Computerized Systems in the Regulated Industry Course

In regulated industries—especially pharmaceuticals and medical devices—proper management of computerized systems is essential to ensure quality and regulatory compliance. This course offers comprehensive training, covering everything from the regulatory landscape to best practices in validation and system maintenance.

• Regulatory environment and Data Integrity: overview of applicable regulations and key principles to ensure data integrity.
• Computerized system lifecycle: detailed review of all phases from concept to retirement, following GAMP 5 guidelines.
• Risk analysis: methodologies to identify and mitigate risks associated with computerized systems in regulated settings.
• Computerized systems validation: required procedures and documentation to ensure systems meet defined requirements.
• Maintaining validation status:
  • Incident and CAPA (Corrective and Preventive Actions) management.
  • Change and configuration management.
  • Periodic system review.
  • Internal audits to ensure ongoing compliance.
• System retirement: best practices for safely decommissioning and disposing of outdated computerized systems.