There isn’t a fixed list of “GMP‑compliant” data processing software, as compliance does not depend on the specific vendor or platform, but on how the software is implemented and validated within a GMP framework.
In LC‑MS HCP analysis, commercial software such as SCIEX OS or other vendor‑provided data acquisition and processing tools can be used, provided they are operated in a validated state with appropriate controls for data integrity, audit trails, user access, and version management. What matters is that the system complies with regulatory expectations (e.g. Annex 11 or 21 CFR Part 11) and is shown to perform as intended.

In our workflows, data processing is performed using validated systems, and all activities—from acquisition to reporting—are controlled within a GMP quality framework with full traceability and documentation.

In summary, GMP compliance is not about choosing a specific software, but about ensuring that the selected system is properly validated, controlled, and fit for its intended use within the overall analytical workflow.

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.