The project targets a critical bottleneck: upstream cell-line qualification is decisive but remains slow, fragmented, and weakly evidenced across sites. Multi-assay workflows span laboratories and instruments with non-aligned thresholds, driving reruns, delays, and inconsistent pass/fail calls; manual evidence collation breaks raw-data lineage, turning audits and deviations into reconstruction exercises. BIOQUALIS delivers a single deployable qualification module that couples standardised wet-lab execution (harmonised procedures, run-validity gates, embedded controls, and statistical process control) with governed, replayable decision logic (immutable logs, version-controlled rules, deterministic replay from raw files). Outputs are packaged as a machine-readable evidence bundle interoperable with laboratory information systems, enabling transfer and review without transcription. The end-state is a routine-operable, site-transferable qualification module demonstrated at TRL 8, with cross-site comparability proven using a cell reference panel, operator proficiency metrics, and quantified baseline improvements. The consortium directly matches this ambition: regulated wet-lab execution (Labena), laboratory digitalisation and integration (Biosistemika), independent cross-site replication (RefGen), industrial reference materials (Bespark bio), and manufacturing-grade contamination validation (SCT Cell Manufacturing).