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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2016 Quality Throughout the Supply Chain eBook.
Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications
December 10th 2024This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.
