Cipla
Cipla Pharmaceutical GMP Compliance Project
Cipla 2024 Maharashtra
GMP-compliant recording and monitoring system for API manufacturing.
The Challenge
What They Faced
Existing chart recorders did not meet FDA 21 CFR Part 11 requirements for electronic records.
Our Solution
How Ecrin Helped
Deployed Chino KR3000 paperless recorders with electronic signatures, audit trails, and Ethernet connectivity across 6 reactor trains and 3 WFI loops.
Instruments Used
Paperless RecordersTemperature TransmittersConductivity TransmittersHygienic Pressure Sensors
The Outcome
Results Delivered
Achieved full FDA 21 CFR Part 11 compliance, eliminated paper chart consumable costs, and enabled remote monitoring from the QA office.
“The Chino recorders installed by Ecrin Solutions have been critical to our FDA compliance journey. The audit trail capability and electronic signatures give our QA team complete confidence in data integrity.”
Dr. Meena Patel
VP Quality Assurance, Cipla
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