The Problem
Stringent US FDA, WHO-GMP, and MHRA compliance mandates required strict electronic records, immutable audit trails, and automated instrument calibration across cleanroom facilities. Managing calibration certificates, batch records, and SOP change controls on paper created high regulatory inspection risk and labor overhead.
The Implementation
Deployed Micraft PrecisionCAL and DoxCraft Document Management System with full 21 CFR Part 11 compliance, encrypted digital signatures, automated SOP distribution workflows, and multi-tier calibration escalation alerts.
The Outcomes
- 100% audit readiness across US FDA, WHO-GMP, and ISO 17025 inspections
- Document approval cycle accelerated by 65% with digital signature workflows
- Zero missed calibration due dates across 600+ analytical balances and instruments
- Instant retrieval of batch records and instrument certificates in under 10 seconds
- Comprehensive tamper-evident electronic audit trails for every parameter modification
"Meeting stringent 21 CFR Part 11 and US FDA compliance is completely seamless now. PrecisionCAL is an indispensable quality and compliance asset."
— Sr. Director - Quality & Compliance, Cipla
