Next Gen CPV
Drive Revenue and Efficiency
Go beyond regulated compliance needs and streamline your entire operations.
Global pharmaceutical companies operate extensive, data-rich manufacturing facilities, constantly adapting to evolving compliance regulations. While data is abundant, traditional tools for ETL (Extract, Transform, Load), reporting, and analytics struggle to bridge the gap between disparate systems and silos.
At Mareana, we offer an AI-driven solution to Continued Process Verification (CPV) that automatically connects diverse systems, unleashing unprecedented value through optimal yields, standardized processes, and on-time prescriptive decisions.
Next Gen CPV Overview
Our NextGen CPV platform is designed to exceed compliance requirements, liberating subject matter experts from labor-intensive data preparation and non-standard analytical tools. Leveraging Mareana’s Manufacturing Intelligence and Modeling core, we drive massive improvements in manufacturing yield while automating manual procedures, all while ensuring compliance with 21 CFR Part 11.
Integrated AI Development and Deployment
- Access native AI libraries for ad-hoc analysis.
- Seamlessly integrate with third-party AI libraries or develop custom AI models.
- Expedite testing and deployment of analytical models with integrated charting options.
Manufacturing Intelligence
- Leverage built-in AI models for real-time release, optimal efficiency, and continuous quality control.
- Perform multivariate and cross-batch analysis.
- Receive automated alerts and notifications through various channels (Email, Pop-up, SMS, ERP, etc.).
Single-click Compliance Reporting
- Generate automated CPV reports for product batches.
- Utilize default report templates or customize them effortlessly.
- Streamline report validation workflows for efficient compliance management.
Data Integration with External Sources
- Configure data integration options for externally manufactured batches.
- Perform one-time and incremental data integration with third-party systems.
- Handle various data formats, structured or unstructured, with ease.
Digital Twin Native
- Gain complete visibility into your manufacturing process and product genealogy with effortless scalability.
- Easily navigate processes for instant root cause analysis (RCA).
- Seamlessly import and harmonize data from third-party and contract manufacturing organizations (CMOs).
Embedded Data Mining
- Continuously capture documents in non-standard formats, including paper batch records and third-party datasets.
- Harness AI and NLP-powered models for handwritten notes.
- Validate data from non-GxP sources effortlessly.
Benefits
Improved Predictability
Ensure consistent product quality across product batches and maximize product yield.
Reduced Costs
Enhanced efficiency reduces waste, while saving valuable man-hours previously dedicated to manual tasks.
Increased Efficiency
Automate manual processes, eliminate paper batch records, and simplify complexity by establishing a single source of truth.
Ensured Compliance
Auto-generate compliance reports, standardize processes, and enforce data traceability.
