Alternatives to Clearlane CAPA

AlisQI is a cloud-based Quality Management platform built for process and batch manufacturers who want to move beyond reactive firefighting toward stable, predictable operations while maintaining full compliance control. Rather than organizing quality around static documents and isolated events, AlisQI was designed as a data-first system. Quality, laboratory, and production data are structured and connected in a shared operational backbone. This gives cross-functional teams early visibility into deviations, faster response times, and greater confidence in product integrity and daily execution. The platform combines configurable quality modules, including document control, training, deviations, CAPA, audits, risk management, supplier quality, SPC, and EHS, with targeted, ready-to-use Solvers. Solvers integrate forms, workflows, dashboards, and business logic to address specific operational problems without unnecessary scope. Because the system is built on structured data, manufacturers can apply practical AI within workflows, from automated COA extraction to conversational access to quality data and pattern detection across incidents. Solvers are production-ready from day one and evolve as processes, products, or plants change. This progression does not require custom development or disruptive IT projects. Manufacturers use AlisQI to harmonize quality practices across sites, reduce waste and rework, strengthen audit readiness, accelerate root cause analysis, and connect shop-floor and lab data directly to quality decision-making across industries including chemicals, plastics, packaging, food and beverage, personal care, automotive, and industrial manufacturing.

isoTracker Quality Management is a popular cloud-based quality management software (QMS) system. It is used on a worldwide basis by businesses to manage their ISO 9001, ISO 13485, ISO 22000, ISO 17025, ISO 14001 systems...plus many others. It is a modular product which can be configured to meet an organization's specific requirements and is competatively priced with superg customer support. Any module combination of Document Control, Complaints, CAPA, Audits, Training, Non-Conformance and Risk can be subscribed to.

The SBS QMS Suite consists of 5 software modules that work together for efficient Quality compliance: 1) SBS Quality Database - CAPA / 8D corrective and preventive actions (CAR) with root cause analysis - Nonconformance management - Risk analysis including FMEA, SWOT, interested party risk register - Internal, customer, and third-party audit management - Environmental Health and Safety (EHS / HSE) management 2) SBS Ground Control - Employee training management (LMS) - Self-Paced training - Change control - Document control 3) SBS Asset Tracking Database - Calibrated equipment control - Preventive maintenance - Asset inventory management 4) SBS Inspection Database - Record incoming material, in process, and final product inspection data - Generate real time SPC charts - Inspection plans and Control Plans - Archive data for further statistical analysis 5) SBS Vendor Management - Maintain an approved vendor list or AVL - Develop vendor / supplier qualification plans - Maintain vendor / supplier qualification history Modules may be purchased separately or in any combination. On-premise and cloud-based options are available. Free demos are available for download or contact us for a cloud-based demo.

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.

TLM QMS Software is a powerful and robust quality, risk and material management software (QMS) which is validated and 21 CFR Part 11 compliant. TLM is a cutting-edge, all-in-one quality management system that can be customized to integrate with online CRM software, QuickBooks or ERP databases. Total Lean Management (TLM) QMS Software is specifically intended to be a low cost, highly integrated, flexible and continuously improving landscape to which specialty systems can be added where needed to create the digital business landscape that enables work flows the way your company needs them to work.

It is difficult to make data available and actionable when a manufacturing site has many processes. As operations grow, it is becoming more difficult to comply with safety, quality, and environmental regulations. Manufacturing is built on predictability and reliability. Manufacturing by nature is all in the execution of established processes. TenForce was built from the feedback of our clients to map the operational reality in a plant.

SimplerQMS is an expert-driven electronic Quality Management System (eQMS) purpose-built for Life Science organizations. Our eQMS is designed by professionals with deep industry experience and supports compliance with FDA, ISO, and GxP requirements through automated, audit-ready quality processes. The platform centralizes and automates core quality workflows within a cloud-based, fully validated system. Customers benefit from reduced manual work, fewer errors, and consistently organized, inspection-ready records. Unlike generic QMS tools, SimplerQMS comes pre-configured for Life Science needs, with built-in templates, workflows, and controls aligned with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other applicable standards. Beyond software, customers gain a trusted partner backed by deep regulatory and quality expertise. This includes: • Audit-proven insights • Guidance from compliance specialists • Continuous system validation • User training • 24/7 global support • Smooth implementation and data migration • Dedicated Customer Success Experts With a mission to help Life Science companies manage quality and regulatory documentation efficiently, SimplerQMS supports organizations from early-stage growth to global scale to strengthen compliance, operational control, and quality culture.

Qualityze delivers cloud-based Quality Management System (QMS) and Enterprise Quality Management Software (EQMS) solutions built natively on the Salesforce platform. Designed for regulated and compliance-driven industries, Qualityze centralizes and standardizes enterprise quality processes within a secure, scalable cloud environment. The platform supports CAPA management, audit management, document control, training management, change control, risk management, and supplier quality workflows through configurable automation and role-based governance. Real-time dashboards, advanced reporting, and end-to-end traceability provide full visibility across quality operations. Built to eliminate siloed systems and manual processes, Qualityze enables life sciences, manufacturing, and other regulated organizations to streamline compliance with global standards while improving operational efficiency and accountability. With seamless Salesforce integration and enterprise-grade scalability, Qualityze helps organizations modernize quality management, reduce compliance risk, and drive measurable continuous improvement across global teams.

Founded in 2004, Sunday Business Systems (SBS) specializes in providing quality management software and consulting services that help businesses comply with a range of ISO certifications like ISO 9001:2015 and ISO 13485. SBS’s product suite includes tools for document control, asset tracking, corrective actions, and preventive maintenance. Their cloud-based solutions are designed to simplify and automate key business processes, while their consulting services offer expert guidance for businesses aiming for ISO certification or requiring customized software for manufacturing or compliance needs.

Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals. QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations. Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included. Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com

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.

Qualcy Biomed QMS Software was designed for Bio-Medical businesses (including Biotech and Pharma) to manage QMS records in accordance with FDA and ISO13485 requirements. * Meets 21 CFR Part 820 requirements * Features include E-sign, audit trails, and compliance with 21 CFR part 11. This software manages Doc. Change control, complaints, audits CAPA, NC Records Training Records and many more.

Artintech ERP is a comprehensive enterprise resource planning solution designed to optimize and streamline your business operations across various departments. Tailored for small to medium-sized enterprises (SMEs), Artintech ERP offers robust functionality with a user-friendly interface, allowing businesses to seamlessly manage their resources, inventory, human capital, finances, and customer relations all in one integrated platform. Why Choose Artintech ERP? * User-Friendly Interface: Designed for ease of use, Artintech ERP minimizes the learning curve, ensuring a smooth transition and quick adoption across your organization. * Cloud-Based Flexibility: Access your ERP system anytime, anywhere, with our secure cloud-based solution, which provides the flexibility to manage your business on the go. * Comprehensive Support: Our dedicated support team is available to assist you every step of the way, from initial implementation to ongoing maintenance and updates.

MediaLab's Intelligent Quality Engine (IQE) solution is designed to deliver powerful automation for laboratory non-conforming event management processes. IQE eliminates the need for paper-based, manual investigation and CAPA processes while reducing cost and supporting the quality improvement program. IQE helps your laboratory follow corrective and preventive action standards as outlined by CAP, joint commission, ISO, and other accrediting bodies. You'll benefit from a streamlined approach that supports your regulatory compliance. Start by using our online form templates, or create your own. Allow employees to create events as problems arise. MediaLab will route your event through each phase of the event management lifecycle, from initial event description to risk analysis, closure, and change effectiveness evaluations. Your current processes and forms work beautifully in IQE.

FREE CAPA SOFTWARE — 2 USERS, FOREVER! No credit card, no setup fees, and no time limits. CAPA Manager is a cloud-based corrective and preventive action management system designed for engineering, manufacturing, and quality professionals. Investigate problems, identify root causes, and manage corrective actions using configurable 8D, A3, DMAIC, and PDCA workflows. Integrated 5 Why and 6M tools support structured root cause analysis, while automated notifications, action tracking, approval workflows, and audit trails help teams maintain accountability. CAPA Manager also offers configurable fields, interactive KPI dashboards, advanced reporting, data exports, and optional API and Single Sign-On (SSO) capabilities. Start free with two users and scale as your organization grows.

SolvoNext – NCR CAPA empowers small and medium-sized factories to replace outdated paper-based NCR and CAPA processes with a robust, digital-first solution. The platform guides teams through a structured workflow—starting with NCR initiation, moving through root cause analysis, recording financial data, and ending with secure approvals—all while maintaining a complete knowledge library. Interactive dashboards display key metrics like NCR status, departmental tracking, and monthly progress, helping leaders make quick, data-backed decisions. Its COPQ tracking feature calculates the financial toll of inefficiencies, waste, and defects, giving organizations a clearer view of quality performance. Built-in quality tools such as the 5 Whys and Fishbone diagrams make problem-solving systematic and collaborative. Users can assign role-based permissions, manage multi-level approvals, and receive automated alerts for faster communication. Optional AI integration enhances the platform with predictive analytics, advanced diagnostics, and automated reporting tailored to each plant’s needs. SolvoNext ultimately improves compliance, transparency, and operational efficiency across all manufacturing environments.

A web-based software suite for medical device companies that automates their processes and simplifies regulatory compliance. Modules include Audit Management, CAPA and Complaint Handling. Designed from the start for ISO 13485 compliance and 21 CFR Part 11 compliance.

Workflows are specifically developed to assist you in preparing all necessary components for a 510(k) submission, while also ensuring compliance with the quality record requirements set forth in 21 CFR Part 820 as you prepare to market your device. These workflows come equipped with tools to facilitate the drafting of essential policies, procedures, and work instructions. Furthermore, you can monitor non-conformances, deviations, and CAPAs through tailored quality management reports. As your processes evolve and enhance, you can ensure your team receives automatic training updates. The system also automates validation testing for devices, applications, websites, and custom software tailored to your business needs. This automation significantly reduces the time and resources that would otherwise be consumed by extensive testing, reporting, and approval processes. Additionally, you can compile all your policies, procedures, and artifacts into standard documents, making them readily available for audit evaluations. Overall, this solution streamlines the compliance and validation processes, thereby enhancing operational efficiency.

QualityKick is a cloud-based Quality Management System (QMS) tailored for the biological sciences sector, designed to enhance compliance and streamline various quality management processes. It offers a suite of modules, each addressing critical components such as document control, training, change management, incident tracking, CAPA (Corrective and Preventive Actions), risk evaluation, qualification, and supplier and equipment audits. Being a web-based platform, it ensures accessibility from any location and on any mobile device, including computers, smartphones, and tablets. New users benefit from an automated guided tour upon their initial login, facilitating a smoother onboarding experience. The system supports document editing with MS Word and enables a customizable review and approval workflow, enhancing collaboration and efficiency. Various event types, including deviations, nonconformities, and customer complaints, can be configured to suit organizational needs. Additionally, it allows users to establish CAPA plans, document necessary actions, and assess their effectiveness, making it a comprehensive solution for quality management in the pharmaceutical, biotechnology, and medical fields. With its user-friendly interface and robust features, QualityKick is poised to transform how organizations manage quality compliance.

The SBS Quality Database is a simple, inexpensive, ISO 9001 compliant software program that allows small businesses to efficiency manage the Quality Management System or QMS. The database tracks corrective actions, preventive actions (CAPA), internal audits, safety improvement, supplier corrective actions, continual improvement projects. Compile and analyze Customer Survey results. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Document interested parties as part of the Context of the organization. Use the dashboard for a quick view of the overall performance. Cloud based or locally installed options are available. The program is ideal for small businesses striving for ISO 9001:2015, API Q1, AS9100, or TS16949 compliance. Free demo downloads are available from our website so you may try before your buy.

TRACKMEDIUM is a cloud-based Quality Management System (QMS) software tailored for small to medium enterprises (SMEs), operating on a subscription model that offers a variety of modules such as Audit Management, CAPA, Document Control, Management of Change, Nonconformance Management (NCM), and Training Management. This platform empowers organizations to enhance product quality and safety, boost operational efficiency, and ensure adherence to industry regulations like ISO 9001, 14001, and OSHA, all while minimizing costs and mitigating risks. The Audit Management module of TRACKMEDIUM simplifies the audit process by allowing users to create standardized templates for audits and checklists, formulate comprehensive audit plans, carry out audits, pinpoint nonconformances and recommendations, manage CAPAs until resolution, and effectively report on findings. Additionally, TRACKMEDIUM's user-friendly interface and comprehensive support make it an ideal choice for businesses looking to integrate quality management seamlessly into their operations.

FactoryQA is a quality management software that can be used by manufacturers. Software Features 1. Management of Non-Conformance/CAPA 2. Document Control 3. Instructions for Work 4. Inspection sheets 5. Audits 6. Analytics Services: 1. ISO Certification Consultants 2. Workshops for ISO Certification 3. Fractional Quality Management Services

ZenQMS is an electronic Quality Management System (eQMS) built for life sciences and GxP-regulated organizations, including biotech, pharma, CROs, and CMO/CDMO organizations. The cloud-based, AI-enabled, fully validated platform 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 Corrective and Preventive Actions Deviations, non-conformances, complaints, issues, and other quality events Change controls Audit management Critical quality workflows Supplier and vendor management Electronic signatures with 21 CFR Part 11-compliance Risk management Quality metrics tracking and reporting

Software designed for ISO and BRC compliance fulfills the criteria of various management standards, such as ISO 9001, 14001, ISO 45001, ISO 27001, and the BRC benchmarks. It features a robust and user-friendly CAPA system that effectively documents continuous improvement initiatives, non-conformities, root cause analyses, corrective and preventive actions, and key performance data on losses. The software also ensures efficient version and change control for system documentation and regulated forms. Additionally, it implements location-based controls to restrict user access to documents based on their specific roles. There is a compliance evaluation tool that details the necessary compliance obligations, assigns departmental responsibilities, and provides guidance on adhering to legal and other relevant standards, applicable to both single and multiple standards, including ISO 9001, ISO 14001, ISO 45001, ISO 27001, and others. Furthermore, it simplifies the qualification, ongoing evaluation, and performance improvement of suppliers, service providers, and contractors through tailored risk management workflows, assessments, scheduled re-assessments, and focused action logs. This comprehensive approach ensures that organizations not only meet compliance standards but also foster a culture of continuous improvement and accountability.

IONI - AI Agents for Food & Beverage Compliance and Operations. Most food safety software gives you blank templates and expects you to fill everything in manually - every SOP, every CCP, every supplier certificate. That takes weeks. Or you hire a consultant to do it for you. IONI works the opposite way. Upload your existing documents: SOPs, recipes, HACCP plans, supplier certificates — and IONI's AI agents read them and automatically build your complete compliance system. Your HACCP plan. Your operator checklists. Your supplier certificate tracker. Configured to your actual operation, not a generic template. Who it's for IONI is built for QA Managers, Production Managers, and operational founders at food and beverage manufacturers, co-packers, brands, and ingredient suppliers. If you're preparing for a certification audit, onboarding a new retail account, or maintaining ongoing compliance - and you don't have months to spend on manual setup - IONI is built for your situation. The platform supports any food safety standard or retailer requirement: SQF, BRCGS, FSMA, CFIA, FSSC 22000, GMP, and private requirements from retailers like Whole Foods, Walmart, Costco, and Sprouts. Available globally.

QFacts is a comprehensive cloud-based Quality Management System designed specifically for pharmacies, compounding facilities, and other regulated sectors. It encompasses the entire quality lifecycle, featuring controlled document management with versioning and approval workflows, training and competency tracking with curriculum-aligned assignments, as well as event and complaint management, root cause analysis, CAPA oversight, and change control, all accompanied by thorough audit trails. This system is built to comply with GAMP 5 and adhere to European GMP and GDP standards, employing role-based access controls that span organizations, locations, and departments. Quality managers can customize review workflows, keep track of due dates, and oversee compliance via real-time dashboards. Each action taken within the system is meticulously logged and traceable, providing inspectors and auditors with a transparent chain of accountability that extends from document approval through to the completion of training and the resolution of corrective actions. By ensuring such detailed oversight, QFacts significantly enhances the overall efficiency and reliability of quality management processes.

ExtraView serves as a comprehensive software solution designed for enterprises, focusing on business process management and global quality management systems, particularly in areas like CAPA, adverse event reporting, food safety, bug tracking, change management, and customer support. Users can choose between pre-built solutions or tailor their own specifications to meet unique needs. It can be deployed as a cloud service or installed on local servers, making it versatile for various operational environments. The platform is user-friendly, allowing for easy configuration while also supporting the implementation of fully validated systems for incident management, CAPA, adverse event reporting, root cause analysis, clinical trial data management, and food safety initiatives. Additionally, it facilitates the establishment of bug-tracking, customer support, requirements management, and other vital issue-tracking systems. A noteworthy aspect is that many users can benefit from a robust, free downloadable version of the software. Furthermore, financial organizations often utilize ExtraView to enhance their systems for auditing, ensuring corporate governance, and managing risks effectively. This adaptability makes it an essential tool for a wide range of industries looking to streamline their workflow processes.

QualityPro by TecWork is an 𝐞𝐧𝐭𝐞𝐫𝐩𝐫𝐢𝐬𝐞-𝐠𝐫𝐚𝐝𝐞 𝐰𝐞𝐛/𝐜𝐥𝐨𝐮𝐝-𝐛𝐚𝐬𝐞𝐝 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦 (𝐐𝐌𝐒) designed to help manufacturing, automotive, and regulated organizations digitize, automate, and scale quality operations with confidence. Built to eliminate disconnected spreadsheets and document-heavy processes, QualityPro unifies critical quality workflows into a single intelligent platform that delivers end-to-end compliance, workflow automation, and real-time operational visibility. The platform centralizes essential quality processes including Nonconformance and Deviation Management, 𝐂𝐨𝐫𝐫𝐞𝐜𝐭𝐢𝐯𝐞 𝐚𝐧𝐝 𝐏𝐫𝐞𝐯𝐞𝐧𝐭𝐢𝐯𝐞 𝐀𝐜𝐭𝐢𝐨𝐧𝐬 (𝐂𝐀𝐏𝐀), Complaint Handling, Audit Management, Document Control, Change Management, Risk Assessment, Training and Competency Tracking, Calibration, and Inspection Management. Configurable workflows, automated alerts, audit trails, and centralized dashboards help teams stay audit-ready while reducing manual effort and compliance bottlenecks. Designed for 𝐈𝐒𝐎-𝐜𝐞𝐫𝐭𝐢𝐟𝐢𝐞𝐝 𝐚𝐧𝐝 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞-𝐝𝐫𝐢𝐯𝐞𝐧 𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞𝐫𝐬, QualityPro supports global standards such as 𝐈𝐒𝐎 𝟗𝟎𝟎𝟏, 𝐈𝐀𝐓𝐅 𝟏𝟔𝟗𝟒𝟗, 𝐈𝐒𝐎 𝟏𝟑𝟒𝟖𝟓, 𝐚𝐧𝐝 𝐅𝐃𝐀 𝟐𝟏 𝐂𝐅𝐑 𝐏𝐚𝐫𝐭 𝟏𝟏. Whether operating as a single site or multi-location enterprise, organizations gain structured governance, improved accountability, and measurable quality performance improvements. QualityPro empowers leadership teams with actionable insights, strengthens regulatory compliance, reduces operational risk, and fosters a 𝐜𝐮𝐥𝐭𝐮𝐫𝐞 𝐨𝐟 𝐜𝐨𝐧𝐭𝐢𝐧𝐮𝐨𝐮𝐬 𝐢𝐦𝐩𝐫𝐨𝐯𝐞𝐦𝐞𝐧𝐭, transforming quality management into a strategic competitive advantage.

SoftExpert EQM stands out as an all-encompassing enterprise quality management software (EQMS) that aids organizations in obtaining and upholding ISO 9001 certification by automating and enhancing quality processes specifically designed for their unique products, operations, and business practices. This modular and adaptable platform integrates all essential quality initiatives, including process mapping and the management of documented information such as standard operating procedures, work instructions, and records, along with non-conformance reports, corrective and preventive actions, and quality indicators. Furthermore, the software efficiently oversees supplier relationships, addresses customer complaints, conducts quality audits, manages training and competencies, and evaluates quality risks and controls, as well as quality inspections and statistical process control, all of which contribute to a more agile and resilient quality management system. By streamlining these diverse functions, SoftExpert EQM empowers organizations to enhance their overall quality performance and compliance.

Clearlane Delivery is an application designed for Jira Cloud that facilitates the organization and monitoring of project activities. It features an intuitive drag-and-drop Gantt chart equipped with milestones, dependencies, and customizable working-day configurations. The app tracks the time spent in each Jira status and emphasizes tasks that exceed the team's typical completion rate. Monte Carlo simulations provide predictions for probable and safer finish dates for projects, releases, or epics, while budget views allow users to compare actual logged hours and expenses against planned budgets and anticipated final costs. Additionally, the application offers various Jira dashboard widgets that display metrics such as flow, throughput, cumulative flow, sprint burndown, velocity, work-in-progress aging, and cycle time. Teams have the flexibility to enable or disable different sections of the app and can utilize existing Jira data and permissions without needing to transfer work items. Clearlane Delivery is built on Atlassian Forge for Jira Cloud and supports users in their preferred language, including English, French, or German, ensuring a tailored experience for diverse teams. This comprehensive tool streamlines project management, enhances visibility, and aids in decision-making for more efficient workflows.

Clearlane Breach & Incident Reporting is a Jira Cloud application designed for teams handling GDPR personal data breaches as well as NIS2 or DORA incidents. This tool features a qualification workflow that documents the incident along with the time the organization became aware of it, subsequently calculating relevant reporting deadlines and monitoring the status within a register. Additionally, the application generates notification texts that can be easily copied into forms required by authorities, while also recording the submission dates and references, and it maintains a comprehensive evidence trail with signed decisions and PDF documentation; the breach register is also available for export in CSV format. It supports work items from both Jira and Jira Service Management, although it does not have the capability to submit notifications to authorities or perform legal assessments, nor does it include national authority forms. Operating on Atlassian Forge within the user's Atlassian site, the application is available in English, French, and German, making it accessible to a diverse range of users. Overall, Clearlane Breach & Incident Reporting streamlines the process of managing compliance and incident reporting for teams.

qmsWrapper is a connected Quality Management System (eQMS) built for medical device startups and SMEs. It helps organizations move from paper forms, Word documents, and spreadsheets to a scalable, AI-enabled QMS that grows with their business through Foundation, Lifecycle, and Vigilance. Designed for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects documents, quality events, risk, training, CAPA, technical documentation, and traceability in one platform. Best For: - Medical device and SaMD companies implementing or modernizing an ISO 13485 QMS. - Startups and SMEs that want to grow from controlled documents to connected quality workflows without replacing their QMS.

Clearlane CRA is a Jira Cloud application designed specifically for manufacturers and product security teams to facilitate the management of vulnerability reporting in accordance with the Cyber Resilience Act. This innovative tool transforms Jira's vulnerability and incident work items into comprehensive records that meet the Article 14 deadlines, while also preparing the necessary ENISA reporting fields for users to review and copy. Additionally, it efficiently tracks affected products and their respective versions utilizing CycloneDX or SPDX software bills of materials. Teams can document fixes, notify users, generate CSAF 2.0 security advisories, and maintain PDF evidence alongside Jira work items, ensuring thorough documentation. The application is available in English, French, and German, and operates seamlessly on the Atlassian Forge platform. Notably, the app does not directly submit reports to ENISA; instead, it enables users to evaluate their reporting obligations and submit through the designated authority's platform, empowering teams to take charge of their compliance processes. This flexibility allows organizations to stay proactive in managing their cyber resilience efforts.

Tollgate equips you with essential tools to oversee the financial aspects, scope, and timelines of your projects and portfolios directly within Jira, ensuring that these functions remain distinct from your agile delivery processes and do not interfere with Jira work items. You can develop a cash flow model while computing NPV and IRR efficiently. Moreover, it allows you to create work packages from cost components, establishing baseline costs, timelines, and scopes while linking them seamlessly to Jira work items, all without altering your product breakdown structure. Additionally, you can manage risks, decisions, and change requests without exiting Jira, enhancing workflow efficiency. The platform also enables the creation of portfolios that span multiple projects, providing a comprehensive view of total investments, associated risks, and more. Every action and decision made within the system is recorded in exportable audit logs, ensuring accountability. The RAG status and project reporting commentary are maintained and displayed on a single interface, eliminating the need for cumbersome monthly slide presentations. Furthermore, a custom "Ask Tollgate" agent powered by Atlassian Rovo offers in-depth insights across relevant Jira, Tollgate, and Confluence pages, with access governed by project membership and oversight groups, thereby enhancing data security and collaboration. This holistic approach not only streamlines project management but also fosters better-informed decision-making.

PaKalite serves as a comprehensive quality management system tailored for small to mid-sized manufacturers in the automotive and industrial sectors, adhering to standards such as IATF 16949, ISO 9001/14001/45001, AIAG (including PPAP, APQP, MSA, SPC), and VDA 6.3. The system comprises 17 interconnected modules, which include elements for PPAP (18 elements, PSW, MSA/GRR), phases for APQP (5 phases), various audit types (14 types, question bank, scoring, findings leading to CAPA), KPI scorecards (featuring targets, deviation alerts, and supplier ratings), as well as inspection and control plans (12 types, utilizing SPC Cp/Cpk, quarantine, and EN 10204 certifications). Additional modules facilitate calibration, drawing revision control, nonconformity management (NCR/8D), continuous improvement practices (like Kaizen and 5S), supplier quality assurance, management reviews, meeting tracking, HR competence and training, TPM maintenance, occupational health and safety, and document management. These modules work in synergy: for instance, an audit finding can initiate a corrective action, and persistent KPI deviations can automatically trigger responses. The platform operates in the cloud and is complemented by a Windows desktop client and an Android application designed for shop-floor use. Moreover, it supports PDF reporting, Excel data importation, role-based access permissions, and ensures data isolation per company, all while offering a free plan and featuring a Turkish interface for user accessibility. This comprehensive approach enhances operational efficiency and quality assurance across diverse manufacturing processes.

BizPortals QCFlow is a comprehensive Quality Management System (QMS) software designed to help organizations manage quality, ensure regulatory compliance, and support continuous improvement. The platform provides an integrated solution for CAPA management, document control, audit management, nonconformance management, risk management, training management, inspection management, and supplier quality management.

Quality Forward is an advanced cloud-based electronic Quality Management System (eQMS) tailored for organizations operating in stringent regulatory environments, facilitating the digitization, oversight, and automation of quality processes on a centralized platform. Leveraging the ServiceNow framework, it allows teams to efficiently manage essential workflows, including deviations, corrective and preventive actions (CAPAs), audits, complaints, change control, documentation, training, supplier quality, and risk management, ensuring comprehensive traceability and documentation that meets audit requirements. The system offers features like real-time monitoring and automated workflows, along with AI-generated insights that enhance compliance, minimize manual tasks, and boost operational efficiency throughout the product lifecycle. Additionally, it provides a highly customizable, no-code platform that empowers quality assurance teams to modify their processes in response to changing regulatory demands without the need for IT intervention, all while adhering to international standards such as FDA, ISO, and GxP. By integrating these capabilities, Quality Forward not only strengthens quality management but also fosters a culture of continuous improvement and agility within organizations.

Document Control is a document management system that supports controlled processes and practices in creating, reviewing, correcting and issuing documents. The QMS QISS is an ISO-based QMS QISS Software System that automates corrective action processes in regulatory environments. Your own risk-based thinking. To reduce and mitigate your risk, centralize. Standardized workflows allow you to keep track of all changes within your organization. You will enjoy many additional benefits from a paperless document management system. Establish a culture of continuous improvement and make sure that each non-conformance is visible.

Foodflou provides comprehensive visibility into suppliers for food companies while ensuring robust document management for all aspects of food safety and compliance. By consolidating CAPAs, NCRs, complaints, forms, inspections, audits, risk assessments, supplier questionnaires, and other related documents into a single, customizable platform, it eliminates the chaos of fragmented PDFs, spreadsheets, and shared drives that often lead to version control challenges and audit complications. This streamlined approach fosters clear accountability among teams and ensures that everyone has access to the latest information, while suppliers benefit from straightforward sharing and seamless data imports. With automated processes and user-friendly workflows, companies can effectively manage requirements and mitigate common audit risks. The quick onboarding process and centralized system empower organizations to enhance their food safety practices and uphold consistent performance in GFSI and BRCGS audits, ultimately leading to improved operational efficiency. This holistic solution not only elevates compliance but also fosters a culture of proactive quality management across the food industry.

IMSXpress is an innovative software solution designed for document control and quality management systems (QMS). Its user-friendly interface ensures a straightforward installation process, enhancing overall business efficiency while ensuring adherence to compliance standards. This comprehensive solution provides a wide range of modules, including but not limited to document distribution, control, internal audits, training, management reviews, Corrective/Preventive Action (CAPA), customer management, risk assessment, preventive maintenance, calibration of measuring equipment, and supplier oversight, among others. With such a diverse set of features, IMSXpress aims to address the varied needs of modern organizations looking to streamline their operations and improve quality management practices.

IMSXpress is an advanced platform designed for managing document control, ensuring regulatory compliance, and overseeing quality systems in alignment with ISO 13485 and FDA 21 CFR part 820 standards, incorporating features such as document distribution, control, CAPA management, complaint handling, auditing, training management, MDR processes, supplier oversight, and non-conformance product tracking among others. This state-of-the-art software can be deployed either as a local installation or through cloud hosting, and it is conveniently equipped with ready-made template manuals, procedures, employee training materials, and audit checklists to streamline implementation. Additionally, its intuitive interface enhances user experience, making compliance management more efficient than ever.

The most comprehensive suite of Health & Safety software solutions will streamline your processes and help you manage the risks. ProcessMAP helps companies achieve consistency and provides real-time insights to improve their Health & Safety performance. Standardize, streamline, and track the processes required to comply with various regulations and compliance frameworks. Built-in alerts, robust CAPA Management, and advanced reporting capabilities increase accountability and provide visibility across an organization. They also make it easier to be ready for inspections and audits. The correlation of safety and claims data can reduce risk. Analyze the root causes of claims and events to identify and mitigate risk. Our platform reduces risk by stopping claims from happening. The industry's best cloud platform for sustainability management and metrics reporting. Streamline the collection, verification and analysis of company-wide KPIs.

Enhance your quality compliance management through our secure, cloud-based solutions that streamline every aspect of your audits in a single platform. This includes features such as CAPA follow-ups, auditor CVs, real-time updates on audit statuses, and a comprehensive audit report repository, among other functionalities. Our platform facilitates seamless connections between customers, suppliers, and auditors, enabling centralized control across multiple sites. Gain access to an extensive audit database featuring over 2,300 audits, utilizing our shared audits model and pre-existing reports to eliminate the complexities associated with organizing new audits. Additionally, our supplier directory makes it easy to find both new and backup suppliers from a pool of over 24,000, offering the widest variety of products and services available in the industry. Qualify and choose the best partners effortlessly, with instant access to their most recent audit reports, compliance information, warning letters, and quality ratings. Moreover, experience the fastest onboarding process available in the industry, complemented by our weekly updates on observation ratings and CAPA performance metrics, ensuring you remain informed and compliant at all times. Don't miss out on the opportunity to revolutionize your quality compliance management with our innovative solutions.

Clearlane Tests integrates test management capabilities into Jira Cloud without introducing any new work item types. This tool allows for versioned test cases that encompass steps, test data, and expected outcomes, while also linking to the relevant requirement work items they address. Additionally, a coverage view functions as a traceability matrix, highlighting requirements that lack corresponding test cases. Users can plan campaigns for each version or sprint and execute tests step by step. Each test run meticulously documents the specific version of the test case, the pass or fail results, comments for each step, as well as the tester's information and date of execution. Should a step fail, it can instantly generate a Jira bug report that includes reproduction steps with a single click. Upon concluding a campaign, it is sealed with a fingerprint for added security. The app also offers optional electronic signatures that capture the name, date, time, and significance; any subsequent modifications will render the signatures invalid. Comprehensive PDF reports are generated, detailing the summary, coverage, results, and historical data of the tests. Moreover, users can import test cases from CSV files, facilitating seamless integration. This application supports teams in maintaining verification records in compliance with IEC 62304, ISO 13485, and 21 CFR Part 11 standards. Operating on Atlassian Forge ensures that all data remains securely within the customer’s Atlassian environment, providing peace of mind regarding data privacy.

SalesForge CRM revolutionizes Jira by turning it into a comprehensive hub for sales and relationship management. As a fully Forge-native application, it operates securely within the Atlassian environment, allowing both sales and project teams to collaborate seamlessly without the need to toggle between different platforms. Key Features & Capabilities - Management of Lead & Deal Pipelines - Comprehensive Contacts, Accounts & Customer Records - Built-in Email Functionality & Templates - Secure and Forge-Native Data Management - Enhanced Team Collaboration & Visibility With SalesForge CRM, teams utilizing Jira can effortlessly oversee their sales pipelines, customer interactions, and communications, all while remaining within the Jira framework. This integration of CRM functionalities into the Atlassian ecosystem eliminates the need for context switching, curbs the development of data silos, and synchronizes the efforts of sales with those of product and support teams. Consequently, users experience quicker onboarding, improved transparency, and a significant boost in both efficiency and revenue generation. Furthermore, the streamlined approach fosters better teamwork and ensures that all stakeholders are aligned toward common goals.