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Case Studies Mar 15, 2026 · 8 min read
How Acme Pharma cut audit prep time by 78%
From 12 weeks of binders to 3 days of dashboards — the playbook one mid-size pharmaceutical company used to transform their audit posture.
Acme Pharma (anonymized) is a 600-person specialty pharmaceutical with operations in three countries. Before Quays, every audit triggered 12 weeks of war-room mode.
Starting state
- 180 SOPs in shared drives across three jurisdictions
- 12 weeks of audit prep, all hands on deck
- $340K in external consulting per major audit
- 3 critical findings in last ISO 13485 surveillance
After 6 months on Quays
- 100% of SOPs in single source of truth
- 3 days of audit prep using Quays AuditReady™ packs
- $72K in external consulting (78% reduction)
- 0 critical findings in subsequent surveillance audit
"The auditor told us it was the cleanest QMS he had reviewed in 12 years. That alone justified the project."
\u2014 Director of Quality, Acme Pharma
SC
Written by
Sara Chen
Solutions Engineer
