Electronic Batch Record (eBR) Readiness
Question 1 of 20 · Master Data Quality
Paper is the truth
Paper master formulas and BMRs are the authoritative record. Digital copies (if any) are convenience prints.
Digital exists but drifts
Recipes/BOMs exist in ERP or shared spreadsheets, but paper is what gets followed because the digital versions are known to drift.
ERP-governed with known gaps
ERP is the system of record; recipes sit in a formal recipe-management module; documented gaps with a resourced remediation plan.
Validated, release-ready
Master data is reviewed, reconciled, and validated as part of the eBR programme; controlled change-approval workflow with named owners.
Automated lifecycle
Permanent master-data governance with KPIs; approved QMS changes auto-trigger new MES/eBR recipe versions.