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.
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.
With a multi-site setup, you can compare and align production quality across all your facilities:
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:
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:
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:
A Multi-Site Digital CPV system brings several key benefits that improve both operational efficiency and product quality across your facilities:
Table 1 - Feature-benefit of a Multi-site Digital CPV
| Feature | Benefit |
| Real-Time Monitoring | Immediate issue detection and resolution. |
| Centralized Data | Simplifies compliance and reporting. |
| Comparability Across Sites | Ensures consistent quality and process performance worldwide. |
| Scalability | Easily integrates with additional sites or products as needed. |
| Enhanced Collaboration | Facilitates knowledge sharing between sites, for example during a tech transfer. |
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:
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:
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.
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.
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.
Provide training on how to use the CPV system effectively. Make sure staff understand how to interpret real-time data and respond to alerts.
Regularly review the data collected by the CPV system to detects adverse trends and identify opportunities for process optimization across all sites.
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.