Extending QMS to Contract Partners
Advances in cloud-based IT and user interfaces make it easier to collaborate, but a strong foundation, based on knowledge of data and risk management principles, is needed first.
This interview with Patricia Santos Serrao, director of clinical and regulatory solutions, and Matt Lowe, executive vice president of Master Control, discusses the roots of problems with corrective and preventive action (CAPA) and documentation of standard operating procedures (SOPS), and how Quality Management Systems (QMS) software is being improved to address them, and to make it easier to collaborate and communicate with contract partners.
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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.
