White Paper

Computer System Validation (CSV) – Thought Process & Importance! Supporting an FDA Inspection!

FDA Inspection, the one event that challenges the team and tests the resilience in handling tough situations on the fly. Historically, someone from Global team, with prior experience in handling inspections would come to local site to support the Local Business teams. For that particular FDA Inspection, the challenge was for the local team to lead the preparations/strategy/execution with guidance from the Global team.

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