Best Medical Quality Management Systems in South America - Page 2

Greenlight Guru is the only product development and quality management platform designed specifically for medical device companies. The Medical Device Success Platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance, and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control, and more. Device makers across the globe are replacing their outdated paper-based and general-purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and achieve True Quality.

Ensuring uniform product quality and robust quality management procedures poses significant challenges in the current landscape of pharmaceutical manufacturing. Industries governed by strict regulations, including Pharmaceuticals, Biotechnology, and Life Sciences, must adhere to Good Manufacturing Practices (GMP) to comply with legal standards. Beyond merely fulfilling GMP obligations, it is essential to provide evidence of compliance. Relying on paper forms, isolated systems, or manual procedures to oversee, monitor, and document quality issues and responses fails to offer effective solutions for establishing cohesive and integrated quality management practices that align with industry standards. Consequently, organizations must seek more advanced and automated systems to enhance their quality assurance efforts and streamline compliance.

EQUMAS tailors digital solutions to meet the specific operational requirements of its clients. Our innovative, modular, and multimodal technology enables manufacturing firms to oversee their Quality Management System (QMS) alongside all other operational components seamlessly. While you could opt for different systems to handle quality control, inventory management, equipment oversight, and report generation separately, choosing EQUMAS streamlines your entire workflow through a robust, integrated software solution. This platform incorporates cutting-edge AI technology that facilitates data-driven decision-making, identifying manufacturing irregularities even before human intervention is possible. Every facet of our system is interconnected, promoting real-time communication across the platform. This remarkable capability significantly reduces the time and effort needed to synchronize various software applications to manage all your data collectively. Furthermore, you can effectively oversee each employee by assigning specific roles and responsibilities, as EQUMAS meticulously tracks and retains individual information throughout the system, enhancing overall operational efficiency. In doing so, we empower organizations to optimize performance while ensuring compliance and accountability across all levels.

Explore innovative strategies for overseeing your projects and data management. Whether your organization is small, medium, or large, Laby seamlessly integrates with your specific structure and expertise. Become part of our user community and collaborate with us to shape future advancements. Effectively structure your projects, experimental protocols, and academic papers. Create detailed recipes for producing finished goods. Streamline item management and ensure traceability with automation. Oversee laboratory equipment and handle their upkeep efficiently. Laby offers a unified platform for all your documents, facilitating straightforward access and retrieval. Prepare and approve quality assurance documents prior to their release. Easily search, share, and review all relevant scientific literature. Generate reports compliant with 21 CFR part 11 and EIDAS regulations. Monitor time spent on each project and export your findings as needed. This comprehensive management system ensures a high level of oversight and efficiency. Additionally, receive training to help you transition smoothly and maximize your productivity every day. Engage with others in the community to exchange ideas and enhance your experience.

Quality Collaboration By Design (QCBD) offers a comprehensive quality management software solution tailored for the manufacturing sector. This cost-effective, Windows-compatible application streamlines the process of obtaining and sustaining compliance with various quality management standards, including ISO 13485, ISO 9001, TS 16949, AS9100, and SQF 2000 / ISO 22000. Developed by CAMA Software, QCBD encompasses a wide range of modules that facilitate training management, supplier oversight, process deviation tracking, document control, equipment management, and additional functionalities. With its user-friendly interface, QCBD not only enhances operational efficiency but also ensures that businesses can easily adapt to evolving quality requirements.

Qualio is a one-stop solution for quality and compliance management. It's ideal for growing companies in healthcare and life sciences. Qualio is reliable, affordable and easy to use. It helps companies build life-saving products faster and achieve 100% ISO, GxP and FDA compliance. Qualio makes it easy for companies to manage document control, training and NCRs, audits as well as suppliers, complaints, and other tasks in one platform.

ARMATURE Fabric™, allows you to manage all aspects of your accreditation, certifications, credentialing, audit quality, and compliance activities from one platform. Our software allows you to save time, work more efficiently and securely, and better serve your stakeholders. Whether you manage institutional, programmatic or specialized accreditation programs, certify individuals, products or organizations, conduct audits or assessments, or resolve non-conformances, ARMATURE Fabric can make it simpler and more efficient for both you and your stakeholders. Our cloud-based, secure software allows you to collect data in multiple methods (through online applications and audits, assessments and self-evaluations), manage your accreditation, certification, audit and compliance workflows, capture and manage documents and artifacts and identify and resolve issues; generate reports; and spot trends.

For a system to be effectively utilized, it must be easily accessible! Users should not have to endure long loading times or delays in search results. Instead, the goal is to swiftly and effortlessly access information or add records at any time and from any location! Wismatix QMS is designed to meet these needs. With years of expertise in auditing and implementing Quality Management Systems, we have crafted Wismatix QMS to ensure exceptional speed and reliability. Our commitment to customer service is unparalleled. You will receive comprehensive support while using our online quality management system, and should you decide to discontinue its use, we guarantee that your data will be provided to you for easy transfer to your own server. Moreover, we strive to maintain the highest standards of user satisfaction throughout your experience with us.

NWA Quality Analyst®, an award-winning SPC charting and analysis solution, is the best. It offers the best combination power, flexibility, ease-of-use, and flexibility of any SPC software. It allows users to visually analyze process behavior and evaluate the impact of process improvements.

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.

Natively built and operated on the Salesforce platform, QHSE is the fastest growing Enterprise Quality, Health and Safety Management System. Unified QHSE solutions combine EQMS with EHS to help customers of all sizes deliver high quality products and services in a safe and sustainable manner. They reduce risk, inefficiencies, and inefficiencies, while protecting their customers, employees, and brand.

Quality Link 7 is designed with a focus on both individuals and technology, leveraging our extensive experience and established platform to assist organizations in streamlining processes, reducing costs, and ensuring regulatory compliance through an intuitive business operating solution. By utilizing our document management module, Quality Link enhances efficiency and eliminates the need for cumbersome manual paperwork, allowing for seamless storage and management of every document generated. Users can conveniently print "uncontrolled" copies of documents and engage in a variety of document-related tasks directly within the module. This strategic organization significantly cuts down on clerical work performed by quality personnel by up to 90 percent. Our software also simplifies the transition by effortlessly converting documents from your former management system without any learning curve, while easily integrating with your preferred applications. With Quality Link, you can finally eliminate the burdensome task of manual document upkeep that often necessitates ongoing supervision, empowering your team to focus on more strategic initiatives. Additionally, the user-friendly interface ensures that all staff members can navigate the system with ease, further enhancing productivity across the board.

The SoftTrace system offers a customizable and cost-efficient software solution that effectively captures essential smart data throughout the entire manufacturing workflow. This system enhances process optimization by creating a Smart DataBridge that integrates production floor automation systems, ERP, MES, and OEE with laboratory analysis tools, as well as warehouse and raw material inventory management systems, thereby delivering a comprehensive profile of products and processes from the entry of raw materials to the dispatch of finished goods, all within a single platform. For more than two decades, SoftTrace has been delivering cutting-edge software solutions tailored to the dairy sector. Our knowledgeable team possesses a deep understanding of the numerous challenges that the modern dairy industry encounters. At SoftTrace, we prioritize being problem solvers and solution providers, dedicated to assisting you in optimizing your operations at every stage of the process. We are committed to continuous innovation, ensuring that we adapt to the ever-evolving needs of our clients in the dairy industry.

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.

QAD EQMS (Enterprise Quality Management System) is a fully integrated enterprise quality management system that provides timely visibility into manufacturing and quality-related issues across the enterprise. It facilitates a preventative approach that helps to build quality into the process from the product design phase.

AlisQI, a cloud-based Quality Management platform that is easy to integrate and use, is flexible and easy to use. Our platform allows manufacturing companies to make their Quality Management data-driven and automated. Our platform is used by more than 70 factories around the world for Quality Control, Quality Assurance, and QESH management. Our customers can reduce waste by upto 15%, improve their quality and save upto 20% on time. We are proud to be able to serve customers from all six continents, from startups to Fortune500. We have never lost a customer. Our customers are found in almost every manufacturing sector: Chemicals, Personal Hygiene and Food & Beverage, Automotive and Manufacturing.

Software that helps you comply with regulations. Fannie Mae, Wendy's and Walmart trust the best mobile inspection and audit platform. This will help you improve safety and accuracy. The #1 field management platform for teams, FORM OpX will transform your Excel, paper, and digital processes. FORM OpX combines advanced data gathering and configurable workflows with powerful operational insight to increase compliance in real time. To ensure compliance and team compliance, you can set up audits, inspections, or workflows. Digital forms allow you to capture data and guide teams to the right actions. Set up automated alerts and escalates to prompt corrective action when issues arise. You can save time and money by creating customizable workflows that improve processes, increase compliance, and reduce errors.

Transform your Life Sciences operations by significantly enhancing the control, efficiency, and quality of your products and processes. Maintain inspection readiness consistently with our fully compliant platform, which has undergone pre-validation in line with GAMP5 standards. Gain complete oversight of your processes and documentation, allowing for perfectly customized workflows and maximized automation wherever feasible. Experience smooth operations and comprehensive traceability through our seamlessly connected modules. Our committed team is available to address any inquiries you may have at any moment. Only the finest Scilife experience meets our high standards! The Scilife platform not only streamlines but also automates and organizes every aspect of your industry, whether in Medical Devices, Pharma & Biotech, or ATMP. Click below to explore the specific Scilife modules that cater to the distinct lifecycle stages within your industry. Our software is not just equipped with all the essential quality tools you would anticipate; it also comes with numerous additional features that surpass expectations, ensuring your operations thrive. We're excited to partner with you on this transformative journey!

To expedite the introduction of new products while adhering to international regulations, companies must streamline and automate their processes for gathering, monitoring, analyzing information, and addressing related challenges. QUMAS EQMS, previously known as ProcessCompliance, is a cloud-based platform designed for Enterprise Quality and Process Management, offering extensive integrated solutions for regulatory, quality, and compliance management within a validated Quality Management System (QMS) framework. By leveraging QUMAS’s data-centric methodology, organizations can adeptly manage quality-related content and easily access and repurpose quality data, ensuring thorough visibility into the quality landscape. Furthermore, QUMAS features interactive quality dashboards that provide an overview of QMS performance across various business sectors and quality initiatives. Users can generate reports that are easily exportable, shareable via email, or scheduled for regular updates. This platform also facilitates secure, efficient, and compliant information exchange among QMS departments in the cloud, enhancing collaboration and operational efficiency. Ultimately, QUMAS empowers organizations to meet their quality objectives while navigating the complexities of regulatory compliance.

InSilicoTrials.com is an online platform that offers a user-friendly environment for computational modeling and simulation, featuring a range of integrated, easy-to-navigate in silico tools. It primarily serves professionals in the medical device and pharmaceutical industries. The in silico tools designed for medical devices facilitate computational testing across various biomedical fields, including radiology, orthopedics, and cardiovascular health, during the stages of product design, development, and validation. For the pharmaceutical industry, the platform grants access to in silico tools that support all phases of drug discovery and development across diverse therapeutic areas. We have developed a unique cloud-based platform grounded in crowdscience principles, allowing users to efficiently utilize validated models and reduce their R&D expenses. Additionally, users can explore a continuously expanding catalog of models available for use on a pay-per-use basis, ensuring flexibility and accessibility for their research needs.

Advantum stands out as an ideal solution for your information management needs, offering exceptional security combined with remarkable flexibility. You can opt for a tailored industry solution, select individual modules, or collaborate with us to design a customized system that meets your unique specifications while ensuring cost-effectiveness and dependability. In today's world, the ability to work from any location has become essential, which is why Advantum is designed to operate seamlessly on smartphones, tablets, and computers alike. With its unparalleled adaptability, Advantum equips you to tackle contemporary challenges while remaining poised for future technical and organizational shifts. The system's flexibility extends to our licensing model, which focuses on the number of concurrent users, making it a financially savvy choice when licenses are shared. Our clients frequently express high levels of satisfaction with our dedicated support services, highlighting the value we bring to their operations. Ultimately, Advantum not only addresses your current needs but also evolves with you, ensuring long-term success and satisfaction.

Cloud-based Enterprise Quality Management Software tailored for the life sciences sector is essential in navigating today’s intricate operational landscape. With technology at the forefront, it ensures that quality assurance teams are promptly informed of issues as they arise, fostering a culture of proactive management. By gaining a clear view of the quality management system's performance alongside operational conditions, organizations can significantly reduce risks and avoid expensive delays. Montrium has crafted its Enterprise Quality Management System (EQMS) specifically to help life science companies confront their quality management challenges directly, particularly in content management. Our SharePoint QMS modules are designed for flexibility; they can function independently or as part of a cohesive quality management system. These modules are accessible through our Montrium Connect Platform and can be implemented either on-premise or via cloud solutions, making them ideal for pharmaceutical firms, contract manufacturing organizations, and medical device companies. Each component is meticulously built to ensure compliance with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP), thereby supporting organizations in maintaining the highest quality standards. Ultimately, this comprehensive approach not only enhances efficiency but also strengthens the overall integrity of the quality management process.

Vault QualityDocs enhances quality processes and mitigates compliance risks through automated workflows and thorough audit trails. By streamlining review and approval procedures, it ensures efficient sharing of SOPs and other GxP documents among staff and collaborators. The automation of workflows, coupled with real-time visibility into content status, empowers organizations to manage SOPs effectively, further minimizing compliance risks. Its user-friendly interface promotes higher adoption rates and operational efficiency. In addition, the system provides detailed audit trails, organized content, and robust search capabilities that greatly improve audit preparedness and inspections. Users can securely access and interact with documents via any major web browser, and if configured, can print, distribute, and monitor controlled PDF copies. The incorporation of predefined document taxonomies, metadata, and selection lists for quality, manufacturing, and validation documents not only streamlines operations but also enables organizations to swiftly embrace industry best practices, ensuring continuous improvement and compliance alignment. Thus, Vault QualityDocs stands as a pivotal tool in modern quality management.

When utilizing LC-MS/MS for either research purposes or routine tasks, you anticipate obtaining results that are not only swift but also precise and definitive. The SCIEX software suite enhances the functionality of your high-performance LC-MS/MS system by providing tailored workflow and application modules to complement your operating system. Consequently, your mass spectrometer operates with an optimized software mix that aligns with your specific requirements. These components represent the fundamental engines behind SCIEX's nominal mass and accurate mass LC-MS/MS systems, facilitating quick and dependable data collection, processing, and reporting, all while ensuring compliance readiness. By integrating high performance with user-friendly features and additional modules, you can refine both quantitative and qualitative workflows. Furthermore, the implementation of application-specific software modules allows for a more rapid transformation of your data into definitive results, streamlining your research process significantly. This combination of efficiency and adaptability in software applications is crucial for advancing your analytical capabilities.

Loftware Prisym 360 offers cutting-edge content management capabilities tailored to comply with the intricate regulatory demands vital for clinical supplies labeling. Teams responsible for clinical labeling frequently employ English MLT/CLT variants to articulate the details for clinical trial labels and accompanying booklets. As the number of countries participating in each study grows, each with its own set of regulatory content, phrases, and language stipulations, the traditional method of designing and printing booklets consumes more time and resources, heightening the potential for mistakes. By utilizing Prisym 360’s MLT/CLT solution, users are guided to input study-specific information, which subsequently allows for the automated creation of MLT, CLT, and booklet designs based on established content and design criteria. This streamlines the process of producing clinical labels and booklets, reducing the necessary time from weeks down to mere hours, ensuring compliance with regulatory standards, and significantly mitigating the likelihood of errors. Ultimately, this innovative approach enhances the efficiency of clinical supply operations, providing a robust solution to a complex challenge.