TenForce
It is difficult to make data available and actionable when a manufacturing site has many processes. As operations grow, it is becoming more difficult to comply with safety, quality, and environmental regulations. Manufacturing is built on predictability and reliability. Manufacturing by nature is all in the execution of established processes. TenForce was built from the feedback of our clients to map the operational reality in a plant.
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Adaptive Compliance Engine (ACE)
Adaptive Compliance Engine® (ACE®) is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant.
Our one-stop software includes:
-Office 365 Integration
-Inspection Management
-Document Management
-Risk Management
-Product Lifecycle Management
-Learning Management
-Audit Management
-Quality Events
-Paperless Validation
-Electronic Signatures (21 CFR Part 11 Compliant)
-Endless Workflow Configurations
-And so much more!
Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform.
ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions.
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CaliberPulse
CaliberPulse is an advanced analytical platform specifically designed for the pharmaceutical sector, aimed at converting intricate data into practical insights that enhance efficiency and ensure compliance in quality assurance and manufacturing processes. This platform boasts integrated reporting capabilities that deliver immediate insights into statistical process control and quality metrics, specifically catering to the requirements of the pharmaceutical field. By effortlessly integrating with applications such as MS Excel, LIMS, EBR, and SAP, it allows for streamlined data extraction and real-time reporting while minimizing the need for manual input. Additionally, CaliberPulse features sophisticated tools like automated Box-Cox data transformation, critical attribute assessments, and comprehensive data visualization options that render results in a user-friendly format through graphical representations and color-coded interfaces. Furthermore, the system guarantees adherence to regulatory requirements by automating the processes of data ingestion and storage, while maintaining complete traceability throughout. Ultimately, CaliberPulse empowers pharmaceutical organizations to make data-driven decisions with confidence and precision.
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Quality Connect
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.
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