price: $7,500 annually -
3
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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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 -
5
Qualityze EQMS Suite
Qualityze
Qualityze is a leading provider of cloud-based Quality Management System (QMS) and Enterprise Quality Management Software (EQMS) solutions built natively on the Salesforce platform. Designed to streamline quality processes, ensure regulatory compliance, and drive operational excellence, Qualityze empowers organizations to manage CAPA, audits, document control, training, change management, risk management, and supplier quality within a unified, scalable ecosystem. Focused exclusively on quality and compliance, Qualityze delivers purpose-built QMS and EQMS solutions without distractions from unrelated custom development. Our platform enables organizations across life sciences, manufacturing, and other regulated industries to simplify compliance with global standards while improving visibility, traceability, and accountability. Qualityze fosters a true culture of quality by making enterprise quality management intuitive, user-friendly, and collaborative.Starting Price: $30/User/Month -
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6clicks
6clicks
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. -
7
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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ARMATURE Fabric
ARMATURE
With ARMATURE Fabric™ you can manage your accreditation, certification, credentialing, audit, quality, and compliance activities within a single platform. Our software enables you to save time, operate more effectively and securely, and better serve your stakeholder communities. Whether you are managing institutional, programmatic, or specialized accreditation programs; certifying individuals, products, or organizations; conducting audits or assessments; or resolving non-conformances or other issues, ARMATURE Fabric can make it easier and more efficient for you and your stakeholders. Our secure, cloud-based software allows you to collect data in multiple ways (through online applications, audits, assessments, self-evaluations, inspections, forms, and surveys); manage your accreditation, certification, audit, and compliance workflows; capture and manage documents and artifacts, identify and remediate issues; generate reports; and spot new trends. -
9
Vanta
Vanta
Thousands of fast-growing companies trust Vanta to help build, scale, manage and demonstrate their security and compliance programs and get ready for audits in weeks, not months. By offering the most in-demand security and privacy frameworks such as SOC 2, ISO 27001, HIPAA, and many more, Vanta helps companies obtain the reports they need to accelerate growth, build efficient compliance processes, mitigate risks to their business, and build trust with external stakeholders. Simply connect your existing tools to Vanta, follow the prescribed guidance to fix gaps, and then work with a Vanta-vetted auditor to complete audit. -
10
Proliance 360
Proliance
Proliance is a compliance management platform that helps organizations simplify data protection, information security, AI governance, and regulatory compliance requirements. The company combines software solutions with support from certified experts to assist businesses in meeting standards such as GDPR, NIS2, ISO 27001, ISO 42001, DORA, and the EU AI Act. Its platform provides audit readiness tracking, risk management tools, documentation workflows, employee training, and compliance monitoring capabilities. Proliance offers services including external data protection officers, information security management systems, AI compliance consulting, vulnerability assessments, and whistleblower system management. The platform is designed to reduce manual compliance work through automation while helping organizations maintain legal and regulatory requirements. -
11
Mycroft
Mycroft
Mycroft is an end-to-end security and compliance platform built to get companies CMMC certified and turn security busywork into work done for them. It combines a security and compliance stack with AI Agents that operate like teammates, helping teams achieve enterprise-grade security without the overhead of managing multiple tools, endless checklists, or a massive internal team. Mycroft identifies CUI boundaries, creates required documentation, including SSP and POA&M, implements controls, configures the security stack, collects evidence, and supports compliant SPRS score submission on a continual basis. Its integrated platform supports CMMC, SOC 2, GDPR, HIPAA, PCI, FedRAMP, ISO 27001, ISO 42001, CPRA/CCPA, PIPEDA, and other frameworks, with cross-mapping designed to reduce unnecessary overhead. For audits and compliance, Mycroft provides a security frameworks dashboard, custom controls, automated tests, evidence collection, real-time dashboards, integrations, monitoring, etc. -
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qmsWrapper
qmsWrapper
qmsWrapper is an interconnected Quality Management Software for startups and small businesses. It helps all companies that want to increase productivity with ISO 9001:2015 and MedDev creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820. At qmsWrapper, we cater to each industry’s unique quality management needs with tailored features: Compliance Made Easy: Adhere to standards like ISO 13485 and ISO 9001 effortlessly, maintaining a robust QMS. Risk Management: Simplify risk assessment with ISO 14971-compliant tools, effectively mitigating risks. Document Control: Intuitively manage documents for enhanced traceability and version control. Cloud-Based Accessibility: Access your QMS anytime, anywhere. Electronic QMS: Embrace efficiency with digitized QMS for faster approvals and real-time updates. Audit Management: Prepare for audits confidently with scheduling, tracking, and reporting tools.Starting Price: $500/month/10 users -
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Orcanos
Orcanos
Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation. -
14
CyberManager
IRM360
Time and cost-saving. Easy set-up & management, intuitive and user-friendly. Subscriptions suit your objectives and organization. Integrated management systems for cyber security, information security, privacy & business continuity. The CyberManager management system gives you full insight and control of an ISMS according to the ISO 27001, NEN 7510, or e.g. BIO norms, and is in line with the certification requirements. Tasks with clear deadlines can be assigned in a focused and often recurring manner, saving you time and money. Everyone, from information security officers, audit managers, or task users, know what to do! With the PIMS integrated with the ISMS, you can manage your AVG/GDPR requirements from within CyberManager. From the dashboard, you have instant insight into the level of compliance with, for example, the AVG or standards such as ISO 27701. Connects to the cyber security concepts identify, protect, detect, respond and recover.Starting Price: €1,850 per year -
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Scytale
Scytale
Scytale is an AI GRC platform supported by a team of dedicated GRC experts, designed to help organizations achieve and maintain compliance across more than 80 security and privacy frameworks, including SOC 2, ISO 27001, ISO 42001, PCI DSS, GDPR, HIPAA, and SOX ITGC. The platform and its multi-agent suite centralize GRC workflows by automating evidence collection, continuous control monitoring, user access reviews, vendor risk management, policy management, and audit preparation within a unified platform. Scytale also provides penetration testing, AI security questionnaires, and customizable Trust Center solutions to help organizations strengthen security transparency and maintain continuous compliance. Built for organizations at every stage, from fast-growing startups to established enterprises managing complex GRC programs, Scytale combines AI-powered automation with dedicated GRC expertise to help organizations reduce manual effort, streamline operations, and scale -
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Perium
Perium BV
Perium; the most user-friendly platform for complete risk management Perium is the all-in-one platform for risk management. In no time at all you will be equipped with an intuitive and flexible system for risk management and reporting. From now on, meet all standards for security, privacy, and digital resilience. Protect the data of your employees, customers, suppliers, and your organization quickly, simply, and smartly with Perium. Standards available (new ones added all the time): ISO27001, ISO27002, BIO, NEN7510, NTA7516, NEN7512, NEN7513, ISO27701, HKZ, ISO9001, ISO50001, DigiD, DNB Good Practice, BIC, ISQM, PCI-DSS, Suwinet, Wpg, IBP Onderwijs, NIS2 Directive, DORA, PIMS, ISMS, NCSC Handreiking, NIST CSF, NIST AI, NVZ Gedragslijn, Cloud Control Matrix, Horizontaal ToezichtStarting Price: $500 -
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ISMS.online
Alliantist
Compliance and control for multiple certifications, standards and regulations including ISO 27001, ISO 27701, ISO 22301 and GDPR. A pre-configured ISMS offering up to 77% progress for ISO 27001 the minute you log on. All the help you need with Virtual Coach, Assured Results Method, live customer support and an in-built knowledge base. We’ve developed a series of intuitive features and toolsets to save you time, money and hassle. With ISMS.online you can quickly achieve ISO 27001 certification and then maintain it with ease. Forget about time consuming and costly training. Our Virtual Coach video series is available 24/7 to guide you through. Save time with our pre-configured asset inventory – specifically compiled to reflect the most common information assets in ISO 27001 – or add your own. Assign team members to input and review details and track progress. You can even identify priorities based on the risk and financial value of your assets. -
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risk3sixty
risk3sixty
Work with us to assess your program with a seamlessly integrated audit. Get help building framework-based programs for SOC, ISO, PCI DSS & more. Outsource your compliance program and focus more of your time on strategy. We bring the right technology, people, and experience to eliminate security compliance pains. Risk3sixty is ISO 27001, ISO 27701, and ISO 22301 certified. The same methods we employ with our clients allowed us to become the first consulting firm to obtain all three certifications. With over 1,000 engagements under our belt, we know how to audit, implement, and manage compliance programs. Visit our comprehensive library of security, privacy, and compliance resources to help you level up your GRC program. We help companies with multiple compliance requirements certify, implement, and manage their program at scale. We help staff and manage the right-sized team so you don’t have to. -
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Compleye
Compleye
Welcome to the world’s most user-friendly compliance platform, with a 100% certification success rate among internally audited clients. Discover the most user-friendly compliance platform, seamlessly supporting ISO 27001, ISO 9001, ISO 27701, and SOC 2 frameworks for easy and straightforward adherence to industry standards. Achieve GDPR compliance for your company in no time. Our structured roadmap, a dedicated platform for evidence management, and collaborative strategy sessions with a seasoned privacy expert create a holistic and customized experience. Clients passing our internal audit have consistently achieved certification afterward. Internal audits identify risks, enhance operational efficiency, and ensure regulatory compliance. By answering a couple of questions you’ll know exactly how ready you are for external audit and you’ll be able to see a snapshot of what’s missing. We offer a range of compliance modules that you can mix and match to create a solution that works for you.Starting Price: €149 per month -
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XGRC Product Range
XGRC Product Range
An Information Security Management System (ISMS) is a set of policies and procedures implemented by organizations to manage information risks such as cyber attacks or data theft. ISO 27001 is the auditable international standard that requires a company to establish, implement and maintain best-practice information processes via its ISMS. As with any other compliance standards, ISO 27001 follows the plan-do-check-act (PDCA) cycle. An accredited certification to ISO/IEC 27001 is essential to demonstrate world-class information security standards to customers and potential clients. An ISO 27001-certified ISMS helps to protect your organization against information security threats like cyber attacks, data leaks or theft. Also, effective security measures minimize the financial and reputational damage that can result from weak security policies and catastrophic data breaches. -
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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 -
22
Sekorti
Sekorti
Sekorti--> Enterprise Trust, Built in Minutes. Scan your domain and get a live security report with attack paths. Build a free Trust Center. Answer security questionnaires, RFPs, DDQs, and SIG, CAIQ, and VSAQ frameworks in seconds with AI. Prove SOC 2, ISO 27001, GDPR, ISO 42001, and EU AI Act readiness, without spreadsheets, without delays, without losing deals. Sekorti is the security trust platform for B2B SaaS teams who are tired of losing enterprise deals to compliance friction. 📍 Copenhagen, DenmarkStarting Price: $25/month -
23
Copla
Copla
Copla is a compliance automation platform designed to help organizations manage complex regulatory requirements more efficiently. The platform supports frameworks such as DORA, NIS2, ISO 27001, SOC2, and other security and governance standards. Copla automates tasks like evidence collection, control monitoring, and policy generation to reduce the manual workload involved in compliance management. By continuously monitoring systems and collecting documentation automatically, the platform ensures businesses remain audit-ready at all times. Copla also cross-maps controls across multiple frameworks, allowing companies to complete compliance work once and apply it to several standards. In addition to automation, the platform provides guidance from experienced CISOs who help organizations build effective compliance strategies. Through a combination of expert support and intelligent automation, Copla enables companies to meet regulatory requirements with less effort and greater confidence. -
24
QCBD
CAMA Software
Quality Collaboration By Design (QCBD) is a fully integrated quality management software solution designed specifically for manufacturing businesses. This affordable, Windows-based application reduces the cost of achieving and/or maintaining compliance with quality management standards such as ISO 13485, ISO 9001, TS 16949, AS9100, and SQF 2000 / ISO 22000. QCBD by CAMA Software offers a host of modules for training management, supplier management, process deviations, document control, equipment management, and more. -
25
Maiky
Maiky
Maiky is an AI-driven governance, risk, and compliance (GRC) tool designed to help organizations automate security and compliance workflows, reduce manual tasks, and maintain real-time visibility across risk and control frameworks. It unifies governance, risk, compliance, and customizable workflows into one system that makes risks instantly visible, prioritizes mitigation, and supports continuous monitoring and evidence collection without fragmented spreadsheets or manual reporting. Maiky enables users to automate repetitive tasks, collect and validate evidence, and prepare audit-ready reports with minimal effort, transforming compliance into a proactive, ongoing process instead of a periodic scramble. Its flexible architecture lets workflows run locally or in the cloud and adapt as businesses grow, with pre-built templates and controls mapped to standards such as ISO 27001, SOC 2, NIS2, DORA, HIPAA, and more, reducing duplication and supporting multiple frameworks simultaneously.Starting Price: €250 per month -
26
Validfor
Validfor
Validfor is a secure, modular digital validation platform that centralizes the entire validation lifecycle on a single, paperless system. Designed specifically for regulated industries, Validfor enables efficient validation while ensuring full compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11. The platform supports electronic records and advanced electronic signatures with full audit trails, role-based workflows (Author, Reviewer, Approver), and complete CSV compliance. All documents and records are securely managed in a centralized repository, capturing every change with full traceability to protect data integrity and Quality Assurance. Validfor offers integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, enabling seamless impact assessments, CAPA tracking, Computer Software Assurance (CSA), and audit-ready lifecycle management. -
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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 -
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Cyberday
Cyberday
Cyberday splits chosen frameworks (e.g. ISO 27001, NIS2, DORA, ISO 27701) down to prioritized security tasks and guides you in implementing them directly inside Microsoft Teams. Set your goals by activating your most relevant frameworks from our library. Requirements are instantly turned into policies you can start implementing. Choose the first theme and start evaluating how your current measures cover requirements. You’ll quickly see your starting compliance and understand the gap. Tasks are proven to be implemented (for auditors, top management, or your own team) through assurance information. Assurance info differs according to task type. With the report library's dynamic templates, you can create the desired summaries of cyber security with "one-click". Once you have a clear plan, you can start improving it smartly. You can utilize our tools for risk management, internal auditing, and improvement management to get better every day.Starting Price: €680 per month -
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ACE Essentials
PSC Software
Reduce risk with ACE Essentials, the pre-validated Electronic Quality Management System (EQMS) software created for all highly regulated industries. ACE Essentials comes equipped with 10 workflows built in and all the necessary Standard Operating Procedures and Policies, resulting in a fully compliant quality management system from the beginning. Understand the risks associated with your assets with ACE Essentials features including a full audit trail tracking every single action in the system. Pre-Configured Workflows. Pre-Configured Event Management (Due Dates, Scheduling and Reminders). Pre-Configured Permission-Based Security. Full Documentation Pre-Configured. 50+ Documents. Multiple Site Capability. Free Upgrades Throughout the Life of the Product. Pre-Configured Tasks List. No Validation Time. Pre-Configured In-System Notifications. Pre-Configured Email NotificationsStarting Price: $500 one-time payment -
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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. -
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Veeva Vault QualityDocs
Veeva Systems
Providing automated workflows and comprehensive audit trails, Vault QualityDocs reduces compliance risk and improves quality processes. It accelerates review and approval processes and facilitates the sharing of SOPs and other GxP documents among employees and partners. Automated workflows and visibility into the content status and processes enable effective SOP management, reducing compliance risk. Intuitive, easy-to-use user interface drives adoption and efficiency. Detailed audit trails, content organization, and powerful search facilitate better audits and inspections. Securely access and use documents from any major web browser, or if enabled, print, distribute, and track controlled PDF copies. Predefined document taxonomy, metadata, and pick lists for quality, manufacturing, and validation documents facilitate operational harmonization and allow organizations to quickly adopt best practices. -
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27k1 ISMS
27k1
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 -
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Cetbix GRC & ISMS
Cetbix
In three steps, you can achieve information security self-assessment, ISO 27001, NIST, GDPR, NFC, PCI-DSS, HIPAA, FERPA, and more. Cetbix® ISMS strengthens your certification. Information security management system that is comprehensive, integrated, documents ready and paperless. Cetbix® online SaaS ISMS. ISMS software from Cetbix®. Other features include IT/OT Asset Management, Document Management, Risk Assessment and Management, Scada Inventory, Financial Risk, Software Implementation Automation, Cyber Threat Intelligence Maturity Assessment, and others. More than 190 enterprises worldwide rely on Cetbix® ISMS to efficiently manage information security and ensure ongoing compliance with the Data Protection Regulation and other regulations. -
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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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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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Virje
Virje
Virje complies with the requirements of 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. Overwhelmed by the thought of Part 11 software validation? Accessible from wherever you are, for whenever you work. Eliminate paper, reduce cost, and increase efficiency with automation and centralized collaboration. Perfect for small to medium-sized businesses. Built from the ground up specifically for medical device quality management. A system that is flexible enough to adjust to your workflows and processes, without having to compromise. Configurable change order approvals by employee role and by document type. Notifications to responsible personnel at every stage in the change process. Ability to designate material dispositions for individual documents. Easy access to released and historical versions of documents. Quick viewing of document change history. Tracking of where-used locations and distributed hard copies. Periodic document review notification. -
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Matrix Connect
MatrixOne
Matrix Connect (formerly Galen Data) eliminates the complexity and high cost of building medical device cloud connectivity from scratch. It provides a purpose-built, secure, and compliant infrastructure that allows engineering teams to connect devices to the cloud in weeks rather than months. Highly scalable and fully configurable, the platform features pre-built compliance frameworks (including ISO 13485, IEC 62304, HIPAA, GDPR, and FDA/EU MDR standards) to eliminate regulatory friction. It bridges the gap by letting teams monitor real-time data, integrate with EHR/EMR systems, and scale deployments seamlessly while maintaining end-to-end data security.Starting Price: $500 -
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Akitra Andromeda
Akitra
Akitra Andromeda is a next-generation, AI-enabled compliance automation platform designed to streamline and simplify regulatory adherence for businesses of all sizes. It supports a wide range of compliance frameworks, including SOC 2, ISO 27001, HIPAA, PCI DSS, SOC 1, GDPR, NIST 800-53, and custom frameworks, enabling organizations to achieve continuous compliance efficiently. The platform offers over 240 integrations with major cloud platforms and SaaS services, facilitating seamless incorporation into existing workflows. Akitra's automation capabilities reduce the time and cost associated with manual compliance management by automating monitoring and evidence-gathering processes. The platform provides a comprehensive template library for policies and controls, assisting organizations in establishing a complete compliance program. Continuous monitoring ensures that assets remain secure and compliant around the clock. -
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Sprinto
Sprinto
Replace the slow, laborious and error-prone way of obtaining SOC 2, ISO 27001, HIPAA, GDPR & PCI DSS compliance with a swift, hassle-free, and tech-enabled experience. Unlike generic compliance programs, Sprinto is specifically designed for cloud-hosted companies. SOC 2, ISO 27001, HIPAA, GDPR & PCI DSS have different implications for different types of companies. This is why generic compliance programs end up giving you more compliance debt and less security. Sprinto is specifically built to suit your needs as a cloud-hosted company. Sprinto is more than just a SaaS tool, it comes baked in with security and compliance expertise. Compliance experts handhold you in live sessions. Custom designed for your needs. No compliance cruft. 14 session, well-structured implementation program. Sense of clarity & control for the head of engineering. 100% compliance coverage. No evidence is shared outside Sprinto. Compliance automation for policies, integrations and all other requirements. -
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DHC VISION
DHC Business Solutions
We offer solutions for companies with a high demand for quality. Our software solutions inspire with a modern UX, useful functionality, high modularity, and consistent compliance. Integrated solutions for quality management and quality assurance. Focused on the digitization of controlled documents and QA processes. Solutions specifically designed to meet the needs of the financial industry for the written rules of procedure, management of policies, and the control of information security. The cloud-based, pre-validated solution to automate your validation processes and to digitally control and manage validation documents. Early set-up of a digital QMS with a dedicated solution for startups and young companies. Based on DHC VISION. It can be used out of the box with immediate compliance and no license costs. Together, we digitize quality management and quality assurance processes and ensure regulatory compliance. -
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Almond
Almond
Almond is a professional, cloud-based, quality management software for healthcare companies. The software enables computerized management of the quality processes in compliance with regulatory requirements. The system maintains a document audit trail, and full document indexing and ultimately achieves documented evidence of all QMS processes. Manage your suppliers seamlessly through the electronic organization of certificates and agreements; all information is concentrated in one place. Assign permission to your suppliers to perform training, required by your system at their premises, using your quality system. Receive automatic email notifications before supplier certification expires. An electronic control dashboard allows you to be updated at any time on the status of the project. Create as many logbooks as you need, with no budget considerations or storage restrictions. Automatic conversion to effective after training completion. -
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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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Compliance Aspekte
expertree consulting GmbH
Compliance Aspekte is an intuitive and easy-to-use GRC solution for compliance management. The Compliance Aspekte SCM tool helps SMBs and large enterprises from different business domains implement ISMS and DSMS to comply with any standard, be it general or industry-specific. The solution supports GDPR, TISAX, ASPICE, B3S, ISO 9001, ISO 1400, ISO 22301, ISO 27001, ISO 27019, ISO 31000,BSI IT Grundschutz and counting. It’s a perfect fit for companies that want to: - receive more than just a compliance solution: - combine ISMS and DSMS; - have the support of any standard; - get an affordable pricing model; - use modern UX and UI; - have a flexible and customizable GRC tool.Starting Price: €55/user/month -
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Neumetric
Neumetric
Certification without automation is almost impossible, and compliance should be inexpensive to be effective. Security and compliance are an ongoing journey that needs to be enabled by a reliable partner. Certification is an orderly & organized journey, success begins with a well-planned roadmap. Good execution along all security tracks and automation speeds up reaching milestones. With Neumetric, complex compliance is made easy and is supported by security experts, so you can reduce the need for in-house experts. Neumetric streamlines compliance management with its centralized task management system, simplifying adherence to regulations such as GDPR and ISO certification by consolidating tasks onto one platform. It enhances tracking, ensures effective administration & prepares organizations for diverse regulatory requirements. Simplifies document creation & management across domains, particularly beneficial for systems like ISMS, automating tasks and providing a centralized dashboard. -
45
Secfix
Secfix
Secfix has been leading the security compliance market, helping hundreds of small and medium-sized businesses and startups achieve ISO 27001, TISAX, GDPR, and SOC 2 compliance with a 100% audit success rate. Our mission is to simplify security compliance for SMBs and startups across Europe. Secfix was born from a clear realization - Small and medium-sized businesses were struggling with outdated, costly, and inefficient methods of achieving security compliance. By combining automation with hands-on expertise, Secfix empowers SMBs and startups to achieve ISO 27001, TISAX, NIS 2, SOC 2, and GDPR compliance faster and easier. Secfix is powered by a growing, diverse team of experts committed to helping SMBs achieve compliance. -
46
Carizma QM
Axicos
Carizma QM is a web-based software that supports users in managing the entire lifecycle of regulated documents from authoring, review, approval and release to archiving. Creation and management of regulated documents, e.g. SOPs. Integrated workflows for review and approval. Automatic start of training workflow, read and understood upon approval. Electronic signature – 21 CRF part 11 compliant. Display of users who have read and understood. Validated and audit trail. Supports users to manage the entire lifecycle of regulated documents within Carizma-QM itself. The author defines key information e.g. document type (SOP, work instruction, form, checklist, etc.), title of document, process owner (department), groups of users to whom the document is applicable, review cycle. Users are defined in due time by e-mail when a document needs to be reviewed. Carizma creates the skeleton document. -
47
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 -
48
otris privacy
otris software
Control your data protection management with otris privacy, the software solution for internal and external data protection. The system simplifies the ongoing review of all relevant processing operations and guides the structured implementation of measures. Through process automation, otris privacy increases efficiency in analysis, documentation and communication. The implementation of and compliance with the EU Data Protection Regulation (GDPR) is an indispensable part of modern corporate governance. However, a high level of data protection can only be achieved if the topic is not perceived as a burden in the company. Processes and workflows must not be disrupted and employees must not be hindered in their actual work. otris privacy supports internal and external data protection officers in automating and standardizing data protection processes. With the software, you optimize data protection-relevant processes such as the review of processing operations/processing contracts. -
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QUMAS EQMS
Dassault Systemes
To bring new products to market as quickly as possible in compliance with global regulations, organizations need to standardize and automate their business processes that manage the collection, tracking and analysis of information and the resolution of related issues. QUMAS EQMS (formerly ProcessCompliance) is a cloud-based solution for Enterprise Quality and Process Management that delivers comprehensive integrated regulatory, quality and compliance management capabilities in a validated QMS environment. QUMAS’s data-centric approach allows you to flexibly manage quality content and to access and re-use all quality data, providing comprehensive visibility into Quality. QUMAS’s interactive quality dashboards provide QMS overview across business areas and quality initiatives. Reports are available for export, email and scheduling. QUMAS allows QMS departments to exchange information securely, efficiently and compliantly in the cloud. -
50
TrackWise
Honeywell International
Honeywell's TrackWise Digital® is a cloud-based Quality Management System (QMS) designed to help organizations efficiently manage quality and compliance processes. Leveraging nearly three decades of industry experience, it offers integrated modules that support various quality management aspects, including document control, training management, and corrective and preventive actions (CAPA). The platform incorporates advanced digital technologies such as artificial intelligence and machine learning to provide actionable, real-time insights, enabling proactive quality management. Its flexible, modular architecture allows for seamless integration with existing enterprise systems, facilitating rapid deployment and scalability. By streamlining quality processes and ensuring compliance with industry standards, TrackWise Digital® empowers organizations to bring products to market faster while minimizing risk.Starting Price: $200 per month
