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 ...
Two-day training with real-world cases and practical application organized in collaboration with Prescription Pharma Support ...
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 ...
Major compliance overhaul: Gilead revamped core validation procedures, shifting to a risk-based approach that reduced redundancy and streamlined approvals. Next-gen systems rollout: A global Quality ...
On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
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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