Digital Continued Process Verification

Experience automatic and effortless process control.

Benefits this Solution Provides

Implement continued process verification (CPV) plans for a large number of products using a simple workflow.

Integrate all your systems for registry, collections, and storage of data.

Check process status in real time through monitoring dashboards.

Accelerate and automate report generation without human input.

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Before	After
Research often conducted one variable at a time.	Systematic — relates the mechanistic understanding of material attributes and process parameters to drug product (CQA).
Based on an initial full-scale batch; focused on optimization and reproducibility.	Adjusted continuously; more robust and allows for the creation of control strategies.
In-process tests primarily for go/no-go decisions.	PAT tools are utilized with appropriate feedforward and feedback controls to optimize product performance using supportive, relevant real-time data.
Based on the batch data available at the time of registration.	Based on the desired product performance with relevant supportive data.
Drug product quality is controlled by intermediate- and end-product testing.	Drug product is ensured by a risk-based control strategy for well-understood product and processess.
Reactive (no alarms).	Preventive action (with alarms).

Before	Research often conducted one variable at a time.
After	Systematic — relates the mechanistic understanding of material attributes and process parameters to drug product (CQA).

Before	Based on an initial full-scale batch; focused on optimization and reproducibility.
After	Adjusted continuously; more robust and allows for the creation of control strategies.

Before	In-process tests primarily for go/no-go decisions.
After	PAT tools are utilized with appropriate feedforward and feedback controls to optimize product performance using supportive, relevant real-time data.

Before	Based on the batch data available at the time of registration.
After	Based on the desired product performance with relevant supportive data.

Before	Drug product quality is controlled by intermediate- and end-product testing.
After	Drug product is ensured by a risk-based control strategy for well-understood product and processess.