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Mareana Connect™ delivers specialized solutions crafted to meet the unique needs of Contract Development and Manufacturing Organizations (CDMOs), which often grapple with intricate process integrations and stringent compliance requirements. Our platform optimizes the coordination of diverse manufacturing processes and data streams through advanced AI-driven analytics and adaptable data management tools. By boosting operational efficiency and enhancing data integrity, we empower CDMOs to improve service delivery and exceed client expectations in the competitive pharmaceutical industry.

Challenge

Mareana Connect™

Diverse Manufacturing Demands

CDMOs must continuously adapt their internal systems to meet the unique product requirements and varied specifications demanded by different sponsors, posing significant operational challenges.

Tailored Manufacturing Solutions

  • Offers bespoke solutions that adapt easily to each product’s specific manufacturing requirements without the need to overhaul existing backend systems.
  • Enhances flexibility to meet both standard operations and specific sponsor demands efficiently.
  • Allows for rapid customization of manufacturing processes to accommodate diverse and evolving product lines.

Expertise and System Complexity

CDMOs often face challenges due to limited internal expertise and the complexity of managing multiple systems across various client projects, which complicates the development of scalable solutions.

Simplified System Integration

  • Reduces reliance on internal expertise by simplifying system interfaces and automating complex processes.
  • Streamlines integration of multiple systems, ensuring seamless data flow and management across platforms.
  • Enhances system scalability and future readiness, preparing for new technological advancements without extensive system redesign.

Data Integration and Quality

Ensuring the accuracy and consistency of data from multiple client projects and diverse sources is both time-consuming and costly for CDMOs, impacting their ability to deliver reliable outcomes efficiently.

Enhanced Data Management

  • Automates and simplifies the integration of diverse data sources, reducing time and cost while ensuring data accuracy and consistency.
  • Implements robust data governance frameworks to ensure quality and reliability of data across all manufacturing stages.
  • Provides real-time monitoring and validation tools to maintain high data integrity and compliance with industry standards.

Future-Proof Scalability

CDMOs must ensure their systems remain relevant and adaptable to the rapidly changing technological and business landscapes to keep pace with client needs and industry standards.

Scalable, Future-Ready Systems

  • Delivers scalable solutions that grow with your business needs, allowing for easy expansion and adaptation without significant reinvestment.
  • Ensures systems remain cutting-edge with automatic updates and integration of the latest technological advancements.
  • Supports long-term strategic planning with tools that adapt to changing market and regulatory environments.

Compliance and Security

Achieving and maintaining GxP validation and CFR Part 11 compliance is essential for CDMOs to uphold their reputation and operational integrity in a highly regulated industry, yet this is complex and resource-intensive.

Robust Compliance Assurance

  • Guarantees compliance with GxP validation and CFR Part 11 regulations through stringent security protocols and built-in compliance features.
  • Provides comprehensive audit trails and control mechanisms to ensure data security and regulatory adherence.
  • Offers continuous compliance monitoring and reporting capabilities to manage risks and maintain global standards.

Custom Solution Needs

Responding to the evolving and specific needs of their clients often requires CDMOs to make costly investments in custom solutions or new software, increasing the financial and operational burden.

Customizable Solutions Development

  • Enables the development of tailored solutions with modular design features that can be customized to meet specific operational needs without extensive development time.
  • Reduces dependency on external software solutions by providing flexible, in-house customization capabilities.
  • Offers a cost-effective approach to managing and implementing custom solutions that align with strategic business objectives.

Mareana Connect™ Features

Business Outcomes

Platform

A CFR Part 11 compliant, cloud-hosted SaaS platform that streamlines all manufacturing data needs, enabling collection, connection, and contextualization of data across systems. Features native AI support and built-in analytics for comprehensive ad-hoc analysis.

Enhanced Data Integrity and Efficiency

  • Ensures accuracy and reliability of data across all manufacturing processes with a GxP CFR Part 11 compliant SaaS solution.
  • Automates the extraction and contextualization of data from paper batch records and other third-party sources, utilizing AI to significantly reduce manual effort and increase efficiency.

Genealogy

Offers an intuitive visual mapping of complex manufacturing steps, enabling thorough traceability through forward and backward exploration. Automatically adjusts data models in response to changes in recipes or processes, integrating real-time data for a comprehensive view across all sources.

Improved Batch Traceability

  • Enhances traceability and recall of batches, empowering users to independently navigate and understand complex data without extensive SME dependency.
  • Simplifies the validation and analysis process, enabling just-in-time availability of contextualized data for various needs including RCA and reporting.
  • Acts as a comprehensive knowledge repository for all manufacturing data, streamlining information sharing and technology transfer across sites.

Views

Facilitates the accounting for recipe changes and resolves data inconsistencies. Integrates validated and non-validated data and supports the creation of complex data transformations with built-in version management and GxP approval workflows.

Unified Data Management

  • Provides a unified view of data across the enterprise, simplifying maintenance and traceability.
  • Reduces time for changes with built-in change control and GxP compliant workflows.
  • Decreases chances of data errors through sophisticated data transformation tools and version management.

Statistical Process Control

Provides complete control over the chart’s appearance and functionality, customizes alerts, and integrates with the CAPA system for compliance. Features built-in approval for change control and allows for single-click exploration of Genealogy.

Improved Process Integrity

  • Minimizes the risk of errors from incomplete or unapproved data, ensuring data integrity and compliance.
  • Enables scheduled and on-demand generation of customized reports and alerts, facilitating proactive management of manufacturing processes.
  • Provides full traceability of data sources, transformations, and updates, enhancing control over production data and documentation.

Data Science Studio

Features purpose-built Python libraries for advanced data analysis and machine learning, tailored to enhance analytical capabilities in manufacturing.

Advanced Analytics Readiness

  • Enables advanced analytics and machine learning directly on the platform, eliminating extensive prep time for data analysis.
  • Provides state-of-the-art analytics capabilities, enhancing organizational insight and operational forecasting.

PBR

Automates the processing of data from handwritten paper records into a digital format, streamlining the transition from manual to digital documentation.

Reduced Workload for Employees

  • Significantly reduces the effort required by full-time employees (FTEs) by automating data entry from handwritten paper records.

EBR Lite

Converts paper records to digital entry screens with real-time checks for valid values and dependencies, maintaining flexibility for additional notes and QA approval within hours using a built-in approval workflow.

Rapid Transition to Digital

  • Transition from paper-based systems to digital solutions in weeks.
  • Maintains continuity between traditional and digital record-keeping, allowing some products to remain on paper while others move to electronic batch records (EBR) on the same platform.

AI Copilot for Batch Release

Detects inconsistencies in paper batches, facilitates collaborative review and resolution processes, and offers an intuitive UI for easy training and navigation.

Accelerated Batch Processing

  • Reduce batch release cycle time by several days
  • Reduce time to review batch records to minutes.
  • Eliminates the risk of missing out on review of critical items
  • Enables thorough review of CMO batches in minutes

Reports

Generates integrated reports combining charts, graphs, and narratives; supports one-click report generation with compliance checks; offers customizable template options for internal and external reporting.

Streamlined Reporting

  • Saves substantial time and effort in report authoring and integration.
  • Eliminates the need for manual updates to reports following changes in data elements, reducing errors and enhancing efficiency.
  • Accelerates report generation activities, allowing for timely decision-making and response.
  • Reduces manual errors in handling data and charts, increasing the reliability of reported outcomes.

In Process Controls

Integrates IoT data contextualized by batch and process steps, provides user-defined alerts, and employs complex multivariate analysis for operational insights.

Proactive Process Monitoring

  • Facilitates easy exploration and manipulation of time series data for various analyses.
  • Enables complex anomaly detection through multivariate time series analysis, improving the detection of outlying events or trends.
  • Supports the development and implementation of complex multivariate prediction models, enhancing forecasting and strategic planning capabilities.

Data As a Service

Delivers APIs for seamless integration and extraction of data across Genealogy and Views, ensuring controlled access based on user-defined access definitions, promoting efficient data sharing and management.

Secure Data Sharing

  • Elevates organizational capabilities by offering integrated data-sharing solutions across internal and external systems.
  • Provides out-of-box solutions for seamless data sharing and collaboration, enhancing interoperability with partners and across different platforms.
  • Ensures data security and compliance with user-defined access controls, enhancing data governance.

Make Confidently, Release Confidently, and Comply Confidently with Mareana Connect™ for CDMOs

Schedule a demo now to see how Mareana Connect™ can transform your operations by streamlining data management, enhancing regulatory compliance, and facilitating scalable growth through advanced analytics and AI.

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Mareana Connect™

Take your pharmaceutical manufacturing to the digital age with an AI-driven platform that empowers you to Make Confidently, Release Confidently, and Comply Confidently.

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