Category: Computerized Systems

The Computerized Systems category focuses on how digital tools are validated and maintained in pharmaceutical environments. As software becomes central to manufacturing and compliance, assurance must be risk-based and continuous, not a one-time task.

Topics include Computer System Validation (CSV), the FDA’s Computer Software Assurance (CSA) approach, and the role of risk management in balancing compliance with efficiency. Other areas such as eQMS, data governance, and cybersecurity are also addressed.

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Software Validation in GMP featured image with digital binary code and compliance theme.

Software Validation in GMP: Continuous, Risk-Based Control Across the Lifecycle

Explore risk-based software validation in GMP, from CSV to continuous assurance, ensuring compliance, data integrity, and efficiency....
Quality Risk Management in Computer System Validation (CSV) featured image with digital compliance and validation icons.

Quality Risk Management in Computer System Validation (CSV)

Explore how risk management in CSV optimizes validation by focusing on critical functions, ensuring compliance and efficient use of resources....
CSV vs CSA software validation differences – featured image showing a professional using a laptop with digital icons representing compliance, documentation, and data security.

CSV vs CSA: Key Differences in Software Validation

Discover the key differences between CSV and CSA in pharma, shifting from document-heavy compliance to risk-based assurance...
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Computer System Validation (CSV) in the Pharmaceutical Industry

Practical guide to CSV in pharma: lifecycle validation, Annex 11 updates, GAMP 5 methods, CSA approach, and real-world compliance practices....
Electronic Quality Management System eQMS

Electronic Quality Management Systems – eQMS

Optimize compliance and quality control in the pharmaceutical industry with eQMS (Electronic Quality Management System). Streamline documentation, enhance regulatory adherence,...

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