Digital Product Management
Start with your end product in mind
Built on Quality by Design principles, QbDVision turns scattered product knowledge into a single, governed, lifecycle-aware system of record.
Build a product blueprint that takes you from initial vision to patient delivery
Standardize product definitions
Create a consistent product quality profile across programs, portfolios, and therapeutic areas.
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 approved product knowledge forward across variants, markets, and future programs.
Overview
Capture and connect your product knowledge
Digital Product Management in QbDVision captures the full logic behind your product, like QTPP, CQAs, specifications, risk, justification, and control strategy, in one connected environment.Every attribute is versioned, traceable, and linked to downstream process and analytical controls, so you never lose context, even as changes are made.
Product definition
Define your product’s blueprint
Outline the high-level clinical, commercial, and patient-centric objectives that guide your product's development strategy.
Translate clinical intent into tangible, measurable attributes that ensure product quality, safety, and efficacy.
Specification management
Manage specifications across products, variants, and markets
Support product variations, market designations, and specification differences within integrated records.
Connect specifications to FQAs, control methods, material attributes, and process parameters to see how each requirement is tested, controlled, and supported.
Use structured product data to generate specification content for documentation, review, and regulatory workflows.
Variant management
Manage product variants without losing traceability
Create structured DS and DP records for different variants, formulations, or product-specific definitions, with the correct CQAs connected to each one.
Work with common product attributes, specifications, and quality requirements while managing the differences that matter across variants, formulations, and markets.
Use structured product definition and specification data to create consistent outputs for review, documentation, and regulatory preparation.
Real-world impact for CMC teams
20-30%
reduction in number of local specification documents
Unlocked
additional laboratory capacity and accelerated batch release to market
5-10%
reduction in number of SKUs for raw materials, intermediates, and final products
One connected system for end-to-end CMC
Beyond implementation
A people-first approach to product management
We partner with pharma, biotech, and CDMO teams to build a platform that captures and connects your product knowledge so it’s accessible to teams across the full development lifecycle.
We’re here to help you deliver