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
Aug 11, 2025
Quality
Lifecycle Management
Validation
Aug 06, 2025
Quality Assurance
Jul 25, 2025
Data Integrity
Jul 24, 2025
Information Systems
Artificial Intelligence
Data Integrity
Jul 17, 2025
Manufacturing Operations
Oral Solid Dosage
Jul 08, 2025
Pharma 4.0™
Jun 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
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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Validation in Transition: Why 2025 is the Turning Point for the Industry
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