Quality/GMPs

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Digitalization of QbD Risk Assessments

The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

Digitalization of QbD Risk Assessments

Subjectivity in Quality Risk Management

The authors discuss subjectivity in the ICH Q9 (R1) guidance document.

Subjectivity in Quality Risk Management

Phase-appropriate Compliance for Cell and Gene Therapies

Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.

Phase-appropriate Compliance for Cell and Gene Therapies

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Document Review and Quality Control Concept. Document with a checkmark, quality assurance, and process control. auditing, compliance, verification, data inspection, and business workflow management. | Image Credit: © Supatman - stock.adobe.com

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.