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 ...

Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...

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 ...

Title 21 CFR Part 58 provides guidance on Good Laboratory Practice (GLP) for executing non-clinical laboratory studies that support applications for research permits for Food and Drug Administration ...