What is a Multi-Site Digital CPV, and Why Should You Want It?

A Multi-Site Digital Continued Process Verification (CPV) system allows you to manage and monitor manufacturing processes across multiple sites in real-time. For pharmaceutical companies, this system offers a streamlined way to ensure quality, regulatory compliance, and process consistency globally.

Understanding Multi-Site Digital CPV

What is Digital CPV?

Digital CPV refers to software that performs Continued Process Verification, collecting real-time data on Critical Process Parameters (CPPs), In Process Controls (IPC) and Critical Quality Attributes (CQAs). This data-driven approach helps you quickly identify and address deviations to the expected process behavior or performance as they happen.?

Digital CPV outperforms traditional CPV by leveraging real-time data and automated processes for data lifecycle management and process control. In a traditional CPV setup, data collection often requires hands-on data input, which is both time-consuming and prone to errors. By contrast, Digital CPV offers continuous, automated data collection, allowing you to monitor pre-selected process parameters and quality attributes without interruption. This automated approach enables faster, more accurate insights, supporting a proactive response to departures to the expected process behavior or performance prematurely preventing quality deviations.

If you’d like to watch a case study on the implementation of a Digital CPV, check our webinar.

Digital CPV systems reduce reliance solely on end-product testing by enabling real-time monitoring and process adjustments. With traditional CPV, issues are often identified only after they’ve impacted production. Digital CPV’s predictive capabilities mean you can address potential issues before they escalate, minimizing downtime and improving overall product quality. The system supports informed decision-making through data-driven insights, helping you optimize and benchmark processes across multiple facilities.

You can learn more about the differences between traditional and Digital CPV here.

Key Features of Multi-Site Digital CPV

With a multi-site setup, you can compare and align production quality across all your facilities:

• Real-Time Monitoring: Tracks CPPs, IPC and CQAs in real-time to detect and resolve issues immediately.
• Global Comparability: Ensures product consistency across different sites by benchmarking data centrally.
• Data Centralization: Consolidates process data across sites for comprehensive analysis and simplified compliance.

Why You Should Consider Multi-Site Digital CPV

Improved Quality Control Across All Locations

With Multi-Site Digital CPV, quality assurance becomes proactive rather than reactive. Real-time data allows you to detect departures from the controlled state immediately, avoiding production delays and non-compliance issues:

• Quick Issue Identification: Problems are detected and addressed right away, reducing the likelihood of producing out-of-spec products.
• Uniform Quality: By monitoring processes at all sites, you ensure each batch meets the same quality and process performance standards, regardless of location.

Simplified Compliance with Regulatory Requirements

Pharmaceutical regulations demand consistent quality and transparency in your manufacturing processes. Multi-Site Digital CPV supports compliance by making data from all locations accessible from one platform, streamlining reporting for regulatory audits:

• Centralized Data Access: Compliance documentation becomes easier with all necessary data in one place (for example for the generation of PQR – Product Quality Reviews)
• Easier Audits: When regulatory bodies need to review your processes, you’ll have comprehensive, site-wide data ready to share.

Data-Driven Decision Making

Centralizing data across all sites means you get a complete view of your operations, enabling better decisions based on facts. You can analyze trends, identify inefficiencies, and continuously improve processes:

• Proactive Adjustments: Act on trends in the process behaviour to implement changes before problems escalate.
• Informed Strategy: Use data from all facilities to guide improvements and standardize best practices company-wide.

Benefits of Multi-Site Digital CPV for Your Organization

A Multi-Site Digital CPV system brings several key benefits that improve both operational efficiency and product quality across your facilities:

Key Components of a Multi-Site Digital CPV System

A Multi-Site Digital CPV system, in order to be functional, needs to include several essential components that work together to monitor and optimize your manufacturing processes:

1. Real-Time Data Collection: Collects and processes CPP, IPC and CQA data continuously, providing an up-to-date view of each facility’s operations.
2. Central Data Repository: Stores all process data centrally, allowing for easy access, analysis, and comparison across sites.
3. Automated Alerts and CAPAs: The system can automatically generate alerts for deviations to the expected process behaviour and assign Corrective and Preventive Actions (CAPAs) as needed.
4. Dashboards and Reporting Tools: Offers user-friendly dashboards that display key metrics and generate reports.

How to Implement Multi-Site Digital CPV

Implementing a Multi-Site Digital CPV system involves several key steps to ensure you’re fully utilizing its capabilities. Here’s a breakdown of each step to help guide you through the implementation process:

Step 1: Define Your Goals

Start by identifying your specific quality and compliance goals. This might include improving your product quality, reducing time-to-market, or achieving faster audit readiness.

Step 2: Choose the Right CPV Software

Look for lifecycle management software that offers multi-site capabilities and that can be integrated into the existent digital ecosystem, allowing your team to monitor, compare, and adjust production processes globally.

Step 3: Integrate Your Facilities

Implement the software at each site, ensuring it’s connected to local data sources. Test each connection to ensure seamless data flow to the central repository.

Step 4: Train Your Teams

Provide training on how to use the CPV system effectively. Make sure staff understand how to interpret real-time data and respond to alerts.

Step 5: Continuously Review and Optimize

Regularly review the data collected by the CPV system to detects adverse trends and identify opportunities for process optimization across all sites.

Conclusion

Multi-Site Digital CPV empowers you to maintain high-quality standards across all your manufacturing facilities while meeting regulatory requirements.?

By centralizing data, you gain a clearer view of your processes and the ability to make faster, more informed decisions. In a highly regulated industry, Multi-Site Digital CPV provides a competitive edge, improving your product quality and process performance, compliance, and overall efficiency.

If you’re interested in joining the Digital CPV revolution, we suggest you check our webinar on the topic.

The opinions, information and conclusions contained within this blog should not be construed as conclusive fact, ValGenesis offering advice, nor as an indication of future results.