Explore how AI can increase batch release efficiency by 50% and beyond. Engage with experts on October 1, 2024.
Register Now!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
Connect™ CPV’s AI-driven approach supports a globally distributed manufacturing base, tackling challenges from mergers, acquisitions, and evolving compliance requirements. These features are designed to empower pharmaceutical companies to make, release, and comply with confidence:
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.
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% |
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% |
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% |
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% |
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% |
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% |
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.
Create end-to-end batch genealogy with forward and backward data traceability and easy visual navigation across all process steps for root cause analysis.
Extract vital insights for process enhancement, release on-hold batches through data-driven decisions to improve yield and unlock capital from built-up inventory.
Provide automated reports for compliance filing and leverage all data sources to minimize errors.
Extract & contextualize data from paper-based & third-party sources with automated data validation framework.
Enable real-time release & continuous quality control for optimal efficiency.
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.
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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