Save Time and Resources with Digital Continued Process Verification

Biopharmaceutical industries are under constant pressure to ensure the highest quality standards during manufacturing while also maximizing efficiency and controlling costs. Continued Process Verification (CPV) plays a central role in achieving these goals.

 Traditionally, CPV has been a manual, resource-intensive effort – from data collection and handling to analysis- often limited to passive, retrospective monitoring. The next generation of CPV is different: it shifts to a real-time, integrated, and intelligent process that offers greater traceability and delivers deeper and actionable insights. 

As both industry and regulators demand stronger traceability and lifecycle-based process control, and as digitalization accelerates across pharmaceutical operations, digital CPV is becoming more practical and scalable than ever before. 

In this blog post, we explore how digital CPV reduces resource use, shortens timelines, and cuts costs compared to traditional, manual approaches,  highlighting the transformative impact it can have on manufacturing operations and on the broader process and product lifecycle.

Real-time Quality Control: Manual vs. Digital CPV in Commercial Manufacturing

Running a manual CPV program in commercial manufacturing is resource-intensive and requires significant time and personnel to track and investigate multiple critical process parameters (CPP) and critical quality attributes (CQA). 

A digital CPV program starts by defining a multivariate space for monitored CPPs and CQAs, which then supports real-time statistical process control (SPC) and the configuration of statistical signals tailored to the behavior of each monitored parameter. Automation in data collection and analysis is a major enabler of real-time digital CPV, allowing early detection of deviations and proactive quality oversight.  On the other hand, with traditional CPV, deviations may go unnoticed until each batch manufacturing process is complete, triggering lengthy investigations, costly delays, and potential batch rejection​. 

Digital CPV runs continuously. In the initial CPV phase, it is possible to run a preliminary assessment of process variability, refine the rationale for reference batch selection, configure statistical process control charts, and dynamically calculate process capability metrics. Once the CPV program is robust and approved, it transitions into long-term, routine monitoring. At this stage, real-time tracking of trends and process capability metrics ensures early detection of deviations, allowing immediate corrections to prevent escalation, avoid out-of-specification (OOS) results, and minimize rework or discarded batches.

(Read Industry Insight: Digital CPV for Continuous Manufacturing by ValGenesis Senior Consultant Daniel Pais for a deeper analysis.)

Manufacturing Processes: Continuous Adjustments vs. Fixed Batches

In a manufacturing process, the time- and resource-saving potential of digital CPV becomes even more pronounced. Leveraging digital CPV enables a design space to be used, which in turn minimizes any potential issues in the manufacturing process. Traditionally, without digital CPV, this issue might go unnoticed until the batch is complete, leading to time-consuming investigations and potential waste. 

Digital CPV operates continuously, allowing for real-time adjustments within the design space. This enables manufacturers to adjust the process dynamically, adding robustness and flexibility while ensuring that any deviations from the expected process are corrected immediately, preventing defects and reducing the need for rework or discarded batches​.

By enabling automatic trend analysis and deviation alerts, digital CPV supports rapid response, deviation-free production, and data-driven decision-making, while fostering continuous improvement through data insights (Table 1).

Table 1: Differences in manufacturing processes between a digital vs. manual CPV program.

Lifecycle Management: Turning CPV into a Proactive Strategy

Adopting a digital CPV process delivers far more than efficiency gains, access to real-time insights, and enhanced quality assurance in commercial manufacturing. It also ensures knowledge continuity, simplifying lifecycle management and maintaining consistency across products and plants. 

In a manual CPV environment, improvement opportunities affecting product quality are largely reactive, meaning that corrective actions occur only after a deviation or anomaly has been identified. On top of that, because data is siloed and knowledge is scattered, root cause investigations and cross-functional decision-making are delayed.  

By contrast, digital CPV provides continuous and integrated oversight of manufacturing performance. Acting as a centralized tool for historical production data and analytics, it builds a knowledge base that enables proactive investigations, effective CAPA implementation, justified process changes, and refinement of control strategies. This continuous feedback loop supports ongoing improvement throughout the product lifecycle.  

Transitioning to a digital CPV transforms this ongoing activity from a reactive task into a proactive strategy, strengthening compliance, deepening product and process understanding, and driving improvement across the organization.

Resource Savings: Reduced Labor and Material Waste

One of the most impactful benefits of digital CPV is its ability to save resources by significantly reducing manual effort. In a manual CPV process, highly skilled personnel must collect, collate, and analyze data, then generate reports. This process is time-consuming, prone to human error, and vulnerable to inefficiencies that can cause delays and compliance risks​. 

A scalable, enterprise-integrated digital CPV program automates data handling, storage, and analysis, while ensuring data accessibility and integrity through access controls, audit trails, and standardized procedures that align with ALCOA+ principles and regulatory requirements. This shift allows professionals to focus their expertise on higher-value activities such as data trends interpretation and informed decision-making.

Automated workflows for data collection, trending, and analysis minimize the risk of errors, ensuring reports and decisions are based on accurate and reliable information. Continuous, real-time quality monitoring further enables rapid issue detection and resolution, which reduces material waste, avoids unnecessary rework, and supports a more sustainable, efficient manufacturing operation.

Digital CPV: Powering the Next Era of Manufacturing

Digital CPV offers a clear edge over traditional CPV by automating manual tasks, reducing the risk of human error, enabling real-time visibility, and fostering a proactive approach to process monitoring. 

With digital CPV, manufacturers can reduce the time spent on investigations, cut material waste, and improve overall product quality. Additionally, continued and real-time oversight ensures processes run at peak efficiency, optimizing resource use and ultimately saving both time and money.

In the long run, the shift to digital CPV is not just a cost-saving measure—it is a necessary step toward creating a more efficient, flexible, and robust manufacturing process.

ValGenesis is ready to support your digitalization journey by designing and implementing an effective digital CPV strategy tailored to your needs. Explore ValGenesis solutions to automate data acquisition, monitor trends in real-time, and respond to deviations proactively.