A process with completed hardware qualifications cannot be considered to have fully met quality standards as a whole unless the associated software is also validated. This is because ensuring traceability of process parameters is essential. Under data integrity, user management, authorization, data storage, transfer, and retention are requirements of the quality management system.
Even if not directly used in production processes, administrative software such as ERP, CRM, logistics, building management, product tracking, and data warehousing, which are employed for critical purposes affecting product quality and safety and ensuring traceability, must also be validated in accordance with standards and regulations such as ISO 80002, ISO 13485, GMP, and FDA.
