Quality Management Suite

Document Control & 21 CFR Part 11

on track
Document CodeTitle & ScopeDocument TypeDepartmentVersionEffective Date21 CFR Part 11Read & Ack %Status
1. Effective & Released (Active Standard)2
SOP-MNT-QA-001
Prosedur Identifikasi & Pengendalian Produk Tidak Sesuai (NCR)Author: Lead Author
SOP
Quality Assurance
Rev 2.0
2026-01-15
3/3 Signed
94.2%
EFFECTIVE
SOP-MNT-QA-002
Prosedur Tindakan Korektif & Pencegahan Masalah Berulang (CAPA)Author: Lead Author
SOP
Quality Assurance
Rev 2.1
2026-03-01
3/3 Signed
94.2%
EFFECTIVE
2. Under Review / In-Tray Approval1
SOP-MNT-PRD-008
Instruksi Kerja (WI): Pemesinan CNC Precision Housing & Tool Wear CheckAuthor: Lead Author
WORK_INSTRUCTION
Production & CNC Cell
Rev 1.2
2026-08-26
3/3 Signed
94.2%
UNDER_REVIEW
3. Draft Working Copy0
Tidak ada data rekaman pada kategori ini.
4. Obsolete / Archived Superseded0
Tidak ada data rekaman pada kategori ini.