QbDVision for Commercial
Move faster to multiple markets
Structure and connect your CMC knowledge in a platform that enables ongoing lifecycle management, continuous improvement, and alignment between manufacturing execution and regulatory expectations.
Maintain control, consistency, and compliance at scale
Monitor process performance
Monitor process performance and variability to ensure that product quality is consistently achieved.
Manage change without introducing risk
Assess the impact of process, material, or site changes to improve the process without destabilizing it.
Make improvements based on real-world data
Easily analyze manufacturing and quality data to identify improvement opportunities and justify optimization decisions.
Overview
Achieve consistent product quality
QbDVision enables commercial teams to maintain control of their process during manufacturing execution. The platform supports ongoing monitoring and improvements, giving organizations confidence that product quality is consistently achieved.
Ongoing process control
Maintain control during commercial manufacturing
Create a shared view of defined CQAs and CPPs along with their acceptance criteria and control ranges.
Create a centralized knowledge repository that can be easily accessed during audits and inspections.
Easily access process definitions along with critical context to maintain process intent and product quality.
Change impact and risk management
Manage change without introducing risk
Generate knowledge and risk-based assessments of process, material, or site changes.
Centralize knowledge to support narratives for post-approval submissions.
View a history of prior changes to understand what changed, when, and why.
Continuous process improvement
Make improvements based on real-world data
Retain and analyze institutional knowledge across projects and teams.
Capture knowledge to support improvement justification and ensure that improvements are aligned with regulatory expectations.
Ensure that improvements are traceable back to design space and controls so knowledge can be reused for future projects.
Real-world impact for CMC teams
90%
increase in FAIR data quality, reducing data search time
80%
reduction in change control cycle time to complete post-regulatory approval change to digital PFD
30 days
faster batch release through deviation avoidance during tech transfer
Beyond Implementation
Our people-first approach
We’re here to help you deliver
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