Guess who’s coming for inspection?
Unichem Laboratories of Mumbai, India is a multinational pharmaceutical company. One of the biggest challenges is keeping each manufacturing facility ready for international inspection without losing productivity. Audits often occur with little or no advance warning.
It was during one of those unannounced inspections that an auditor found raw data with a bit too many cancellations and suspected something was askew. Proving the data had been properly captured could have put productivity into slowdown mode.
But it didn’t.
It didn’t because of Empower Software from Waters. The chromatography data software not only automates laboratory workflow, it also takes the managing of advanced security, data integrity, and audit trails to new levels. The scientists at Unichem guided the inspector through all the chromatographic data stored on the Empower system. He was convinced and Unichem received audit approval.
Today, the Unichem facilities continue to do what they do best: bring new drugs to market and face every surprise inspection with total confidence.