THE LIFE OF ONE BATCH
Scroll through B-2607, dispensing to release.
01 · ON THE FLOOR
The record fills itself in, correctly
Operators execute step-by-step at the machine. A value outside limits is refused at the keyboard — it never gets far enough to become a deviation, a rework, or a finding.
02 · SOMETHING DRIFTS
A wobble becomes a routed deviation
One reading drifts. The deviation opens from the record itself, routes to the right owner, and closes with CAPA evidence attached. Nothing lives in email, nothing gets forgotten.
03 · REVIEW
QA reads 3 steps, not 200 pages
Review by exception: only the steps that flagged reach QA. Review effort drops by two-thirds — without cutting a single corner.
04 · THE TRAIL
Every touch is already evidence
Attributable, time-stamped, immutable. The audit trail Part 11 and Schedule M expect isn't a report you run — it's just how the record exists.
05 · RELEASE
Released 12 days sooner
QA e-signs and B-2607 ships. Twelve days of working capital freed — on every batch, every month.
BMR-2607 · B-2607-PCM
GRANULATION · LIVE ENTRYSTEP 4.2 · DRY MIX · POVIDONE K-30
512.4kg
✓ IN SPEC · LIMIT 505.0–515.0
Signed at entry · Suresh Kumar · Operator, Granulation
⚠ DEV-114 · MINORAUTO-OPENED 09:12
Granulation endpoint drift — impeller torque above trend
SK · raised→RK · assessed→PS · QA
CAPA-041 attached · impeller calibration interval tightened 90d → 30d
✓ CLOSED · 11:38 · NO EMAIL INVOLVED
BATCH RECORD · 14 STEPS EXECUTED
3/14steps need a human eye. The rest are clean by construction.
▼ 67% QA REVIEW HOURS
AUDIT TRAIL · IMMUTABLE
06:45P. Sharma · line clearance verified#a41f
08:02S. Kumar · step 4.2 value entered · 512.4 kg#7c2e
09:12R. Khanna · DEV-114 assessed · reason logged#d90b
11:38P. Sharma · CAPA-041 approved · e-signed#33f7
EVERY EDIT LOGGED · NOTHING OVERWRITTENPART 11 ✓ SCHEDULE M ✓
QA RELEASE · FINAL SIGN-OFF
RELEASEDB-2607-PCM
12 days sooner
than the paper baseline
than the paper baseline
WORKING CAPITAL FREED · EVERY BATCH