Best Qualcy QMS Alternatives in 2025

Find the top alternatives to Qualcy QMS currently available. Compare ratings, reviews, pricing, and features of Qualcy QMS alternatives in 2025. Slashdot lists the best Qualcy QMS alternatives on the market that offer competing products that are similar to Qualcy QMS. Sort through Qualcy QMS alternatives below to make the best choice for your needs

  • 1
    Intelex Reviews
    Top Pick

    Intelex Technologies

    128 Ratings
    See Software
    Learn More
    Compare Both
    Intelex delivers a unified software system for overseeing Environmental, Health, Safety, and Quality (EHSQ) initiatives. Its expandable platform is crafted to consolidate, oversee, and scrutinize EHS and Quality data comprehensively. The solution works on any device to meet the realities of your workplace. With Intelex, your organization can: Elevate your EHSQ program outcomes by supervising workflows for superior performance and command. Discern patterns and propensities through goal-setting to deepen understanding and improve decision-making in your EHSQ program. Diminish occurrences and cut down on administrative tasks by efficiently supervising, managing, refining, and extracting insights from your safety data via our intuitive safety software. Simplify the management and reporting of air, water, and waste emissions, and oversee environmental outputs to fulfill sustainability objectives. Foster ongoing improvements in quality by seamlessly logging and monitoring all instances of nonconformity within a unified, web-based system. Investigate trends across various departments, sites, or locations. Intelex can help you manage compliance with international standards and regulations such as: OSHA, WCB, ISO 45001, EPA, ISO
  • 2
    isoTracker Quality Management Reviews
    See Software
    Learn More
    Compare Both
    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.
  • 3
    SBS Quality Management Software Reviews
    Top Pick See Software
    Learn More
    Compare Both
    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.
  • 4
    Dot Compliance QMS Reviews

    Dot Compliance QMS

    QMS for Life Sciences

    $10,000 / Annually
    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.
  • 5
    Total Lean Management (TLM) Software Reviews
    Top Pick
    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.
  • 6
    SimplerQMS Reviews

    SimplerQMS

    SimplerQMS

    $13,750/year
    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.
  • 7
    LIMSey Reviews
    LIMSey is a cloud based software designed specifically for engineering, mechanical, and other labs which test physical products. Automate resource scheduling, track jobs, manage changing priorities, generate test reports, support regulatory audits and accreditation, manage equipment, calibrations, training records, and more. All features, updates, and support are always included with no additional modules to buy.
  • 8
    Qualityze EQMS Suite Reviews
    Top Pick
    Qualityze EQMS Suite is a next-generation Enterprise Quality Management Software. It is specifically designed for businesses to efficiently manage their quality processes, customer expectations and compliance requirements. It helps them address operational challenges so they can achieve excellence in terms of quality, safety and reliability. It comes with pre-defined templates for controlled documents, audit checklists, regulatory forms, material compliance reports and many more. Qualityze EQMS Suite is a set of 14 integrated modules that help create a closed-loop system to manage end-to-end quality from anywhere. Our range of smarter quality solutions is built on the Salesforce.com technology platform. These modules are Nonconformance Management, CAPA Management, Document Management, Change Management, Audit Management, Training Management, Supplier Quality Management, Inspection Management, Customer Complaints Management, Material Compliance Management, Forms Management, Permit Management, Calibration Management, and Maintenance Management, Forms Management and Field Safety Management. Our Quality Management solutions help create a culture of quality and continuous improvements by proactively mitigating quality issues.
  • 9
    Qualer Reviews
    Qualer is a cloud-based asset and service management platform that supports, enables, and perfects your asset maintenance and calibration. With Qualer, you'll have complete transparency and seamless collaboration between your organization and service providers, both internal and external. Qualer acts as an ecosystem for asset lifecycle and service event management that provides clarity and accountability, enhancing asset management and compliance no matter where you are.
  • 10
    BPAQuality365 Reviews
    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.
  • 11
    QT9 QMS Reviews

    QT9 QMS

    QT9 Software

    $2,300/year
    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
  • 12
    Artintech ERP Reviews
    Top Pick
    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.
  • 13
    [FP]-LIMS Software Reviews

    [FP]-LIMS Software

    Fink & Partner

    $2500 one-time fee
    The [FP]-LIMS modules rely on a powerful SQL database solution. These modules allow for quick queries and data processing. We guarantee maximum user friendliness. Our job server is the central element of automation, which executes event- and time-controlled tasks. To monitor limit values and send an alarm message (email, message on monitor, etc.) automatically. When they are exceeded. Modern LIMS software, including modules such as inspection planning, workflow management, and analysis management, can help you design your quality management system in the most efficient way. This will make your production processes more efficient.
  • 14
    Qualtrax Reviews
    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.
  • 15
    Intellect Reviews
    Top Pick
    Intellect's QMS software has been proven to improve quality operations and reduce overall quality cost by up to 40%. Our apps were designed by certified quality professionals and can be easily customized with our no-code platform or drag-and-drop technology. Remote access for your team, mobile apps, dynamic workflows, analytics, reporting, and remote access are all possible with this modern and simple solution. Apps include Document Control and Employee Training, Audit Management CAPA, Nonconformance, as well as other useful features.
  • 16
    GoCodes Reviews
    Check out office assets with ease. Work smart using our total solution that harnesses the power of cloud software, top-rated smartphone scanner apps & customized tags. We make office asset tracking easy! Track and manage your office assets & inventory, easily! Use our app-store 4.5 star-rated mobile app to check your office equipment in and out, fast. Get going in minutes with your customized QR labels included in the price. Build reports in seconds to show equipment utilization and more.
  • 17
    Calibration Control Reviews
    Calibration Control (CC), is used for maintenance, calibration, and general asset management. You can quickly and visually track equipment that needs calibration or maintenance using customizable highlighted grids or auto emails. Audit trails are maintained to track equipment traceability, people and companies, as well as attachments, certificates, and other information. Automate calibration control with custom or default barcode labels scannable by time-saver dialogs to increase speed. You can create custom reports or modify existing ones using the Report Designer. CC is used by ISO, FDA, and ANSI quality systems to maintain compliance and communicate that compliance to auditors or internal customers. Although CC was developed in a manufacturing environment, it can also be used in other industries such as Metrology Services, Health Care, Aviation/Aerospace, Mining, Testing, Maintenance, Designer Engineering, Oil Wells, Distribution, Packaging, among others.
  • 18
    CompliantPro Reviews
    CompliantPro's Quality Management System Software serves as a comprehensive solution that consolidates a company's quality assurance needs into one cohesive platform, effectively breaking down the barriers created by disparate point solutions. This software empowers organizations to oversee their compliance and regulatory obligations, extending its capabilities well beyond mere document management. Critical focus areas encompass Environmental Health & Safety, Enterprise Risk Management, employee Training & Qualifications, Auditing processes, as well as the management of customer and supplier relationships. By utilizing CompliantPro, businesses can streamline their operations and enhance overall efficiency.
  • 19
    Grand Avenue Software Reviews
    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.
  • 20
    TrackPro Reviews

    TrackPro

    TrackPro

    $0.01 one-time payment
    TrackPro is an innovative software application designed to help users monitor and manage recurring tasks such as calibrations, maintenance schedules, and reminders effectively. By managing these activities, you can ensure compliance with the stringent demands of today’s regulated industries. This solution supports adherence to standards like QSR, cGMP, ISO 9000, QS 9000, and ISO 13485, among others. For smaller enterprises, TrackPro is available free of charge for up to 100 entries and features a built-in report designer with 31 essential report and label formats. The software's multilingual interface includes options for languages such as Czech, Danish, Dutch, English, French, German, Italian, Norwegian, Polish, Portuguese, Spanish, and Swedish. The single-user version is fully compatible with Windows 7, 8, 8.1, and 10, while the multiuser version can operate on Microsoft Servers from 2008 to 2019. Additionally, TrackPro includes an audit trail feature and dynamically generated lookup lists that expedite the creation of new items, along with automated email notifications to keep custodians informed about important tasks. Overall, TrackPro streamlines task management, ensuring that users remain organized and compliant in their operations.
  • 21
    GageManager Reviews

    GageManager

    ALTEGRA

    $298 one-time payment
    GageManager, developed by Altegra, offers comprehensive calibration management software tailored for service and repair facilities. This robust tool enables users to efficiently track and calibrate their equipment in a manner that is both swift and compliant with auditing standards. The software encompasses various features such as inventory oversight, calibration scheduling, and measurement system analysis (MSA). Additionally, it boasts a user-friendly, dashboard-oriented interface that allows for quick access to calibration status updates. Our software suite also includes solutions for gage calibration management, guidance for job execution at the machine, real-time predictive statistical process control, statistical quality control, and support for production decision-making. Since its inception in 1999, our offerings have empowered companies in manufacturing, industrial, and technical services sectors to enhance their productivity and profitability by minimizing unplanned downtime, lowering defect rates, and averting equipment failures. By integrating these functionalities, GageManager not only streamlines operations but also fosters a culture of continuous improvement in businesses.
  • 22
    Calibrate Reviews
    For high-integrity measurement and control systems, it is essential to meticulously calibrate each instrument to ensure they operate within their designated parameters. Calibrate™ oversees the entire calibration procedure and offers easily accessible certification that can be audited without hassle. The era of managing calibrations through numerous separate spreadsheets across various devices is behind us. Calibrate™ serves as an online management system for metering calibration, specifically engineered to enhance the calibration workflow through a single, centralized database that preserves a comprehensive audit trail of all calibrations conducted. Users can set up one or more calibrations for each piece of equipment stored in the database by utilizing templates from Calibrate™'s extensive library of metering calculations. Furthermore, these templates are adaptable, modifying themselves to accommodate the necessary form type as options and parameters are established. This innovative system not only boosts efficiency but also significantly reduces the chances of errors in the calibration process.
  • 23
    CAQ.Net Reviews

    CAQ.Net

    CAQ AG Factory Systems

    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.
  • 24
    GxPReady! Suite Reviews
    Unwind and discover how GxPReady! Suite can assist you in fulfilling your obligations without stretching your budget, featuring Calibration, Validation, and Maintenance modules that can function both collaboratively and independently to provide you with exceptional adaptability. Getting started is a breeze, requiring little disruption to your IT infrastructure. With secure web access, you can achieve validation efficiently while maintaining your existing processes with minimal data entry required. Our suite of validated SaaS solutions is specifically crafted to support managers of FDA-regulated organizations in adhering to regulatory standards, such as cGMPs, 21CFR11, and Annex 11 requirements. Additionally, our validated CMMS system is available on a subscription basis, allowing you to launch your equipment management system with low initial costs. Furthermore, our innovative Flash Validation method for qualification ensures the quickest path to GxP compliance possible. Experience the ease and efficiency of our solutions today!
  • 25
    Nova-CPM Reviews
    Novatek International delivers extensive software solutions that not only fulfill but surpass the quality and compliance standards essential for the life sciences sector. Their process-specific offerings create an integrated platform that ensures uniformity and standardization across various departments within a single site and among multiple locations. This integration significantly lowers the total cost of ownership and enhances the return on investment. The NOVA-CPM tool is a cutting-edge automation solution that expertly manages all aspects of equipment qualification, calibration, and maintenance procedures. Designed with global regulatory compliance and data integrity in mind, the system features robust security protocols, electronic signatures, and comprehensive audit trails. As a premier Computerized Maintenance Management System (CMMS), NOVA-CPM encompasses the entire life cycle of equipment, addressing needs from initial purchase and validation to calibration, maintenance tasks, repairs, and ultimately, end-of-life replacement. This holistic approach ensures that organizations can maintain operational efficiency while adhering to stringent regulatory demands.
  • 26
    Virje Reviews
    Virje meets the standards set forth by 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. If you're feeling daunted by the complexities of Part 11 software validation, rest assured that help is just a click away, no matter where you are or when you need it. By eliminating paperwork, cutting costs, and enhancing productivity through automation and unified collaboration, it becomes an ideal solution for small to medium-sized enterprises. Designed specifically for medical device quality management, this system is constructed to be adaptable to your unique workflows and processes, ensuring you don’t have to make any sacrifices. It features configurable change order approvals that can be tailored by employee role and document type, along with timely notifications sent to accountable team members throughout every phase of the change process. Users can assign material dispositions for specific documents, gain easy access to both released and archived versions, and quickly view the history of document changes. Additionally, it tracks where-used locations and the distribution of hard copies, while also providing reminders for periodic document reviews to ensure compliance and efficiency remain top priorities. This comprehensive approach not only streamlines quality management but also empowers organizations to maintain rigorous standards effortlessly.
  • 27
    ProCalV5 Reviews
    Prime Technologies has been a leader in calibration and maintenance management software for almost three decades. Our programs are used by thousands of companies all over the world to eliminate paper. The program has powerful math and data verification capabilities to meet FDA, ISO, and other regulatory requirements. The program supports both off-line and automatic calibrations using tablets/laptops, and documenting process calibrators. Each version is pre-validated and 21 CFR Part 11 compatible for life sciences facilities. Accounts can be divided and configured to suit the preferences of a single site or harmonised for enterprise-level deployment. Integration to ERP, CMMS and LIMS can be achieved using APIs and technical support.
  • 28
    Sirwill FBM Tools Reviews

    Sirwill FBM Tools

    Sirwill Software

    $85 one-time payment
    Crafted and verified by our team of SPC and Six Sigma experts, this software stands out as one of the most adaptable and cost-effective solutions for the analysis of statistical process control (SPC) data. Additionally, it is capable of calculating six sigma process metrics and forecasting the process average for Engineering Process Control (EPC). This tool is essential for organizations and students aiming to excel in Six Sigma methodologies. Our management consultants bring extensive experience in the successful implementation of a range of management systems including ISO9001:2015, ISO14001:2015, ISO17025:2017, ISO22000:2018, ISO27001:2013, ISO45001:2018, ISO50001:2018, and SA8000:2014 across various client organizations globally. Drawing from their extensive background, our consultants have developed comprehensive, step-by-step guidelines for system implementation, offering precise instructions for managers and representatives tasked with planning and executing these systems. Adhering to these guidelines can significantly reduce both the cost and timeline of your projects, making processes more efficient and effective. Organizations that leverage this software alongside our experts’ insights can enhance their operational excellence.
  • 29
    GageList Reviews
    GageList is FREE for up to 25 tools, and offers economical plans for every size of organization. Free features include: UNLIMITED USERS, MULTI-SITE CONTROL PANEL, free MOBILE APP for iOS and Android. ALSO INCLUDES Public API for integration with enterprise applications. GageList supports compliance with ISO 9001, ISO 14001, API Q1, AS 9100, IS) 17025 and other standards. It's web-based so your unlimited users can access it anywhere, any time, on any device, and it's scalable to meet the needs of any organization. No software to install. So easy to learn and use that no training is required.
  • 30
    Paradigm 3 Reviews

    Paradigm 3

    Interax Group

    $1000.00/one-time
    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.
  • 31
    Asset Controller Reviews

    Asset Controller

    PCP Software Solutions Ltd

    £39 per month
    Discover a comprehensive range of services including Calibration Management, Asset Management, Workload Management, Project Management, and more, all available with a 14-day free trial that requires no credit card and includes free updates. As a UK-based company, we prioritize understanding your specific requirements and goals, enabling us to tailor Asset Controller to fit your unique needs and adapt as those needs evolve. With its user-friendly interface and a wealth of features, managing your assets has never been simpler or more efficient. Asset Controller guarantees data protection through robust redundancy measures and incremental backups, allowing you to focus on what truly matters without the hassle of managing costly storage systems. Designed to foster teamwork, Asset Controller enables collaboration among your team members through updates, notes, and photos, ensuring that everyone remains informed and engaged. Furthermore, Asset Controller excels at accurately tracking and maintaining your inventory levels, helping you optimize your stock management effectively. Embrace the ease of use and flexibility of Asset Controller to streamline your operations and drive success in your organization.
  • 32
    Sierra QMS Reviews
    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.
  • 33
    Veeva Vault QMS Reviews
    Enhance quality and ensure GxP compliance through Vault QMS, which integrates established best practices and automated workflows to connect all stakeholders, including pharmaceutical and biotech firms, contract manufacturers, and suppliers, into cohesive quality processes for improved oversight and control. This system facilitates seamless collaboration among various departments, sites, contract manufacturers, suppliers, and testing labs, promoting a culture of continuous quality enhancement. By leveraging automated workflows, organizations can achieve greater operational efficiency while simultaneously improving risk visibility throughout products and processes via a consolidated risk management strategy. The unified suite of quality applications accelerates speed, boosts efficiency, and strengthens GxP compliance across all activities. Additionally, Vault QMS allows for the smooth implementation of essential quality management processes, incorporating built-in best practices for handling deviations, conducting internal and external audits, managing complaints, executing lab investigations, overseeing change control, addressing CAPA, and facilitating quality risk management, ultimately fostering a robust quality culture across the organization. By doing so, businesses can not only meet compliance requirements but also enhance their overall productivity and reputation in the industry.
  • 34
    Caliber v18 Reviews

    Caliber v18

    Dhruthi Technologies

    $1000 one-time payment
    Caliber v18 enhances the performance and efficiency of your organization's gauge system by seamlessly capturing and producing Dues, status updates, and trend analyses. It safeguards the company's investment in measurement instruments through systematic tracking and diligent maintenance practices. By enabling quick searches and data entry for various gauges, it significantly saves time and effort. The software streamlines calibration sessions with its intuitive and efficient user interface. Additionally, it guarantees that all essential quality standards, such as ISO 9001, ISO 13485, ISO 14001, ISO 17025, TS 16949, AS 9100, and 21 CFR Part 11, are consistently met or exceeded, ensuring compliance and quality assurance across the board. This comprehensive approach allows businesses to focus on their core activities while maintaining high standards in measurement accuracy and reliability.
  • 35
    ZipQuality Reviews
    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.
  • 36
    xTrak Reviews
    Experience the convenience of a comprehensive service center. There's no need to juggle multiple calibration vendors when you can access Calibration, Repair, and New Equipment Sales for effective asset life cycle management all in one place. With the most extensive onsite calibration services in Southern California, we truly stand unmatched. Our technicians generate certificates on-site, eliminating any waiting time for documentation. We pride ourselves on delivering expert quality service for all major equipment types. Customer service is our priority, ensuring prompt responses to all inquiries. We also offer weekly pick-up and delivery services throughout Southern California. You can manage your calibration needs effortlessly with our Cloud Calibration Management system, xTrak, available on both tablet and PC. Over the past six years, we have achieved a remarkable record of zero deficiencies in A2LA ISO Audits. Since 1997, we have been dedicated to serving the Aerospace, Medical, Automotive, Electronics, and Energy sectors. The xTrak® system automatically updates calibration records and statuses after every service, streamlining your calibration management process significantly. This allows you to dedicate more time and resources to your primary business activities, ensuring your operations run smoothly and efficiently.
  • 37
    Qualipro Reviews
    QUALIPRO is a comprehensive management software designed for quality, environmental, occupational health and safety, and food safety management. It offers assistance, research, and consulting services in quality, environmental issues, workplace health and safety, and HACCP standards. The software also provides training and awareness programs related to quality, environment, health and safety at work, food safety, and auditing techniques. Its customizable nature and specialized modules allow QUALIPRO to meet the specific needs of the Pharmaceutical and medical device industries effectively. QUALIPRO adheres to the principles of “Good Manufacturing Practices (GMP)” and complies with ISO13485 standards. Additionally, it aligns with key international standards such as ISO 9001, EN 9100, ISO IATF 16949, ISO 14001, ISO 17025, ISO 15189, ISO 22000, IFS, ISO 27001, and ISO 45001. As a state-of-the-art and modular software solution, QUALIPRO serves as a powerful tool for managing Quality, QSE, SHEQ, and SHE systems. Its versatility makes it an essential resource for organizations striving for excellence in quality and safety management.
  • 38
    Database Providers Calibration Management Software Reviews
    Oversee all the measuring instruments utilized in your business with our straightforward, effective, and efficient solution. This solution features a flexible and scalable method for identifying calibration needs, establishing requirements, and updating the status of all measuring tools, equipment, and devices within the Calibration system. It offers a quick and simple way to document successful calibrations and extend the next due dates for each instrument. The scheduling of calibrations is streamlined through a calendar interface that highlights the due dates of measuring devices. Additionally, our solution automatically sends emails to notify you of any measuring devices whose calibration is overdue or approaching within the next 30 or 60 days, significantly enhancing the effectiveness of calibration initiatives. When integrated with ISO 9001-compliant calibration programs, this Calibration Management Software ensures that all necessary information, documentation, and records are readily available, thereby streamlining compliance and maintenance processes. Users can also benefit from comprehensive reporting features that provide insights into calibration trends over time.
  • 39
    iPassport Reviews

    iPassport

    Genial Genetic Solutions

    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.
  • 40
    IndySoft Reviews

    IndySoft

    IndySoft

    $99 per user per month
    IndySoft is dedicated to enhancing the efficiency and effectiveness of your quality systems. Our comprehensive solution enables significant savings in both time and resources. Whether you operate a small calibration lab or a large international network, IndySoft ensures your workflow remains organized and your data is always current and readily available, all while adhering to ISO/IEC 17025 standards. Revolutionize your operations with our adaptable workflows and advanced data searching capabilities. This solution is particularly beneficial for multi-site operations that require data that is always ready for audits. IndySoft's calibration management software includes various modules such as gage studies, tooling, maintenance, uncertainty, and trend analysis, offering both global scalability and data that meets audit readiness. Our system guarantees precise process management that aligns with the industry's essential requirements, while also providing easy access to digital calibration certificates and a user-friendly reporting module. By utilizing IndySoft, you can streamline your quality assurance processes, making them more robust and reliable.
  • 41
    Eupry Reviews
    Eupry is a comprehensive temperature compliance solution that adheres to GxP standards, integrating automated monitoring, mapping, and calibration within a singular cloud-based platform, eliminating the chaos of spreadsheets. Its wireless data loggers continuously transmit real-time temperature and humidity information, even when Wi-Fi connectivity is compromised; the innovative sensor tips allow for quick recalibration of devices in less than a minute without the need to change loggers; and the customizable mapping kits yield accurate, audit-ready reports with ease. Operating in an environment accredited by ISO 17025 and certified for ISO 9001 and ISO 27001, Eupry incorporates FDA 21 CFR Part 11 regulations along with automatic deviation notifications, digital calibration certificates, and hassle-free documentation features. Whether you desire comprehensive oversight or prefer to select specific modules for monitoring, mapping, or calibration, this platform provides a reliable source for compliance information, simplifies the audit process, minimizes manual tasks, and ensures you remain proactive in adapting to regulatory changes. With its user-friendly interface and robust features, Eupry not only enhances operational efficiency but also instills confidence in maintaining compliance standards.
  • 42
    CAPA Manager Reviews

    CAPA Manager

    Adaptive Business Management Systems

    $12.49 per user/month
    6 Ratings
    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.
  • 43
    YunQuality Reviews

    YunQuality

    YunQuality Information Technology

    1 Rating
    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.
  • 44
    SoftExpert EQM Reviews
    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.
  • 45
    Arena QMS Reviews
    Arena's quality management system (QMS) software, designed specifically for product-centric environments, empowers medical device manufacturers to efficiently bring safe and compliant products to the market. By integrating quality and product processes, Arena QMS simplifies the new product development and introduction (NPDI) process. It provides assurance of regulatory compliance with essential quality standards and regulations, such as FDA 21 CFR Part 820, Part 11, and ISO 13485. Furthermore, Arena QMS improves visibility and traceability by managing quality processes in conjunction with various essential documentation, including bills of materials (BOMs), standard operating procedures (SOPs), device master records (DMRs), design history files (DHFs), specifications, drawings, and training plans. This holistic approach not only facilitates compliance but also fosters a culture of quality throughout the organization.