QbDVision for Development
Start with your end product in mind
Build connected product and process knowledge in a platform that’s built on Quality by Design principles.
Create a clear product and process foundation
Establish clear product requirements
Create a product quality profile to ensure product efficacy and patient safety.
Connect quality targets to execution
Link product quality attributes to specifications, analytical, process parameters, materials, and control strategy decisions.
Reuse product knowledge as programs evolve
Carry forward approved product knowledge across variants, markets, molecules, and future programs.
Overview
Integrate quality from the start
QbDVision enables development teams to integrate product quality from the start. The platform captures the full logic behind your product, like QTPP, CQAs, specifications, risk, justification, and control strategy, in one connected environment. And as your process matures, your product knowledge matures with it, streamlining scale-up and tech transfer and supporting consistent regulatory readiness.
Process and product feasibility
Establish your product and process concept
Define your initial process intent and structure.
Capture assumptions, decisions, and rationale as development evolves.
Explore feasible operating ranges and early hypotheses.
Utilize your structured data to create a coherent story of development intent without locking into final formats.
Early risk identification and prioritization
Identify and prioritize quality and process risks
Identify, score, and prioritize CQAs and CPPs.
Keep early risk rationale available downstream.
Development knowledge capture and reuse
Structure R&D knowledge that can be reused later
Create a centralized development knowledge repository that can be reused for future projects.
Maintain traceability across experiments, decisions, and outcomes.
View full version history to see how knowledge evolved throughout a project.
Generate reports that contain development history and rationale.
Process design maturation
Ensure that your process is robust, controlled, and scalable
Manage process changes without losing rationale.
Confirm your design space through experimentation.
Define CQAs and CPPs and establish their acceptance criteria and control ranges to ensure product quality.
Tech transfer enablement
Enable reliable, compliant tech transfer
Digitally transfer process definitions along with critical context to maintain process intent and product quality.
View side-by-side analysis of process elements across sites to identify gaps and risks in parameters, quality attributes, materials, and equipment.
Work from a single, governed source of truth to focus on analyzing changes instead of gathering and consolidating data.
One connected system for end-to-end CMC
Real-world impact for CMC teams
60%
reduction in time to perform process risk assessments and generate an FMEA report
50%
reduction in time to perform process definition gap assessment during tech transfer
$600K
reduction in annual costs per clinical manufacturing site
Beyond Implementation
Our people-first approach
We partner with pharma, biotech, and CDMO teams to build a platform that captures structured CMC data, preserves process knowledge, and maintains continuity across the full development lifecycle.
We’re here to help you deliver
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