This presentation explores the role of data control and management systems in ensuring pharmaceutical quality assurance. It discusses the importance of establishing robust data control procedures, including data entry controls, access controls, and data encryption, to prevent unauthorized access, alteration, or deletion of critical data. Discussion of electronic data management systems (EDMS), laboratory information management systems (LIMS), and other technologies used to facilitate data control, audit trails, and data traceability in compliance with regulatory requirements such as 21 CFR Part 11.
Learning Objectives:
Understand the significance of data security in preserving confidentiality within the pharmaceutical sector, including its impact on patient safety, intellectual property, and regulatory adherence.
Learn about various threats to data security, such as cyberattacks and insider threats, and their implications for pharmaceutical organizations.
Gain knowledge of key data security principles and techniques like encryption and intrusion detection and learn from real-world case studies to develop proactive security strategies and incident response plans.
