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Most organizations already generate compliant audit trails. Far fewer actually review them the way ICH E6(R3) and GVP expect – with defined scope, meaningful timing, and documented outcomes. An audit trail records who did what, when, and sometimes why. But having an audit trail enabled is not the same as actively reviewing it. So, where […]

The European Union Artificial Intelligence Act represents one of the world’s first comprehensive regulatory frameworks governing Artificial Intelligence. In simple terms, Article 50 is designed to ensure that individuals are aware when they are interacting with AI systems or consuming AI-generated content. The underlying principle is that users should not be unknowingly influenced, misled, or

“Testing into Compliance” is a phrase frequently encountered during GMP audits, regulatory inspections, FDA Form 483 observations, and Warning Letters. Across pharmaceutical and life sciences organizations, it continues to remain one of the most recurring data integrity concerns identified by inspectors and auditors At the surface, repeated testing may appear scientifically cautious or operationally justified.

Moving from Computer System Validation (CSV) to Computer Software Assurance (CSA) is more than a terminology shift it’s a major change in approach, especially for QA auditors assessing software validation The focus is moving from protocol execution to providing substantial evidence that the system functions as intended, shifting the question from “Did we follow the

CDER and CBER have partnered with the European Medicines Agency (EMA) to establish 10 guiding principles aimed at assisting industry and product developers in utilizing artificial intelligence (AI) to enhance drug and biological product development. Most of the other nine principles formalize practices that pharmaceuticals and Biologics industry already understands well such as validation, traceability,