Digital Process Management
A single source of truth for your process
Build a shared, structured process model that evolves with governance from early development through commercial manufacturing.
Create process clarity throughout the product lifecycle
Define in detail
Define, manage, and trace your full manufacturing process with risk-based traceability per ICH Q9.
Automate key visualizations
Automate flow map and knowledge graph generation to track the evolution of your product and process.
Scale knowledge with speed
Atomize, structure, and connect your data to reuse knowledge and leverage AI accelerators.
Overview
A structured, connected process model
Digital Process Management in QbDVision replaces static process documentation with a structured, connected process model that links unit operations, parameters, materials, equipment, and risk. The result is a process record that is scientifically rigorous, audit-ready, and built to scale from early development through commercial manufacturing.
Process definition
Define and manage your processes
Define and atomize key process information including Unit Operations, Steps, Process Parameters and Materials, so that it’s accessible across teams and sites.
Track, review, and approve process versions through a controlled lifecycle, so teams always know what changed, when, and why.
Once risks are defined, they are automatically linked to process parameters, CQAs, and acceptance criteria.
General to site relationships
Visualize and compare key process data
Generate process flow maps that include Unit Operations, Steps, Materials, and Components to help you better understand your process.
Compare process versions side-by-side across key fields to enable faster and more efficient decision-making.
Process versioning
Manage versions and track changes
Create new draft versions from approved records to manage iterative changes and ensure data quality and compliance.
View full version history for any process record to maintain data integrity.
Real-world impact for CMC teams
90%
increase in FAIR data quality
30 days
faster batch release
80%
reduction in change control cycle time
"During a key meeting, we validated tightening a critical specification based on our process capability using QbDVision in real time. My colleague said, 'You just paid for the platform right here.'"
One connected system for end-to-end CMC
Beyond implementation
A people-first approach to process management
We partner with pharma, biotech, and CDMO teams to build a platform that structures process knowledge to ensure product quality.
We’re here to help you deliver