GxP Consulting Services

CPV aims to verify that a production process remains in a state of control during commercial manufacturing. It requires precise data collection and analysis to identify product or process issues. Creating a detailed plan for monitoring the manufacturing process is a significant challenge. This GxP Jumpstart Package will help you understand the data analytics and science behind CPV and develop a plan to future-proof your process verification systems.

Deliverables:

• A risk-based CPV plan for one selected product
• Process monitoring results at defined intervals for a defined number of batches (based on the selected product)
• Access to ValGenesis iRisk and Process Insight products to visualize the risk assessment, CPV plan, and monitoring data and CPV report (for the selected product)
• A CPV methodology that can be replicated throughout the product portfolio

Adequately balancing risk, regulatory expectations, aggressive go-to-market timelines, and the increased transfer volume between teams, sites, and organizations demands an efficient methodology to prevent development bottlenecks. This GxP Jumpstart Package aligns traditional tech transfer principles with a strong risk management focus and leverages modeling (e.g., first principles, mechanistic, hybrid) and advanced data science tools to streamline your tech transfer implementation throughout the product lifecycle.

Deliverables:

• Tech transfer risk gap assessment
• Tech transfer plan
• Tech transfer tasks execution (e.g., scale-up/scale-down/scale-out support, process modeling)
• Tech transfer report
• Continued project management support with executive status progression reports
• A tech transfer methodology that can be replicated throughout the organization 

Computer software assurance, the FDA’s new framework for performing CSV, encourages us to take a risk-based, least burdensome approach using critical thinking and unscripted testing methods. While the promise of simplified, less costly validation is exciting, many companies are confused about how to adopt the new framework. This GxP Jumpstart Package will show you how to implement a standardized CSA methodology and reclaim the quality-centric mindset lost in the document-centric CSV approach.

• CSV to CSA gap assessment
• CSA project plan
• CSA-ready procedures and work instructions
• Validation of one system using the CSA framework
• Access to ValGenesis iRisk and VLMS products to visualize risk assessment and validation execution with customer data
• A CSA methodology that can be replicated throughout the organization