The certification that a computer is operating according to specification. It includes the observation of the hardware, software, connected instruments, as well as the practices trained staff employ ...
The life sciences industry operates under uniquely stringent regulatory requirements where technology systems must not only ...
Dublin, June 25, 2025 (GLOBE NEWSWIRE) -- The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech" has been added to ResearchAndMarkets.com's offering. The seminar ...
This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...
This course covers the key concepts of GxP computerised systems validation and compliance, including the key regulatory requirements and effective industry good practice based on GAMP®5. Computerised ...
Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...
Validation of computerised systems is a regulatory requirement for both GMP and GLP laboratories. Although computerised system validation (CSV) has been required for over 40 years, the approaches ...
LIMERICK, Ireland, Dec. 17, 2024 (GLOBE NEWSWIRE) -- kneat.com, inc. (TSX: KSI) (OTCQC: KSIOF), a leader in digitizing and automating validation and quality processes, is pleased to announce that a ...
Although the pharmaceutical industry works to the same regulations there are wide differences in company interpretations. Often the interpretation for CSV can be inflexible, onerous, slow and a ...
Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...
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