QbDVision for Manufacturing
Execute your manufacturing process with confidence
Execute your commercial manufacturing process using complete, structured product and process knowledge.
Set yourself up for manufacturing success
Streamline tech transfer
Create a live, shared digital model for transfer that captures product, process, and analytical procedure knowledge and accelerates alignment between teams.
Reduce deviations
Utilize MES integrations to reduce deviations by eliminating manual transcription during Process Performance Qualification.
Improve batch success rates
Connect process information to quality attributes and testing methods to ensure that quality product is produced reliably.
Overview
Produce quality product consistently
QbDVision enables manufacturing teams to produce quality product consistently. The platform creates a single source of truth for CMC knowledge and its rationale, streamlining scale-up, tech transfer, and regulatory submissions while supporting ongoing process monitoring and improvements.
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.
Development knowledge capture and reuse
Maintain traceability for regulatory readiness
Trace relationships from product quality attributes through Performance Characteristics, Analytical Procedure Attributes, Materials, and Procedure Parameters.
Easily access previous versions of records that may be needed for submissions.
Generate documentation using your live CMC data.
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.
One connected system for end-to-end CMC
Real-world impact for CMC teams
80%
reduction in labor costs for site-to-site transfers
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 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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