UAE Pharma Company Passes 21 CFR Part 11 Validation
Pharmaceutical · UAE
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The Challenge
Paper-based batch records and manual signatures. Audit trail gaps threatening regulatory compliance. Multi-month validation cycles.
The Solution
Sage X3 with electronic signatures, enforced quality gates, full batch genealogy, and automated audit trail capture.
Results
21 CFR Part 11 validated in 16 weeks
Batch release time reduced by 60%
Zero compliance findings in FDA audit
Electronic batch records eliminate paper
Client identity withheld for confidentiality. Named references can be coordinated subject to customer approval.