I
Regulatory inspections increasingly focus on how quality systems are implemented in practice, not just how well they are documented. An inspection-ready quality system is one that is embedded into daily operations and consistently followed across functions.
Beyond SOPs, organizations must ensure effective training, clear ownership, real-time deviation and CAPA management, and meaningful management review. Risk-based thinking, data integrity, and traceability are now key inspection themes. When quality systems are designed to support operations rather than burden them, inspection readiness becomes a natural outcome rather than a last-minute exercise.
