QEHSSituation
Validation packets were manual. Deviations sat in email threads. Change control bypassed QA regularly. FDA warning-letter risk was elevated.
Customers / Pharma
Deviation + change-control cycle time halved under 21 CFR Part 11.
A mid-size contract manufacturer replaced a legacy eQMS with a Composer-built quality system — 21 CFR Part 11 compliant.
PharmaQualityDeviationChange control21 CFR Part 11Batch record review
-52%
Deviation cycle time
10d
FDA audit prep
0
Part 11 findings
Approach
- Composer modules for deviation, change control, and investigation
- E-sign with step-up MFA on regulated transitions (W3C VC)
- ALCOA+ audit trail with hash-chained record history
- Validation packets generated via report engine per batch
Outcomes
- Deviation cycle time cut 52%
- FDA audit prep reduced from 6 weeks to 10 days
- Zero Part 11 findings on the following audit
“Hash-chained audit + step-up MFA + ALCOA+ — we ticked every box FDA asked about. The validation packet regenerates on demand, per batch, without an export marathon.”
Identifying details anonymised pending reference agreement. Metrics reported by deployment team.
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