Posts tagged "CPOB"
3 articles across the Voltrus blog.
This collection brings together every CPOB article published on the Voltrus blog. "Checklist Persiapan Audit BPOM: CPOB, CPKB, CPPOB", "Dokumen Batch Record Elektronik: Ganti Binder dengan Catatan yang Menulis Diri Sendiri", "MES for Pharmaceutical Manufacturing: CPOB Batch Records and Data Integrity": each one is a practical, hands-on guide written for engineers and system integrators. Whether you are choosing between protocols, troubleshooting a connection, or planning an integration, these articles cover the concepts, the trade-offs, and the step-by-step details you need.
Checklist Persiapan Audit BPOM: CPOB, CPKB, CPPOB
Apa yang benar-benar diminta inspektur BPOM per standar — PerBPOM 7/2024 (CPOB, kini mencakup sistem terkomputerisasi dan audit trail), PerBPOM 31/2020 (CPKB), PerBPOM 22/2021 (CPPOB) — plus checklist 12 item siap cetak.
Read articleDokumen Batch Record Elektronik: Ganti Binder dengan Catatan yang Menulis Diri Sendiri
Apa itu electronic batch record (EBR/eBMR), isi yang wajib ada per batch, posisi CPOB 2024 (PerBPOM 7/2024) terhadap catatan elektronik dan audit trail, serta jalur migrasi dari binder kertas tanpa menghentikan produksi.
Read articleMES for Pharmaceutical Manufacturing: CPOB Batch Records and Data Integrity
CPOB 2024 (PerBPOM 7/2024, revised by PerBPOM 7/2025) now covers computerized systems and data integrity explicitly. What a pharma MES must do beyond generic traceability, the mid-market tooling gap, and an honest note on where Voltrus fits today.
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