5 Digital Strategies That Reduce CGT Batch Review Time by 75%
Patient-Centric CGT Production Efficiency
In cell and gene therapy (CGT) manufacturing, every minute saved in batch review is another minute a patient doesn't have to wait for life-saving treatment. With quality testing and batch release consuming up to 70% of manufacturing lead time, outdated processes create costly bottlenecks that delay critical therapies. This industry brief reveals how leading CGT organizations are revolutionizing their manufacturing workflows with advanced digital strategies to dramatically reduce review times while maintaining rigorous quality standards. Learn how purpose-built cell and gene therapy management solutions are transforming operations across the industry.
- Discover how implementing digital batch records can cut management, issuance review, and closure processes by half.
- Learn why review-by-exception capabilities reduce GMP record review staff requirements by 30%-40% while accelerating approval timelines.
- Understand how connecting quality and manufacturing systems transforms quality from a post-production bottleneck to an in-line enabler of faster batch releases.
Trusted By these Life Science Manufacturers
Digital Transformation: The CGT Imperative
With the CGT market projected to reach $39.61 billion by 2034, manufacturers face a critical capacity shortage. Current facilities can handle only 5%-10% of anticipated commercial demand, making operational efficiency not just desirable but essential for survival. Electronic batch review systems and comprehensive cell therapy quality management software provide the foundation needed to scale operations while maintaining perfect compliance. Organizations that embrace digital transformation now gain the agility to adapt to evolving regulatory frameworks, reduce documentation burdens, and eliminate production inconsistencies that plague manual processes. By implementing the five strategic approaches outlined in this brief, CGT manufacturers can achieve the "Right First Time, Right on Time" standard that patients and stakeholders demand—transforming groundbreaking research into commercial production without compromising on quality or speed.
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Download the Brief NowCell and Gene Therapy Software FAQ
What is electronic batch review and why does it matter?
Electronic batch review transforms paper-based processes into digital workflows that capture data at the source, automate calculations, and flag exceptions. This dramatically reduces review times while improving accuracy, allowing CGT companies to release life-saving products faster.
How does EBR review differ from traditional methods?
While traditional batch review requires examining every entry on every page, EBR review employs "review by exception" to highlight only entries requiring attention. This focuses expert resources where needed and can reduce review staff requirements by 30%-40%.
Can cell and gene therapy software improve data integrity?
Yes! Manual documentation reaches only 91% accuracy—unacceptable when patient lives depend on precision. Modern cell and gene therapy quality manufacturing software implements automated data integrity checks that prevent errors before they happen.
What ROI can companies expect from digital manufacturing solutions?
Organizations implementing modern cell and gene therapy management solutions typically experience 75% faster batch reviews, 90% fewer data integrity errors, 25% reduction in deviations, and 30%-40% fewer staff dedicated to GMP record reviews.
MasterControl Manufacturing Excellence for CGT
Our purpose-built solutions help cell and gene therapy manufacturers accelerate time-to-market while maintaining perfect compliance and quality standards
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Streamlined Documentation
Replace hundred-page batch records with intuitive digital workflows that capture data at the source and prevent documentation errors.
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Automated Quality
Embed compliance directly into production processes with integrated quality checks that reduce deviations by 25% and improve data integrity.
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Connected Systems
Break down silos between quality and manufacturing with seamless process integration that transforms quality from bottleneck to enabler.
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Scalable Platform
Deploy cloud-based solutions that standardize processes across sites, ensuring consistent procedures as your organization grows globally.
