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Mareana Connect™ offers a robust array of solutions specifically designed for large pharma manufacturers facing complex integration challenges,
high compliance demands, and extensive operational scales. Our platform streamlines the synthesis of large datasets and diverse system inputs using advanced AI-driven analytics and scalable data management tools. By enhancing operational efficiency and providing powerful insights, we enable large pharma companies to not only meet but exceed the rigorous demands of the global pharmaceutical market.

Challenge

Mareana Connect™

System Complexity

Large pharma companies face challenges navigating multiple systems with varying data standards, which complicates scalability and integration across global operations.

Accelerated Factory 4.0 Integration

  • Connect seamlessly with all systems in the manufacturing technology stack using standard data connectors.
  • Extract data from paper sources easily, without requiring prior data standardization.
  • Accelerate the integration and utilization of all manufacturing data, enhancing the flexibility and power of multiple use cases.

Data Integration & Quality

Integrating and ensuring the accuracy and consistency of data from diverse sources across extensive research, clinical, and production landscapes is both costly and time-consuming for large pharma companies.

Real-Time Data Quality Monitoring

  • Integrate data across all layers (ISA 95 Level 1 to ISA 95 Level 4) from various sources like ERP, MES, LIMS, QMS, PLC/DCS, IoT, and PAT.
  • Utilize AI algorithms to connect and contextualize data at a batch or unit-operation level, reducing dependency on SMEs.
  • Ensure consistent data quality across all operations without the need for extensive manual validation or changes in data models.

Scalability and Future Proofing

For large pharma manufacturers, it is critical to ensure that solutions are not only scalable but also flexible enough to adapt to rapidly evolving technological and business environments to support global operations.

Flexible Manufacturing Transitions

  • Facilitate smooth transitions from external to internal manufacturing or between different types of manufacturing (small molecules, large molecules, or cell therapy).
  • Maintain historical data integrity and continuity throughout all manufacturing changes.
  • Provide a flexible platform that supports and adapts to your business growth at every step.

Compliance & Security

Adhering to GxP validation and CFR Part 11 compliance is crucial for large pharma companies to maintain security and meet strict regulatory standards across international markets.

Validated Compliance Platform

  • Benefit from each software release that is thoroughly validated and comes with its own validation package.
  • Utilize built-in audit trail capabilities to track all user changes, ensuring compliance and accountability.
  • Secure data changes with digital signatures and reason codes, recording everything appropriately for audits and traceability.

Multi-Value

Large pharma companies often find that existing solutions fall short in meeting their complex needs, requiring expensive customizations or the development of new software to stay competitive and innovative.

Consolidated Operations

  • Move from disparate point solutions to a single multi-value platform that can handle diverse functions and applications.
  • Reduce complexity by centralizing manufacturing operations, process development, analytical development, quality assurance, and tech transfer on one platform.
  • Streamline operations and enhance process efficiency by integrating multiple functions into a cohesive system.

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 minute

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 Large Pharma

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.

Stay Ahead with
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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