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)
+Commissioning & Qualification (1)
+Data Integrity (17)
+GAMP® (15)
+Knowledge Management (1)
+Pharma 4.0™ (1)
+Process Analytical Technology (1)
+Quality Assurance (1)
+Quality by Design (1)
+Regulatory (1)
+Validation (13)
+Community Discussions
Community Discussions
Jul 17, 2025
Manufacturing Operations
Oral Solid Dosage
Jul 08, 2025
Information Systems
Artificial Intelligence
Data Integrity
Jul 08, 2025
Pharma 4.0™
Jun 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Jun 19, 2025
Quality
Lifecycle Management
Validation
May 22, 2025
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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