You’re absolutely right that GMP goes beyond method validation and includes full qualification of both equipment and software.

For LC‑MS HCP analysis, we typically operate within a framework where instruments are qualified according to standard GMP expectations, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). This ensures that the LC‑MS system consistently performs within predefined specifications and is suitable for its intended use.

Software validation is equally critical, particularly as data acquisition and processing are integral to the final reported result. Systems such as SCIEX OS are therefore used in a validated state, with appropriate controls in place for data integrity, audit trails, user access management, and version control. Validation activities typically ensure that the software performs as intended for data acquisition, processing, and reporting, and that it complies with regulatory expectations for electronic records (for example, ALCOA+ principles).

In practice, this means that both the analytical method and the full analytical platform—including instrumentation and software—are controlled and documented within a GMP framework, ensuring data reliability, traceability, and regulatory compliance.

Thomas Kofoed, PhD, CEO of Alphalyse in Denmark, discussed key factors in implementing GMP-compatible LC-MS methods for release assays and highlighted successful cases where this approach has replaced traditional ELISA methods. Don’t miss his presentation and expert insights at the panel discussion.