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 Surely, we wouldn’t even consider applying old-fashioned, superseded and outdated medical science or medical practices, so why should it be different for IT and software?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.
ISPEAK APPLICATION SOFTWARE
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. For a more intensive travel language guide that also includes voice playback, try these other travel apps.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.
ISPEAK APPLICATION HOW TO
For now, though, iSpeak for iPhone is a good, basic translator that can also coach you in how to pronounce words and phrases. The next step after that, of course, is to let non-English travelers translate among iSpeak's language directories, for example translating from French to Swedish. Here's another item for our iSpeak wish list: an all-in-one version of the translation app that lets frequent international travelers translate from English to any language in iSpeak's greater lexicon, not just from English to one other language. Acapela says in a press release that new languages are part of the company's plan. The heavy focus on European languages is likely attributed to Acapela Group, which is a European voice company that provided the "speak" element of the iSpeak app. ISpeak costs $2 for each of its separate nine translators of Spanish, French, German, Italian, Portuguese, Dutch, Polish, and Swedish.
iSpeak stores a list of the translations you saved, and can helpfully switch the direction of translation, from Polish to English and back again, for instance, by pressing a toggle button. You'll also be able to save a translation or e-mail a particularly useful one to a friend. The application's extra features are modest, and include two sliders to control the volume and speed of the voice that utters your translation. Still, as long as we're drawing up a wish list, voice input is at the top. Of course, voice recognition is a different technology, and one that adds layers of complexity if multiple dialects are involved. We wish we could speak phrases into the app rather than type them, because that would save time as well as joint use. iSpeak got our basic Spanish-to-English and English-to-Spanish test phrases pretty closely, though it didn't manage to pronounce the read-out as Catalonians would (though, to be fair, Catalan is not the same language as Spanish). If you're not sure how to pronounce the phrase, pressing a button triggers the app to speak the words aloud. You type your phrase into the app, which quickly translates your text. ISpeak is a set of translation apps that can convert words and sentences from English to another language, or vice versa. For Senior Editors Bonnie Cha and Kent German, Future Apps' new language program for the iPhone and iPod Touch may be just the thing to get them around Barcelona next week as they attend the GSMA Mobile World Congress in that famed Spanish city.
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