Digital Control Strategy
Create a clear, connected control strategy
Create and manage a digital control strategy that is fully integrated with development and manufacturing activities across the lifecycle.
See how every piece of the process contributes to product quality
Integrate risk management
Risk management is integrated throughout the product lifecycle, allowing teams to assess risk based on custom schemas.
Improve technical success
Actively connect process information to quality attributes and testing methods to ensure that quality product is produced reliably.
Stay regulatory-ready
Our platform is built on Quality by Design principles and grounded in the global regulatory expectations of ICH Q8-Q12.
Overview
Build your control strategy in a living, traceable system
Digital Control Strategy in QbDVision connects quality attributes, material attributes, process parameters, analytical procedures, and risk assessments into a single, evidence-based framework for decision-making and compliance. This living, traceable system empowers organizations to maintain robust product quality from development through commercialization.
Risk management plan
Proactively manage risk
Risk management models allow for both quantitative and qualitative assessments that can evolve over time to match phase-based fidelity.
Build risk management schemas fit for purpose, customizing schemas by record type.
Link risks to the record level to build a greater understanding of your process and which factors impact product quality.
Control strategy definition
Define your control strategy
Systematically identify and define CQAs and CPPs to ensure product safety, efficacy, and consistent performance.
Establish acceptance criteria and control ranges for each CQA and CPP to ensure product lots consistently meet predetermined quality standards.
Risk visualization and reporting
Generate visualizations and reports
View an interactive visualization that details the relationships between process steps, quality attributes, and parameters to easily identify and formulate risk-based mitigation strategies.
Consolidate key information, including Critical Process Parameters (CPPs), acceptance criteria, control methods, and associated risks for each unit operation.
Real-world impact for CMC teams
45%
reduction in time to perform and author risk assessment documents
60%
reduction in time to perform process risk assessments and generate an FMEA report
30%
reduction in time to perform historical trend analysis
One connected system for end-to-end CMC
Beyond implementation
A people-first approach to building your control strategy
We partner with pharma, biotech, and CDMO teams to build a platform that allows you to manage your control strategy across the full development lifecycle.
We’re here to help you deliver