IT quality system in regulated environments

In the life sciences sector, managing quality in IT systems is critical to ensuring regulatory compliance and operational efficiency. This course offers comprehensive training on how to establish and maintain an IT Quality Management System in regulated environments—from planning to implementation and continuous improvement.

Course topics

• Processes within the IT Quality System: identification and management of critical processes.
• Design, implementation, and maintenance of an IT QMS: steps to develop a robust and adaptable system.
• Essential documentation: creation of manuals, policies, processes, procedures, annexes, and work instructions.
• Roles and responsibilities: clear assignment of functions to ensure system effectiveness.

Support tools
Selection and use of technology to facilitate IT quality system management.