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Adaptive Compliance Engine (ACE)The Adaptive Compliance Engine® (ACE®) is a versatile, workflow-driven eQMS/eDMS solution that can seamlessly adjust to various business processes, providing real-time oversight, management, and reporting for compliance, quality, and operational tasks. By utilizing ACE®, organizations can alleviate administrative burdens and enhance ROI through immediate productivity improvements, while maintaining adherence to 21 CFR Part 11 regulations. Our comprehensive software suite features: -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 numerous additional capabilities! Enable every tier of your organization with user-friendly interfaces, effortlessly locate all documents and records, and convert your data into insightful intelligence through advanced analytics, all within one unified platform. Every essential application is bundled together at a single price with ACE, eliminating the need for separate purchases. Enjoy the convenience of one software solution with countless functionalities, making it a truly invaluable asset for your business.
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Matrix RequirementsOptimize every phase of the development lifecycle with a versatile solution tailored for SxMD, allowing for effective management of design controls that span from initial requirements to compliance, all while ensuring comprehensive traceability to reduce risk. Accelerate innovation through a flexible item-based documentation strategy that caters to the intricate demands of even the most sophisticated SxMD products. Improve quality management by maintaining full traceability from design inputs to outputs with a specialized software platform that fosters collaborative quality practices across all departments. Take command of the shifting landscape of design, quality, and regulatory criteria while promoting team independence, ensuring your product reaches the market more swiftly. Achieve seamless integration across platforms with built-in connections to Jira, GitLab, GitHub, Azure DevOps, and more, while also utilizing our REST API to link all your essential tools effortlessly. This comprehensive approach empowers teams to not only adapt but thrive in a fast-paced development environment.
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Interfacing Enterprise Process Center (EPC)Interfacing's Digital Twin Organization software enhances transparency and governance, which in turn boosts quality, efficiency, and ensures adherence to regulatory standards. This comprehensive platform enables users to map, analyze, and automate their workflows while effectively managing compliance and evaluating risks. The Enterprise Process Center (EPC) serves as an enterprise management solution that empowers businesses to digitally evolve their operations, facilitating streamlined processes, heightened productivity, and improved overall efficiency. Additionally, Interfacing's Rapid Application Development Tools (RAD), utilizing a Low Code Development approach, optimize your technical assets and enhance transparency, paving the way for ongoing improvements. Experience the power of our Low-Code Rapid Application Development module, which equips you with the essential tools to swiftly create and deploy custom, scalable, and secure applications that are ready for mobile use, significantly reducing development time from months to mere days. With these innovative solutions, organizations can achieve remarkable agility and responsiveness in today’s fast-paced business landscape.
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Komodo HealthAt Komodo Health, we blend a deep understanding of patient interactions with state-of-the-art algorithms and extensive clinical expertise to develop our Healthcare Map, which provides the most precise depiction of the U.S. healthcare system. This map serves as the foundation of our robust array of software solutions, designed to empower you to deliver outstanding value to your customers, colleagues, and patients. Relying exclusively on conventional academic data for strategic decision-making has become obsolete in today's rapidly evolving landscape. Our Aperture platform has been expertly designed to offer unmatched insights into clinical leadership and influence, facilitating enhancements in care standards precisely where they are most needed—be it the most cited author, a well-known social media figure, or the physician with the largest patient base. Additionally, traditional open or sampled prescription and patient-level data frequently miss crucial trends necessary for accurately identifying individuals with complex healthcare needs or rare medical conditions. By bridging these gaps, we strive to improve patient outcomes and optimize healthcare delivery while adapting to the continuously changing environment of the medical field. This commitment to innovation ensures that we remain at the forefront of healthcare solutions that truly make a difference.
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RegDeskRegDesk stands out as the leading RIMS platform enhanced by AI, tailored specifically for Medical Device, Pharmaceutical, and IVD companies. • Our unique Regulatory Intelligence encompasses data from over 120 countries, all presented in a uniform format, and includes timely alerts regarding regulatory updates. • With our AI-driven Application Builder, regulatory affairs teams can efficiently create and submit global applications in a fraction of the usual time. • The Change Assessment feature enables RA teams to evaluate the implications of changes on current products and determine the necessary actions. • Our Distributor Collaboration tool facilitates smooth workflows for communication and document sharing with external partners. • The Standards Management function simplifies the process for RA teams to locate and oversee both international and country-specific standards. • Additionally, our Tracking & Reporting capability empowers teams to monitor regulatory initiatives worldwide, receive notifications for renewals, and quickly compile reports on key performance indicators. To learn more about our offerings, please explore our website.
What is Quality Connect?
Cloud-based Enterprise Quality Management Software designed specifically for the life sciences industry is crucial for successfully navigating the complexities of today's operational environment. By placing technology at the center of operations, it enables quality assurance teams to be swiftly alerted to emerging issues, which cultivates a proactive management culture. Organizations that achieve a comprehensive understanding of their quality management system's performance in relation to operational conditions can effectively mitigate risks and sidestep costly delays. Montrium has developed its Enterprise Quality Management System (EQMS) with the specific aim of assisting life science companies in tackling their unique quality management hurdles, especially in the area of content management. Our SharePoint QMS modules are crafted with adaptability in mind; they can operate autonomously or integrate seamlessly into a unified quality management system. Accessible via our Montrium Connect Platform, these modules can be deployed either on-premises or through cloud-based solutions, making them particularly suitable for pharmaceutical companies, contract manufacturing organizations, and medical device manufacturers. Each module is carefully constructed to ensure adherence to Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP), thus helping organizations uphold the highest standards of quality. This all-encompassing approach not only boosts operational efficiency but also fortifies the integrity of the quality management process, reinforcing the commitment to excellence within the life sciences sector. As a result, companies can better navigate regulatory landscapes while achieving their business objectives.
What is ExtendMed?
Engage with key players in the healthcare sector to extract valuable insights, boost your clinical research initiatives, and foster opportunities for online learning. Collaborating with ExtendMed can greatly enhance the effectiveness and frequency of your interactions while reducing expenses to one-third of traditional methods. Our extensive knowledge allows you to amplify your impact and efficiency within the healthcare arena. With over twenty years of experience partnering with pharmaceutical companies, agencies, and associations, we provide a wide range of solutions in scientific, marketing, education, and training via our Health Expert Connect platform, which offers features such as:
- Organizing virtual advisory boards to encourage dialogue and gather feedback
- Overseeing speaker bureaus, including aspects like contracting, training, logistics, and adherence to Sunshine reporting regulations
- Enabling smartphone engagement at events, which includes managing sign-ins, presentation slides, polling, surveys, assessments, and follow-up actions
- Hosting online product theaters and satellite symposia to highlight innovations and progress in healthcare.
By utilizing our platform, you can ensure that your projects resonate more deeply with your target audience, ultimately leading to improved outcomes and greater satisfaction. This strategic partnership not only elevates your initiatives but also positions you as a leader in the rapidly evolving healthcare landscape.
Media
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Integrations Supported
Montrium Connect
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
Montrium
Company Location
Canada
Company Website
www.montrium.com
Company Facts
Organization Name
ExtendMed
Date Founded
2000
Company Location
United States
Company Website
www.extendmed.com
Categories and Features
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management