ICH E6(R3) in Effect: Transforming Quality in CGT Trials
Compliance Meets Innovation
In an industry where current manufacturing capacity meets only 5%-10% of projected demand, the ICH E6(R3) guideline update arrives at a critical moment for cell and gene therapy (CGT) developers. This transformative regulatory framework aligns with the speed and flexibility required by CGT innovators, replacing prescriptive checkbox compliance with a principle-based approach centered on quality risk management. Discover how forward-thinking CGT manufacturers are leveraging this shift to accelerate therapies to patients while maintaining rigorous quality standards.
- Learn how ICH E6(R3)'s principle-based approach provides the flexibility needed for unique CGT manufacturing processes while ensuring compliance.
- Discover the digital tools and integrated systems that leading CGT manufacturers are implementing to reduce errors by 90%-100% and accelerate batch release times by 75%-80%.
- Gain practical strategies to assess your current quality systems and implement changes that align with ICH E6(R3)'s quality-by-design philosophy.
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Digital Excellence: The Future of CGT Manufacturing
As ICH E6(R3) explicitly endorses digital technologies for managing complex clinical research, cell and gene therapy manufacturers face a critical inflection point. Paper-based systems and disconnected digital tools simply can't support the intricate requirements of advanced therapy manufacturing—from maintaining chain of identity to ensuring batch-of-one consistency. The guideline's focus on connected systems directly addresses the industry's biggest challenge: bridging gaps between manufacturing execution, quality management, and supply chain operations. CGT companies implementing comprehensive digital cell and gene therapy solutions are seeing dramatic improvements, including 30%-40% fewer personnel dedicated to good manufacturing practice (GMP) record review and near-elimination of data input errors. These digital transformations aren't just about compliance—they're about creating the manufacturing capacity necessary to meet exploding patient demand in the coming decade.
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Download the BriefFAQs on CGT Compliance and Digitization
How does MES support ICH E6(R3) compliance?
Modern cell and gene therapy software embeds compliance directly into workflows with automated in-line quality checks, digital work instructions, and real-time parameter verification, aligning perfectly with E6(R3)'s quality-by-design philosophy.
Can MES reduce documentation burden?
Yes! CGT manufacturing solutions eliminate paper-based processes, enabling review-by-exception approaches that focus resources on critical quality attributes while reducing administrative overhead that delays therapy delivery.
How quickly can we implement digital solutions?
With experienced partners, CGT manufacturers can implement key digital capabilities in phases, seeing meaningful improvements in batch release times and error rates within months rather than years.
What ROI can we expect from digital transformation?
Leading CGT manufacturers report 75%-80% faster batch review cycles, 90%-100% fewer data entry errors, and 20%-25% fewer deviations, translating to significant time and cost savings.
MasterControl Manufacturing Excellence for CGT
Our solutions are purpose-built to meet the unique demands of cell and gene therapy manufacturing while ensuring compliance with evolving regulations like ICH E6(R3)
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Connected Systems
Seamlessly integrate manufacturing, quality, and supply chain operations to maintain complete chain of identity and custody throughout your processes.
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Error Prevention
Implement digital workflows that eliminate manual data entry, reducing errors by up to 100% while ensuring right-first-time manufacturing.
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Risk Management
Apply proportionate quality controls focused on critical process parameters that truly impact patient safety and therapy efficacy.
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Digital Compliance
Automatically enforce compliance requirements at execution while generating the documentation needed for regulatory submissions and inspections.
