GMP Insiders - Your trusted source for GMP compliance!
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.
If you don’t find what you are looking for, try using a different term or contact us.
Stay in touch and be the first to get the latest GMP News!