Notifications
New request to confirm10:04
Auditor requested last 6 months of CAPA effectiveness checks for the top-5 CAPAs.
From Scribe — L. Ito · Discussion around CAPA-2451 effectiveness.
Concern / Potential Observation10:11
Potential observation: training records for the new operator batch appear incomplete.
From Scribe — L. Ito · Reviewing training matrix vs batch record 8871.
Highlight this to the organization?
Call-to-Front-Room10:15
SME B. Chen (Sterilization) is on the way to the Front Room. ETA 3 min.
Requested for sterility assurance line of questioning.
Ready to bring in
2
R-014·FR-A/23
Design History File — Project Halo
SME — D. Park
R-015·FR-A/24
Supplier audit reports (2024) — Vendor Alpha
SME — E. Kaur
In progress + ETA
3
R-016·FR-A/25
Complaint trend analysis Q1–Q2
SME — T. Okafor · SME confirmed / In work
ETA
12 min
R-017·FR-A/26
Sterilization validation reports — Line 3
SME — B. Chen · Backroom – SME assigned
ETA
20 min
R-018·FR-A/27
Management review minutes 2025
SME — M. Iqbal · SME confirmed / In work
ETA
8 min
Concerns / Potential Observations
Training matrix version control gaps flagged on 2 lines.
Verified 09:47 · pinned org-wide
SMEs in Front Room
J. Alvarez
QA Manager
R. Thompson
CAPA Lead
Moodometer
Auditor mood: neutral