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.