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Glossary

Core terms related to agile GxP manufacturing, electronic batch records and enablement-driven digital transformation.

Choose a term:

(Future: Part 11, Contextual workflows, Recipe modularization)

Digital bottleneck

Zustand, in dem ein monolithisches oder schwerfälliges digitales System (z.B. klassisches EBR/MES) zum dominierenden Verzögerungsfaktor für Prozessänderungen und Innovation wird.

Golden cage

Metaphor for an expensive enterprise system that delivers perceived control & compliance while constraining flexibility, change autonomy and domain ownership.

Delta validation

Validation approach where only the changed portion (delta) of a digitized process / recipe is assessed and documented – not the entire chain.

Word-native EBR

Approach to creating electronic batch records directly from existing Microsoft Word® recipe or SOP documents, enriched with Word® standard elements.

Change cycle time

Time span between initiating a process or recipe change and its productive, validated deployment.

Audit trail

A tamper-evident event log in a GxP-relevant system that records creation, changes, approvals and access with timestamp, user identity and—where required—justification.