Mareana’s Connect™ platform offers a comprehensive suite of solutions crafted to address the hurdles of limited resources, process inefficiencies, and regulatory complexities being faced by emerging pharma manufacturers. From seamless integration of digital and paper-based processes using AI to advanced analytics and scalable data management, we empower small pharma companies to maximize their potential and drive growth in the competitive pharmaceutical landscape.

Challenge

Mareana Connect™

Insufficient Expertise and Infrastructure

Small pharma companies often struggle with limited access to expert knowledge and the necessary infrastructure for effective data management, which is crucial for making informed decisions and maintaining competitiveness.

Rapid Platform Deployment

  • Transition your organization to a state-of-the-art SaaS data management and analytics platform within 4 to 6 weeks.
  • Derive insights in seconds rather than days, significantly enhancing decision-making speed and effectiveness.
  • Manage all data according to FAIR standards, ensuring best practices in data governance and accessibility.
  • Continuously incorporate Mareana innovation to leverage new features and technologies as they emerge.

Manual Data Processing

Small pharma manufacturers typically rely more on manual, paper-based data processing, which significantly hampers operational efficiency and increases the risk of errors, affecting overall productivity.

AI-Enhanced Data Processing

  • Transform manual, unreliable, and unscalable processes into structured, auditable, and scalable workflows using AI.
  • Automate the contextualization of data from paper batches, certificates of analysis, equipment records, and other paper sources, enhancing accuracy and efficiency.

Scalability Concerns

There is a critical need for scalable solutions that can grow with the business, supporting both the current operational scope and future expansions as small pharma companies evolve.

Seamless Manufacturing Transitions

  • Supports your transition from early-stage external manufacturing to advanced internal manufacturing, accommodating all intermediate steps.
  • Adapts to your evolving manufacturing needs, ensuring smooth and continuous operations throughout growth phases.

Slow Regulatory Response

Small pharma manufacturers may experience delays in root cause analyses  and slower responses to regulatory inquiries due to limited resources and less streamlined processes, potentially impacting compliance and market speed.

Data-Driven Investigative Efficiency

  • Save time through data-driven investigations that expedite understanding and resolution of issues.
  • Ensure full traceability of information, enhancing the speed and reliability of regulatory inquiries and submissions.

Inefficient Data Management Processes

Small pharma manufacturers often lack structured and scalable processes for managing data efficiently, leading to challenges in data integration, reporting, and utilization across the organization.

Scalable Data and Process Management

  • Scales with your growing data and process needs, suitable for both small-scale and large, multi-site operations.
  • Maintain performance and data integrity across various operational scales and complexities.

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.

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

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.

Make Confidently, Release Confidently, and Comply Confidently with Mareana Connect™ for Small 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.

Contact Us

Would you like to learn more about our pharmaceutical manufacturing solutions? Fill out the form below and one of our experts will reach out to you promptly.