Alternatives to AutoSHEQ

Process Street is the Compliance Operations Platform built for teams that need to move fast without breaking standards. It combines document control, workflow automation, and AI-powered oversight in a single system so every policy is followed, every step is tracked, and every audit is effortless. Unlike legacy GRC tools or static SOP docs, Process Street turns compliance into a living system. Policies are documented in governed, version-controlled Pages. Those policies are executed through dynamic workflows with built-in task assignment, approvals, and forms. Every action is logged, monitored, and optimized in real time by Cora, our AI compliance agent. Used across industries like financial services, real estate, healthcare, and manufacturing, Process Street helps teams automate employee onboarding, streamline audits, manage policy updates, enforce vendor reviews, and run critical processes at scale. No code required. No micromanagement. Just proof that work gets done right, every time. Companies like Salesforce, Colliers, Drift, and Hartford Healthcare trust Process Street to eliminate busywork, improve operational visibility, and reduce compliance risk across the business. With native integrations, role-based access, audit trails, and ISO-aligned workflows, it is the platform that makes compliance a competitive advantage. From onboarding to audits, Process Street is how high-stakes teams enforce standards, automate execution, and prove compliance by default.

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.

Adaptive Compliance Engine® (ACE®) is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant. Our one-stop software includes: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And so much more! Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform. ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions.

SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry. SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5. The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more. SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel. Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.

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.

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.

DataLyzer SPC Qualis (a fully-integrated webbased statistical process control (SPC), software) simplifies the task of real-time data gathering, charting and analysis in any manufacturing operation. It provides powerful analysis, reports and dashboards, supports efficient data collection from any source, and delivers programmable shopfloor screens. The solution provides instant operator feedback, real time data entry, and audit traceability to IATF16949, VDA and RM13006 compliance. It has powerful features to be integrated with MES or ERP systems. DataLyzer Qualis integrates with DataLyzer Gage management for calibration and MSA and with DataLyzer FMEA software offering a complete APQP suite.

Adjust the fields to align with your organization's actual operations. Authorize permissions and establish your timelines. Take command of your documents. Assess your suppliers thoroughly. Develop a SWOT analysis. Create status reports for corrective actions, alongside fulfilling all requirements set by ISO standards. Receive timely reminders and notifications regarding approaching deadlines and newly assigned tasks, both via email and on the dashboard. Log comments and version histories to enhance tracking. It keeps a detailed record of creation, edits, and variations in collaboration processes. Oversee the planning, registration, and monitoring of processes, audits, and procedures. Attach relevant evidence and documentation as needed. This approach optimizes time, reduces costs, improves process visualization, and enhances interaction, providing methodologies for effective follow-up and prompt problem resolution. Embracing digital transformation in your management system through inblue QMS offers a range of advantages that can significantly enhance operational efficiency and compliance.

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

For more than a decade, our top-tier software has been instrumental in assisting businesses with enhancing safety and compliance. Featuring exceptional functionalities, an intuitive and customizable interface, and cloud-based solutions, Beakon stands out as one of the most advanced safety system providers available. The Safety Management software by Beakon is crafted based on the insights of leading organizations that have successfully managed and minimized workplace incidents. With Beakon’s Risk Register software, you can efficiently document and oversee the potential risks your organization may encounter. Additionally, our Task Management software is tailored to provide your business with versatile tools for assigning tasks, tracking progress, and ensuring that projects remain on schedule. Developed in consultation with our clients, the Task Management module employs straightforward interfaces to promote effective collaboration among all project participants; a united team is key to achieving optimal outcomes and maximizing returns for any business. Overall, Beakon's comprehensive suite of tools not only enhances operational efficiency but also fosters a safer working environment.

iPassport is an advanced software solution tailored for healthcare laboratories, aimed at enhancing the digitization, organization, and overall management of quality and compliance on a daily basis. This platform offers a comprehensive array of quality management modules, making it simple to oversee various aspects, from document control to employee training. All controlled documents are conveniently centralized, complete with designated access and editing permissions, alongside thorough revision histories. It encompasses everything necessary to manage both internal and external audits effectively. Users can record and oversee non-conformities, corrective actions, and incidents, while also managing staff training, competencies, tasks, meetings, and leave. Additionally, it features a robust supplier database and auditing tool that includes performance evaluations. The system also allows for efficient management and tracking of assets and inventory, including comprehensive maintenance records for equipment. With iPassport, healthcare laboratories can ensure operational efficiency and compliance with regulatory standards.

Document control made easy. You can create, review/approve and revise documents, as well as retire them. All transactions are recorded using e-signatures, timestamps, and stored in the Audit Trail. Audits from start-to-finish The SOLABS QM10 Audit APP allows you to track and document all aspects of your audits, from planning and preparation to closing. The SOLABS QM Essentials package offers advanced reporting capabilities and intuitive reporting. Trending and tracking are critical components of any quality management system. The dashboards and reports are easy-to-use, customizable, and can be shared in the most popular formats such as Excel, PowerPoint and PDF. You can share the reports and dashboards with anyone in your organization. In a matter of seconds, you can create, schedule, monitor, and assign training. Online assessments can be used to validate the learnings of your team. You can manage all aspects of training with the SOLABS QM Training section.

AQF is a sophisticated quality management software designed by experts in quality assurance. This comprehensive solution enables companies to completely abandon paper-based processes, facilitating seamless execution of all quality assurance activities. We provide a flexible, modular service that allows organizations to select a product tailored to their specific needs without incurring unnecessary expenses. The only essential module required for implementing additional features is the primary one. Not only does the AQF module enhance its own capabilities, but it also integrates well with any existing software or ERP systems your company may already have in place. You can easily create, manage, and share your internal controls, supplier audits, procedures, and documentation. Streamlining procedures among users is simplified, as it allows for the assignment of specific rights to regulate outgoing information. Additionally, it automates documentation requests to prevent any oversights. With the integration of Internet of Things (IoT) technology, you can effectively monitor and control environmental factors such as temperature and humidity, further enhancing your quality management processes. This holistic approach ensures that quality assurance is not only efficient but also adaptable to the evolving needs of your organization.

QSE SMART is a specialized software application for quality, safety, environmental, and risk management, tailored for small to mid-sized businesses and projects accommodating between 5 to 500 users. This application offers a robust framework that aligns with essential ISO standards such as ISO9001, ISO45001, and ISO14001, thereby streamlining the daily operations of your integrated QSE management system. By making ISO standards relevant to your business, QSE SMART enhances understanding and implementation. Built on a risk-based methodology in line with ISO 31000, it empowers organizations to gather and utilize critical data and metrics that align with their goals regarding quality, safety, environment, and risk management. This includes tracking objectives and targets, conducting management reviews, identifying risks and opportunities, managing non-conformities and improvements, performing audits and inspections, and addressing accidents, incidents, and hazards. Additionally, it covers corrective actions, equipment calibration, and the control of documented information, ensuring comprehensive oversight and continuous improvement in your organization's processes.

With a platform which puts you on cruise control, you can drive exceptional quality and process performances. E-Data Now® Audit & Quality Inspection Platform is a powerful tool that allows you to improve customer satisfaction, reduce safety concerns, and eliminate redundant processes. It includes all the tools needed to connect team performance, simplify checks, identify root causes of non-conformance and improve processes. E-Data Now! E-Data Now! is a cloud-based, no-code platform that provides insights into mobile data and automates workflows. Clearing out your paperwork will help you to reduce the amount of clutter in your audit process and identify any audit redundancies. The simple solution - a platform for creating custom forms and mobile data collection with digital tools designed for tradesmen: to train, record and capture, react, correct and schedule, comply, and build better processes.

Introducing a comprehensive online system for tracking welding and materials tailored specifically for small to mid-sized enterprises that require meticulous oversight of weld and material traceability throughout their manufacturing processes. This system is adaptable to incorporate various subcontracting fabricators, enabling seamless integration and tracking of each subcontractor's fabrication data. By meticulously recording, monitoring, and reporting on materials and welds, the system facilitates an in-depth analysis of every stage in the fabrication and assembly workflow, ensuring rigorous quality audits and assurance. Designed for accessibility, this system can be utilized anytime and anywhere—be it on the shop floor, in the office, or remotely via web-enabled devices—allowing you the freedom to monitor, track, and report in real-time, 24/7. With this innovative solution, organizations can enhance their operational efficiency and maintain superior quality standards without interruption.

CWA SmartProcess is a comprehensive software solution designed for effective business process management (BPM), focusing on workflow, process, and quality management. This online platform allows users to easily model, enhance, and share processes and documents from one centralized location. Additionally, CWA SmartProcess offers optional modules that cater to various needs, including measures, tasks, claims, complaints, and audits. By utilizing CWA SmartProcess, businesses can effortlessly convert their processes into automated workflows, fostering ongoing improvements and efficiency within their operations. Ultimately, this tool empowers organizations to streamline their processes and enhance overall productivity.

ZipQuality offers a software-driven service designed to aid medical device manufacturers in launching innovative products. Our collaborative platform adeptly manages swift design modifications for agile teams while upholding regulatory standards. With a pre-configured system that incorporates processes and tools, there’s no necessity to modify your existing quality system. The integrated platform efficiently accommodates rapid design iterations for product documentation. Our team of seasoned consultants supports your team throughout the entire process. Built on the robust ENOVIA platform, our comprehensive, scalable software tools are tailored to meet your needs. This integrated solution allows for quick design adjustments while ensuring that product documentation and data remain synchronized and that all records are maintained in a state ready for audits. We cover essential areas such as product, hardware, and software requirements. Our expertise extends to the complexities of software-heavy medical devices. The ZipQuality framework is founded on a structured documentation approach that enhances systems engineering, promotes effective risk management, and ensures transparent traceability, making it an invaluable asset for any medical device company. Additionally, our commitment to continuous improvement means we regularly update our service offerings to align with industry advancements.

Paradigm 3 is a comprehensive platform available for both web and desktop use, tailored to assist businesses with compliance management focusing on Document Control, CAPA Compliance, and Competency Tracking and Training. This software provides a variety of features, including an event manager for handling incident investigations and customer complaints, email-delivered task notifications, and tools for preparing audits, among others. Industries such as Healthcare, Manufacturing, Test Labs, and Service Industries greatly benefit from the functionalities of Paradigm 3. With this innovative solution, organizations can eliminate the need for multiple additional modules to fulfill their compliance requirements. The system consists of four primary modules equipped with over 50 standard forms designed to address all aspects of Quality, Safety, and Environmental management. Furthermore, our form designer empowers users to create customized forms or modify existing ones, ensuring that every specific need is met seamlessly. This flexibility in form design enhances the platform's utility, making it an indispensable tool for businesses striving for compliance excellence.

ACE Essentials is the pre-validated Electronic Quality Management System Software (EQMS) designed for highly regulated industries. ACE Essentials includes 10 workflows, as well as all the required Standard Operating Procedures (SOPs) and Policies. This ensures that your quality management system is fully compliant from the start. ACE Essentials features include a complete audit trail that tracks every action within the system. This allows you to understand the risks associated assets. Features of ACE Essentials Pre-Configured Workflows Pre-Configured Event Management (Due dates, Scheduling, Reminders) - Pre-Configured Permission Based Security - Pre-Configured Full Documentation - 50+ documents - Multiple Site Capability - No Charge Upgrades for the Product's Life Pre-Configured Tasks Liste - No Validation Period Pre-Configured In System Notifications Pre-Configured Email Notifications

FlinkISO Quality management system is one of the most popular quality management softwares for small and medium businesses. FlinkISO QMS integrates with ONLYOFFICE editors. This allows you to create custom HTML forms according to your QMS document's requirements. You can create your own QMS with no coding or technical knowledge. Modules such as Audit Management, Customer Complaints and Document Management, Change Control, and Change Control are already built into the application. Drag-and-drop allows you to add custom business rules, email triggers, and additional HTML fields. Flexible and affordable payment options are available for both on-premise and cloud applications. On-cloud users get 45+ days of free evaluation, while the on-premise edition costs USD80/month.

Are you in search of innovative and acknowledged strategies to enhance the management, productivity, performance, and profitability of your organization? By documenting your challenges and examining them closely, you can develop concrete and sustainable solutions systematically, leading to improved efficiency and performance. Our structured, customizable, and integrated software solutions are designed specifically for this purpose. With a focus on operational excellence, quality, compliance, and continuous improvement, we utilize the well-established "Plan - Do - Check - Act (PDCA)" methodology to ensure effective management of all activities. For over two decades, IsoVision has collaborated closely with clients to introduce new modules and features that align the software with their evolving needs. Throughout the year, we remain committed to prioritizing client feedback, integrating their requests into the software as part of our regular updates, ensuring that our solutions continuously evolve to meet the demands of the market. This dedication to our clients fosters a partnership that enhances both their operational success and our software’s capabilities.

ShopXpert is a robust and fully integrated manufacturing software solution that enhances your entire manufacturing process by reducing data entry and boosting productivity levels. By automating various tasks, it effectively minimizes manual processes and inefficiencies that can hinder job shop performance. The software encompasses a wide array of modules, including standard modules, a supplier portal, outsource management, job tracking, an employee portal, vending capabilities, a costing tool, customizable forms, task management, workstations, training notes, an academy, a time clock, in-app messaging, storage solutions, and QR code functionalities. Each of these modules is designed to offer features such as dashboard access, efficient customer and supplier management, document storage capabilities, customizable forms, task scheduling, employee time tracking, and real-time communication with suppliers. Additionally, it empowers employees to manage their jobs seamlessly from tablets or mobile devices, significantly decreasing the reliance on traditional desktop workstations. This flexibility not only enhances operational efficiency but also fosters a more agile work environment.

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.

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.

Enhance the quality of incoming parts and supplier performance to mitigate the risk of production halts while optimizing the overall cost of ownership and managing supply chain uncertainties. Continuously monitor in-process quality and track trends throughout the production cycle, implementing proactive measures to decrease the failure rate. Oversee and ensure the quality of products ready for shipment, thereby boosting their competitive edge in the market. Prioritize customer needs by swiftly addressing complaints and enhancing service and quality, ultimately leading to increased customer satisfaction. Document and track corrective and preventive actions effectively, while providing real-time updates on each team member's task progress. Strengthen the culture of continuous improvement and refine the corporate quality management system. Streamline the audit preparation process to enhance both efficiency and effectiveness, ensuring compliance with required regulations through a reliable mechanism that supports scheduled audits. This comprehensive approach not only promotes a high standard of quality but also fosters a proactive environment committed to excellence.

ZEBSOFT GRC & ISO management platform is a holistic approach for managing Governance, Risk & compliance. ZEBSOFT's intuitive web interface makes it easy to manage ISO standards (9001, 14001 and 22301), 27001, 27001 and 45001 and many others. ZEBSOFT has powerful integrated modules for Risk, Quality, Environmental, InfoSec, Compliances, policies (templates included) & documents, equipment & asset management with maintenance/calibration/testing planning. Improve internal communication, assign ownership, plan, and conduct audits. To see the full potential of ZEBSOFT, book a demo today!

Apollo Root Cause Analysis™ is a method grounded in principles that aids individuals in mastering effective strategies for problem-solving. When paired with the RC Pro® software, it enables the development of a comprehensive, evidence-based comprehension of any issue encountered. Such an understanding of the root causes and their effects fosters solutions that gain acceptance across the entire organization. The Apollo Root Cause Analysis™ approach promotes the establishment of a shared understanding through collaboration with all relevant stakeholders, resulting in a solid evidence-based perspective on the problem at hand. This methodology guarantees that the solutions implemented tackle verified causes, thereby minimizing the chances of future occurrences. It simplifies the problem-solving process and equips trained individuals with the necessary skills to tackle real-world challenges more efficiently and effectively. Additionally, RC Pro serves as a versatile root cause analysis software solution that can be customized for businesses of any scale and in various sectors. By utilizing RC Pro, organizations can enhance and integrate their problem-solving capabilities, leading to improved outcomes. Ultimately, this synergy between Apollo Root Cause Analysis™ and RC Pro empowers teams to create lasting solutions that foster continuous improvement.

Food Safety Plus is an economical software solution that ensures your business is always ready for audits while facilitating document management in a completely paperless environment. Crafted by experts in food safety specifically for their peers, Food Safety Plus™ offers a budget-friendly and user-friendly cloud-based platform designed to minimize compliance risks. This software serves as a vital tool for businesses striving to adhere to the latest FSMA regulations and prepare for third-party audits effectively. You can securely store your documents in the cloud and conveniently access them from any mobile device, enhancing your operational efficiency. Additionally, you can easily approve changes and receive prompt notifications regarding updates. With a specialized portal, you can oversee compliance throughout your supply chain, ensuring that all parties are aligned with the necessary standards. Furthermore, automated communications with suppliers not only streamline processes but also help in reducing operational costs. This comprehensive approach to food safety management allows businesses to focus more on their core operations while maintaining high compliance standards.

Trevally from ManualMaster is a comprehensive QHSE platform designed to cover the entire PDCA loop in a single web or on-premises solution. It provides controlled document and version management with audit trails, process mapping, risk and standard controls, as well as quality assurance registrations and smart web forms. Additional modules manage incidents, complaints, audits, deviations, tasks, and actions, all displayed in role-based dashboards with real-time KPIs, reports, and graphs. With ISO-27001 hosting, backups, single sign-on, two-factor authentication, and granular user permissions, Trevally ensures data security while supporting multi-language interfaces, digital signatures, and mobile access for enhanced user adoption.

Certdox is food safety management software built to simplify compliance and support the real work FSQA teams do every day. It replaces disconnected spreadsheets, paper binders, and outdated tools with a single, organized system that keeps documentation, training, audits, and supplier compliance under control. Created by people who have worked in food manufacturing and lived through audits, recalls, and production crunches, Certdox is designed to make food safety feel manageable. Whether you are getting ready for a GFSI certification like SQF or BRCGS, managing HACCP plans, or tracking supplier approvals across facilities, Certdox keeps your team aligned and audit-ready without the usual scramble. The platform includes all core modules with no feature gating or user limits. Every facility gets full access to document control, audit scheduling, sanitation logs, training records, supplier management, task tracking, and more. Certdox offers flat-rate pricing by facility, so teams can scale without extra fees or surprises. Certdox is cloud-based, works from any browser, and requires no complex setup or IT support. We keep implementation fast and onboarding simple, with templates and guidance built in. From plant floors to QA offices, Certdox helps FSQA teams focus less on paperwork and more on food safety. It’s built for the pace of food production and the pressure of staying compliant. Certdox gives you visibility, traceability, and peace of mind, without the clutter of bloated systems or custom builds. Just what you need to stay ready and in control.

Q-Med Database is ideal for small businesses striving for ISO 13485 compliance. The Q-Med Database is an ISO 13485 compliant database to efficiently manage corrective and preventive actions, nonconformances, internal audit schedules and findings, safety improvement, supplier corrective actions, continual improvement projects. Compile and analyze Customer Survey results. Document QMS review meetings and results. CFR21 Part 11 compliant Cloud based or locally installed options are available. The

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

Starting now, you can effortlessly obtain all the essential documents without sacrificing your valuable work hours and at an attractive price! The subscription process is straightforward; just a few clicks will bring you to the purchase screen. There, you can input your company’s details, including the organization name, logo, and information regarding the procedures approver. Simply complete the forms and implement them according to the ISO 9001 standards presented on your screen. You can easily access controlled reports and forms featuring your organization's name and logo, ensuring you’re well-prepared for the external audit. You can also handle the preparation on your own time, eliminating the need for external assistance. The system is available all year round, allowing you to enter data whenever it suits you. Don’t leave things to the last minute! Everything you need for a robust quality management system is included, along with the ability to create controlled forms emblazoned with your company logo. This all-in-one solution ensures you have everything necessary for the external audit and your ISO quality management system conveniently at your fingertips. By streamlining the process, you can focus on what truly matters—growing your business.

Introducing the Secure Audit, Risk, Compliance & Quality Software, which provides both On-Premise and Cloud-based deployment alternatives. Auditrunner ensures the highest level of security with granular encryption and role-based access control for all audit files and documents that are stored. Your data transfers are safeguarded, enhancing overall security. We have streamlined over 3000 business processes for organizations globally, with our GRC platform modules forming just a portion of these solutions. Whether you choose Cloud-based or On-Premise, you can deploy and begin utilizing the software quickly. Our hassle-free integration process guarantees that you will experience the platform’s advantages within weeks of initiation. Built on a low-code framework, our system is entirely customizable, ensuring compliance with any relevant standard or regulation. Adapt swiftly in today’s dynamic regulatory landscape and effortlessly comply with various legislations without needing external support. The user-friendliness of our platform stands unrivaled, making it an exceptional choice for businesses of all sizes.

The Plex Quality Management System (QMS) enables both process and discrete manufacturers to adhere to stringent industry standards and customer requirements through an integrated digital record-keeping system. By facilitating consistent and reliable quality assurance via in-line quality measures, transparent reporting, and straightforward audit tracking, it ensures that manufacturers can maintain compliance effortlessly. With real-time access to quality documentation available digitally throughout the organization, businesses can effectively meet regulatory demands while fostering operational efficiency. Enhanced delivery performance, improved supplier relationships, and greater customer satisfaction contribute to sustained growth in both new and repeat business. By embedding quality management into everyday workflows and processes, the risk of quality-related losses, warranty claims, or product recalls is significantly minimized, ultimately enhancing brand image and customer loyalty. Furthermore, Plex enables the creation of detailed process control plans that include specific inspection protocols and digital checklists, streamlining quality oversight across various operational areas. This comprehensive approach to quality management not only safeguards compliance but also drives continuous improvement and innovation within the manufacturing sector.

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. Best For 1. For companies who need guidance to implement and adopt validated QMS. 2. For companies who want to automate their quality management and go beyond a paper-based system.

FreePoint Technologies' ShiftWorx provides a ‘holistic’ shopfloor management platform that when applied in whole or in succession affords manufacturers a production optimization solution backed by Toyota Production System (TPS) consulting expertise. ▪ Fully customized modular suite of products. ▪ Toyota Production System (TPS) expertise ▪ Measures and monitors critical production areas. ▪ Managed Services included. ▪ Cloud-connects equipment of any age, type or brand. ShiftWorx is a unique grouping of modules that provide an end-to-end solution for continuous improvement across the production floor. ▪ Production Management - Real-time information on machine performance, jobs, and operator workforce. ▪ Performance Analysis - Metrics at the machine, line or plant for historical, situational and predictive insights. ▪ Quality & Compliance - Benchmarking, standards and procedures to meet audit and compliance regulations. ▪ Team Member Development & Performance - Operators have better tools for creating value added work. Measure, Analyze, and Improve with ShiftWorx! Contact us for a complimentary consultation from our TPS experts! Schedule a software demo specific to your Industry today!

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.

BITqms is a sophisticated software solution designed specifically for quality management within your organization. This professional tool provides comprehensive assistance for all operational processes in your business and facilities, covering areas such as document management, audit and risk management, as well as inspections, tests, and action management. Whether you are working from your office or using the app on the go, BITqms ensures that you maintain control over your tasks and processes at all times. It stands out as one of the most adaptable solutions in the realm of quality management. With BITqms, you can accurately reflect the actual structures of your organization, allowing for flexible and individualized definitions of responsibilities and processes. Our commitment to customer satisfaction is evident, as we offer guidance throughout the sales process, assist with implementation within your company, and provide ongoing support from our dedicated team. No matter the industry, BITqms is designed to be universally applicable, making it an ideal choice for a wide range of sectors seeking quality management solutions. Additionally, our software continuously evolves to meet the specific needs of each client, ensuring that your quality management practices are always ahead of the curve.

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.

QwizPRO revolutionizes quality management for compliance with ISO 9001 and AS9100, making audits effortless and efficient. By utilizing its intuitive automation, the platform reduces errors, conserves time, and enhances the compliance journey. In the fiercely competitive landscape of modern business, QwizPRO is crucial for achieving quality excellence without complications. It enables consistent monitoring and assessment of suppliers, ensuring they meet your rigorous quality standards. Featuring real-time analytics and customizable reporting options, the software provides insightful visibility into supplier performance, showcasing strengths while pinpointing potential vulnerabilities. Equip your team with tailored QMS training that progresses from a basic grasp of industry standards to a comprehensive understanding of intricate procedures. QwizPRO facilitates automatic training deployment, tracks learning advancements, and uncovers areas needing improvement. Additionally, the software ensures immediate access to essential documents necessary for daily operations, further optimizing productivity and efficiency. With such capabilities, QwizPRO stands out as an indispensable tool for organizations striving for continuous quality enhancement.

Automate the identification and resolution of problems in your organization and supply chain. This is one of the most trusted CAPA software applications. It has been trusted by thousands of users worldwide. CAPA Manager corrective actions software automates the assignment of corrective actions, notification, investigation and reporting. It prevents errors in the control of the entire CAPA process from initiation through investigation and closure. CAPA Manager meets all requirements of the most important quality management standards, including ISO 9001, AS9100 and TS 16949. It maintains records of root-cause and corrective actions, and provides pre-defined workflows with approval gates.

Solutions that prioritize safety, compliance, and employee training in the workplace are essential. For over twenty years, SMG has established itself as a reliable ally in process management, enhancing workplace safety, and ensuring compliance with OSHA and various regulatory standards across local, state, and federal jurisdictions for diverse businesses, including food service distribution centers, restaurants, and LTL freight carriers. Leveraging software-based expertise in health and safety management, SMG enables your organization to maintain compliance effortlessly, minimize costly incidents, and streamline operations and logistics. Transition away from generic policy documents and neglected safety plans by utilizing proactive software tools that integrate smoothly with your processes for training staff, performing safety audits, documenting incidents, and implementing corrective measures. By adopting these innovative solutions, businesses can foster a culture of safety and efficiency that benefits both employees and the organization as a whole.