The quality system related to the design, development and manufacture of the marketed device may include software as part of the design (software device), as part of the manufacturing process (automated equipment) or in management of records (electronic documents).
 
 
In such cases, procedures must be written and followed.
 
 
GEMAR can provide the skills you need to revise or write these procedures, including
 
 
  • Validation of software
  • Change control
  • Version control
  • Security and access control
  • Backup & recovery
  • Disaster recovery
  • Infrastructure management
  • Management of electronic records
  • Maintenance
  • Calibration
  • Training