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SOPCleanroom cleaning procedure · MFG-001

Section 4 · Cleaning procedure

Findings · 4

All 11 reviewed
Define particulate count thresholds
CriticalFDA Inspector·§ 4.2 Environmental
Cleaning interval is ambiguous
MajorQA Manager·§ 4 Step 7

Fix

Add glove-change checkpoint
MinorOperator·§ 4.1 PPE
Visual ref. for swab pattern
MinorTrainer·§ 4.4 Sampling
GMP·GLP·ICH Q10·Cleanroom·FDA 21 CFR·ISO 13485·Change Control·CAPA·Deviation·Validation·QMS·Audit Trail·GMP·GLP·ICH Q10·Cleanroom·FDA 21 CFR·ISO 13485·Change Control·CAPA·Deviation·Validation·QMS·Audit Trail·
< 5 min

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The problems
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SOP reviews take three days of back-and-forth.

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Your QA team rewrites the same sections every audit.

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SOP-MFG-001.docx

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SOP-MFG-001-v2.docx

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How it pays off

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01Every reviewer, simultaneously

No waiting for one team to finish before another starts.

Every regulatory angle — FDA inspector, QA manager, operator, trainer — runs in parallel. One structured report with findings classified by severity. What used to take a week of handoffs happens in minutes.

< 5 min

Reviewers · 11

4 of 11 done · 0:42
FDA Inspector
QA Manager
Operator
Trainer
Cleanroom Spec.
Validation

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7 categories

Cleanroom cleaning

GMP

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Aseptic process control

GMP

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Validation

Stability testing

GLP

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Clean DOCX

Triage

3 accepted · 1 rejected
Define particulate count thresholds
CriticalFDA Inspector·§ 4.2
Cleaning interval is ambiguous
MajorQA Manager·§ 4.7

Fix

Ready to export revised draft

Why Eichen AI

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Veeva

$200K · 6 moFree · 5 min

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