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QualioQualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk. With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive. Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box. Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand. The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.
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SBS Quality Management SoftwareThe SBS QMS Suite is composed of five interrelated software modules designed to enhance Quality compliance efficiency. 1) The SBS Quality Database includes tools for managing CAPA and 8D corrective actions, overseeing nonconformance issues, conducting risk analyses such as FMEA and SWOT, handling various audit management needs, and ensuring Environmental Health and Safety (EHS/HSE) compliance. 2) SBS Ground Control focuses on managing employee training through a Learning Management System (LMS), offering self-paced training options, and providing document control features. 3) SBS Asset Tracking Database oversees calibrated equipment, preventive maintenance schedules, and comprehensive asset inventory management. 4) The SBS Inspection Database captures and records inspection data for incoming materials, in-process checks, and final product assessments, allowing for the generation of real-time SPC charts, development of inspection and control plans, and archiving data for future statistical evaluations. 5) The SBS Vendor Management maintains an approved vendor list (AVL), formulates vendor qualification plans, and tracks the qualification history of suppliers. Each of these modules may be purchased individually or in any combination to meet your needs. On-premise and cloud-based options are available. Free demos are available for download or contact us for a cloud-based demo.
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MaintainXMaintainX is a mobile-centric platform designed for work orders and procedures that empowers teams by clarifying their tasks and providing guidance on execution. Our service digitizes and streamlines various essential documents, such as: - Maintenance Work Orders - Safety Procedures - Environmental Checklists - Tooling & Gauge Reporting - Preventative Maintenance Procedures - Auditing/Inspection Workflows - Training Checklists By offering real-time insights from the field, we enable operational leaders to enhance efficiency and make informed decisions that drive productivity. This transformation not only simplifies workflows but also fosters a culture of safety and accountability within the organization.
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Interfacing Integrated Management System (IMS)Interfacing’s IMS is an AI-enabled platform that combines business process modeling, quality management, controlled documentation, and governance/risk capabilities in a single hub. Organizations rely on IMS to document and automate workflows, maintain versioned records, manage risk programs, and keep compliance activities aligned with regulatory requirements through full lifecycle traceability. Developed for industries where accountability and oversight are essential, including aerospace, pharma/biotech, finance, and government, IMS delivers operational insight, workflow automation, and intelligent recommendations that help reduce risk and improve quality outcomes. The platform holds ISO 27001 certification and includes 21 CFR Part 11 validation, supporting secure use in high-compliance environments. Additional capabilities include low-code app creation, AI-based process mining, audit management, CAPA and training modules, and performance dashboards. AI improves governance accuracy, strengthens compliance posture, and supports ongoing improvement.
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flowditflowdit significantly boosts efficiency by automating routine responsibilities and minimizing errors, thereby fostering a connected atmosphere that improves employee productivity. It plays a vital role in adhering to regulatory requirements while simplifying audits and inspections, ultimately contributing to increased profitability for leading companies in various sectors. As a tailored solution designed for connected workers, flowdit shines in fields such as commissioning, quality control, maintenance, and environmental health and safety management. It facilitates seamless communication and teamwork across departments, allowing for ongoing process supervision that helps to detect and alleviate risks proactively. Additionally, the platform leverages AI-powered insights to preserve the integrity of documentation and enforce standard operating procedures, keeping operations smooth and minimizing mistakes. In the context of digital transformation, flowdit supports the digitization of inspection and auditing tasks, maintenance timelines, safety protocols, and environmental assessments, effortlessly integrating with IoT and ERP technologies. This integration not only bolsters operational safety but also ensures effective oversight of numerous sites, making it an invaluable asset for organizations aiming to thrive in a technologically advanced landscape. Furthermore, flowdit's capabilities empower teams to focus on strategic initiatives, ultimately driving innovation and growth.
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IntelexIntelex provides an integrated software solution designed to manage Environmental, Health, Safety, and Quality (EHSQ) initiatives effectively. Its versatile platform is engineered to gather, control, and analyze EHS and Quality data in a comprehensive manner. This solution is accessible on any device, aligning perfectly with the demands of your workplace. Utilizing Intelex allows your organization to: Enhance the results of your EHSQ program by overseeing workflows for improved performance and control. Identify trends and behaviors through effective goal-setting to enrich insights and enhance decision-making within your EHSQ framework. Reduce incidents and minimize administrative burdens by adeptly supervising, managing, refining, and deriving insights from your safety data with our user-friendly safety software. Streamline the management and reporting of air, water, and waste emissions while overseeing environmental outputs to achieve sustainability goals. Encourage continuous quality improvements by effortlessly recording and tracking all instances of nonconformity within a centralized, web-based system, allowing for trend analysis across multiple departments or locations. Intelex also aids in navigating compliance with global standards and regulations like OSHA, WCB, ISO 45001, EPA, and ISO, fostering a culture of safety and accountability within your organization. By leveraging these tools, companies can not only comply with regulations but also drive long-term growth and sustainability.
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Certainty SoftwareCertainty is a comprehensive software solution for auditing and inspection that offers reliable support in managing and reporting on business risks, compliance, and performance indicators swiftly and effectively. Utilized by countless professionals, Certainty Software facilitates millions of inspections and audits annually, equipping users with essential tools to gather, organize, and present precise, consistent, and actionable metrics throughout the organization. In addition to its data management capabilities, Certainty empowers users to design, oversee, and report on inspection and audit findings while also assisting in the identification and mitigation of risks, incidents, and challenges that may arise during the auditing process. This software not only enhances operational efficiency but also ensures that businesses maintain high standards of accountability and performance.
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SupplierGatewaySupplierGateway transforms the landscape of Supplier Management by offering a platform that makes onboarding, compliance, and overall management far more efficient. This cloud-based solution automates traditionally manual processes, consolidates supplier information, and enhances compliance tracking for companies of all sizes. It boasts features such as automated onboarding, comprehensive data management, tracking for compliance and diversity, as well as tools for spend analysis. The platform integrates effortlessly with pre-existing systems and is designed to scale according to your requirements, ultimately lowering costs and promoting innovative practices. The primary benefits include rapid and precise supplier integration, a centralized data hub that enables informed decision-making, streamlined compliance with regulations, and the strengthening of local and diverse supply chains. Additionally, the spend analysis tools provide valuable insights into procurement strategies focused on diverse and local expenditures. Crafted for flexibility, SupplierGateway integrates seamlessly into your business workflows, facilitating growth without introducing additional complexity or expenses. This not only reduces operational costs but also enhances compliance and fosters innovation, thus redefining the approach to supplier management. By adopting this innovative solution, businesses can elevate their operational strategies to unprecedented levels of efficiency while remaining agile in an ever-changing market.
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RipplingRippling simplifies human resources, payroll, IT, and expense management for companies operating on a global scale. With ease, you can oversee the complete employee lifecycle, encompassing everything from recruitment to benefits management and performance evaluations. It offers automation for HR processes, eases the approval workflow, and guarantees adherence to regulations. You can also control devices, manage software access, and monitor compliance, all from a single dashboard. With timely payroll processing, effective expense tracking, and adaptable financial policies, you can save time, lower expenses, and boost overall efficiency in your organization. Discover the advantages of integrated management solutions with Rippling and transform the way your business operates today.
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SDS ManagerSDS Manager stands out as a leading provider of Safety Data Sheet (SDS) Management solutions, boasting one of the most extensive SDS databases globally, which contains over 14 million Safety Data Sheets available in 25 different languages. With SDS Manager, employees can conveniently retrieve crucial SDS information directly on their mobile devices by scanning QR code posters placed in areas where chemicals are handled, thereby enhancing both safety measures and adherence to regulatory standards. This intuitive mobile access not only facilitates immediate information retrieval but also fosters a culture of safety within the workplace. Additionally, our automated data extraction capabilities allow for the effortless integration of SDS files into your library without the need for manual data entry, which greatly enhances accuracy and optimizes the process of SDS management. Your SDS library remains consistently updated, well-organized, and readily accessible, all within a secure cloud environment, ensuring that you are always prepared for audits or emergencies.
What is Tepsivo?
Tepsivo presents cutting-edge software solutions for pharmacovigilance that streamline drug safety processes through automation and smart templates, resulting in a marked reduction in administrative burdens and associated costs. The Tepsivo Platform stands as a comprehensive, cloud-based tool that enables users to manage all elements of pharmacovigilance from a single, cohesive interface. Among its standout features are a Quality Management System, the guidance of a Local Contact Person for Pharmacovigilance (LCPPV), streamlined safety reporting and follow-up procedures, PSUR tracking, signal detection management, automated audit trails, compliance oversight, adverse event intake tools, literature monitoring, risk management system tracking, solutions for managing PSMF, automated reconciliation with external partners, and CAPA management. By incorporating these functionalities, the platform ensures total transparency, adherence to regulatory requirements, readiness for inspections, high-quality deliverables, swift processing times, removal of administrative overhead, and cost savings. Organizations utilizing Tepsivo’s solutions can significantly bolster their pharmacovigilance efforts while maintaining compliance with industry standards in an efficient and productive manner. Ultimately, this not only enhances safety management but also fosters a culture of continuous improvement within the organization.
What is PubHive Navigator?
PubHive Navigator represents a cutting-edge software solution that leverages artificial intelligence to improve the effectiveness of scientific literature management and safety protocols for life science entities of all sizes. It offers a robust array of workflow tools that include literature review, curation, annotation, collaborative efforts, search capabilities, reporting, citation management, and oversight of research activities. The platform features AI-enhanced smart workspaces that enable centralized literature management, collaborative writing for research initiatives, and efficient team communication, all while providing integrations for document delivery and reuse rights, along with pre-configured workflows designed for various operational sectors. Additionally, PubHive Navigator seeks to simplify the intricate challenges tied to enterprise-level scientific literature and safety information processing, making it a flexible resource for teams involved in areas such as drug safety and pharmacovigilance, medical affairs, clinical affairs, and research and development. This adaptability not only streamlines operation but also empowers organizations to refine their research workflows and boost productivity across their teams, fostering a more dynamic approach to scientific advancement. Ultimately, the platform's design supports continuous improvement and innovation in life sciences.
Integrations Supported
Additional information not provided
Integrations Supported
Additional information not provided
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Tepsivo
Company Location
Finland
Company Website
www.tepsivo.com/pharmacovigilance-software/
Company Facts
Organization Name
PubHive
Date Founded
2020
Company Location
United Kingdom
Company Website
pubhive.com/home