Connect™ CPV is a cutting-edge digital SaaS product crafted to provide real-time monitoring, compliance, and optimization of pharmaceutical manufacturing processes. As a leading solution, Connect™ CPV lays the groundwork for a validated, digital manufacturing platform, enhancing product quality and bolstering regulatory confidence across the pharmaceutical industry

Simplify the integration of complex data from multiple sources, including paper batch records, with AI-based data mapping and automatic product genealogy, enhancing data reliability and operational readiness.

Connect™ CPV is a secure, scalable GxP-validated SaaS product that complies confidently with 21 CFR part 11 regulations, ensuring your operations meet all compliance standards.

Implement Connect™ CPV quickly with minimal setup, thanks to an easily configured end-to-end platform that delivers significant ROI, allowing you to release products to market faster and more efficiently.

With its integrated data science studio, Connect™ CPV enables customized analysis for internal reporting and regulatory submissions. This tailored approach ensures that data not only supports decision-making but also complies with regulatory expectations.

Business Benefits

Make Confidently, Release Confidently, and Comply Confidently with Mareana Connect™ CPV — an AI-powered solution designed to accelerate continued process verification for pharma and biotech companies.

Streamline Processes

Enhance Quality

Ensure Compliance

Accelerate Time-to-Market

Connect™ CPV significantly impacts the full pharma manufacturing lifecycle — from Process Engineering all the way to Quality Assurance and Regulatory Compliance.

Connect™ CPV drastically reduces manual intervention in data analysis and process verification, leveraging real-time analytics and AI to enhance process control and efficiency, leading to significant operational improvements and informed decision-making.
Task Description Without Connect™ CPV (hours) With Connect™ CPV (hours) % Improvement
Process Optimization 160 70 56%
Process Validation 320 260 19%
Equipment Selection and Qualification 80 65 19%
Risk Assessment and Management 40 25 38%
Troubleshooting and Root Cause Analysis 80 55 31%
Continuous Improvement 80 45 44%
Regulatory Compliance 20 10 50%
Cross-functional Collaboration 20 10 50%
Process Monitoring and Control 10 5 50%
Connect™ CPV leverages historical data analysis and visual management tools to identify inefficiencies and implement continuous improvements, reducing cycle times and enhancing process stability with less effort and higher accuracy.
Task Description Without Connect™ CPV (hours) With Connect™ CPV (hours) % Improvement
Process Mapping 120 40 67%
Value Stream Analysis 120 40 67%
Standard Work Development 40 20 50%
Visual Management 120 40 67%
Root Cause Analysis 40 20 50%
Continuous Improvement Initiatives 80 35 56%
Cross-functional Collaboration 80 35 56%
Performance Measurement and Analysis 60 20 67%
By streamlining scale-up activities via advanced data management tools that enable effective technology transfer and process optimization, Connect™ CPV ensures swift and compliant scale-up operations.
Task Description Without Connect™ CPV (hours) With Connect™ CPV (hours) % Improvement
Process Evaluation 60 20 67%
Equipment Selection 80 30 63%
Process Optimization 80 30 63%
Technology Transfer 40 30 25%
Scale-up Studies 160 70 56%
Cross-functional Collaboration 80 10 88%
Troubleshooting and Problem-solving 40 20 50%
Connect™ CPV automates the continuous monitoring and verification of manufacturing processes, enhancing quality assurance through real-time compliance checks and reducing errors and deviations significantly.
Task Description Without Connect™ CPV (hours) With Connect™ CPV (hours) % Improvement
Batch Record Review 35 15 70%
Internal Audits 80 30 63%
Change Control Management 80 30 63%
Deviation and CAPA Management 80 30 63%
Complaint Handling 40 20 50%
Data Integrity Oversight 10 5 50%
Connect™ CPV provides clinical researchers with immediate access to critical data, which accelerates clinical trials and enhances the reliability of research outcomes.
Task Description Without Connect™ CPV (hours) With Connect™ CPV (hours) % Improvement
Protocol Development 240 200 17%
Study Design and Planning 120 100 17%
Study Monitoring 240 120 50%
Data Management 120 80 33%
Safety Monitoring 240 200 17%
Statistical Analysis 120 80 33%
Report Writing 240 180 25%
Documentation and Record Keeping 120 90 25%
Continuous Improvement 80 40 50%
Connect™ CPV ensures stringent adherence to regulatory standards by automating data capture and reporting processes, simplifying the compilation and submission of regulatory documents, and reducing the risk of compliance issues.
Task Description Without Connect™ CPV (hours) With Connect™ CPV (hours) % Improvement
Dossier Preparation 520 460 12%
Quality Assurance Collaboration 120 100 17%
Document Management 240 160 33%

Mareana Connect™ CPV

Integrated Enterprise Solution

Deliver real-time insights to enhance efficiency across the entire drug manufacturing process with contextualized data. Integrated Data Science Studio equipped with multivariate analysis capabilities, and comprehensive statistical process control charts, eliminates the need for multiple systems.

Digital Twin Native

Create end-to-end batch genealogy with forward and backward data traceability and easy visual navigation across all process steps for root cause analysis.

Improved Yield & Capital Efficiency

Extract vital insights for process enhancement, release on-hold batches through data-driven decisions to improve yield and unlock capital from built-up inventory.

Streamlined Compliance

Provide automated reports for compliance filing and leverage all data sources to minimize errors.

Automated Data Processing

Extract & contextualize data from paper-based & third-party sources with automated data validation framework.

AI-Driven Excellence

Enable real-time release & continuous quality control for optimal efficiency.

Typical Deployment Timeline

FAQs About Mareana Connect™ CPV

By providing real-time insights and analytics, our solution enables proactive decision-making, minimizes downtime, optimizes resource utilization, and enhances overall efficiency throughout the manufacturing lifecycle.

Connect™ CPV is designed to align with industry regulations, offering features like automated documentation, audit trails, and real-time reporting to support compliance with regulatory standards.

Yes, our solution is designed to seamlessly integrate with various manufacturing systems and databases, facilitating a unified and efficient data flow across the production environment.

It is equipped with advanced analytics and anomaly detection algorithms. When deviations occur, the solution triggers alerts, enabling proactive intervention to address issues promptly and maintain product quality.

The solution employs robust security protocols, including encryption, access controls, and audit trails, to ensure the confidentiality, integrity, and availability of sensitive manufacturing data.

Yes, our solution is designed for scalability, allowing seamless deployment and adaptation to various production environments and facilities, whether local or global.

It provides a centralized platform for stakeholders to access real-time data, collaborate on quality issues, and streamline communication, fostering a more integrated and responsive manufacturing ecosystem.

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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