She tells of her love for Othello, and the marriage stands. The Senators wish to send Othello to Cyprus, which is under threat from Turkey. Before the Venetian Senate, Brabantio accuses Othello of bewitching Desdemona. Othello has promoted Cassio, not Iago, to be his lieutenant.Iago crudely informs Brabantio, Desdemona’s father, that Othello and Desdemona have eloped. Entire Play In Venice, at the start of Othello, the soldier Iago announces his hatred for his commander, Othello, a Moor.
#Ispeak 2003 edition software
GAMP® 5 Second Edition seeks to not only to achieve minimum compliance expectations, but also to apply good IT practices, robust Quality Risk Management approaches, and excellence in software engineering, to achieve better product quality and safety, for the benefit of the patient and the public.
The concepts of computerized systems assurance (CSA) related to US FDA CDRH (Center for Devices and Radiological Health) Case for Quality program are also explored and applied. Guidance on the application of new and developing technological areas such as Artificial Intelligence and Machine Learning (AI/ML), blockchain has been included. Second Edition builds upon the work of the ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management. The technical content of the Guide has been updated to reflect the increased importance of IT service providers including cloud service providers, evolving approaches to software development including incremental and iterative models and methods, and increased use of software tools and automation. The overall GAMP® 5 framework, key concepts, and ICH Q9 aligned Quality Risk Management approach remain unchanged from the First Edition. The Second Edition strongly supports the FDA CDER (Center for Drug Evaluation and Research) vision of a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight, where the vision requires moving beyond simply meeting minimum CGMP standards and towards robust quality management systems. GAMP® 5 Second Edition prioritizes patient safety and product quality over compliance and encourages the application of critical thinking. We do, however, still see too many examples of ineffective and inefficient practices for reasons including organizational inertia, lack of experience and training, compliance-driven tick-box approaches, and a misguided fear of perceived regulatory inflexibility. Surely, we wouldn’t even consider applying old-fashioned, superseded and outdated medical science or medical practices, so why should it be different for IT and software? We cannot provide guidance based on technical concepts, approaches, or techniques that are in some cases decades old, even if they do sometimes remain enshrined in regulatory guidance or company policies and procedures. We must always ensure that GAMP® guidance is well-aligned with current good practice. One of the reasons GAMP® guidance has always been successful, is that it has reflected the current good IT and software engineering practice, based on input from experienced IT, automation and software practitioners.
As a society and as an industry we have learned some important lessons from the global COVID-19 pandemic, not least that innovation and technological advance are essential to safeguarding patient safety and public health, and that industry and regulatory flexibility is vital in meeting these key objectives.
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