Moving from Compliance to Quality
Too narrow a focus on regulatory compliance may prevent organizations from embracing-and profiting from-quality and operational excellence.
Regulators and pharmaceutical manufacturers are debating the best way to measure quality. Discussions center on management and corporate cultures and how they impact operational excellence and customer-focused quality. Observers see the need for more proactive pharmaceutical company managers who actively support and invest in quality efforts and employee training.
Read this article in Pharmaceutical Technology’s December 2019 Regulatory Sourcebook.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, December 2019
December 2019
Pages: 6–10
Citation
When referring to this article, please cite it as A. Shanley, “Moving from Compliance to Quality," Pharmaceutical Technology Regulatory Sourcebook eBook (December 2019).
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli 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.
