Turkish pharmaceutical company Vinder held a Computerized Systems Validation (CSV) and Data Integrity Training Workshop in collaboration with Prescription Pharma Support (PPS) in Istanbul to support ...
Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...
Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...
In pharmaceutical manufacturing, software validation is innovation’s silent killer. A single user requirements specification (URS) takes weeks. Test plans stretch for months. Change controls bog down ...
A straightforward path toward regulatory compliance, data integrity, and computer systems validation
Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...
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