Content focuses on the financial impact of data management systems on drug development, manufacturing, and distribution; the basic computer system life cycle model and the activities and software quality assurance practices in each phase; and the controls and methods necessary to maintain data integrity and security.
Guidance Documents
Advanced Manufacturing (1)
+Artificial Intelligence (1)
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+Data Integrity (16)
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+Pharma 4.0™ (1)
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Community Discussions
Jun 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Jun 19, 2025
Quality
Lifecycle Management
Validation
May 22, 2025
Apr 24, 2025
Validation
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Pharmaceutical Engineering Magazine Articles
White Papers
January / February 2025
GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical…
January / February 2024
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
March / April 2022
This article aims to refresh information on open-source software (OSS) within regulated computerized…

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