Best Quality Management Software for Microsoft 365

HSI Donesafe’s Quality Management Software prioritizes individuals in the realm of quality assurance. Utilizing real-time tools, you can tackle challenges as they occur and foster smooth collaboration across teams to promote ongoing enhancement. Streamline compliance processes and go beyond expectations while nurturing a culture of responsibility and creativity. Experience unparalleled flexibility with our no-code platform, allowing you to effortlessly make adjustments as necessary using our intuitive drag and drop feature. By empowering everyone—from frontline employees to executives—this software cultivates a dedication to achieving exceptional results. Attain quality outcomes that build trust and pave the way for sustained success.

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

Propel's Quality Management solution empowers manufacturers to streamline, automate, and regulate their quality management processes. It offers a cohesive platform to manage nonconformances, corrective and preventive actions (CAPAs), deviations, complaints, and audits, all directly linked to product and change information. Implement a fully-featured, cloud-based electronic Quality Management System (eQMS) within 8 weeks, which includes essential modules such as CAPA, Complaints, Non-Conformance Reporting (NCMR), Audits, Deviations, Training, Equipment Calibration, and Supplier Quality, without the need for Product Lifecycle Management (PLM) systems. Designed specifically for regulated sectors like medical devices, this solution ensures compliance with FDA 21 CFR Part 820 & Part 11, ISO 13485:2016, EU MDR, and DHF/DMR through validated Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation. Incorporating AI-driven features, it can create training quizzes based on quality data to enhance compliance awareness. Integrated workflows promote uniform processes while allowing for flexibility. With comprehensive traceability, teams can achieve a flawless audit pass rate and continually enhance product quality, all while being supported by robust enterprise-level security measures.

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.

Odoo is an open-source, fully customizable and extensible software that includes hundreds of professionally designed business applications. Odoo's intuitive database can meet most business needs including CRM, Sales, Projects, Manufacturing, Inventory, Accounting, and Accounting. Odoo is a software solution that can be used to meet all company needs, regardless of size or budget. Odoo's seamless design makes it easy for businesses to become more efficient and save time. Each module is interconnected to offer a seamless experience from one app to the next. Users can automate many tasks that would otherwise require manual inputs to multiple applications. Odoo enables teams to collaborate with each other from one platform, allowing them to keep all business functions in one place.

QBench allows you to keep track of all your samples and where they are located in the workflow using a single system. QBench eliminates the need for spreadsheets, shared folders in the network, and paper-based tracking systems. You can view hundreds of PDF reports/COAs before publishing or emailing. You can generate barcodes and create labels that you can customize for your samples. Compatible with standard printers and scanners. QBench's billing module allows you to create and send invoices right from the system. You can see counts and latencies for different data types in QBench. This includes metrics like turnaround time, sample counts per test, sample delay, and many others. QBench makes it easy for you to gather the data your lab needs for the assays you perform.

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.

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.

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.

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.

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.

The Intact Platform, a cloud-based and on-premise Enterprise Resource Planning solution (ERP), is the best for audits, assessments certification, accreditation, and other standards. It is more than any other audit collection tool on the market. It offers a complete solution that helps you manage communications and business goals as well as personnel. Intact Platform is unrivaled in functionality and features an end-to-end modular workflow that is easily scaleable. 34% efficiency increase on average (upto 60+%) Unmatched modularity, flexibility and scalability All standards and audit services Digital workflow - no need for paper Remote and on-site auditing Non-conformities and corrective actions Planning and risk-based auditing Communication with clients is easy Reporting and business intelligence (BI). Management and central data hub (incl. Audit trail complete Innovation never stops

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.

Cognidox is an online document-management system for high-tech, life sciences and medical device product development. Cognidox is available in the cloud and as an on-premise solution. It promotes product lifecycle management and knowledge sharing between developers and clients, partners, customers, and customers. Cognidox is secure and reliable. We offer plug-ins for many programs, such as Microsoft Office. We also offer an API that allows you to integrate almost any process with Cognidox. Cognidox's core function is a DMS. An add-on for Cognidox allows you to license and distribute documents to third parties via a fully sandboxed website. This allows you to publish specific documents while keeping your main storage secure. Another popular add-on is gBMS - Graphical Business Management System. Visio can be used to capture your business processes. A good BMS should give clear oversight of your entire operation.

Pro-Sapien is the EHS Software on Microsoft 365. Designed for enterprises with 1,000+ employees, Pro-Sapien makes EHS easier for everyone across the company. Configurable modules for Incident Management, Audits, Inspections, Risk Assessment, Permit to Work and more make Pro-Sapien the ideal one-stop-shop for EHS management in Microsoft 365 enterprises. Mobile-responsive forms help employees stay productive on-the-go, combined with Teams integration for the ultimate easy access. Digitize your EHS forms, automate workflow, and get EHS insights in Power BI to improve performance - all on the platform you already know and love. See why Pro-Sapien is right for your organization by viewing a short demo video today.

Unlock the power of efficient quality management with TQA Cloud QMS Software, tailored specifically for small businesses. Seamlessly integrated with the Microsoft 365 network, our platform ensures robust, reliable, and scalable solutions for your quality management needs. Recognizing that every business is unique, we encourage you to choose the provider that aligns best with your goals for a smooth setup and installation process. Dive into a world of enhanced operational efficiency, streamlined processes, and consistent quality assurance with TQA Cloud QMS. Your success is our priority. Choose smart, choose TQA.

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.

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.

Enhance the quality across your organization with a comprehensive Electronic Quality Management System (EQMS) provided by Qualsys. This adaptable and user-friendly EQMS solution fosters a more positive and productive workplace by offering a suite of modules that empower every employee to take ownership of quality. Key features include Document Manager, Training Manager, Risk Manager, Asset Manager, and Supplier Manager, among others, ensuring that all aspects of quality management are effectively addressed. By integrating these tools, businesses can streamline processes and improve compliance, ultimately driving success and satisfaction for both employees and customers alike.

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

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.

With mindmaxx, you can effectively manage the overwhelming array of your files, tasks, communications, reports, and schedules. This platform serves as a comprehensive library, communication hub, and reminder system all merged into one. An especially valuable feature offered by mindmaxx is its automatic update service, ensuring that any legal changes are promptly addressed by the mindmaxx team who will revise and refresh the necessary documents. You will receive the updated documents automatically and will be kept informed about these changes, along with practical application advice. However, high-quality management involves more than simply adhering to legal standards; it requires recognizing and capitalizing on opportunities, setting clear objectives, and taking proactive steps to reach them, which is crucial for success. This proactive mindset is increasingly vital in today's professional landscape, and mindmaxx provides robust support for you and your team in navigating this journey. All team members can conveniently access essential documents from a centralized platform through mindmaxx, enhancing collaboration and efficiency. By fostering such an organized environment, mindmaxx empowers users to thrive in their professional endeavors.

CAQ.Net software solutions are in action all around the globe wherever it is important to ensure the quality, safety, and functionality of products and services. Whether strategic quality management or operational quality assurance – thanks to its high degree of automation and uniform data structure, CAQ.Net facilitates effective process management, proactive failure prevention, and a company-wide quality mindset.

The AssurX platform is a powerful software platform for enterprise quality management (EQMS) and regulatory compliance to reliably communicate and coordinate information, documentation, and activities. AssurX allows regulated businesses to quickly identify and control quality issues and risk exposure to avoid quality or noncompliance problems while improving workflow. AssurX QMS software is uniquely configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. No other system is easier to deploy, configure, and modify. AssurX solutions integrate seamlessly to create a connected quality system. Solutions include audit management, corrective actions, training management, compliant management, document management, change control, risk management, EHS incident management, and more.

OpenText™ Information Management solutions empower organizations in the life sciences sector to harness data and content insights, enhancing their decision-making and speeding up product development. These tools enable seamless integration, management, and secure sharing of information among individuals, systems, and devices. By utilizing information assets effectively from research and development through to commercialization, organizations can benefit from adaptable cloud-native software that operates in any environment. OpenText for life sciences significantly accelerates the discovery process, facilitating the extraction of actionable insights that foster innovation in the pipeline. Users can convert research papers into electronic lab notebooks through intelligent capture, and uncover valuable insights using text mining techniques. Moreover, the platform allows for the extraction of knowledge hidden within unstructured text of clinical trial reports, study protocols, and findings related to clinical safety and efficiency. It also offers methods to intelligently analyze, categorize, and extract information from clinical trial documents, ultimately minimizing the risk of expensive delays and interruptions in the development process. By effectively utilizing these advanced capabilities, life sciences organizations can significantly enhance their operational efficiency and drive forward their research initiatives.