![]() 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 ![]() ![]() Surely, we wouldn’t even consider applying old-fashioned, superseded and outdated medical science or medical practices, so why should it be different for IT and software?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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