QA for Digital Systems & Emerging Technologies

As digital tools become embedded in regulated workflows, quality assurance oversight must adapt to ensure compliance is maintained. QA for digital systems focuses on governing the use of software and technology within GxP environments.

Digital systems may support clinical operations, quality management, manufacturing, or safety activities. Quality oversight ensures these systems are implemented, validated, and maintained in a manner consistent with regulatory expectations.

Emerging technologies introduce new compliance considerations related to data integrity, system controls, and lifecycle management.

Quality oversight for digital systems commonly addresses:

• Risk assessment of digital tools used in GxP activities

• Alignment of validation and quality controls

• Change management and system updates

• Documentation and traceability

• Ongoing compliance monitoring