Topics

Computerised systems requirements including exit strategies, data lifecycle management, and system validation in the European regulatory framework.

ALCOA++ principles ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.

ISPE best practices for verified electronic copies, enabling paperless validation while maintaining regulatory compliance.

FDA regulations for electronic records and signatures, ensuring authenticity, integrity, and confidentiality.

Modern approaches to pharmaceutical documentation including cloud systems, hybrid records, and digital transformation strategies.

Good Manufacturing Practice requirements for documentation, including Chapter 4 updates and quality system documentation.